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The HPV Vaccine is Both Safe and Effective - FAQ
1) Is there a safe and effective vaccine against HPV, and who is it recommended for?Open or CloseAccording to the CDC, An Estimated 92% of Cancers Caused by HPV Could be Prevented by the HPV Vaccine
This vaccine is both safe and effective, and has been extensively tested:
According to the National Cancer Institute, “The Food and Drug Administration (FDA) has approved three vaccines that prevent infection with disease-causing HPV types: Gardasil®, Gardasil® 9, and Cervarix®. All three vaccines prevent infection with HPV types 16 and 18, two high-risk HPVs that cause about 70% of cervical cancers and an even higher percentage of some of the other HPV-caused cancers. Gardasil also prevents infection with HPV types 6 and 11, which cause 90% of genital warts. Gardasil 9 prevents infection with the same four HPV types plus five additional cancer-causing types (31, 33, 45, 52, and 58).
As of May 2017, Gardasil 9 is the only FDA approved HPV vaccine available for use in the United States. Cervarix and Gardasil are still used in other countries.”
Merck’s Gardasil vaccine was FDA approved in June, 2006; it was sold in Europe under the trade name Silgard.
GSK’s Cervarix vaccine was FDA approved in Oct. 2009; Cervarix was withdrawn from the U.S. market in Oct. 2016.
Merck’s Gardsil 9 vaccine won FDA approval in Dec. 2014. It replaced the original Gardasil vaccine.
China is launching their own bivalent HPV vaccine Cecolin for their domestic market in May 2020. It covers HPV strains 16 and 18. For additional details, see FAQ 29 below.
According to the CDC, the Gardasil 9 HPV vaccine is recommended for all boys and girls ages 11-12; the vaccine can be given as early as age 9. Gardasil 9 is currently given on a two dose immunization schedule for those who are 14 years old or younger. Those who are 15 years old or older get 3 doses of the vaccine. HPV vaccination was recommended through age 26 for women, and through age 21 for men, if they did not get vaccinated when they were younger. This changed in Oct. 2018 when the vaccine was approved to be given to men and women in the 27-45 age range as well (this includes men in the 21-26 year range). Even more recently (June 2019), the US Advisory Committee on Immunization Practices (ACIP) decided in a unanimous vote to recommend catch-up vaccinations with the HPV vaccine for young women and men up to the age of 26 who have not previously received three doses of the vaccine. Although the Food and Drug Administration recently extended the age indication for the vaccine to allow people aged 27 to 45 to be vaccinated, ACIP did NOT recommend all people in that age group get the three-dose vaccine. Instead, the committee voted to leave the choice to patients and their doctors. ACIP recommended that the vaccine be given between the ages of 11 and 12 (though it can be started as early as 9 years old) in both girls and boys. Catch-up vaccination programs were recommended for young women up to the age of 26 who were not vaccinated earlier. The catch-up program for young men was to the age of 21; the vaccine was also recommended for males between the ages of 21 and 26 who have sex with men and those who are immunocompromised.
On the issue of whether to recommend catch-up vaccination for people aged 27 to 45, the committee voted 10-to-4 to leave that decision to patients and their doctors. There would be some people in that age group that would benefit from getting vaccinated, a number of the members noted. A working group that advised the committee noted that recommending vaccination of all adults 27 to 45 would NOT be a reasonable use of resources.
HPV vaccination is also recommended for the following people through age 26, if they did not get vaccinated when they were younger:
Young men who have sex with men or are bisexual
Young adults who are transgender
Young adults with weakened immune systems
According to Merck, the vaccines manufacturer:
“GARDASIL®9 (Human Papillomavirus 9-valent Vaccine, Recombinant) helps protect girls and women ages 9 to 26 against cervical, vaginal, vulvar, and anal cancers and genital warts caused by 9 types of HPV. GARDASIL 9 helps protect boys and men ages 9 to 26 against anal cancer and genital warts caused by those same HPV types.
GARDASIL 9 may not fully protect everyone, nor will it protect against diseases caused by other HPV types or against diseases not caused by HPV.
GARDASIL 9 does not prevent all types of cervical cancer, so it’s important for women to continue routine cervical cancer screenings. GARDASIL 9 does not treat cancer or genital warts.”
Merck has created an HPV vaccine website in the US as well as one in the UK called HPVwise, with a limited set of FAQ
None of the vaccines contained live or attenuated virus. All are made against proteins that make up the structure of the virus (specifically, the L1 major capsid protein). As a result, you cannot get infected with HPV by the vaccine.
Currently available HPV vaccines do NOT contain Thiomersal (an authorized and harmless preservative used in some other vaccines), nor any other form of mercury.
The Kaiser Family Health Foundation has also produced a useful fact sheet about the HPV vaccine.
The National Foundation for Infectious Diseases has put forth a Call to Action for HPV Vaccination as a Public Health Priority
Check out the videos that are part of this archive of a 2017 conference Building Trust, Managing Risk:
Vaccine Confidence and Human Papillomavirus Vaccination. This was put on by the Vaccine Confidence Project, a London based group that works to restore confidence in and to fight misinformation about vaccines. Check out this free paper by Heidi Larson published in Nature The biggest pandemic risk? Viral misinformation Nature 562, 309 (2018) doi: 10.1038/d41586-018-07034-4
The extra cost of vaccinating men from 21 to 45 and women from 26 to 45 was estimated to a cost effective strategy. Source: Laprise, J.-F. et al Effectiveness and Cost-Effectiveness of Human Papillomavirus Vaccination Through Age 45 Years in the United States. Ann Intern Med. 2020;172(1):22-29. DOI: 10.7326/M19-1182
Can We Switch Over to a One-Shot Vaccination Protocol?
Early data suggest it MAY be possible to move to a one-injection vaccination routine in the future, rather than the current two or three vaccinations. “Julia Brotherton at the VCS Foundation in Australia and her colleagues analyzed cervical screening data from a quarter of a million Australian women who were eligible for the vaccination. During the study, sexually active women were encouraged to have a Pap smear test every two years to screen for cellular changes on the cervix that might be a sign of cancer. Analyzing registers of HPV vaccinations and cervical cancer cases, the team found that women who had received three doses of the vaccine were 41 per cent less likely to have these cellular changes – known as precancerous lesions – than unvaccinated women. Women who had been given one or two doses of the vaccine were, respectively, 35 and 39 per cent less likely than unvaccinated women to have these lesions. This suggests that even one dose of the vaccine can be enough to help lower the incidence of cervical cancer. Administering a one-dose vaccination campaign would be cheaper and easier to administer than a multi-dose program.”
The finding could be particularly useful in developing nations, which have the highest burden of cervical cancer but the least access to vaccines. It would mean a greater supply of vaccine would be available, and reduces worries about a shortage of the HPV vaccine.
Brotherton, J. et al Papillomavirus Research, DOI: 10.1016/j.pvr.2019.100177. Also see Brotherton, J.M. and Sundstroml More evidence suggesting that 1‐dose human papillomavirus vaccination may be effective. Cancer Feb. 2020. https://doi.org/10.1002/cncr.32696
Similar results have been published in a study of American women. According the the author’s discussion, “Our study suggests that US women who received 1 dose of the HPV vaccine may have gained similar protection against vaccine-type infections compared with those who received additional doses. These findings support previous observational studies and post hoc analyses of vaccine trials that demonstrated comparable effectiveness of 1 dose to 2 or 3 doses.”
Sonawane, K. et al. Prevalence of Human Papillomavirus Infection by Number of Vaccine Doses Among US Women. JAMA Netw Open. 2019;2(12):e1918571. doi:10.1001/jamanetworkopen.2019.18571 FREE Download.
In a separate analysis, researchers “examined information on females aged 9 to 26 years who were unvaccinated or who received one or more HPV vaccine doses between January 2006 and June 2015.
The analysis included 133,082 females (66,541 vaccinated and 66,541 unvaccinated). For females ages 15 to 19 years, those who received one, two, or three doses of the HPV vaccine had lower rates of preinvasive cervical disease than adolescents who were unvaccinated. Within five years, 2.65 percent of unvaccinated teens aged 15 to 19 years developed preinvasive cervical disease, compared with 1.62 percent, 1.99 percent, and 1.86 percent in the one-, two- and three-dose groups, respectively. The risk of pre-invasive cervical disease was 36 percent, 28 percent, and 34 percent lower for adolescents who received one, two, and three doses, respectively, compared with adolescents who were unvaccinated.
For the youngest (less than 15 years old) and oldest age groups (20 years and older), the investigators did not find significant differences among the vaccinated groups in terms of risk for preinvasive cervical disease.”
“This study shows the impact of vaccinating at younger ages and its lasting long-term protection against cervical cancer,” said Dr. Rodriguez. “It is important to educate parents about the need to vaccinate their children.”
Rodriguez, et al. (2020) Comparison of the long-term impact and clinical outcomes of fewer doses versus standard doses of human papillomavirus vaccine in the United States: a database study. CANCER. DOI: 10.1002/cncr.32700
Bottom line: A one vaccine protocol, if implemented, means that vaccination will be cheaper for both individuals and countries, and that supplies of the vaccine will allow for more people to be vaccinated.
2) What studies have been done to show the vaccine is safe and effective?Open or CloseThe HPV vaccine is one of the most studied vaccines ever!
The Cochrane Library, a well respected database of reviews for all areas of the biomedicine, looked in 2018 at the safety of the HPV vaccines (all the different versions) in retrospective. Their review, Prophylactic vaccination against human papillomaviruses to prevent cervical cancer and its precursors, concluded that the HPV vaccine was indeed safe. You can read their summary conclusions here, or download the entire detailed analysis from their website (same link).
In Nov. 2019, three papers were published in the journal Pediatrics that were focused on the safety of the 9-valent HPV vaccine (the most currently available HPV vaccine).
Their conclusion: the HPV vaccine is remarkably safe.
Here’s what the scientists found:
The first study used data from the Vaccine Safety Datalink system:
“During 105 weeks of surveillance, 838, 991 doses of 9vHPV were administered. We identified unexpected statistical signals for 4 adverse events: appendicitis among boys 9 to 17 years old after dose 3; pancreatitis among men 18 to 26 years old; and allergic reactions among girls 9 to 17 years old and women 18 to 26 years old after dose 2. On further evaluation, which included medical record review, temporal scan analysis, and additional epidemiological analyses, we did not confirm signals for any adverse events.
Conclusions: After 2 years of near real-time surveillance of 9vHPV and several pre-specified adverse events, no new safety concerns were identified.”
Donahue JG, et al. Near Real-Time Surveillance to Assess the Safety of the 9-Valent Human Papillomavirus Vaccine. Pediatrics. 2019 Nov 18;. doi: 10.1542/peds.2019-1808. [Epub ahead of print] PubMed PMID: 31740498.
The second study analyzed post-licensure surveillance reports to the Vaccine Adverse Event Reporting System (VAERS):
Conclusions: “No new or unexpected safety concerns or reporting patterns of 9vHPV with clinically important AEs were detected. The safety profile of 9vHPV is consistent with data from prelicensure trials and from postmarketing safety data of its predecessor, the quadrivalent human papillomavirus vaccine.”
Shimabukuro TT, et al. Safety of the 9-Valent Human Papillomavirus Vaccine. Pediatrics. 2019 Nov 18;. doi: 10.1542/peds.2019-1791. [Epub ahead of print] PubMed PMID: 31740500.
The third paper was a commentary about the value of the HPV vaccine:
“Wherever vaccination campaigns against vaccine-preventable cancers have launched, the rates of the pre-cancerous cervical lesions related to the human papillomavirus (HPV) have been reduced.
For many generations, people have wished for a vaccine that would offer protection against cancer.
Curiously, such a vaccine is now readily available but reluctance to administer or to accept the vaccine has kept HPV immunization rates far below those of other routinely recommended vaccines.
The time has come for all vaccine administrators and parents to understand that the availability of the 9-valent human papillomavirus vaccine (9vHPV) is one end of a remarkable journey of discovery and progress to develop a safe and effective vaccine to prevent suffering and death from common cancer.”
Meissner HC. From Peyton Rous to the HPV Vaccine: A Journey of Discovery and Progress. Pediatrics. 2019 Nov 18;. doi: 10.1542/peds.2019-2345. [Epub ahead of print] PubMed PMID: 31740499.
But wait, there’s more! According to the Global Advisory Committee on Vaccine Safety (GACVS), which is a part of the World Health Organization,
“Since licensure in 2006, over 270 million doses of HPV vaccines have been distributed. GACVS first reviewed the safety data in 2007 and subsequently in 2008, 2009, 2013, 2014, and 2015. Early on, the Committee was presented signals related to anaphylaxis and syncope (fainting). The risk of anaphylaxis has been characterized as approximately 1.7 cases per million doses, and syncope was established as a common anxiety or stress-related reaction to the injection. No other adverse reactions have been identified and GACVS considers HPV vaccines to be extremely safe.
Further safety data have been generated recently from Denmark, the United Kingdom and the United States of America and a comprehensive literature review has been conducted, prompting GACVS to review these new findings. Among the new data were studies looking at Guillain-Barré syndrome (GBS). The Committee has already assessed GBS as a signal and noted discrepant findings. Epidemiological studies assessing the risk of GBS following HPV vaccination have been published. including population cohort studies from Denmark and Sweden. In 2017, in response to an online publication from France suggesting an increased risk, a large self-controlled case-series study from the UK was conducted, based on a population where 10.4 million doses were administered. This most recent study found no significant increased risk for GBS after any dose of vaccine, in any of several risk periods assessed or for either vaccine brand. In addition, GBS was specifically selected as an outcome in studies from the US using the Vaccine Adverse Events Reporting System (VAERS) and the Vaccine Safety Datalink (VSD). GACVS was presented with new data from VAERS following 60 million distributed doses, and the VSD data with over 2.7 million doses administered until the end of 2015. No association between HPV vaccine and GBS was identified. Both the UK and US studies concluded, based on their respective data, that a risk of >1 case of GBS per million doses of vaccine could now be excluded.
In addition, GACVS was presented with new studies assessing other safety concerns, again from the US, as well as from Denmark. These studies included examination of specific outcomes that included complex regional pain syndrome (CRPS), postural orthostatic tachycardia syndrome (POTS), premature ovarian insufficiency, primary ovarian failure, and a further look at the risk of venous thromboembolism. With now large population level data from several countries, the Committee saw no new evidence for a causal association between HPV vaccine and those conditions. While safety data from Denmark and Sweden for >3 million women aged 18–44 years showed an apparent increased risk for celiac disease, the investigators considered that, most likely, this represented an unmasking of an existing condition during the vaccination visit rather than a causal association. Overall the study did not raise any other autoimmune safety issues of concern.
As HPV vaccine is often administered during potential childbearing years it is important to establish the safety profile in pregnant women when inadvertent administration occurs. To date no safety concerns have arisen during the pre-licensure clinical trials or in post-licensure surveillance. These reassuring data now include a recent national cohort study from Denmark that assessed 540,805 pregnancies. In addition, new data from the VSD for >92 000 eligible pregnancies were presented to the Committee. No adverse obstetric, birth or structural abnormality outcomes were observed. Inadvertent administration of HPV vaccine during pregnancy has no known adverse outcomes in either mother or infant.
CRPS and POTS continue to be presented as case reports in association with HPV vaccination, particularly from Denmark and Japan. These were initially assessed by GACVS in 2015. These conditions include a spectrum of diverse symptoms, making assessment using administrative health collections challenging. In June 2017, new data from Japan that assessed cases with diverse symptoms, including pain and motor dysfunction, were presented to the Committee. The cases were identified from a nationwide epidemiological survey involving multiple hospital medical departments of various disciplines including pain, neurology, rheumatology, paediatrics and psychiatry/psychosomatic medicine. These complex syndromes manifested in both sexes, although were more common in girls, and occurred in both vaccinated and unvaccinated individuals. The Committee concluded that since their last review, there is still no evidence to suggest a causal association between HPV vaccine and CRPS, POTS or the diverse symptoms that include pain and motor dysfunction.
Also in 2017, the WHO commissioned a systematic review of serious adverse events (SAEs) following HPV vaccines. A draft was presented to GACVS at the meeting. Using the GRADE system to systematically assess the quality of evidence, the quality of evidence in the studies was considered high across randomized controlled trials. The outcomes considered were all SAEs, medically significant conditions, new onset of chronic diseases, and deaths. Data for 73,697 individuals were reviewed. Lower level studies were excluded in favour of the large body of higher level evidence available. For all outcomes, the evidence from randomized controlled trials was supported by good quality cohort studies, with no difference in rates of selected SAEs between exposed and unexposed to HPV vaccine observed.
There are now accumulated safety studies that include several million persons and which compare the risks for a wide range of health outcomes in vaccinated and unvaccinated subjects. However, despite the extensive safety data available for this vaccine, attention has continued to focus on spurious case reports and unsubstantiated allegations. The Committee continues to express concern that the ongoing unsubstantiated allegations have a demonstrable negative impact on vaccine coverage in a growing number of countries, and that this will result in real harm. While ongoing monitoring and collection of robust data are important to maintain confidence, one of the challenges associated with the continued generation of data is that artefacts will be observed, which could pose further challenges for communication when taken in haste, out of context, and in the absence of the overall body of evidence.
GACVS discussed the importance of ensuring that immunization policy-makers and other stakeholders have ready access to articulate summaries of the vaccine safety information, to assist in evidence-based decision-making. One concrete step will be to update the HPV adverse reaction rate sheet, to reflect the most recent evidence available.
Where HPV vaccination programmes have been implemented effectively, the benefits are already very apparent. Several countries that have introduced HPV vaccines to their immunization programme have reported a 50% decrease in the incidence rate of uterine cervix precancerous lesions among younger women. In contrast, the mortality rate from cervical cancer in Japan, where HPV vaccination is not proactively recommended, increased by 3.4% from 1995 to 2005 and is expected to increase by 5.9% from 2005 to 2015. This acceleration in disease burden is particularly evident among women aged 15–44 years. Ten years after introduction, global HPV vaccine uptake remains slow, and the countries that are most at risk for cervical cancer are those least likely to have introduced the vaccine. Since licensure of HPV vaccines, GACVS has found no new adverse events of concern based on many very large, high quality studies. The new data presented at this meeting have strengthened this position.”
If all of this hasn’t convinced you, check out this comprehensive compilation of HPV Vaccine Safety and Effectiveness 2006 - 2019 from Ireland’s National Immunization Office and see if that does the trick. The evidence is overwhelming.
If you’re specifically concerned about stories linking the HPV vaccine to autoimmune diseases, take a look at this article from Dr. Paul Offit in which he reviews alleged autoimmune harms caused by the HPV vaccine. There is no linkage between the two. As one report concluded, “Investigators found no statistically significant differences between the vaccinated and unvaccinated groups in the incidence of immune thrombocytopenia, autoimmune hemolytic anemia, systemic lupus erythematosus (SLE), rheumatoid arthritis, juvenile rheumatoid arthritis, type 1 diabetes, Hashimoto disease, Graves disease, multiple sclerosis, acute disseminated encephalomyelitis, Guillain-Barré Syndrome (GBS), neuromyelitis optica, optic neuritis, or uveitis.”
3) Has the introduction of the HPV vaccine actually been shown to reduce the incidence of HPV infections, cervical precancers, genital warts, and actual cancers?Open or CloseThe short answer is YES for all of these questions!
The largest analysis to date for the effectiveness of the HPV vaccine was published in The Lancet on June 26, 2019 on behalf of the HPV Vaccine Impact Study Group. It provided substantial evidence of efficacy. As the article states, “This updated systematic review and meta-analysis includes data from 60 million individuals and up to 8 years of post-vaccination follow-up. Our results show compelling evidence of the substantial impact of HPV vaccination programmes on HPV infections and CIN2+ among girls and women, and on anogenital warts diagnoses among girls, women, boys, and men. Additionally, programmes with multi-cohort vaccination and high vaccination coverage had a greater direct impact and herd effects.”
Drolet, M. et al. Population-level impact and herd effects following the introduction of human papillomavirus vaccination programmes: updated systematic review and meta-analysis. DOI:https://doi.org/10.1016/S0140-6736(19)30298-3
Here are some of the most prominent results that came from identifying 1702 potentially eligible articles for this systematic review and meta-analysis, and included 65 articles in 14 high-income countries: 23 for HPV infection, 29 for anogenital warts, and 13 for CIN2+.
After 5-8 years of vaccination, the prevalence of HPV 16 and 18 decreased significantly by 83% among girls aged 13-19 years, and decreased significantly by 66% among women aged 20-24 years.
The prevalence of HPV 31, 33, and 45 decreased significantly by 54% among girls aged 13-19 years.
Anogenital wart diagnoses decreased significantly by 67% among girls aged 15-19 years, decreased significantly by 54% among women aged 20-24 years, and decreased significantly by 31% among women aged 25-29 years.
Among boys aged 15-19 years anogenital wart diagnoses decreased significantly by 48% and among men aged 20-24 years they decreased significantly by 32%.
After 5-9 years of vaccination, CIN2+ decreased significantly by 51% among screened girls aged 15-19 years and decreased significantly by 31% among women aged 20-24 years.
This updated systematic review and meta-analysis includes data from 60 million individuals and up to 8 years of post-vaccination follow-up. The results show compelling evidence of the substantial impact of HPV vaccination programs on HPV infections and CIN2+ among girls and women, and on anogenital warts diagnoses among girls, women, boys, and men. Additionally, programs with multi-cohort vaccination and high vaccination coverage had a greater direct impact and herd effects.
I’ve broken out the data on a country/regional basis below:
Let’s look first to Australia, which has been a worldwide leader in HPV immunization.
The prevalence in Australia of the four HPV types included in the quadrivalent Gardasil vaccine decreased from 22.7% in 2005-07 to 7.3% in 2010-12 to 1.5% in 2015 among women 18-24 years old. That is a 93.4% decrease in HPV types since the introduction of Gardasil in Australia.
Source: Malachek et al Very Low Prevalence of Vaccine Human Papillomavirus Types Among 18- to 35-Year Old Australian Women 9 Years Following Implementation of Vaccination. The Journal of Infectious Diseases, Volume 217, Issue 10, 23 April 2018, Pages 1590–1600. https://doi.org/10.1093/infdis/jiy075
In the first four to five years after vaccination was started in Australia, precancerous abnormalities decreased by 34 per cent in 20–24 year-olds, which means these young women will be at a much lower lifetime risk of ever developing cervical cancer. A reduction in precancerous abnormalities (some of which will go away on their own) means a reduction in the various treatments used to remove these abnormalities, including the loop electrosurgical excision (LEEP) or other cone biopsy procedures, cryosurgery, laser surgery, and even hysterectomy.
Read more at https://www.cancercouncil.com.au/blog/australian-success-story-hpv-vaccine/#HhtSXA7s0SJ8Wwpx.99
In one study of 15-24 year olds, the incidence of genital warts decreased 85% in women and 71% in men following introduction of the HPV vaccine in Australia.
Source: Ali H et al Decline in in-patient treatments of genital warts among young Australians following the national HPV vaccination program. BMC Infect Dis. 2013 Mar 18;13:140. doi: 10.1186/1471-2334-13-140.
Want more proof of the effectiveness of the HPV vaccine? There was also a decrease in the incidence of genital warts in young heterosexual men in Australia, even before boys were added to the vaccination program. This illustrates just how effective the vaccination of girls has been in reducing HPV levels in both sexes. Read more about this here.
But wait, there’s even more. HPV also causes a rare disease known as recurrent respiratory papillomatosis (RRP), which can be diagnosed in both children (juvenile onset) and adults (where it may be acquired via sexual transmission, and not present since birth). It is associated with HPV strains 6 and 11 (these are the virus types that cause genital warts, not cancer). Children born with RRP typically develop symptoms of hoarseness and can develop a raspy voice, a chronic cough, and severe breathing problems during their toddler years. It’s treated by surgeries to remove the HPV lesions from the throat, and because it’s virally caused, these lesions can recur. The incidence of this disease is quite rare; only a small fraction of those infected with the virus will develop this condition. In Australia, which has a very high rate of HPV vaccine usage, the incidence of RRP (or more specifically juvenile onset RRP) was impacted by the vaccine. Rates declined from 0.16 per 100000 in 2012 to 0.02 per 100000 in 2016 (P = .034). Novakovic, D. et al. A Prospective Study of the Incidence of Juvenile-Onset Recurrent Respiratory Papillomatosis After Implementation of a National HPV Vaccination Program. J Infect Dis. 2018 Jan 4;217(2):208-212. doi: 10.1093/infdis/jix498.
Here’s a further look at the data from Australia on the treatment of RRP showing the reduction in this disease following HPV vaccine administration.
Brotherton, J. et al. Reduced rates of juvenile onset recurrent respiratory papillomatosis in Australia after implementation of a national HPV vaccination program. Archives of Diseases in Childhood Vol. 103, 2020.
Finally, the introduction of the HPV vaccine in Australia in 2007 may have prevented 2000 Australian babies being born premature over eight years. Karen Canfell, director of research at Cancer Council NSW, said the research showed a correlation across the population between vaccine coverage of 60-80 per cent and a fall in premature births, low birth weight and other adverse pregnancy outcomes. "What is estimated is in this group of women, aged 37 or less, there’s around a 3.2 per cent decline in premature delivery," Professor Canfell said. "That might not sound very much but we estimate that is equivalent to around 2000 premature births being prevented."
The vaccine was also correlated with a 9.8 per cent fall in births that are small for gestational age. "We know there is a small risk of adverse pregnancy outcomes resulting from treating pre-cancerous lesions and we know that the vaccines result in the reduction in those lesions, and so everything is backed up in terms of this being an effect that we would expect.”
Yuill, S. et al The Journal of Infectious Diseases, jiaa106, https://doi.org/10.1093/infdis/jiaa106
We now have similar data in the US showing that the HPV vaccine is working:
As a result of the introduction of the HPV vaccine in 2006, we are starting to see declines in the prevalence of the HPV types that the vaccine targets. In one study, the prevalence of vaccine-type HPV decreased >90% in vaccinated women, demonstrating high effectiveness in a community setting, and >30% in unvaccinated women, providing evidence of herd protection.
Kahn et al Substantial Decline in Vaccine-Type Human Papillomavirus (HPV) Among Vaccinated Young Women During the First 8 Years After HPV Vaccine Introduction in a Community. Clinical Infectious Disease 63, 1281 (2016) DOI: 10.1093/cid/ciw533
Even better, here’s a paper with actual data showing the effect of herd immunity with the HPV vaccine in young women in the US that was done 2006-2017. Among the women who were vaccinated, 4-valent vaccine–type HPV detection decreased from 35% to 6.7%. Among women who were NOT vaccinated, 4-valent vaccine–type HPV detection decreased from 32.4% to 19.4%. (The 4-valent vaccine refers to the original Gardasil vaccine, which covered four HPV strains. It was replaced with Gardasil 9, which covers nine HPV strains.)
Spinner, C. et al Human Papillomavirus Vaccine Effectiveness and Herd Protection in Young Women. Pediatrics. 2019;143(2):e20181902
In a separate study from Kaiser Permanente Northwest, researchers looked at which strains of HPV in were found in cytology specimens from women aged 20-29 years screened for cervical cancer at Kaiser Permanente Northwest in 2007, and in two vaccine era periods: 2012-2013 and 2015-2016. Detection and typing used L1 consensus PCR with hybridization for 37 types, including quadrivalent vaccine types (HPV 6/11/16/18). Within 9-10 years of vaccine introduction, the prevalence of HPV strains that the quadrivalent vaccine protects against decreased 78% among 20-24 year-olds and 38% in 25-29 year-olds. There were declines in BOTH vaccinated and unvaccinated women, showing evidence of direct and herd protection.
Markowitz, L.E. Declines in HPV vaccine type prevalence in women screened for cervical cancer in the United States: Evidence of direct and herd effects of vaccination. Vaccine. 2019 May 31. pii: S0264-410X(19)30626-7. doi: 10.1016/j.vaccine.2019.04.099
In another study (findings presented at the CDC’s Epidemic Intelligence Service, or EIS, conference in April 2019), researchers used the National Health and Nutrition Examination Survey to evaluate the quadrivalent Gardasil vaccine (4vHPV)-type prevalence among 4,674 females in the prevaccine (2003–2006) and vaccine (2013–2016) eras overall and by race and ethnicity. Their results showed that among females aged 14 to 19 years, 53.9% received more than one dose of vaccine, including 52.6%, 58.1% and 59.5% of non-Hispanic white, non-Hispanic black and Mexican American females, respectively. Among women aged 20 to 24 years, coverage with more than one dose was 51.5%, including 58.5%, 45% and 33.8% in non-Hispanic white, non-Hispanic black (45%) and Mexican Americans, respectively.
In the younger cohort, the 4vHPV-type prevalence decreased from 11.5% to 1.8% from the pre-vaccine to vaccine era, with steep declines seen in all three groups. In the older cohort, prevalence decreased from 18.5% to 5.3%.
Also as a result of the introduction of the HPV vaccine in 2006, we are starting to see declines in the incidence of cervical pre-cancers both in those that are vaccinated as well as those who aren’t via herd immunity in both white and black women:
“In 10,206 cases, the proportion and estimated number of cases of HPV16/18-positive CIN2+ declined from 52.7% (1,235 cases) in 2008 to 44.1% (819 cases) in 2014 (P < 0.001). Declining trends in the proportion of HPV16/18-positive CIN2+ were observed among vaccinated (55.2%–33.3%, P < 0.001) and unvaccinated (51.0%–47.3%, P = 0.03) women; ages 18–20 (48.7%–18.8%, P = 0.02), 21–24 (53.8%–44.0%, P < 0.001), 25–29 (56.9%–42.4%, P < 0.001), and 30–34 (49.8%–45.8%, P = 0.04) years; CIN2 (40.8%–29.9%, P < 0.001) and CIN2/3 (61.8%– 46.2%, P < 0.001); non-Hispanic white (59.5%–47.9%, P < 0.001) and non-Hispanic black (40.7%– 26.5%, P < 0.001).”
McClung et al Trends in Human Papillomavirus Vaccine Types 16 and 18 in Cervical Precancers, 2008– 2014 . Cancer Epidemiology, Biomarkers & Prevention DOI: 10.1158/1055-9965.EPI-18-0885
In addition, the CDC has recorded a decrease in high-grade cervical lesions (CIN2+) during the 2008-2016 period. The rate of CIN2+ per 100,000 women declined significantly in women aged 18–19 years and 20–24 years (many of whom had been given the HPV vaccine) and increased significantly in women aged 40–64 years (none of whom would have been vaccinated). Much of this decrease in cervical pre-cancers is being attributed to the HPV vaccine.
McClung et al Estimated Number of Cases of High-Grade Cervical Lesions Diagnosed Among Women — United States, 2008 and 2016. Morbidity and Mortality Weekly Report (MMWR) Weekly / April 19, 2019 / 68(15);337–343.
In another study, Anil Chaturvedi at the National Cancer Institute and his colleagues looked at a nationwide survey on HPV infections in the years following the vaccines’ introduction. Nearly 14,000 adults took part in the survey, conducted from between 2009 and 2016. Over those years, HPV vaccination rates increased from zero to 5.8 per cent in men and from 7.3 per cent to 15.1 per cent in women. During this period, the prevalence of the types of HPV that the vaccine prevents infection with dropped from 2.7 per cent to 1.6 per cent in men who had not been vaccinated. This represented a 37 per cent drop among the unvaccinated adult men. The authors suggested that herd immunity was protecting these men, which “likely arises from increased levels of female HPV vaccination in the US population.”
Chaturvedi, A.K. et al Prevalence of Oral HPV Infection in Unvaccinated Men and Women in the United States, 2009-2016. JAMA. 2019; 322(10):977-979. doi: 10.1001/jama.2019.10508
Finally, and most importantly, as a result of the introduction of the HPV vaccine in 2006, we are starting to see declines in the prevalence of cervical cancer in the young women first given the vaccine. The 4-year average annual incidence rates for cervical cancer in 2011–2014 were 29% lower than that in 2003–2006 (6.0 vs 8.4 per 1,000,000 people) among females aged 15–24 years, and 13.0% lower among females aged 25–34 years.
Guo et al Cervical Cancer Incidence in Young U.S. Females After Human Papillomavirus Vaccine Introduction. American Journal of Preventive Medicine Volume 55, Issue 2, 197–204, 2018. https://doi.org/10.1016/j.amepre.2018.03.013
We now have similar data in the Nordic countries showing that the HPV vaccine is working:
As a result of the introduction of the HPV vaccine, we now have data from women immunized for 2, 4, 6, 8, and 10 years. The data show that there were exactly zero cases at any time point of HPV 16/18-related cervical intraepithelial neoplasia 2 (CIN2) or worse (CIN3, adenocarcinoma in situ, or actual cervical cancer) among women receiving the quadrivalent HPV vaccine at the start of the study. There were also zero cases of vulvar or vaginal cancer in this same study.
Kajer et al A 12-Year Follow-up on the Long-Term Effectiveness of the Quadrivalent Human Papillomavirus Vaccine in 4 Nordic Countries. Clinical Infectious Diseases (2018) 66, 339-345.
Similarly, another study showed that the rate of cervical cancer in HPV vaccine immunized girls dropped to zero compared to non-vaccinated girls.
Luostarinen, T. Vaccination Protects Against Invasive HPV-Associated Cancers. Int. J. Cancer 142, 2186-2187 (2018) FREE download.
We now have similar data in Scotland showing that the HPV vaccine is working:
As a result of the introduction of the bivalent HPV vaccine (Cervarix) shows that routine vaccination of girls aged 12-13 led to a dramatic reduction in preinvasive cervical disease. The study showed that compared with unvaccinated women born in 1988, vaccinated women born in 1995 and 1996 showed an 89% reduction in prevalent cervical intraepithelial neoplasia (CIN) grade 3 or worse (from 0.59% to 0.06%; an 88% reduction in CIN grade 2 or worse (from 1.44% to 0.17%), and a 79% reduction in CIN grade 1 (from 0.69% to 0.15%). Younger age at immunization was associated with increasing vaccine effectiveness: 86% for CIN grade 3 or worse for women vaccinated at age 12-13 compared with 51% for women vaccinated at age 17. Evidence of herd protection against high grade cervical disease was found in unvaccinated girls in the 1995 and 1996 cohorts.
Palmer, T. et al Prevalence of cervical disease at age 20 after immunisation with bivalent HPV vaccine at age 12-13 in Scotland: retrospective population study. British Medical Journal (2019); 365:1161 doi: 10.1136/bmj.l1161 (FREE paper)
We now have similar data in England showing that the HPV vaccine is working:
A report released by Public Health England reviewed surveillance data from outcomes of a national HPV vaccination program, which began in 2008. The report looked at incidence of HPV infection of the reproductive tract in sexually active 16-24 year-old females. As is the case with many viruses, HPV has many subtypes, some of which are more likely to be associated with aggressive cancers (subtypes 16 and 18 as well as 31, 33, and 45) and others are more likely to be associated with RRP infections and genital warts (subtypes 6 and 11). Until 2012, the bivalent (HPV 16/18) vaccine (CervarixR) was administered as a three-dose regimen. In years since then, the quadrivalent (HPV 16/18/6/11) (GardasilR) has been the standard vaccine administered in the U.K. as well as the U.S. as a two-dose regimen. Cervical cancer is due to HPV 16 or HPV 18 in up to 80% of cancers.
The report analyzed results of over 18,000 vulvovaginal culture specimens obtained from sexually active 16-24-year-old females undergoing chlamydia screening, collected between 2010 and 2018. There was significant decline in HPV infection rates in all subtypes in all age groups. Those who had been vaccinated more recently showed more reduction in HPV 6/11 than those who did not receive coverage for these strains in the earlier years of vaccination. Most notable was that the prevalence of HPV 16/18 in the 16-18-year-old cohort declined from 8.2% in 2010 to 0.0% in 2018. In the older groups, there was less decline (from 14% to 0.7% in 19-21-year-olds and 16.4% to 2.6% in 22-24-year-olds), but all reductions were statistically significant.
Surveillance of type-specific HPV in sexually active young females in England, to end 2018. HPR Volume 14 Number 2 Advanced Access report published 22 January 2020. FREE download.
We now have similar data in the US/Puerto Rico showing that the HPV vaccine is working:
A study analyzing all cervical cancer cases diagnosed in people 15-24 years and tracked in the US, District of Columbia and Puerto Rico found there was a 29% drop after the vaccine was introduced in 2006. This decrease was statistically significant. It’s unusual to have cervical cancer diagnosed in such young women, but as more time passes, we will have more and more data that shows a reduction in actual cervical cancer cases.
Guo, F. et al Cervical Cancer Incidence in Young U.S. Females After Human Papillomavirus Vaccine Introduction. American Journal of Preventive Medicine 55, no. 2 (2018): 197–204. https://doi.org/10.1016/j.amepre.2018.03.013.
The CDC maintains a program focused on monitoring the effectiveness of the HPV vaccine. It’s called the Human Papillomavirus Vaccine Impact Monitoring Project (HPV-IMPACT). According to the CDC website:
“Measuring the impact (such as reduction in HPV-related precancers) of the HPV vaccine on health outcomes is a critical but challenging public health priority. Of highest importance is the impact of the vaccine on reducing the burden of cervical cancer, which is the most common HPV-related cancer in women. However, since it takes many years for HPV infection to progress to invasive cancer, measuring vaccine impact on cervical cancer is difficult and can take decades. Instead, we can monitor high-grade cervical lesions that are likely to progress to invasive cancer if left untreated as early indicators of vaccine impact. In this surveillance project, we monitor these cervical lesions among women age 18 and older in five different communities around the United States.
The CDC collects demographic and clinical information from laboratory and medical records for every woman who has a high-grade cervical lesion identified. For women aged 18-39 years who have a high-grade cervical lesion identified, we collect additional information, such as insurance, cervical cancer screening history, and vaccination history. Additionally, archived tissue specimens are obtained and sent to CDC for HPV type testing for 37 HPV types, including those targeted by HPV vaccines.
The main objectives of HPV-IMPACT are to:
Monitor trends in overall incidence of high-grade cervical lesions over time in women aged 18-39 years;
Monitor prevalence and distribution of HPV types in women aged 18-39 years with high-grade cervical lesions;
Describe the demographic, clinical, and HPV type characteristics among patients with high-grade cervical lesions;
Estimate and monitor trends in cervical cancer screening among residents of the catchment areas; and
Estimate the proportion of patients with high-grade cervical lesions who received the HPV vaccine, and estimate vaccine effectiveness.
The HPV-IMPACT project is a collaboration between two groups at CDC: the Viral Vaccine Preventable Diseases Branch in the Division of Viral Diseases, and the Chronic Viral Diseases Branch in the Division of High-Consequence Pathogens and Pathology.”
Modeling data suggests that the HPV vaccine may be able to greatly reduce the incidence of cervical cancer.
“These findings emphasise the importance of acting immediately on three fronts to scale up vaccination, screening, and treatment for pre-invasive and invasive cervical cancer. In the next 10 years, a one-third reduction in the rate of premature mortality from cervical cancer in LMICs is possible, contributing to the realisation of the 2030 UN SDGs. Over the next century, successful implementation of the WHO elimination strategy would reduce cervical cancer mortality by almost 99% and save more than 62 million women’s lives.
Canfell,K. et al Mortality impact of achieving WHO cervical cancer elimination targets: a comparative modeling analysis in 78 low-income and lower-middle-income countries. The Lancet. Published online January 30, 2020 https://doi.org/10.1016/S0140-6736(20)30157-4 FREE download
Data presented at a recent meeting suggest that the HPV vaccine may be able to greatly reduce cervical dysplasia recurrence risk. Researchers compared recurrence rates of 1,360 women who received HPV vaccination after surgical excision for recurrent cervical dysplasia with those of 1,624 women who received placebo or surgery alone. Follow-up was between 6 months and 48 months. “Overall, 3.3% (n = 99) of women experienced recurrence of CIN grade 2 or higher.What would the mechanism be here? One possibility is that the vaccine can induce an antibody response that stops the spread of active virus into nearby cervical tissue that would eventually result in pre-clinical cancer changes. Alternatively, the vaccine could be working to prevent infection with a new, second strain of the virus. There are currently two ongoing, large, randomized controlled clinical trials that should help to better elucidate the benefit of adjuvant HPV vaccine in this setting.
Lichter K, et al. Abstract 120. Presented at: Society of Gynecologic Cancer Annual Meeting; March 28-31, 2020 (virtual meeting).
4) Why doesn’t the vaccine protect against ALL strains of HPV?Open or CloseHuman papilloma viruses share some common structural proteins, but each strain also differs from one another. The vaccine is made against certain proteins that are different on each type of virus and are found on the outside of the virus (the viral shell) because the outside of the virus is what our immune system sees. Because of this, the vaccine only provides protection against a limited number of strains. A vaccine that targeted a protein that is identical in all human papilloma viruses would, in theory, provide protection against all strains, but such a vaccine has yet to be created.
If you want to get into the details about differences between various strains of HPV, take a look at this paper:
Burk et al Human papillomavirus genome variants Virology. 2013 Oct; 445(0): 232–243. doi: 10.1016/j.virol.2013.07.018
5) Does infection with one strain of HPV prevent a person with being infected by other strains?Open or CloseNo. You can be infected with multiple strains of HPV at the same time. Being infected with one strain does not provide protection against infection with a different strain. A study was done looking at women who were referred for HPV testing when they were having cells from their cervixes examined. Twenty four percent of the women were positive for HPV infection, and 19 percent of those infected with one strain also harbored a second strain. The overall percentage of women who were infected with at least two strains of HPV was 4.6 percent. "Women who harbor multiple infections are at higher risk for cervical lesions than those ever infected with one type only and should be followed more closely," said Eduardo L. Franco, Dr.PH., professor of epidemiology and oncology, and director, division of cancer epidemiology at McGill University.
The research raises the possibility that in women with multiple infections, their immune systems may be less robust in clearing the infections. HPV 16, the most well known cancer causing strain, was found in 9 percent and 14 percent of single and multiple HPV infections, respectively.
6) If you’ve already been infected with one strain of HPV, can the vaccine prevent you from being infected by another strain?Open or CloseIn theory the vaccine should prevent someone who is already infected with HPV from being infected by a second strain, providing that the second strain is one of the nine strains that the Gardail 9 vaccine works against. Those who received the earlier vaccines (Cervarix or Gardasil) that only protected against two strains of HPV (16 and 18) or four strains of HPV (16, 18, 6, and 11), respectively, could also get some benefit from the most recent vaccine, Gardasil 9, that provides protection against a total of nine strains.
Having said that, it’s the two most prevalent cancer-causing strains (16 and 18) that are found in the vast majority of HPV-caused cancers. For example, WHO reports that 70 percent of cervical cancers are linked to these two strains. One study estimated that the Gardasil 9 vaccine may prevent an additional 4.2 percent to 18.3 percent of cancers compared to the vaccines targeted at just strains 16 and 18. Thus, there are diminishing returns in getting the newest vaccine if you have already been immunized with the earlier ones. As always, discuss this with your doctor to weigh the pluses and minuses. You may also want to check if your insurance company would pay for new HPV vaccinations if you’ve previously been vaccinated with one of the earlier vaccines.
7) Has vaccination with the HPV vaccine been shown to actually cause a decrease in oral infections with HPV?Open or CloseYes. A study of more than 2,600 young adults showed that the prevalence of four different types of oral HPV, including two high risk strains (16 and 18), was 88 percent lower in those who had gotten at least one dose of the HPV vaccine compared to those who were not vaccinated.
Take a look at HPV Vaccination Linked to Decreased Oral HPV Infections National Cancer Institute 2017
8) For how long a time period is the vaccine protective?Open or CloseThe exact time period is not known for sure. The most currently used vaccine, Gardasil 9, was only introduced in 2014, so the earliest participants in clinical trials have just been treated for 6-7 years. A report in the journal Lancet showed that vaccine efficacy has been maintained for six years (Lancet. 2017 Nov 11;390(10108):2143-2159. doi: 10.1016/S0140-6736(17)31821-4). A literature review/meta-analysis The Efficacy and Duration of Vaccine Protection Against Human Papillomavirus (Dtsch Arztebl Int. 2014 Sep; 111(35-36): 584–591) showed no loss of long term protection from HPV vaccines.
Mathematical models based on current data estimate that the original Cervarix HPV vaccine will provide full immunity for at least 30 years. According to this article in Science, about the use of virus like particles (VLP) in HPV vaccines, “Trials have shown that nearly everyone vaccinated with that noninfectious VLP develops high levels of HPV-neutralizing antibodies. Those levels decline moderately after 2 years but then remain stable for at least a decade.” The HPV vaccine leads to consistent blood levels of neutralizing antibodies for years on end. According to some scientists, “VLPs trigger production of a different set of B cells called long-lived plasma cells (LLPCs), which reside in the bone marrow and continually produce antibodies specific to different foreign antigens.”
Jon Cohen. Waning immunity: Vaccine protection can fade in months or last a lifetime. Understanding why could lead to more durable immune responses. Science 364 (6437), 224-227. DOI: 10.1126/science.364.6437.224
You can read this article for FREE.
9) Are there side effects associated with getting the HPV vaccine?Open or CloseAs with nearly all vaccines, there are mild side effects associated with getting the HPV vaccine. These usually last a few hours to a day.
According to the World Health Organization, In the arm where the vaccine is given:
“• Pain is felt by about 8 in 10 people.
• Redness or swelling is experienced by about 1 in 4 people.
• Headache: About 1 in 3 people will develop a headache.
• Mild fever (100° F/38° C) is experienced by about 1 in 10
• Moderate fever (102° F/39° C) is experienced by about 1 in
About one in a million people who receive a vaccine of any kind will experience a strong allergic reaction (such as anaphylactic shock). For this reason, health care providers should ask about allergies before giving a vaccine and advise whether a known allergy is relevant to the specific vaccine being given. The person being vaccinated should stay in the clinic for 15 minutes afterwards for observation.”
10) Does getting the HPV vaccine hurt?Open or CloseUnfortunately, it often does. This is because this particular vaccine is one of a type of vaccines that is referred to as reactogenic. According to Wikipedia “Reactogenicity events are adverse events that are common and known to occur”, such as a sore arm at the injection site, or a fever. Typically, reactogenicity with vaccines is often observed when the vaccine contains an adjuvant (a chemical additive intended to enhance the recipient's immune response to the vaccine antigen), but it can also occur with non-adjuvanted vaccines. All versions of the HPV vaccine have had added adjuvants, including the one currently available in the U.S., Gardasil 9.
11) I can’t afford this life-saving vaccine. Who can help pay for it?Open or CloseHelp is available from several sources:
Medicaid - The Vaccines for Children (VFC) program provides vaccines for children ages 18 years and younger, or who are uninsured, Medicaid-eligible, American Indian or Alaska Native. It also covers those who have health insurance, but are underinsured (i.e. the insurance doesn’t cover any vaccines or doesn’t cover certain recommended vaccines). Underinsured children are eligible to receive vaccines only at federally qualified health centers (FQHCs) or rural health clinics (RHCs). FQHCs and RHCs provide health care to medically underserved areas and meet certain criteria under Medicare and Medicaid programs. If you need help locating an FQHC or RHC, contact your state or city’s VFC program coordinator. There are more than 40,000 healthcare providers in the US enrolled in this program. Click this link to find the VFC provider nearest where you live, or call the CDC at 1-800-CDC-INFO (1-800-232-4636) for assistance.
Children’s Health Insurance Program (CHIP) – State CHIP programs that are separate from their Medicaid programs must cover the CDC’s Advisory Community for Immunization Practices (ACIP)-recommended vaccines for beneficiaries since they are not eligible for coverage under the federal VFC. The HPV vaccine is one covered by ACIP.
The Immunization Grant Program (Section 317 of the Public Health Service Act) provides grants to states and local agencies to increase the availability of vaccines to uninsured adults in the United States. Check with your local health agency to see if the vaccine is available.
If you’re over 18, there’s a program to provide the vaccine to young adults. Merck, the manufacturer of the vaccine, has established the Merck Vaccine Patient Assistance Program (MVPAP), which is funded by Merck for adults 19 to 26 years of age who cannot afford vaccines. It’s a private and confidential program provides vaccines free of charge to eligible adults, primarily the uninsured who, without assistance, could not afford needed vaccines. To qualify you must be 19 to 26 years of age, don’t have health insurance, and can’t afford to pay for the vaccine. Details can be found at Merck Helps by clicking this link.
12) Is it safe to give the HPV vaccine to women who are pregnant?Open or CloseApparently so, although this has never been tested due to ethical considerations. According to the Global Advisory Committee on Vaccine Safety (GACVS), which is a part of the World Health Organization, “inadvertent administration of HPV vaccine during pregnancy has no known adverse outcomes in either mother or infant.”
13) If only about 1 in 100 people infected with HPV develop cancer, aren’t I better off avoiding the vaccine since it does on rare occasion have some serious side effects?Open or CloseIn a word, no.
Let’s do the math together to answer this question.
For individuals not vaccinated against HPV, the cumulative risk of developing an HPV-associated cancer in any organ was 1.4% in white women, and about 0.98% in white men. Thus, about 1 in 71 white women will develop one of these cancers, and about 1 in 100 white men will. If we focus just on cervical cancer, the estimated lifetime risk for developing cervical cancer is only 0.68%, or about 1 in 147 women.
Howlader, et al SEER cancer statistics review, 1975-2009 (vintage 2009 populations). National Cancer Institute, https://seer.cancer.gov/archive/csr/1975_2009_pops09/.
According to the CDC, “Gardasil 9 is currently the only HPV vaccine available in the United States. From its licensure in December 2014 through December 2017 (four year period), about 29 million doses of Gardasil 9 have been distributed in the U.S. During the same period, VAERS received 7,244 U.S. reports of adverse events following Gardasil 9 vaccination. Overall, 97% were non-serious reports; 3% of reports have been classified as serious.”
The CDC also cautions people about the data contained in the VAERS database, “The Vaccine Adverse Event Reporting System (VAERS) is a national vaccine safety monitoring system co-managed by CDC and FDA. The system accepts adverse event reports following vaccination from vaccine manufacturers, healthcare professionals, and the public. It serves as an early warning system to detect possible safety problems that require further evaluation; however, the safety data the system provides has limitations. VAERS data limitations include reporting biases, inconsistent data quality and completeness, and a lack of unvaccinated comparison groups. Because of these limitations, VAERS generally cannot determine if a vaccine caused a reported adverse event. While some reported adverse events may be caused by vaccination, others may be coincidental and not related to vaccination. Learn more about VAERS and the safety data it provides.”
Many, if not most, of the serious adverse reports are likely NOT related to getting the vaccine, but let’s just go with the numbers as reported. Three percent of the 7,244 adverse events comes out to 217 potentially serious adverse events. With 29 million doses, that comes means that during a three year period there was one serious adverse event for every 133,640 vaccinations. Each person getting the vaccine should have gotten either two or three doses. Let’s average that out at 2.5 doses per person, which means that there will be one person potentially harmed per every 53,456 people vaccinated. Note that the actual number is likely to be higher than this, because a significant number of people never complete the required number of doses.
We can expand this dataset in the National Vaccine Injury Compensation Program (VICP) to look at ALL versions of the HPV vaccine over a ten year period:
Number of doses given (2006-2016): 101,405,935
Total compensable claims filed: 288
Number of claims dismissed: 160
Total compensable claims awarded: 128 (this includes concessions, court decisions, and settlements)
This works out to be 0.00126 percent of those vaccinated against HPV filed a claim and were compensated at some level. There were an average of 12 claims paid out each year to those who said they were harmed by the HPV vaccine (again, this court does not require absolute proof to award settlements). Each person getting the vaccine will have gotten either two or three doses. Let’s average that out at 2.5 doses per person, which means that the vaccine fully treated about 40,562,374 individuals. Divide that by 128 awards, and we get one claim awarded for every 316,893 people vaccinated. Note that the actual number is likely to be higher than this, because a significant number of people never complete the required number of doses.
So here’s your choice: about 1 in 71 white women, and 1 in 100 white men will develop an HPV-caused cancer during their lifetimes. Let’s just average this to 1 in 85 white adults will develop one of these cancers.
You have about a 1 in 85 chance of getting an HPV-caused cancer in your lifetime.
You have about a 1 in 53,456 to 316,893 chance of being seriously harmed by the vaccine.
Put another way, for every person who might possibly have been seriously harmed by the vaccine, there will be 629 to 3,728 men and women who will develop an HPV-preventable cancer sometime during their life.
Keep in mind that there were a total of 43,371 HPV-associated cancers in 2015 in the US: 24,432 cases in women, and 18,939 cases in men. HPV causes oropharyngeal, anal, penile, cervical, vaginal, and vulvar cancers. It also causes painful genital warts. This is why it’s a good idea to vaccinate both girls AND boys against HPV!
The right choice seems pretty obvious to me.
And for those of you wanting to put these numbers in context: there are about 51 people in the US killed (not just struck) by lightning each year, and sharks attack about 19 people over that time frame. This illustrates just how safe the HPV vaccine is; there are only about 12 compensable claims per year.
The HPV vaccine is safer than sharks or lightning.
14) Does this vaccine cause autism?Open or CloseNo. There is absolutely no evidence that the HPV vaccine (or for that matter, any vaccine) causes autism. None at all.
Most of the misinformation about vaccines causing autism have been focused on the MMR vaccine. It doesn’t. Read this article that reviews in great detail why there is no association. It includes references for 140 papers that all support this, including the most recent huge analysis (Measles, Mumps, Rubella Vaccination and Autism: A Nationwide Cohort Study) of more than 650,000 children in Denmark. This Danish study found zero evidence of any association between the MMR vaccine and autism.
15) When was the vaccine first introduced?Open or CloseIn the US, the Food and Drug Administration (FDA) has approved three vaccines that prevent infection with disease-causing HPV types: Gardasil®, Gardasil® 9, and Cervarix®. Gardasil was originally introduced in 2006 (for girls only), Cervarix was first marketed in the US in 2009 (again, only for girls), and Gardasil 9 replaced Gardasil in the US in 2014. Up until 2010, the vaccines were only given to girls, after which they started to be given to both boys and girls when it was clearly understood that HPV also causes oral, anal, and penile cancers in men. Cervarix was withdrawn from the US marketplace in 2016 due to low market demand, leaving Gardasil® 9 as the only HPV vaccine for sale in the US.
The two Gardasil vaccines are manufactured by Merck, whereas Cervarix is a product of GlaxoSmithKline. Click this link for information on which countries have licensed Gardasil 9, and this link for which countries had licensed Cervarix.
16) Is the HPV vaccine made from live viruses?Open or CloseNo, there is NO live virus in the HPV vaccine, and therefore it is NOT possible to “catch” HPV from the vaccination. HPV vaccines are made by using yeast to generate one of the HPV proteins, called L1, from HPV. The L1 protein is then purified and self-assembles into pentamers (an organized arrangement of five of the protein molecules), and next 72 of the pentamers self-assemble into a structure known as a virus like particle (VLP). Think of the VLP as being like the shell of an egg, but without any yolk or whites contained inside. The VLP are hollow particles that are good at generating an immune response. Scientists at Merck (who manufacture the vaccine) combine VLPs made from L1 proteins from nine different strains of HPV to produce the Gardasil 9 vaccine.
See Conway and Meyers, Replication and Assembly of Human Papillomaviruses. J Dent Res. 2009 Apr; 88(4): 307–317. doi: [10.1177/0022034509333446]
17) How many people would need to be vaccinated against HPV in order to prevent a single case of cancer?Open or CloseThe answer to this isn’t known. A 2007 paper by Brisson et al estimated that using the vaccine available at the time (Gardasil, which only protects against four strains of HPV: 16, 18, 6, and 11; only the first two cause cancer), you would have to vaccinate about 324 girls to prevent one case of cervical cancer. This estimate may be good, or it may be bad. It’s based on mathematical modeling. Whatever the number is, it would actually be much better today for two reasons. One, the most recent vaccine, Gardasil 9, protects against five additional cancer causing strains of the virus (31, 33, 45, 52, and 58) compared to Gardasil original. That makes the current vaccine more effective at preventing cancer, although not hugely so since most cases (about 70%) of cervical cancer are thought to be caused by strains 16 and 18. The other thing to keep in mind is that the HPV vaccine not only prevents most cases of cervical cancer in women, it should also prevent most cases of vaginal, vulval, oropharyngeal, and anal cancer as well.
According to the National Cancer Institute, the HPV virus is believed to be responsible for about 70% of cervical cancers, 65 percent of vaginal cancers, 50 percent of vulvar cancers, 95 percent of anal cancers, and 70 percent of oropharyngeal (back of the throat, tonsil, and base of the tongue) cancers.
Data from the CDC indicates that in 2015, oropharyngeal cancers made up only 14% of all HPV-cancers in women. The most prevalent HPV-cancer in women is cervical cancer (48%), followed by anal cancers (18%), vulval cancers (16%), and vaginal cancers (3%).
So overall, the number of girls needed to treat with the most recent vaccine in order to prevent a single case of cancer might be more in the range of about half of the previous estimate, or around 162 girls. But nobody knows for sure.
I have been unable to find any estimates for the number of boys needed to be vaccinated to prevent a single case of oropharyngeal, anal, or penile cancer in men. Since men have an approximately equal number of HPV cancers each year compared to women, the number is likely to be similar.
Brisson M et al Estimating the number needed to vaccinate to prevent diseases and death related to human papillomavirus infection CMAJ. 2007 Aug 28; 177(5): 464–468. doi: 10.1503/cmaj.061709
18) If the HPV vaccine is truly effective against certain high-risk strains of HPV, won’t those eventually be replaced in the population by other strains not covered by the vaccine?Open or CloseThere is no definitive answer to this question. The subject is complicated, and much of the work done to date revolves around mathematical modeling. But how does this operate in the real world, and specifically, with HPV? There has been evidence of strain replacement with other vaccines, but it is highly likely that this mechanism will vary a lot between different types of vaccines. Factors involved include how many replacement strains are available in the population, how many strains the vaccine is effective against, what percentage of the population is vaccinated, the virulence of the various strains, and how communicable is the particular pathogen (in this case, a virus).
Take a look at Evidence for cross-protection but not type-replacement over the 11 years after human papillomavirus vaccine introduction. Covert et al. Hum Vaccin Immunother. 2019.
Look at theoretical modeling of this phenomenon in Martcheva et al Vaccine-induced pathogen strain replacement: what are the mechanisms?J R Soc Interface. 2008 Jan 6; 5(18): 3–13. doi: 10.1098/rsif.2007.0236
For a look at HPV, see the study by Markowitz et al Prevalence of HPV After Introduction of the Vaccination Program in the United States Pediatrics. 2016 Mar;137(3):e20151968. doi: 10.1542/peds.2015-1968.
Finally, this issue has also been addressed in Murall et al Could the human papillomavirus vaccines drive virulence evolution? Proc Biol Sci. 2015 Jan 7; 282(1798): 20141069. doi: 10.1098/rspb.2014.1069
19) If a woman’s been given the HPV vaccine, does that mean that she no longer requires screening for cervical cancer?Open or CloseNo. The CDC recommends that she should still be screened. Both older versions of the HPV vaccine as well as the current one don’t protect individuals against all HPV types that cause cervical cancer. Vaccination would certainly reduce the odds of her developing cervical cancer, because the vaccine is directed against the most prevalent cancer causing strains, but it cannot guarantee it. Finally, women who got the vaccine after they became sexually active may not get the full benefit of the vaccine if they had already been exposed to HPV. That’s why screening would still be a good idea.
20) Does the U.S. have a national goal for the percentage of people who should be immunized against HPV?Open or CloseYes there is, but let’s start by saying where we are now. As of 2017, nearly half of all adolescents age 13-17 were up to date (i.e. had gotten the full number) of shots of the HPV vaccine.
Source: CDC. (2018). National, Regional, State, Selected Local Area Vaccination Coverage Among Adolescents Aged 13-17 Years—United States, 2017. MMRW 67(33)
What percentage of vaccinated youth is the goal?
According to the CDC, “After the quadrivalent HPV vaccine was licensed in 2006, Healthy People 2020 stated an objective of 80% coverage with 3 doses of HPV vaccine for females by age 13 to 15 years. It also stated objectives to “Reduce the death rate from cancer of the uterine cervix below a target of 2.2 deaths/100,000 females (from a baseline of 2.4 per 100,000 in 2007)” and “Reduce invasive uterine cancer to 7.2 new cases per 100,000 females.55 There is also a stated goal to “increase the proportion of women who receive a cervical cancer screening based on the most recent guidelines” with a target of 90% of women 21 to 65 years of age receiving screening (from a baseline of 84.5% in 2008). There are currently no stated goals for reduction of anogenital warts, RRP, or non-cervical HPV-associated cancers.”
What is Healthy People 2020? It’s a program launched by the US Department of Health and Human Services in 2010 that has four overarching goals:
“- Attain high-quality, longer lives free of preventable disease, disability, injury, and premature death;
- Achieve health equity, eliminate disparities, and improve the health of all groups;
- Create social and physical environments that promote good health for all; and
- Promote quality of life, healthy development, and healthy behaviors across all life stages.”
Because it is not looking likely that this goal will be met, the American Cancer Society has set a new goal of 80% coverage with the HPV vaccine for 2026. Note that the Healthy People 2020 goal was specifically set for girls only, whereas the new goal from the ACS is for both girls AND boys.
21) What, exactly, is herd immunity, and how does that concept work with viruses and vaccinations?Open or CloseHerd immunity is a concept where non-immunized individuals are protected against infection by some agent because they are surrounded by a large number of people who have been immunized. These immunized people serve to break a chain of contagion, and as a result the infectious agent does not reach the non-immunized person. The exact percentage of the population that needs to be immunized for the population to be protected varies depending on the ease and mechanism of transmission of the infectious agent. For example, a greater percentage of people need to be immunized to prevent the spread of viruses that are transmitted by coughing or sneezing compared to those like HIV and HPV that are sexually transmitted.
Herd immunity becomes very important in protecting those who can’t be immunized for some reason, such as those with weakened immune systems, including newborns, people with HIV, cancer patients who have received chemotherapy and radiation, etc. For sexually transmitted infections (STIs) including HPV, high levels of immunity in one sex induces herd immunity for both sexes in many instances. Vaccinating women against HPV, however, would provide no protection to men who are exclusively homosexual.
Modeling in this paper suggests that at 80% vaccination coverage of both girls AND boys would lead to the elimination of four strains of HPV, including the two most prevalent cancer causing strains, 16 and 18. M Brisson et al Population-level impact, herd immunity, and elimination after human papillomavirus vaccination: a systematic review and meta-analysis of predictions from transmission-dynamic models. Lancet Public Health. 2016 Nov;1(1):e8-e17. doi: 10.1016/S2468-2667(16)30001-9. Epub 2016 Sep 27.
Even better, here’s a paper with actual data showing the effect of herd immunity with the HPV vaccine in young women in the US that was done 2006-2017. Among women who were vaccinated, 4-valent vaccine–type HPV detection decreased from 35% to 6.7%. Among women who were NOT vaccinated, 4-valent vaccine–type HPV detection decreased from 32.4% to 19.4%.
Spinner C, et al Human Papillomavirus Vaccine Effectiveness and Herd Protection in Young Women. Pediatrics. 2019;143(2):e20181902
Wikipedia has a very detailed explanation for how herd immunity works.
I also found this interesting visualization graphic that shows how herd immunity provides protection by throwing up barriers around infected people.
Here’s another terrific visualization graphic of herd immunity. It’s set up for measles, but the same principle applies to HPV infections.
22) What is the Vaccine Adverse Event Reporting System (VAERS), and how good is it in tracking harm caused by vaccines? How does this tie in to the National Vaccine Injury Compensation Program?Open or CloseThe Vaccine Adverse Event Reporting System (VAERS) is a reporting process that has been put in place for patients or doctors to record information about problems observed after people have been vaccinated. Its purpose is widely misunderstood. It does NOT exist to track specific and proven adverse reactions caused by vaccines; it is simply there to record information. The purpose of the system is clearly denoted on the VAERS website as follows:
“When evaluating data from VAERS, IT IS IMPORTANT TO NOTE THAT FOR ANY REPORTED EVENT, NO CAUSE-AND-EFFECT RELATIONSHIP HAS BEEN ESTABLISHED. Reports of all possible associations between vaccines and adverse events (possible side effects) are filed in VAERS. Therefore, VAERS COLLECTS DATA ON ANY ADVERSE EVENT FOLLOWING VACCINATION, BE IT COINCIDENTAL OR TRULY CAUSED BY A VACCINE. THE REPORT OF AN ADVERSE EVENT TO VAERS IS NOT DOCUMENTATION THAT A VACCINE CAUSED THE EVENT.”
So the reporting of any event after receiving a vaccination is simply a record. It does NOT prove the vaccine caused that issue. Let me put this in a different context to see if that helps. Imagine if there was a similar system that was in place for people to report problems for some period of time after they have shopped at Target or taken a taxi. That database might note that you began to feel sick four days after your shopping trip, or the taxi ride. But does that mean that your sickness was CAUSED by the shopping excursion or the taxi ride? No. It could be related, but maybe not. Coincidences happen all the time. Keep this in mind as you look at data from VAERS.
If you want to look at specific numbers of claims filed, and those that were paid, and how much the payments were, you can click on this link to get the numbers from the National Vaccine Injury Compensation Program (VICP). They have data from all of the vaccines. Let’s look at HPV for an example and see what the numbers tell us:
Number of doses given (2006-2016): 101,405,935
Total compensable claims filed: 288
Number of claims dismissed: 160
Total compensable claims awarded: 128 (this includes concessions, court decisions, and settlements)
This works out to be 0.00126 percent of those vaccinated against HPV filed a claim and were compensated at some level. Put another way, there was 1 compensated award for every 792,233 doses of vaccine given.
There were an average of 12 claims paid out to those who said they were harmed by the HPV vaccine (again, this court does not require absolute proof to award settlements). “Approximately 70% of all compensation awarded by the VICP comes as result of a negotiated settlement between the parties in which HHS has not concluded, based upon review of the evidence, that the alleged vaccine(s) caused the alleged injury.”
By contrast, 51 people in the US are killed (not just struck) by lightning each year, and sharks attack about 19 people. This illustrates just how safe the HPV vaccine is. Keep in mind that there were a total of 43,371 HPV-associated cancers in 2015 in the US: 24,432 cases in women, and 18,939 cases in men. HPV causes oropharyngeal, anal, penile, cervical, vaginal, and vulvar cancers. It also causes painful genital warts. This is why it’s a good idea to vaccinate both girls AND boys against HPV!
Here’s more data covering ALL vaccines from the US government vaccine injury compensation from the National Vaccine Injury Compensation Program:
“Being awarded compensation for a petition does not necessarily mean that the vaccine caused the alleged injury. In fact:
Attorneys are eligible for reasonable attorneys’ fees, whether or not the petitioner is awarded compensation by the Court, if certain minimal requirements are met. In those circumstances, attorneys are paid by the VICP directly. By statute, attorneys may not charge any other fee, including a contingency fee, for his or her services in representing a petitioner in the VICP.”
“According to the CDC, from 2006 to 2017 over 3.4 billion doses of covered vaccines were distributed in the U.S. For petitions filed in this time period, 6,314 petitions were adjudicated by the Court, and of those 4,328 were compensated. This means for every 1 million doses of vaccine that were distributed, approximately 1 individual was compensated.
Since 1988, over 20,728 petitions have been filed with the VICP. Over that 30-year time period, 17,923 petitions have been adjudicated, with 6,597 of those determined to be compensable, while 11,326 were dismissed. Total compensation paid over the life of the program is approximately $4.1 billion.”
Here’s a good summary look at Why the Government Pays Billions to People Who Claim Injury by Vaccines
Note that Australia has an equivalent database called DAEN: the Database of Adverse Event Notifications. It has the same limitations as VAERS in that the data is self reported, and no evidence of causality can be inferred from the data.
Getting back to the U.S., you should know that payments made to people who allege harm from vaccines are rare. Check out this excellent article Vaccine Injury Claims Are Few and Far Between detailing this story. The graphic below is from that article:
23) What’s the difference between a preventative HPV vaccine, and a therapeutic one?Open or CloseMost of the time when we speak about HPV vaccines, we are talking about those that are preventative and are used in immunizations to prevent infection with the virus, such as Gardasil 9 (see above). All of the existing vaccines to date have been preventative.
However, efforts are underway to develop therapeutic vaccines, which are designed to be given to patients diagnosed with HPV-caused cancers. These vaccines are often designed to target the E6 and E7 proteins, which are thought to be the key ones the virus uses to turn normal cells into cancer cells. You can read a report about efforts to develop one of these therapeutic vaccines here. As of 2018, there have been no therapeutic HPV vaccines approved in the US by the FDA.
An international, drug-company sponsored study has been launched to investigate the use of a therapeutic vaccine in treating CIN2 (this is high grade cervical intraepithelial neoplasia) in women who are contemplating future pregnancies. This therapeutic vaccine, MEDI0457, features two main components. They are VGX-3100, a DNA plasmid containing modified sequences for E6 and E7, and INO-9012, a DNA plasmid containing the immune activator IL-12.The vaccine will be given as an alternative to surgery, which can weaken the cervix and lead to problems in future pregnancies.
Another therapeutic vaccine being looked at is known as MEL-1, and is also referred to as MVA E2. It is derived from the smallpox virus vaccine MVA, which was originally developed in Germany during the 1940s. The World Health Organization has approved MVA for use in other human vaccines in the early 1990s (note that this does not imply that the U.S. Food and Drug Administration, or FDA, or any other governmental regulatory agency will approve any vaccine based on the use of MVA). Scientists working for Virolab Mexico experimented by inserting certain genes from the Bovine Papillomavirus into MVA. One of the genes inserted was E2, an anti-tumor protein that self-regulates the activity of HVP’s tumor-generating proteins. Why a gene from a cow virus was used instead of the human virus is unclear to me.
In a phase III clinical trial conducted in Mexico, the MVA E2 recombinant vaccinia virus to treat intraepithelial lesions associated with papillomavirus infection. A total of 1176 female and 180 male patients with intraepithelial lesions were studied. They were injected with 107 MVA E2 virus particles directly into their uterus, urethra, vulva, or anus. Patients were monitored by colposcopy and cytology. Immune response was determined by measuring the antibody titer against MVA E2 virus and by analyzing the cytotoxic activity against cancer cells bearing papillomavirus DNA. Papillomavirus was determined by the Hybrid Capture method or by polymerase chain reaction analysis. By histology, 1051 (89.3%) female patients showed complete elimination of lesions after treatment with MVA E2. In 28 (2.4%) female patients, the lesion was reduced to CIN 1. Another 97 (8.3%) female patients presented isolated koilocytes after treatment. In men, all lesions were completely eliminated. All MVA E2–treated patients developed antibodies against the MVA E2 vaccine and generated a specific cytotoxic response against papilloma-transformed cells. Papillomavirus DNA was not detected after treatment in 83% of total patients treated. According to the authors, MVA E2 did not generate any apparent side effects.
Rosales, R. et al. Regression of Human Papillomavirus Intraepithelial Lesions Is Induced by MVA E2 Therapeutic Vaccine. Hum Gene Ther. 2014 Dec 1; 25(12): 1035–1049. Published online 2014 Sep 30. doi: 10.1089/hum.2014.024 FREE paper
Despite these apparently promising results, I have been unable to find any info regarding licensing of this vaccine by the FDA.
There is a similar sounding, but clearly distinct trial currently in progress at multiple locations in the U.S. NCT03610581. Safety, Reactogenicity and Immunogenicity of Adenovirus Serotype 26 (Ad26)- and Modified Vaccinia Ankara (MVA)-Vectored Vaccine Components in Otherwise Healthy Women With Persistent Human Papillomavirus HPV16 or HPV18 Infection of the Cervix. It is sponsored by Janssen Vaccines & Prevention B.V. According to the clinical trials.gov website, “Participants will receive a dose of adenovirus serotype 26 (Ad26)-human papillomavirus (HPV)16 or HPV18 (Ad26.HPV16 or Ad26.HPV18) as prime immunization and a dose of Modified Vaccinia Ankara (MVA)-HPV16/18 (MVA.HPV16/18) as boost immunization.” This is clearly different from the Mexican trial cited above. The trial started in 2018.
So what, exactly, are these vectors? According to the paper below, the investigators “developed HPV16- and HPV18-specific antigens consisting of fusion proteins of E2, E6 and E7. The vaccine will be suitable for every disease stage, from incident and persistent infections where E2 is predominantly expressed up to late stages where E6 and E7 expression are upregulated. Importantly E6 and E7 are pre- sent as reordered fragments to abrogate the transforming activity of these two proteins.”
Khan, S. et al. Development of a replication-deficient adenoviral vector-based vaccine candidate for the interception of HPV16- and HPV18-induced infections and disease. Int. J. Cancer: 141, 393–404 (2017) FREE paper.
Another therapeutic vaccine approach is being tested in cervical intraepithelial neoplasia grades 2 and 3 using a drug known as Tipapkinogen Sovacivec therapeutic HPV vaccine. You can read about it here. Early results from a randomized controlled phase II trial with 2.5 years of follow-up look promising. The drug completely resolved CIN 3 lesions significantly more frequently than placebo; completely cleared HPV16 viral DNA associated with CIN 2/3 significantly more often than placebo; achieved significantly greater complete resolution rates of CIN 2/3 regardless of HR HPV type; and offered 36% complete resolution or partial response of CIN2/3 associated with all HR HPV types.
What is Tipapkinogen Sovacivec (also referred to here as TS)? According to the paper below, it is a “modified vaccinia virus Ankara (MVA) is a highly attenuated replication-deficient strain of vaccinia virus used widely as a gene- delivery system of vaccines. TS has inserted genes that code for three proteins: human cytokine IL-2, and modified forms of HPV 16 E6 and E7 proteins that have been rendered non oncogenic. MVA by itself contributes to the immune reaction by the induction of an Interferon-alpha response . Upon sub-cutaneous injection, TS infects the surrounding cells. The expressed HPV16 E6 and E7 proteins are then processed and presented by dendritic cells which are co-activated by the viral infection. These dendritic cells migrate to the draining lymph-node and present E6 and E7 peptides to the naive T-cells present in the lymph-node, which should allow development of a targeted cell mediated immune response.”
Harper, D.M. et al The efficacy and safety of Tipapkinogen Sovacivec therapeutic HPV vaccine in cervical intraepithelial neoplasia grades 2 and 3: Randomized controlled phase II trial with 2.5 years of follow-up. Gynecologic Oncology. 2019
You can find the paper for FREE here, or read this article about how this treatment is being tested at the U. of Michigan.
Another approach seeks to make a therapeutic vaccine by expressing fragments of the E2, E6, and E7 proteins in and adenovirus vector. By using just fragments it prevents the proteins from having a cancer-promoting function while creating immunogenic targets for training the immune system. Here’s a brief summary:
“High-risk Human papilloma virus (HPV) types are the causative agents of cervical cancer and several other anogenital malignancies. The viral proteins expressed in the (pre)malignant cells are considered ideal targets for immunological intervention. Many approaches have been evaluated for this purpose, mostly aiming at the induction of HPV16 E7- and/or E6-specific cellular immunogenicity. As clinical success has so far been limited, novel approaches are required. We describe the development and pre-clinical testing of a vaccine candidate consisting of replication-deficient adenovirus type 26 and 35 based vectors for the interception of HPV16- and HPV18-related disease. We developed HPV16- and HPV18-specific antigens consisting of fusion proteins of E2, E6 and E7. The vaccine will be suitable for every disease stage, from incident and persistent infections where E2 is predominantly expressed up to late stages where E6 and E7 expression are upregulated. Importantly E6 and E7 are pre- sent as reordered fragments to abrogate the transforming activity of these two proteins. Loss of transforming activity was demonstrated in different in vitro models. Robust T-cell immunogenicity was induced upon immunization of mice with the vaccine candidate. Finally, the developed vaccine vectors showed considerable therapeutic efficacy in the TC-1 mouse model. The absence of transforming activity of the antigens and the favorable immunogenicity profile of the adenovirus based vectors along with the fact that these vectors can be readily produced on a large scale makes this approach attractive for clinical evaluation.”
Khan et al Development of a replication-deficient adenoviral vector-based vaccine candidate for the interception of HPV16- and HPV18-induced infections and disease. Int. J. Cancer: 141, 393–404 (2017) FREE download
Another approach seeks to make a therapeutic vaccine against HPV by injecting long peptide fragments of the E6 and E7 proteins of HPV, which are thought to be the primary viral proteins involved in causing cancer. The investigators looked at the immunogenicity and efficacy of their therapeutic vaccine in women with HPV-16–positive, high-grade vulvar intraepithelial neoplasia. “Twenty women with HPV-16–positive, grade 3 vulvar intraepithelial neoplasia were vaccinated three or four times with a mix of long peptides from the HPV-16 viral oncoproteins E6 and E7 in incomplete Freund's adjuvant. The end points were clinical and HPV-16–specific T-cell responses. The most common adverse events were local swelling in 100% of the patients and fever in 64% of the patients; none of these events exceeded grade 2. At 3 months after the last vaccination, 12 of 20 patients (60%; 95% confidence interval [CI], 36 to 81) had clinical responses and reported relief of symptoms. Five women had complete regression of the lesions, and HPV-16 was no longer detectable in four of them. At 12 months of follow-up, 15 of 19 patients had clinical responses (79%; 95% CI, 54 to 94), with a complete response in 9 of 19 patients (47%; 95% CI, 24 to 71). The complete-response rate was maintained at 24 months of follow-up. All patients had vaccine-induced T-cell responses, and post hoc analyses suggested that patients with a complete response at 3 months had a significantly stronger interferon-γ–associated proliferative CD4+ T-cell response and a broad response of CD8+ interferon-γ T cells than did patients without a complete response.” The authors concluded that “clinical responses in women with HPV-16–positive, grade 3 vulvar intraepithelial neoplasia can be achieved by vaccination with a synthetic long-peptide vaccine against the HPV-16 oncoproteins E6 and E7. Complete responses appear to be correlated with induction of HPV-16–specific immunity.”
Kenter, G.G. et al Vaccination against HPV-16 Oncoproteins for Vulvar Intraepithelial Neoplasia. N Engl J Med 2009; 361:1838-1847
DOI: 10.1056/NEJMoa0810097. FREE download
Another approach seeks to make a therapeutic vaccine against HPV by creating a multi-genotype immunogen that comprises segments from each of six early proteins and is delivered by replication-deficient chimpanzee adenovirus and MVA vectors. This immunogen is predicted to provide coverage of 85% of circulating global cancer-causing HPV genotypes that cause cervical cancer, and builds upon existing concepts that have been focusing predominantly on E6/E7 from HPV16/18. This particular vaccine is designed to elicit an immune response against six different HPV encoded proteins, not just E6 and E7 as some of the other vaccines do.
A trial of this vaccine is planned to begin in March, 2020 and is an international undertaking. It is expected to involve 15 hospitals in the UK and Belgium. The doctors hope to recruit 105 women aged 25 to 55 with a persistent high-risk HPV infection. While 73 will be given two shots of a particular dose of the vaccine, the rest receive a placebo. They will then be tested for the presence of HPV over a period of 12 months to see if the virus has disappeared.
The team hopes to recruit 105 women aged 25 to 55 with a persistent high-risk HPV infection. While 73 will be given two shots of a particular dose of the vaccine, the rest receive a placebo. They will then be tested for the presence of HPV over a period of 12 months. Women interested in joining the trial can contact the team via email at firstname.lastname@example.org
Hancock, et al. A multi-genotype therapeutic human papillomavirus vaccine elicits potent t cell responses to conserved regions of early proteins. Scientific Reports (2019) 9:18713 | https://doi.org/10.1038/s41598-019-55014-z FREE download
Another approach seeks to make a therapeutic vaccine against HPV by using a mix of long peptides from the HPV-16 viral oncoproteins E6 and E7 in incomplete Freund's adjuvant. The study was done in women diagnosed with vulvar intraepithelial neoplasia. In view of the low rate of spontaneous regression of lesions in patients with grade 3 vulvar intraepithelial neoplasia, a single-center, single-group (noncontrolled), observational phase 2 study was designed. The investigators concluded that vaccination with synthetic long peptides that represent the entire length of the two oncoproteins E6 and E7 of HPV-16 is effective over a period of 12 to 24 months for the treatment of high-grade vulvar intraepithelial neoplasia lesions. This clinical effcacy is probably related to a vaccine- induced HPV-16–specific T-cell response. This study was conducted by the Leiden University Medical Center (LUMC), which holds a patent on the use of synthetic long peptides as vaccine (U.S. patent number 7,202,034). The LUMC does not share the financial benefit from this patent with its employees. ISA Pharmaceuticals, a biotechnology company, has licensed the patent from the LUMC.
Kenter et al Vaccination against HPV-16 Oncoproteins for Vulvar Intraepithelial Neoplasia. N Engl J Med 2009; 361:1838-1847 DOI: 10.1056/NEJMoa0810097. Note: as this study was done in 2009, it is unclear what happened next.
IMV Inc. is testing a therapeutic vaccine against E7, which is one of two viral HPV proteins expressed in cervical and other HPV-related cancers. The hope is that the DPX-E7 HPV vaccine may stimulate the human immune system to mount an anti-cancer T cell response against tumors expressing the HPV16 E7 protein. Trials are focused on patients with incurable oropharyngeal, cervical and anal cancers caused by HPV. ClinicalTrials.gov Identifier: NCT02865135
24) How does HPV vaccine coverage vary from state to state?Open or CloseIn the US, vaccination rates vary quite a bit between the states. They also, of course, vary a lot over smaller areas within each state, and at least some of that is driven by pockets of anti-vaccine parents. For example, in the Seattle area where I live, there’s a community on Vashon Island that has had vaccination opt-out rates that are five times the state average. However, due to a recent measles outbreak in Vancouver, WA, it’s been reported that vaccination rates even on Vashon Island have soared in response to this.
So what are the laws covering vaccination? According to the Kaiser Family Foundation, “Presently at least 25 states and Washington D.C. have laws that either require HPV vaccination for school entry, provide funding to cover the costs of the vaccines, or support public education about HPV and the vaccine. D.C. and Virginia require the vaccine for girls to enter the sixth grade, but allow parents to opt out of the requirement due to medical, moral, or religious opposition. Rhode Island requires ALL seventh-grade students to be vaccinated.” In 2020, Hawaii will become the next state to require HPV vaccination of all students entering the sixth grade.
You can see a map with state by state vaccination rates here. Rural states in general have much lower vaccination rates that other states.
The CDC has set a goal, as part of the Healthy People 2020 initiative, of getting to 80% vaccination rates for girls by 2020. As we are unlikely to meet this goal, the American Cancer Society has put forth a new goal of 80% vaccination rate for both girls AND boys by 2026.
You can also look at this paper published in the journal Pediatrics, Legislation to Increase Uptake of HPV Vaccination and Adolescent Sexual Behaviors. The authors concluded, “Implementation of HPV legislation was not associated with changes in adolescent sexual behaviors in the United States.”
25) Do all of the major religions around the world approve of or permit the HPV vaccine?Open or CloseYes they do. The short answer is that ALL of the major religions of the world are OK with ALL of the currently available vaccines. Here’s a pretty comprehensive review of the subject:
Grabenstein, J. What the World’s religions teach, applied to vaccines and immune globulins. Vaccine 31 (2013) 2011–2023. FREE download.
Note that the courts in the US have consistently ruled against religious objections raised by parents who don’t want to vaccinate their children. Here’s an article discussing a recent case where the court ruled against the parents. One court ruling said that “the right to practice religion freely does not include liberty to expose the community or the child to the communicable disease or the latter to ill health or death.” People v. Pierson, 176 N.Y. 201, 68 N.E. 243.
26) Who invented the HPV vaccine?Open or CloseThe vaccine was first developed at the University of Queensland in Australia by researchers Ian Frazer and Jian Zhou. Their work built upon the initial discovery that HPV was associated with and causes cervical cancer, which is credited to German researcher Harald zur Hausen. He shared the Nobel Prize in Medicine in 2008 for this groundbreaking work, along with the discoverers of the HIV virus.
Professor Frazier is currently spearheading an effort to develop a therapeutic vaccine that can be used as an immuno-therapeutic approach to treat those with HPV-caused oropharyngeal cancers.
27) What exactly are adjuvants and excipients, and why are they added to vaccines?Open or CloseThe current Gardasil 9 HPV vaccine contains the follow substances: amorphous aluminum hydroxyphosphate sulfate (AAHS), sodium chloride, L-histidine, polysorbate 80, sodium borate, and yeast protein.
These adjuvants and excipients are substances added to vaccines that serve two purposes: to stabilize the vaccine, and to make the vaccine more effective.
Of the ingredients:
Yeast protein represents an engineered form of the L1 protein made by nine different strains of HPV. They are actually manufactured in yeast cells via genetic engineering, and then are highly purified. These form the core component of the vaccine.
AAHS is the adjuvant that makes it work better. The L1 proteins adhere to the aluminum salts, and makes it easier for our immune system to recognize these proteins and develop an immune response.
Sodium chloride (salt), L-histidine, polysorbate 80, and sodium borate are there to stabilize the vaccine so that it does not degrade over time. Vaccines need to be stored cold so that they do not degrade.
The CDC has a very clear explanation of what adjuvants are:
“An adjuvant is an ingredient used in some vaccines that helps create a stronger immune response in people receiving the vaccine. In other words, adjuvants help vaccines work better. Some vaccines that are made from weakened or killed germs contain naturally occurring adjuvants and help the body produce a strong protective immune response. However, most vaccines developed today include just small components of germs, such as their proteins, rather than the entire virus or bacteria. Adjuvants help the body to produce an immune response strong enough to protect the person from the disease he or she is being vaccinated against. Adjuvanted vaccines can cause more local reactions (such as redness, swelling, and pain at the injection site) and more systemic reactions (such as fever, chills and body aches) than non-adjuvanted vaccines.”
The current vaccine against HPV, Gardasil 9, is not a weakened virus vaccine. It contains but a single protein made by the virus (see the answer to question 27 above). That’s why an adjuvant is used to generate a stronger immune response. In the case of Gardasil 9, this adjuvant is an aluminum based compound. Aluminum based adjuvants are the most commonly used ones in vaccines. The CDC notes that “aluminum salts, such as aluminum hydroxide, aluminum phosphate, and aluminum potassium sulfate have been used safely in vaccines for more than 70 years. Aluminum salts were initially used in the 1930s, 1940s, and 1950s with diphtheria and tetanus vaccines after it was found they strengthened the body’s immune response to these vaccines.”
To learn even more about the levels of aluminum in vaccines vs. the levels found in breast milk and formula, and why aluminum amounts in vaccines are too small to be harmful, check out this detailed Q&A from the Vaccine Information Center at the Children’s Hospital of Philadelphia.
You can also look at this page on vaxplanations to see a good explanation about why aluminum in vaccines is not a safety risk, or at this page produced by the Immunization Advisory Centre of New Zealand.
28) The HPV vaccine has to be given BEFORE infection to prevent cancer and genital warts, but the vaccine to prevent shingles (Shingrix) is given to older adults decades AFTER they were infected with the virus that causes chickenpox. Why is there a difference? Why won’t the HPV vaccine work after infection, like the shingles vaccine?Open or CloseThe short answer is that the two viruses are of different types and function in distinct ways to cause disease. Human papilloma virus infections are generally fought off by your immune system, but in some cases the virus itself integrates itself into your cellular DNA. On rare occasions this leads to the development of cancer, sometimes many decades later. Put another way, it’s not an active viral infection that causes disease; its the activity of only a few viral genes within your cells that can eventually lead to problems. The vaccine is meant to attack the virus BEFORE it can integrate itself into your DNA. The vaccine cannot prevent the cells from developing cancer once the viral DNA has been integrated, nor does it target the infected cancer cells.
With the chickenpox virus (varicella-zoster) that causes shingles, the entire virus itself can lurk for decades within your nerve cells. As you get older, a decline in the efficiency of your immune system allows the virus to re-emerge, where it can lead to the painful rashes and nerve damage associated with shingles. The shingles vaccine works by generating an immune response against the entire virus, thereby preventing it from causing disease, or at least lessening severity.
The incidence of infection with HPV and chickenpox viruses are similar in that the infection rate is very high in adults in the U.S. More than 90 percent of sexually active adults will get an HPV infection during their lifetimes, and nearly 100 percent of adults will have been exposed to the chickenpox virus (even if they don’t realize it). Gardasil 9 (the current HPV vaccine) is targeted at preventing cancer and genital warts in older adults (except for cervical cancer, which strikes younger women), and the shingles vaccine (Shingrix) is also targeted at the older adult population. In that way they share another similarity. However, the HPV vaccines are meant to be given to kids (and now adults up to age 26), whereas Shingrix is only given to older adults in their 50s, 60s, and older.
The viruses are transmitted in different ways. Chickenpox is transmitted from person to person by directly touching the blisters, saliva or mucus of an infected person. It can also be transmitted through the air by coughing and sneezing. In contrast, HPV is passed via sexual contact; it is NOT transmitted via coughing and sneezing. See question 4 on the HPV FAQ page for more details.
Finally, researchers are trying to develop therapeutic vaccines against HPV that would work after you’ve been infected, just as the shingles vaccine works following infection. Whether such efforts will be successful is unknown. See the answer to FAQ 23 above for more details.
29) I hear there’s an effort to make some new HPV vaccines. Why would someone try to do that?Open or CloseGSK, which makes the Cervarix HPV vaccine, has entered into a collaboration agreement with collaborative agreement with the Chinese company Xiamen Innovax Biotech to develop and commercialize a next generation HPV vaccine. The partnership will aim to deliver a HPV vaccine that uses GSK’s adjuvant systems that is part of the Cervarix vaccine. Innovax has already developed a cervical cancer vaccine, Cecolin, which is HPV 16 & 18 bivalent – these two HPV types are known to cause at least 70% of cervical cancers. This GSK/Innovax vaccine was approved for sale in China on Dec. 31, 2019. Innovax also has a 9-valent HPV vaccine in a phase 2 clinical trial, which will help to protect individuals against diseases caused by nine types of HPV. Note that the GSK/Innovax vaccine uses a different adjuvant system than Merck’s Gardasil 9. The adjuvant is GSK's proprietary AS04 adjuvant system. AS04 is composed of an aluminium salt and monophosphoryl lipid A (MPL); MPL is an immunostimulant capable of directly activating key immune mechanisms, which will ultimately enhance the immune response to the antigens included in the vaccine.
It was announced in late March 2020 that China's first domestically produced vaccine against the human papillomavirus (HPV), Cecolin, will be available by appointment from May, making China the third country in the world to achieve an independent HPV vaccine supply after the US and the UK. Prior to the new vaccine, HPV vaccines available in China were all imported ones, produced by a British pharmaceutical company, which makes a two-valent HPV vaccine and a US drugmaker that produces a four-valent vaccine and a nine-valent HPV vaccine, according to a December notice published on the official website of the National Medical Products Administration.
“The vaccines, especially the 9-valent one, have been in short supply in China, compared to the high demand. Statistics show that a total of 1.46 million doses of HPV vaccines were issued in China in 2017; 7 million issued in 2018; and 8.7 million issued from January to November in 2019. But there are currently 356 million people aged from 9 to 45 in China who are potential candidates for HPV vaccination, according to media reports.
A staff member at a health service center in Jing'an district of Shanghai told the Global Times on Tuesday that people now need to wait about two to three months to get four-valent and nine-valent vaccines at their center.
"I registered for vaccination with the four-valent HPV vaccine at the health service center of my community in October last year and have not been vaccinated yet," Zhang Yanli, a Shanghai resident, confirmed with the Global Times.
The new vaccine is much cheaper with each dose priced at 329 yuan ($46.50), compared to imported ones.
The staff member at the Jing'an service center said that vaccination with the all three types of imported vaccines take three doses. The two-valent and four-valent vaccines at the center cost 585.5 yuan and 808.5 yuan per dose respectively, while the nine-valent one could reach over 1,300 yuan per dose.
The price is even higher at private clinics. At a Shanghai-based private clinic that Global Times reached out to, three doses of imported two-valent HPV vaccines cost 2,788 yuan, the four-valent costs 3,888 yuan and the nine-valent costs 5,980 yuan.
"I am going to get vaccinated (with the domestically made vaccine), it is much cheaper," one Sina Weibo user commented, while some others are still looking forward to four- or nine-valent ones to be developed in China.
Wang Jun (pseudonym), a Beijing based medical expert in immunology, sees the new vaccine as a sign of China's huge market in HPV vaccine and expects to see China-made HPV vaccines that cover more virus types. "Chinese women have high regard for HPV vaccines as people are more likely to be protected through one immunization," Wang added.
A nine-valent vaccine by the company has reportedly entered into a clinical trial.”
One new approach is to make the HPV vaccine in plants. Why would people want to do that? Simply because it might be cheaper to produce. Making vaccine components in plants would be a way to get the cost of the vaccine down, which would make it easier to get it to more people worldwide. It might also make it easier to create a vaccine that guards against more strains of the virus than the current standard, Gardasil 9, which only protects against nine strains. In this study, they expressed the L2 protein encoded by HPV, whereas the current vaccine targets the L1 protein. The resulting proteins were shown to be highly immunogenic in mice.
This is simply a demonstration project for the technology. You can read about this project here, or look at the scientific paper reporting it:
Diamos et al Vaccine synergy with virus-like particle and immune complex platforms for delivery of human papillomavirus L2 antigen. Vaccine Volume 37, Issue 1, 3 January 2019, Pages 137-144. (FREE download).
30) I’ve heard that it’s now possible to get the HPV vaccine from my dentist. Is that true?Open or CloseYes, and no. Oregon just became (May 2019) the first state in the country that will allow dentists to give all vaccines to their patients. Minnesota and Illinois also allow dentists to administer vaccines, but only to protect against the flu and only in adult patients. While it’s unlikely that many people will turn to their dentists for their MMR, chickenpox, or shingles vaccines, this new law provides dentists an opportunity to both educate and administer the HPV vaccine to their patients. There’s a good rationale for this: HPV causes about 70 percent of oropharyngeal cancers in both men and women. The vaccine, if given to people prior to infection, will prevent the majority of these cancers from every happening.
Oregon is, however, the only state that allows dentists to vaccinate. Now that they have blazed this trail, other states may follow their lead. Many states will likely look to Oregon in a few years to see how successful this program has been statewide.
There are some headwinds that need to be overcome for dentists to become frequent providers of vaccines:
1) Education of dentists about the advantages of providing vaccines to their patients. The Oregon Health Sciences University is working with the Oregon Board of Dentistry, Oregon Board of Pharmacy, Oregon Health Authority, and the Oregon Dental Association to determine how dentists should be trained to provide vaccinations. As the state’s only dental school, the School of Dentistry will likely provide hands-on vaccination training to both practicing dentists and dental students. Which vaccines should dentists give? Since HPV causes a large percentage of oropharyngeal cancers in both men and women, it would make sense for dentists to offer to vaccinate their patients to prevent this. Dentists need to be educated about the fact that HPV causes this type of cancer, and what they can do about it. It’s likely that dentists will generally focus on giving only a subset of possible vaccines rather than give them all. It doesn’t make sense, for example, for them to give vaccines that traditionally are given to babies to older kids. In the case of HPV, dentists can also help with oral cancer exams and sending patients that have any suspicious findings to see an ENT doctor. Dentists could be in the unique position of both preventing the oral cancers caused by HPV as well as helping to screen older patients for the presence of HPV-caused cancers.
2) Educate parents as well. Patients are not used to getting vaccines from dentists, only from their doctors. They will need to be made more comfortable with this new way of doing things.
3) A need to set up their offices for vaccinations. This will require dentists to purchase special refrigerators that can store vaccines at the proper temperature, and that keep a record of that. Dentists will also likely want to subscribe to electronic health records (EHR) that will record the vaccination information and interface with similar EHR systems used by doctors. This is to avoid having individuals vaccinated against the same diseases by both their doctors and their dentists because the patients themselves do not always remember when or if they got particular vaccines, or who gave it to them.
4) Insurance coverage will be important here. Dentists will need to coordinate with different insurance providers (e.g. medical insurance) to provider reimbursement for vaccines, or dental insurers will need to start providing vaccine coverage as well.
31) What’s been the focus of TV ads for the HPV vaccine?Open or CloseThe early ads for the first HPV vaccine (Cervarix) were focused exclusively on vaccinating girls, and the intent was clearly on prevention of cervical cancer.
That’s changed now with current ad campaigns making the case that girls AND boys need to be vaccinated. The only HPV vaccine still being used in the US is Gardasil 9 that’s produced by Merck. They’ve run several types of ad campaigns as of late. The focus of the first campaign was on showing parents feeling guilty that they didn’t vaccinate their kids, who went on to develop HPV-caused cancers. Here’s an example.
The second ad campaign by Merck is called Versed, and focuses on reaching out to young millennials with an educational question and answer approach. Some liked the approach, but I question how effective it will be on a population that has had all of their vaccination decisions made by their parents when they were growing up.
32) I know that the HPV vaccine only targets a small number of strains. How many different strains of HPV are there?Open or CloseLots. Scientists have found around over 170 different strains of HPV. The strains are not equally prevalent in people. Some are quite common, while others are very rare. Only strains that either cause cancer or genital warts are targeted by the current vaccine.
33) How many cancer-causing strains of HPV does the current vaccine protect you from?Open or CloseThere are 16 strains that are thought to cause cancer (16, 18, 31, 33, 34, 35, 39, 45, 51, 52, 56, 58, 59, 66, 68 and 70). These strains are often referred to as “high risk” strains. The term 'high-risk' means that these types of HPV are more likely than other types to cause cancer. However, most HPV-associated cancers are linked to just two types of HPV: types 16 and 18. There are over 170 different types of HPV that have been identified to date. Forty HPV strains are sexually transmitted.
The current HPV vaccine, Gardasil 9, provides protection against seven of these strains: 16, 18, 31, 33, 45, 52, and 58.
34) Why don’t more parents get their kids vaccinated against HPV if it’s so dangerous?Open or CloseThis is a very complex subject that’s been looked at in a number of studies. There are many reasons, and they cut across all parts of the ideological spectrum. Many parents are simply uninformed about the long-term dangers of HPV infections, and don’t understand the need to vaccinate boys as well as girls. They’ve picked up on the general climate of fear and misinformation about vaccines that pervades some communities. This leads them to take the path of least resistance and skip the vaccines.
Parents also grossly underestimate the age at which kids start to have sex, and the percentage of them that do. As you can see in the graphic below, 20% of kids are having sex before the age of 15! The data below are from the CDC and can more details can be found here.
Let’s take a look at many of the oft-stated (but erroneous) reasons parents refrain from getting their kids vaccinated, but now with a cancer context.
Belief That Childhood Illnesses Are Not All That Dangerous
For many of these diseases, parents wrongly believe that they’re innocuous, a mere inconvenience in their lives. No big deal. They’ve bought into the erroneous idea that vaccines may do more harm than the disease ever could. They’ve never seen children hospitalized and/or dying from measles, diphtheria, or whooping cough (pertussis) infections. Every one of these diseases can be fatal, but few parents personally know anyone who died from them. They think it won’t happen to their kids, or their friend’s kids. Out of sight, out of mind.
HPV-induced cancers are a significantly more serious medical issue than the usual spectrum of childhood illnesses. Let me share what I’ve learned about one of the two most prevalent HPV cancers (and the one I was diagnosed with): oropharyngeal (oral) cancer. Unless it’s detected very early, patients are not even eligible for surgery. It’s straight to radiation and chemo, with their accompanying side effects. Nausea. Vomiting. Tiredness. Radiation burns. Difficulty swallowing. Loss of taste. Damaged salivary glands. And that’s if it hasn’t spread yet. The vaccine would prevent most of the cancer-causing infections with HPV, and could cut the number of oropharyngeal cancer cases in men by 70 percent. Cancer prevention is always preferable to cancer treatment.
When you daydream about your kids growing up, you likely picture graduations, weddings, and grandchildren, not their funerals. Maybe what parents need to see is an illustrative display of guts and gore, something reminiscent of the movies used to scare the crap out of teenagers in high school drivers ed classes. Imagine a series of cancer horror films in the same vein as Mechanized Death, Wheels of Tragedy, or Highway of Agony. These days, that would take the form of YouTube videos showing how HPV infections can lead to bulging tumors, feeding tubes, disfigured patients, and bereaved family members. Would this help turn the tide and up the vaccination rate?
Objection To Mandated Vaccination Requirements
Some parents resent being told by their state or local governments, or school districts, that they need to get their kids vaccinated against a variety of childhood diseases. For them, it’s an issue of freedom, being able to choose what’s right for their kids. That’s NOT the case with the HPV vaccine. Only three jurisdictions (RI and VA, along with the District of Columbia) currently mandate HPV vaccinations to attend school. Yes, many states have introduced legislation around HPV infections, but that simply funds vaccinations and/or educates families about the vaccine. Parents are simply being given the chance to make a good decision for their children. We need more of them to take advantage of this opportunity. These vaccines are truly lifesaving!
They Don’t Know About HPV Or The Cancers It Causes
Vaccinations against HPV differ from the ones given for most childhood diseases in three important ways: (1) the common childhood diseases are easily transmitted between kids via the air or casual contact. HPV cannot be passed that way. (2) HPV immunization is recommended for both boys and girls when they’re about 11 or 12, which is much later than for other childhood vaccines. (3) Unlike other childhood illnesses, where acute disease rapidly follows exposure, the cancer-causing effects of HPV only manifest themselves many years, or even decades, after infection.
Concerns That The Vaccine Will Lead Kids To Promiscuity
Because HPV is a sexually transmitted disease, some parents fear (as with birth control) that vaccination will quell their kids fears about sex. This will lead their children down the path to promiscuity. There’s simply no data that supports that conclusion. And while it’s clear that the virus is sexually transmitted, it’s unclear as to how that process takes place. Research on this subject is continuing.
Lack of Trust in Companies That Make Drugs in General, and Vaccines in Particular
People will say they simply don’t trust pharma companies to make vaccines that are both safe and effective. They argue that these companies are just in it for the money. Neither of these things are true. Pharma companies do have a bad reputation with the public due to a number of highly-publicized scandals over the past couple of decades. I wrote an opinion piece about this, Pharma’s tarnished reputation helps fuel the anti-vaccine movement, for those of who are interested in the subject.
Many parents think they can’t get their kids immunized against HPV because they simply don’t have the money to pay for it. They haven’t heard about the Vaccines for Children program of the CDC. It provides vaccines at no cost for children whose families have an inability to pay. The government buys the vaccines at a discount and sends them to providers who have signed up with the program. It’s not limited to the HPV vaccine and covers immunizations that will protect children from as many as 16 diseases. See the answer to the next question for more details about other ways to get the vaccine at no or reduced cost.
There are effective strategies for geting parents to vaccinate their kids against HPV. Here’s a link to a one hour video on Strategies for Recommending HPV Vaccination for Pre-teen Youth (2018) by Kristin Oliver, MD, MHS Icahn School of Medicine at Mt. Sinai.
The American Academy of Pediatrics also had suggestions for educating parents. Check out their HPV Champion Toolkit
You can also see recommendations from the American Cancer Society on this subject.
You can also check out this Powerpoint presentation on HPV infection and immunization rates in adolescents by Jennifer E. Dietrich, MD, Msc, Baylor College of Medicine. It looks at such issues as age of first intercourse (7% BEFORE the age of 13!), infection statistics of women, and vaccine coverage by different racial/ethnic groups.
35) I’m worried that the HPV vaccine will make my kids promiscuous.Open or CloseThere’s no need for parents to worry about this. First, a number of studies have shown that kids getting the vaccine don’t wind up having sex any more often than kids who don’t. Also, keep in mind that the vaccine, while protecting against HPV, does nothing to prevent other sexually transmitted infections, including gonorrhea, syphilis, chlamydia, herpes, and HIV. There are no vaccines to prevent these other sexually transmitted infections. Therefore, the HPV vaccine should really have little effect on whether or not kids have sex. Parents should remember that cancer prevention via the HPV vaccine beats having their kids someday need cancer treatment.
Here’s a recent cohort study you can look at that reinforces the message that the HPV vaccine does not lead to promiscuity: Brouwer, A.F. et al HPV vaccination has not increased sexual activity or accelerated sexual debut in a college-aged cohort of men and women. BMC Public Health201919:821. https://doi.org/10.1186/s12889-019-7134-1 FREE download.
You can also look at this paper published in the journal Pediatrics, Legislation to Increase Uptake of HPV Vaccination and Adolescent Sexual Behaviors. The authors concluded, “Implementation of HPV legislation was not associated with changes in adolescent sexual behaviors in the United States.”
36) I heard a story saying that data suggesting that the HPV vaccine causes cervical cancer was faked. What’s the story?Open or CloseThis is a sad story and it’s true; a real example of “fake news”. This was apparently done as part of a deliberate effort to stop people from vaccinating their kids against HPV. The data was contained in an article in the Indian Journal of Medical Ethics entitled “Increased incidence of cervical cancer in Sweden: Possible link with HPV vaccination”. The paper was published under a pseudonym by someone claiming to be a member of the Karolinska Institute in Sweden. However, no one with that name ever worked there, and the paper was subsequently withdrawn from the journal. You can read more about the incident here. This also illustrates why one should be suspicious of articles published in obscure journals.
37) If HPV usually clears by itself, why should we vaccinate our kids against it?Open or CloseBecause usually isn’t always. You don’t usually crash your car every time you drive it, but does that mean you don’t wear a seatbelt?
Your 5 year old doesn’t fall off her bike every time she rides it, but she still needs a helmet to keep her safe.
There is simply no way to predict today if your kids will be the lucky ones who are able to clear the infection, or if they’ll be unlucky ones who won’t. Let’s look at some of the numbers. It’s estimated that 14 million people in the US get infected with HPV every year. That’s a lot of people, and there are about 35,000 cases of HPV-caused cancer diagnosed each year. That includes all of the cancer sites: oropharyngeal and anal cancers in both genders, penile cancers in men, and vulval, vaginal, and cervical cancers in women (see FAQ6 on this page for details). And that’s just cancer. About 1% of people develop genital warts following HPV infection (see FAQ11 on this page), and the vaccine can prevent most of these as well. Finally, if you’re worried about rare side effects, keep in mind that more people are struck by lightning or attacked by a shark each year than suffer a serious adverse event from the vaccine (see FAQ 13 above). Vaccination is the smart choice for parents.
38) Can teenagers get the HPV vaccine without their parents consent?Open or CloseSometimes. It depends on where they live.
According to this 2019 report from NBC News, each state has legal exceptions that allow minors to get diagnosed and treated for sexually transmitted diseases. In addition to New York, California, Delaware and Washington, D.C., allow teens under 18 to be vaccinated for HPV and hepatitis B, which is also sexually transmitted.
There are at least 24 states that allow dependent teens to be vaccinated without their parents’ consent. Generally, unless teens are legally emancipated, married or are already parents, they have no recourse when their parents or other legal guardians refuse vaccines, including the HPV shot, on their behalf.
However, because of the rise of anti-vaccination movement and concern over the measles outbreaks in the U.S., more state legislatures are trying to create a legal way for dependent teens to get vaccinated, in particular for HPV, without their parents' consent. Difficulties in achieving this legislatively have led some state Departments of Health (e.g. NY state) to change regulations allowing teenagers to get the HPV vaccine on their own.
Expect this topic to be in flux for the next few years, and results will vary from state to state.
39) How many countries vaccinate their kids with the HPV vaccine?Open or CloseAccording to the World Health Organization, “Over 100 countries have licensed one or more HPV vaccines, and as of 9 August 2017, globally 74 countries (including 33 countries in the WHO European Region) have added HPV vaccination to their national immunization programme for girls, and 11 countries also for boys.”
One year later, 16 more countries had added the HPV vaccine: By July 2018, “the HPV vaccine was introduced in 90 countries covering 31 percent of global cohort of 9-14 years old girls. Estimates are now available for 74 countries: 31 reach coverage of less than 50%, 18 reach over 80% of their target. Unfortunately, those most at risk of cervical cancer are least likely to have access to the vaccine. Just 13 lower-income countries have made it available to date.”
Note that the number of countries now vaccinating boys has increased in 2018 (see the question below).
The World Health Organization has recommended that ALL countries include the HPV vaccine in their routine vaccination schedules. However, if you look at the graphic below, you will see that there are many countries that have NOT yet introduced the vaccine as of 2019:
40) Are there many countries that vaccinate only girls, and not boys?Open or CloseYes. In fact, these countries are the rule, not the exception. According to the World Health Organization, of the 74 countries that have national HPV immunization programs, only 13 of those countries (as of 2017) vaccinate boys as well as girls (that’s only 15% of these countries). As of late 2018, about 20 countries have now decided to vaccinate boys as well as girls (see below).
I do not believe there are any countries that only vaccinate boys, not girls.
Let’s look at some other countries making news recently:
New countries adding the vaccine for girls:
Not all countries even have a policy of vaccinating girls, but this is slowly changing. On Oct. 10, 2018, Hong Kong officials announced that all school girls age 9-11 will be vaccinated against HPV. Vaccinations will be given at school. The goal is to decrease the number of cervical cancer cases. In 2015, there were 500 new cervical cancer cases in Hong Kong, and 169 women died of the disease. Taiwan also announced that they will start vaccinating girls at the end of 2018. Kenya announced it will provide the vaccine for free to girls starting in 2019 following a successful pilot program. Malawi will start vaccinating girls in 2019. Singapore will be providing free HPV vaccine to girls starting in 2019. Zimbabwe launched a campaign to vaccinate over a million girls in a week in May 2019. Costa Rica started vaccinating girls in June 2019. Kenya began vaccinating girls in Oct. 2019. Qatar will be adding HPV to their immunization schedules in 2020 (not clear the genders involved).
Another recent success story is the Philippines. While the government has a program for vaccinating girls, it does not reach those living in the poorer corners of the islands. Doctors Without Borders launched a massive vaccination program in the Tondo slums to vaccinate 25,000 girls between the ages of 9 and 13. Merck provided the vaccine at a discounted rate. You can read about this successful effort here.
Countries that have recently started to vaccinate boys:
Australia has been a leader in HPV vaccination. It mandated the HPV vaccine for girls beginning in 2007. In 2013, the mandate was expanded to boys. In 2017 New Zealand added boys in their HPV vaccination program as well.
The UK has just agreed to finally start vaccinating boys as part of the Department of Health and Social Care, although a start date for the vaccinations has not been announced. This will include England, Wales, and Scotland. Denmark announced in late 2018 that boys would get the HPV vaccine. Portugal announced that boys would get the HPV vaccine starting in 2019. Germany will start vaccinating boys in 2018 or 2019. Ireland will start vaccinating boys in 2019, as will Northern Ireland. Antigua will start vaccinating boys in 2019. I am trying to confirm that Belgium’s French-speaking Wallonia region and the Dutch speaking part of the country will start paying for HPV vaccines for boys as well! Guyana announced in 2019 that boys will get the HPV vaccine. The Netherlands are adding boys to the vaccination schedule in 2021. France is adding boys to the vaccination schedule starting in 2020.
With so many countries in Europe coming on board to vaccinate boys, some at WHO have raised concerns that this will lead to a shortage of the vaccine for immunizing girls in poorer countries of the world. This issue may be ameliorated if dosing eventually switches from 2 or 3 doses per individual to a single dose. Several studies have now been done (see FAQ 1 above) indicating that a single dose of the vaccine may be equally active as the current multiple dose scheme.
41) Are there global disparities in the use of the HPV vaccine?Open or CloseHere’s an article from 2016 that looks at HPV vaccination rates globally. It explains why women in poor countries (where the vaccine is not generally available) remain at greater risk of developing cancer (especially cervical cancer) and dying from HPV than women from wealthier countries. See Global estimates of human papillomavirus vaccination coverage by region and income level: a pooled analysis: Bruni et al Lancet Vol. 4, No. 7, e453-3463 (2016).
One of the countries that has shown the greatest success in providing the HPV vaccine to girls is Rwanda, with 99% of school age girls vaccinated. To learn how they did this, take a look at How Rwanda could be the first country to wipe out cervical cancer.
42) I’ve heard that laws mandating vaccinations (including the HPV vaccine) are very strict in Australia. What’s happening there?Open or CloseVery strict indeed, and these apply to all required vaccines, not just the HPV vaccine. In 2016 the Australian federal government introduced a law called “no jab, no pay,” under which parents of unvaccinated children lose government benefits and welfare rebates — costing them up to 15,000 Australian dollars. That policy also didn’t allow for non-medical exemptions. You can get more details by reading this NY Times piece No Jab No Pay: How Australia is Handling Vaccinations.
There is legislation pending that would ban unvaccinated children in preschool and child care centers, and would fine these centers up to 30,000 Australian dollars, or about $24,000, if they allow an unvaccinated child to attend. Parents who object to vaccination on philosophical or religious grounds would not receive exemptions. The new laws are meant to combat the efforts of anti-vaccination groups.
As a result of their aggressive vaccination program for girls, Australia may become the first country to eradicate HPV-caused cervical cancers (according to the International Papillomavirus Society). You can read more about this in In Australia, Cervical Cancer Could Soon Be Eliminated, or look at this free paper in The Lancet The projected timeframe until cervical cancer elimination in Australia: a modelling study DOI:https://doi.org/10.1016/S2468-2667(18)30183-X
Compare this with the United States, where only three states have gotten rid of their personal belief exemptions that made it possible for parents to opt out of required vaccines because of their beliefs. California just did it in 2015, becoming only the third state — along with Mississippi and West Virginia — to have such a strict requirement. It’s much easier for parents in the other 47 states to opt out of having their children vaccinated for “personal reasons”, putting their kids and others at risk.
43) Why did Japan stop recommending the HPV vaccine after it had been on the market?Open or CloseThe HPV vaccine was introduced in Japan in 2013, and was widely accepted, and the percentage of girls being vaccinated in Japan was about 70 percent. The withdrawal of the vaccine recommendation several months after introduction happened because the government was concerned about adverse events associated with the vaccine. Note that government did NOT order the vaccine be taken off the market. They simply decided to stop recommending it. This was based on the fact that the Health Ministry was investigating 43 adverse events that were seen out of around 3.3 million HPV vaccinations given. This number was later bumped up to 176 adverse events, or 0.0019% of the cases. This is equal to about 1.9 events per 100,000 Gardasil vaccinations. The adverse events were temporally linked (that is, an event was noted after someone was immunized), but they could not establish a causal link to the vaccine. You can read more about this here.
In 2016, the Japan Expert Council on Promotion of Vaccination, representing seventeen Japanese academic health and medical societies involved in immunization, issued a statement appealing to the government to reverse the suspension and resume the proactive recommendation of the HPV vaccine based on the investigations and advice of the global scientific community. The government did nothing in response to this request, and this is where the situation still stands.
So did the vaccine work well in Japan while it was being given? We have a preliminary indication that this was indeed the case. I say preliminary because this info below was reported at a recent science meeting, and NOT in a published, peer reviewed journal. I will update this when the actual paper is published. Here is what the early data says, according to this Skeptical Raptor blog report:
“Results from a prospective cohort study of young Japanese women who received the HPV vaccine were presented to the Society of Gynecologic Oncology 50th Annual Meeting on Women’s Cancer which was held in Honolulu, Hawai’i in March 2019.
In this study, HPV screening and type-specific HPV testing were performed on 2,493 Pap test specimens collected from Japanese women aged 20 to 21 years during the period covering 2014 to 2017. Study participants provided HPV vaccination history through the completion of a questionnaire provided to the participants.
Here are some of the key results:
For the years 2014 to 2017, HPV vaccination rates were 28.6%, 74.8%, 76.7%, and 80.0%.
The prevalence of HPV 16/-18 infection (the subtypes most linked to cervical cancer) was 1.3% in 2014, 0.5% in 2015, 0.4% in 2016, and 0% in 2017. These are all statistically significant.
In 2014, the most prevalent strains were HPV-52, HPV-16, and HPV-56. HPV-52, HPV-51, and HPV-58 were most prevalent in 2017.
This study makes some very important observations. First, the Japanese HPV vaccine uptake has increased despite the Health Ministry error – it seems higher than the uptake in the USA which has never withdrawn recommendations for the vaccine.
Second, HPV 16/18 has apparently disappeared (or it’s so rare that it can’t be detected). This is powerful evidence for the effectiveness of the vaccine.
Finally, the population of HPV strains has shifted to HPV-52, HPV-51, and HPV-58. Of course, the “newer” Gardasil 9 protects against 52 and 58, so that will probably begin to reduce those subtypes.”
If you want to learn more about the HPV vaccine in Japan, read A Hundred Thousand Wombs by Riko Muranaka for a personal look at how rumors about the safety of HPV vaccine in Japan caused vaccination rates to plunge from about 70% to 1%. The author, a doctor, medical writer, and lecturer at Kyoto University won a prestigious award (the John Maddox prize) for exposing that data supporting a claim made by Dr. Ikeda that the “HPV vaccine is dangerous” were false. Ironically, Dr. Muranaka was later found guilty of defaming the researcher and ordered to pay him damages. According to the journal Science, “Ikeda had presented preliminary results based on an experiment with one mouse as “scientifically proven.” Japan’s health ministry issued a statement saying Ikeda’s results “have not proven anything about whether the symptoms that occurred after HPV vaccination were caused by the HPV vaccine,” and blasting him for his “very regrettable” responsibility in “causing misunderstanding among citizens.” Normile, D. Science (2019) Japanese court rules against journalist in HPV vaccine defamation case doi:10.1126/science.aax4915
The story is also covered in Why Japan’s HPV vaccine rates dropped from 70% to near zero, and how one doctor is fighting back.
Similarly problematic was another paper published by a Japanese group claiming that the HPV vaccine could lead to neurological damage. This paper, Murine hypothalamic destruction with vascular cell apoptosis subsequent to combined administration of human papilloma virus vaccine and pertussis toxin, was later retracted by the journal that published it, Nature Scientific Reports. The reasons given for retracting the paper included “the experimental setup, the use of a dose proportionally far larger than what is normally given, the use of the toxin, and inconsistencies between the data presented and the descriptions of results, among other issues.”
As a result of Japans essentially stopping giving the HPV vaccine, it’s been estimated that, if a vaccination catch-up program is NOT put in place, then there will be an additional 24,600–27,300 cervical cancer cases and 5,000–5,700 deaths over the lifetime of cohorts born between 1994 and 2007, compared with if coverage had remained at around 70% since 2013.
Simms, K.T. et al Impact of HPV vaccine hesitancy on cervical cancer in Japan: a modelling study. Lancet Public Health 2020. Published Online February 10, 2020 https://doi.org/10.1016/ S2468-2667(20)30010-4. FREE download.
44) What is the HPV-FASTER concept?Open or CloseThe basic goal of this idea is to speed up the elimination of cervical cancer across the world The concept, proposed in 2016 by Xavier Bosch and colleagues, is a generalised HPV vaccination campaign aimed at females aged from 9 up to 30–45 years, paired with at least one HPV-screening test at any age above 30 years, and triage/diagnostic assessments of women who screen HPV positive. You can read more about this in HPV-FASTER: broadening the scope for prevention of HPV-related cancer. This article is an abridged version of Nat Rev Clin Oncol 13:119–132. doi:10.1038/nrclinonc.2015.146
45) I heard recently that Merck’s ability to produce their HPV vaccine was seriously damaged a few years ago by a global Russian cyberattack. Is this true, and if so, what exactly happened?Open or CloseThis is a true story. Merck, the manufacturer of the Gardasil 9 HPV vaccine, came under Russian cyberattack in the summer of 2017. The attack was NOT focused on Merck; they were simply collateral damage and their computers were not the primary focus of the assault. The attack was actually launched against Ukraine. The NotPetya cyberattack crippled the company’s computers for weeks, and as a resulted it greatly inhibited the ability of the company to make this life-saving vaccine. According to this article about the attack, “Merck estimated initially in regulatory filings that the malware did $870 million in damages. Among other things, NotPetya so crippled Merck’s production facilities that it couldn’t meet demand that year for Gardasil 9, the leading vaccine against the human papillomavirus, or HPV, which can cause cervical cancer. Merck had to borrow 1.8 million doses—the entire U.S. emergency supply—from the Pediatric National Stockpile. It took Merck 18 months to replenish the cache, valued at $240 million. (The Centers for Disease Control and Prevention say the stockpile’s ability to deliver medicine wasn’t affected.)”
46) I heard that the HPV vaccine trials were done without using a saline control. Are these studies valid?Open or CloseThere were many trials done to establish the safety and efficacy of the HPV vaccine. Many of the trials were done with additional ingredients (typically, an aluminum adjuvant) in the control group. That is actually the best way to test out vaccines to see if there is a difference between the control and vaccinated groups caused by the immunogen (which in this case is a protein from HPV that evokes the important immune response). Of the many trials done, two of them were done with saline controls. Both showed that the vaccine was both safe and effective. So if anyone tells you that the HPV vaccine trials were done without saline control groups, you can tell them they are wrong, and share these two papers with them.
Reisinger, K.S. et al Safety and persistent immunogenicity of a quadrivalent human papillomavirus types 6, 11, 16, 18 L1 virus-like particle vaccine in preadolescents and adolescents: a randomized controlled trial. Pediatr Infect Dis J. 2007 Mar;26(3):201-9.
Ferris, D. et al Long-term Study of a Quadrivalent Human Papillomavirus Vaccine. Pediatrics Volume 134, Number 3, September 2014
A binary choice: cancer prevention with the vaccine, or someday possible treatment without it.