Human Papillomavirus (HPV) Vaccines
Vaccination against human papillomavirus (HPV) is recommended to prevent new infections and associated diseases, including cancers, says the WHO.
There are safe and effective HPV vaccines to protect males and females against cancers caused by HPV. These vaccines include 9vHPV, 4vHPV, and/or 2vHPV, says the US Centers for Disease Control and Prevention (CDC). HPV vaccination for adolescents has been recommended for females since 2006 and males since 2011. The current HPV vaccine recommendations are found on this CDC website.
The American Cancer Society updated its guideline for HPV vaccination. The new recommendations are for healthcare providers to routinely offer the HPV vaccine series to boys and girls between ages 9 and 12.
HPV Preventive Vaccines - Approved
Gardasil - Merck's Gardasil vaccine consists of 4 proteins of HPV types 6, 11, 16, and 18. Gardasil is highly efficacious in preventing virus types 16 and 18 infections responsible for approximately 70% of cervical cancer cases globally. The quadrivalent vaccine is also highly efficacious in preventing anogenital warts, a common genital disease virtually always caused by infection with HPV types 6 and 11.
Gardasil 9 - Gardasil 9 consists of HPV proteins, Types 6, 11, 16, 18, 31, 33, 45, 52, and 58. HPV infections can lead to certain cervical cancers. Many females with cervical cancer were probably exposed to cancer-causing HPV types in their teens and early 20s. Additionally, males can get HPV, causing anal and throat cancers and genital warts.
Cecolin - Innovax's Cecolin HPV Vaccine protects women against HPV 16 and 18, two HPV types causing 70 percent of all cervical cancers, the third most common cancer among women. Starting May 18, 2020, the HPV vaccine developed by Chinese researchers is available in provincial Maternity and Child Healthcare Hospital in Wuhan.
Cervarix - GlaxoSmithKline's Cervarix is a non-infectious recombinant, AS04-adjuvanted vaccine that contains recombinant L1 protein, the major antigenic protein of the capsid, of oncogenic HPV types 16 and 18. This HPV vaccine was pulled from the US market on 10/2016.
HPV Therapeutic Vaccines - Candidates
TG4001 - TG4001 is Transgene's vaccine candidate using an attenuated and modified poxvirus as a vector expressing the HPV16 E6 and E7 proteins interleukin-2.
VGX-3100 - Inovio's investigational immunotherapy vaccine includes DNA plasmids targeting the E6 and E7 proteins of HPV types 16 and 18.
INO-3107 - Inovio's DNA medicine is evaluated in a Phase 1/2 trial to treat recurrent respiratory papillomatosis, a rare disease caused by human papillomavirus types 6 and 11 infections.
VTP-200 - Vaccitech's ChAdOx1-HPV immunotherapy for high-risk HPV infection and associated low-grade cervical intraepithelial neoplasia. The platform has a differentiated ability to induce CD8+ T cells and cells of the immune system that naturally clear HPV-infected cells in cervical tissue. In addition, VTP-200 targets six early proteins from five different high-risk HPV groups and therefore covers more types of HPV than any other immunotherapy previously tested.
HB-201 - HOOKIPA Pharma Inc.'s monotherapy is designed to use an arenavirus backbone (LCMV for HB- 201) while expressing the antigen, an E7/E6 fusion protein derived from HPV16+.
HPV Vaccine News 2021
September 17, 2021 - The JAMA Network published an Original Research: Trends in Human Papillomavirus Vaccine Safety Concerns and Adverse Event Reporting in the United States. This cross-sectional analysis of the 2015 to 2018 National Immunization Survey indicates a 79.9% increase in the proportion of parents who refused the HPV vaccine for their adolescents due to safety concerns. In contrast, the national vaccine safety surveillance system estimates found that the HPV vaccine adverse event reporting rate per 100 000 doses distributed decreased from 44.7 in 2015 to 29.4 in 2018.
September 2, 2021 - A new study published by the JAMA Network regarding future oropharynx cancer (OPC) incidence concluded by stating, 'These findings forecast a continued shift in the landscape of OPC to an older population. The results of this study suggest that the association of current HPV vaccination trends with OPC will be modest during the next 25 years because the reduction in OPC incidence associated with HPV vaccination among older adults, who have the highest incidence of disease, will take longer.'
August 30, 2021 - Yale Cancer Center and all National Cancer Institute (NCI)-designated cancer centers and 15 leading academic and freestanding cancer centers with membership in the Association of American Cancer Institutes have issued a joint statement urging the nation's health care systems, physicians, parents, children, and young adults to get HPV vaccinations back on track during National Immunization Awareness Month.
August 28, 2021 - The Lancet Europe published a study that constructed a nationwide cohort of all Danish females 10 to 29 years of age from 2007 to 2016 with information on quadrivalent human papillomavirus vaccination status and infectious disease hospital contacts using national registers. Nested in this cohort, we conducted a self-controlled case series (SCCS) analysis comparing the hospitalization rates in a 90-day main risk period following the latest vaccination to reference period rates with adjustment for age and season. This study found 'Reassuringly, our large, well-controlled study does not support that human papillomavirus vaccination increases the risk of non-targeted infectious disease in any clinically meaningful way. While our study does not provide evidence against adverse effects of other non-live vaccines, it does provide evidence against the claim that all non-live vaccines increase the risk of heterologous infections in females.'
August 23, 2021 - PLOS Medicine published: Organized primary human papillomavirus (HPV)–based cervical screening: A randomized healthcare policy trial. Clinical trials have demonstrated that preliminary HPV-based screening protects against cervical cancer than cytology, but evidence from real-life implementation was missing. Conclusions - In this study, the researchers observed that a real-life randomized healthcare policy of primary HPV-based screening was acceptable and effective when evaluated against cytology-based screening, as indicated by comparable participation, referral, and detection rates.
August 23, 2021 - The JAMA Network published an Original Investigation: Incidence and Types of Human Papillomavirus Infections in Adolescent Girls and Young Women Immunized With the Human Papillomavirus Vaccine. Conclusions and Relevance - Whereas lower detection rates of vaccine-related HPV types were observed since the introduction of vaccines in female youth in New York City, rates of some nonvaccine high-risk HPV types were higher.
August 8, 2021 - Dr. Sukhum Karnchanapimai, Thailand's Director-General of the Department of Medical Sciences, reports that all lots of HPV vaccines registered have been certified by the Institute of Biological Products.
August 6, 2021 - Vaccitech's ChAdOx1-HPV immunotherapy for high-risk HPV infection phase 1/2 clinical trial was last updated. The study consists of an open-label, non-randomized, dose-escalation Lead-in phase, with nine participants with high-risk HPV in cohorts of 3 in 3 dose ascending groups will be vaccinated after SMC safety data reviews.
July 30, 2021 - The Lancet published a recent study based in Australia: Effect on genital warts in Australian female and heterosexual male individuals after introducing the national HPV gender-neutral vaccination program: an analysis of national sentinel surveillance data from 2004–18. Interpretation: The national gender-neutral HPV vaccination program has led to substantial and ongoing reductions in genital warts among Australian female and heterosexual male individuals, with a marked reduction in young individuals who received the vaccine at school.
July 28, 2021 - Study: Effectiveness Of Human Papillomavirus (HPV) Vaccination Against Penile Hpv Infection In Men Who Have Sex With Men And Transgender Women. Finding: prevalence was significantly lower in participants vaccinated at age ≤18 years than in participants with no/unknown vaccination (aPR=0.15, 95%CI:0.04-0.62), corresponding to vaccine effectiveness of 85% against 4vHPV-type HPV.
July 7, 2021 - The JAMA Infectious Diseases published a new study: Optimal human papillomavirus vaccination strategies to prevent cervical cancer in low-income and middle-income countries in the context of limited resources: a mathematical modeling analysis. We predicted that HPV vaccination could eliminate cervical cancer in Vietnam, India, and Nigeria, but not in Uganda. Compared with no vaccination, strategies that involved vaccinating girls aged 9–14 years with two doses were predicted to be the most efficient and cost-effective in all four LMICs.
June 28, 2021 - JAMA Pediatrics published a study regarding HPV vaccine uptake in the USA. The HPV vaccine has been found to prevent several squamous cell carcinomas, yet the population-level uptake of HPV vaccines remains low.
June 10, 2021 - Studies by Penn State College of Medicine researchers demonstrate that misinformation on social media may affect parents' willingness to have their children vaccinated against HPV. In the first study, a group of investigators conducted an experimental comparison of vaccine-related tweets. In the second study, researchers assessed parental support for implementing social media standards to combat misinformation.
May 31, 2021 - The Lancet published: Sustainability of neutralizing antibodies induced by bivalent or quadrivalent HPV vaccines and correlation with efficacy: a combined follow-up analysis of data from two randomized, double-blind, multicentre, phase 3 trials. Interpretation - The observed significant differences in the immunogenicity of the two vaccines are in line with the differences in their cross-protective efficacy. Protective HPV vaccine-induced antibody titers can be detected up to 12 years after vaccination.
May 31, 2021 - The Lancet published: Elimination of cervical cancer depends on HPV vaccination and primary HPV screening. Cytology as a primary screen has been replaced by primary human papillomavirus (HPV) cervical screening, which has a 70% greater protection against invasive cervical cancer than cytology.
May 24, 2021 - A study by Monash University and Alfred Health found a 70% reduction in one type of human papillomavirus (HPV) in gay and bisexual men after implementing an HPV vaccination program. The HYPER2 study, published in The Lancet Infectious Diseases, found a significant reduction in all four vaccine-preventable genotypes in gay/bisexual men aged 16-20 years. The fall in anal HPV16 and 18 may lead to a reduction in the incidence of anal cancer.
May 10, 2021 - A study published by PLOS found that HPV infection shortly before or during pregnancy was associated with PTD, pPROM, PROM, and neonatal mortality. CIN's previous treatment was associated with even greater risks for PTD and pPROM and was also associated with PROM, neonatal mortality, and maternal and neonatal infectious complications.
April 29, 2021 - The JAMA published a cohort study of 2,299,177 commercially insured women aged 30 to 65 who underwent cervical cancer screening in 2013 through 2014; 64.7% underwent repeat testing within 36 months of index testing.
April 28, 2021 - Oropharyngeal cancer surpassed cervical cancer as leading HPV cancer.
April 27, 2021 - Research Letter published by JAMA: HPV Vaccination Among Young Adults in the US.
April 20, 2021 - Study: Real-world Effectiveness of Human Papillomavirus Vaccination Against Cervical Cancer. Conclusion: The HPV vaccine's effectiveness against cervical cancer at the population level is high among girls vaccinated before age 20. The lack of immediate effect in women vaccinated at age 20–30 points to early vaccination's importance.
April 16, 2021 - The Lancet published a study: Human papillomavirus vaccination uptake in low-and middle-income countries: a meta-analysis. During 2008–2020, an estimated 3.3 million females received at least one dose of the HPV vaccine, with 61.69% of the target population vaccinated. In countries with high uptake, the pooled estimate of uptake was higher in females than males (45.48% vs. 8.45%) and showed a significant decline in 2015–2020 compared to 2006–2014 (89.03% vs. 41.48%).
April 14, 2021 - BioVaxys Technology Corp. announced the results of a clinical study conducted by ProCare Health Iberia, its EU partner for marketing its gynecological cancer and viral vaccines, which demonstrated the efficacy of Papilocare® in preventing and treating lesions caused by HPV. BioVaxys has the right to refuse US marketing of Papilocare, the world's first and only product to prevent and treat HPV-dependent cervical lesions.
April 12, 2021 - Rubius Therapeutics, Inc. announced that the first patient had been dosed in a Phase 1 clinical trial of RTX-321 to treat HPV 16-positive cancers. RTX-321 is an allogeneic, off-the-shelf Red Cell Therapeutic product candidate engineered as an artificial antigen-presenting cell (aAPC) with a dual mechanism of action: boosting HPV 16-specific CD8+ T cell responses and promoting broad stimulation of both innate and adaptive immune responses.
April 10, 2021 - HOOKIPA Pharma Inc. published positive preliminary Phase 1 immunogenicity data for its lead oncology candidates, HB-201 and HB-202, to treat Human Papillomavirus 16-positive (HPV16+) cancers. Preliminary data showed a strong antigen-specific T cell response after one dose of HB-201 or HB-202, based on direct Enzyme-Linked ImmunoSpot (ELISpot) T cell analysis. Also, the antigen-specific T cell response analysis showed an increase in CD8+ T cells specific to HPV16+ cancer after a single dose of HB-201 (baseline 0% to 2.8% two weeks later) and HB-202 (baseline 0% to 8.1% two weeks later). In addition, other preliminary immunogenicity data highlight immune system activation following a single dose of HB-201.
April 5, 2021 - According to a study published by the JAMA Network Open, women who received the human papillomavirus (HPV) vaccine inadvertently in early pregnancy show the vaccine did not cause miscarriages adverse birth outcomes. In addition, this study suggests that, in an insured population, adverse events after exposure to the 9vHPV vaccine during or around pregnancy were uncommon and not associated with small-for-gestational-age or selected adverse birth outcomes.
March 30, 2021 - The Irish Pharmacy Union announced students who received their first dose of the HPV vaccine, which protects girls against cervical cancer, fell from 80% in 2019 to just 53% in 2020. According to the union, school closures and the redeployment of school vaccination teams to Covid-19 vaccine roll-out centers have interrupted school HPV vaccination programs. As a result, around 300 women are diagnosed with cervical cancer each year in Ireland. More than nine in ten cervical cancer diagnoses from HPV infections, leading to around 90 deaths every year.
March 25, 2021 - This CDC report adds to the robust data on the national HPV vaccination program's impact, including herd effects. In addition to decreases in the prevalence of vaccine types, decreasing rates of cervical precancers and anogenital warts also have been demonstrated in the United States and other countries after the introduction of HPV vaccination. In addition to significantly lower 4vHPV-type prevalence among sexually experienced vaccinated females than in the prevaccine era, the 4vHPV-type prevalence was also lower among unvaccinated females: 87% in females aged 14–19 65% in those aged 20–24 years.
March 18, 2021 - Oxford-based Vaccitech Ltd announced the dosing of the first patient as part of the HPV001 clinical study, a randomized, placebo-controlled Phase 1/2 clinical trial designed to evaluate the safety and preliminary efficacy of VTP-200, Vaccitech's immunotherapy for high-risk HPV infection, and associated low-grade cervical intraepithelial neoplasia.
March 11, 2021 - PLOS published: Human papillomavirus vaccination for adults aged 30 to 45 years in the United States: A cost-effectiveness analysis. HPV vaccination of women and men aged 30 to 45 years provides limited health benefits at the population level, at a substantial cost (at current HPV vaccine prices). Therefore, public health decision-makers considering the option to extend HPV vaccination to adults up to age 45 years should consider this evaluation of the value—and the opportunity costs—of adopting such a policy.
March 10, 2021 - Transgene, a French biotech company that designs and develops virus-based immunotherapeutics against cancer, announces the expansion of a randomized, controlled study with TG4001 combination with avelumab versus avelumab monotherapy in patients with HPV16-positive anogenital tumors.
March 4, 2021 - "It's far better to prevent cancer than treat cancer," says Andrew Kung, Chair of the Department of Pediatrics at Memorial Sloan Kettering Cancer Center MSK Kids. This Vaccine Can Protect Your Child Against Cancer: Get the Facts about the HPV Vaccine.
March 4, 2021 - A global partnership of over 80 organizations led by the International Papillomavirus Society has mobilized to raise awareness and understanding about HPV worldwide. Partners of the HPV Awareness Campaign' think globally and act locally,' using social media and community events to get people of all ages and backgrounds talking about HPV, learning how it affects them, and taking action to reduce their risks.
March 2021 - Preventive Medicine published: Current and future vaccine clinical research with the licensed 2-, 4-, and 9-valent VLP HPV vaccines: What's ongoing, needed? Conclusion: Additional clinical studies (both ongoing and recommended) will help move towards cervical cancer elimination by simplifying vaccine regimens, expanding vaccine use to other populations and age groups, increasing vaccine acceptance, and decreasing vaccination costs and supply needs.
February 9, 2021 - A Research Brief published by the American Academy of Pediatrics reported 'Adolescents' receipt of the human papillomavirus (HPV) vaccine is primarily a decision of their parents. Despite a health provider recommendation, parents of 60.6% of unvaccinated adolescents had no intention to initiate the HPV vaccine series. Overall, the study's data showed that 7.3 million HPV vaccine eligible US adolescents were unvaccinated in 2018.
February 5, 2021 - WHO Request: Technical Support for updating the WHO/UNICEF HPV vaccine coverage and the WHO cervical cancer screening coverage estimates in 2021-2023. In November 2020, the Global strategy towards eliminating cervical cancer was launched. HPV vaccination and screening coverage estimates contribute towards the monitoring of the cervical cancer strategy. However, given the comprehensive nature of cervical cancer prevention, further work will be carried out in developing a complete and integrated monitoring framework for cervical cancer elimination. This will include additional exploration and development of a comprehensive cervical cancer protection index across the primary and secondary prevention pillars.
February 1, 2021 - The results of a new study focused on Oral Human Papillomavirus infections in children during the first six years of life indicate that HPV infection can be acquired non-sexually and is already common at an early age. This longitudinal study found children develop their first oral HPV infection at an early age.
January 29, 2021 - The US CDC published Volume 27, Number 3—March 2021: Research: Oral Human Papillomavirus Infection in Children during the First 6 Years of Life, Finland. This study reported oral HPV prevalence for children varied from 8.7% (at a 36-month visit) to 22.8% (at birth), and 18 HPV genotypes were identified. HPV16 was the most prevalent type to persist, followed by HPV18, HPV33, and HPV6. Persistent, oral, high-risk HPV infection for children was associated with the mother's oral HPV carriage at birth and seroconversion of the mother to high-risk HPV during follow-up. This data indicates HPV status of the mother has a major impact on the outcome of oral HPV persistence for her offspring.
January 29, 2021 - Research: Association between human papillomavirus vaccination and serious adverse events in South Korean adolescent girls: a nationwide cohort study. In this national cohort study, with more than 500 000 doses of HPV vaccines, no evidence was found to support an association between HPV vaccination and serious adverse events using cohort analysis and self-controlled risk interval analysis. However, inconsistent findings for migraine should be interpreted with caution considering its pathophysiology and interest population.
January 26, 2021 - Study: Impact of the human papillomavirus vaccine supply shortage on Tanzania's national HPV vaccine introduction. In 2018, WHO issued a call to action toward global cervical cancer elimination with a global target of 90% of girls vaccinated with HPV vaccine by 15 years of age. As the international community responds to this call to action, the vaccine supply needs to be increased concurrently to reach eligible girls through planned HPV vaccine national introductions, particularly among countries with the highest cervical cancer burden—also most impacted by vaccine supply constraints. While additional vaccine manufacturers and single-dose vaccination strategies might relieve the supply constraints in the future, country programs and the global community must work together now to align efforts and utilize the currently available resources optimally.
January 22, 2021 - "Given the effect that HPV vaccination has had on cancer prevention, it is important to identify factors influencing HPV vaccination coverage," said Bernard Fuemmeler Ph.D., associate director for population science, the Gordon D. Ginder, MD, Chair in Cancer Research and co-leader of the Cancer Prevention and Control research program at VCU Massey Cancer Center. Fuemmeler and his team conducted the first-ever systematic review of area-level data reported in the United States between 2006 and 2020 to determine how geography, neighborhoods, and sociodemographic factors impact HPV vaccination rates among adolescents and young adults. The study was published in Cancer Epidemiology, Biomarkers, and Prevention. "Our findings demonstrate the need to adopt geospatial, standardized, and collaborative approaches in future studies that allow for the effective mapping, detection, and reporting of geographic areas with low HPV vaccination coverage," Fuemmeler said.
January 20, 2021 - Robert L. Coleman, MD, chief scientific officer of The US Oncology Research, explained that 2021 is expected to be a banner year for cervical cancer treatment. "Other essential things that are happening in cervical cancer this year would be the continuous move of immunotherapies into earlier lines of treatment, all the way up to not only in the adjuvant setting but also with chemoradiation or radiation plus [immunotherapy], followed by maintenance therapy. [There is] the concept of moving maintenance therapy into cervical cancer and earlier therapy lines, which will be an important addition. We'll hear data starting to emerge from those kinds of strategies. That's going to be really exciting for cervical cancer; we just haven't had anything for quite a while for that space."
January 14, 2021 - the American Cancer Society published Special Section: Cancer in Adolescents and Young Adults - Cancer Facts 2020.
January 8, 2021 - From bad to worse II: Risk amplification of the HPV vaccine on Facebook. Conclusion: Nearly four out of every ten Facebook posts about the HPV vaccine contained messages that amplified the risk of the HPV vaccine, and the data suggest that these posts had momentum over time. Research must continue to address the perception of vaccine safety. The vaccine is perceived as the health threat, with deep research into online communities to discover the perceived ripples and impacts.
January 7, 2021 - The NEJM reported 'Two cases of pediatric lung cancer (in 23-month-old and 6-year-old boys) resulting from mother-to-infant transmission of uterine cervical tumors were incidentally detected during routine next-generation sequencing paired samples of tumor and normal tissue. Spontaneous regression of some lesions in the first child and the slow growth of the second child's tumor mass suggested alloimmune responses against the transmitted tumors. In addition, immune checkpoint inhibitor therapy with nivolumab led to a strong regression of all remaining tumors in the first child.'
January 6, 2021 - The US Department of Health and Human Services, Office of the Assistant Secretary for Health (OASH), Office on Women's Health is launching the HPV VAX NOW campaign with the long-term goal of increasing human papillomavirus (HPV) vaccination rates among young adults ages 18–26. The campaign will specifically target young adults and healthcare providers in Mississippi, South Carolina, and Texas — states with some of the country's lowest HPV vaccination rates. Currently, fewer than half of young adults in the United States have received one or more doses of the HPV vaccine, and only 22% have completed the vaccine series. According to the Centers for Disease Control and Prevention, HPV causes nearly 36,000 cases of cancer in men and women each year in the US.
January 5, 2021 - Monique Luisi, an assistant professor at the University of Missouri School of Journalism, has studied more than 6,500 public HPV vaccine-related posts on Facebook from 2006 to 2016. In a previous study, Luisi used these Facebook posts to identify a negative trend on Facebook related to how people perceive the HPV vaccine. She suggests this negative trend on Facebook may also cause people to develop a false perception of the vaccine's health risk. After looking at the percentage of posts that made the vaccine seem more dangerous, less dangerous, or neither, Luisi found nearly 40% of Facebook posts about the HPV vaccine amplified a perceived risk. The data suggest these posts had momentum over time.
January 1, 2021 - American Academy of Pediatrics study: Antibody responses persisted through 2 to 2.5 years after the last dose of a 2-dose 9vHPV vaccine regimen in girls and boys. In girls and boys, antibody responses generated by 2 doses administered 6 to 12 months apart may be sufficient to induce high-level protective efficacy through at least 2 years after the second dose.
Click here to see 2020 HPV News Articles.
HPV Vaccination Overview
The CDC recommends individuals should receive the complete HPV vaccine series, regardless of the age group. The CDC recommends that 11- to 12-year-olds receive two doses of HPV vaccine at least six months apart, rather than the previously recommended three doses to protect against cancers caused by HPV infections.
Teens and young adults who start the series later, at ages 15 through 26 years, will continue to need three doses of HPV vaccine to protect against cancer-causing HPV infection. Young women can get the HPV vaccine through age 26, and young men can get vaccinated through age 21.
HPV vaccination is also recommended for men and women with compromised immune systems (including people living with HIV/AIDS) through age 26 if they did not get fully vaccinated when they were younger.
The US FDA approved an expanded indication for GARDASIL9 to prevent oropharyngeal cancers caused by HPV types 16, 18, 31, 33, 45, 52, and 58 on June 13, 2020.
Approximately 33,700 cancers are caused by HPV in the USA each year, including 12,900 oropharyngeal cancers among men and women, 10,800 cervical cancers among women, and 6,000 anal cancers among men and women; vaginal, vulvar, and penile cancers are less common.
CONTENT SOURCES: World Health Organization, US Centers for Disease Control and Prevention, FDA, research studies, manufacturer announcements, and the Precision Vax news network, reviewed by healthcare providers, such as Dr. Bob Carlson.