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HPV Vaccines 2023

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Last reviewed
January 25, 2023
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Human Papillomavirus (HPV) Vaccines For 2023

Vaccination against human papillomavirus (HPV) is recommended to prevent infections and associated cancers, says the World Health Organization (WHO). There are effective HPV vaccines that protect males and females against cancers caused by HPV. These vaccines include 9vHPV, 4vHPV, and/or 2vHPV, says the U.S. Centers for Disease Control and Prevention (CDC).

In the U.S., HPV vaccination for adolescents has been recommended for women since 2006 and men since 2011. The current CDC schedule is posted at this link.

HPV Vaccines Approved For 2023

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. In addition, the quadrivalent vaccine is highly efficacious in preventing anogenital warts, a common genital disease caused by infection with HPV types 6 and 11. Unfortunately, Gardasil is not available in Canada.

Gardasil9 - 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.

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.

Cecolin - Innovax Biotech Co., Ltd.'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 will be available in Wuhan's provincial Maternity and Child Healthcare Hospital. In addition, it is conducting a phase 3 clinical study.

Walvax Biotechnology's recombinant bivalent HPV vaccine is effective against HPV strains 16 and 18, which China's National Medical Products Administration approved on March 25, 2022.

Cervavac is Serum Institute of India's Quadrivalent Human Papillomavirus vaccine (qHPV) authorized in India for 9 to 26-year-olds, protecting against HPV types 6, 11, 16, and 18. Local availability in 2023.

HPV Vaccine Dosage

The CDC recommends two doses of HPV vaccine for all adolescents at age 11 or 12. On October 1, 2022, a peer-reviewed study - Comparing one dose of HPV vaccine in young women aged 9–14 years with one dose of HPV vaccine in historical cohorts: an immunobridging analysis of a randomized controlled clinical trial - concluded one dose of HPV vaccine in young girls might provide sufficient protection against persistent HPV infection. 

On December 16, 2022, the WHO published an updated Position Paper that replaces its 2017 Paper, which includes recommendations for a single-dose HPV vaccination option.

HPV Vaccine 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 announced positive interim results from an ongoing Phase 1/2 clinical trial evaluating INO-3107. It showed a statistically significant improvement in the clinical endpoint of the number of surgical interventions needed to control papilloma growth. INO-3107 was also observed to be well-tolerated and immunogenic in the trial.

VTP-200 - Vaccitech's ChAdOx1-HPV immunotherapy for high-risk HPV infection and 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 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+.

VB10.16 - Nykode Therapeutics is a potential first-in-class off-the-shelf therapeutic cancer vaccine in development to treat HPV16-positive cancers. VB10.16 is currently being investigated in the VB C-02 trial in patients with advanced or recurrent, non-resectable HPV16-positive cervical cancer.

REC603 - Jiangsu Recbio Technology's REC603 is a recombinant HPV 9-valent vaccine conducting a phase 3 clinical trial. The REC604a is equipped with the novel adjuvanted BFA04 independently developed by the Company, which aims to reduce the vaccination dose by enhancing the immunogenicity and cross-protection effects. In addition, REC603 adopts the H. polymorpha expression system to achieve high-yield and stable expression of HPV virus-like particles and to make the Company's vaccine candidate more suitable for commercial production at an annual output of 20 million doses.

Defence Therapeutics Inc. developed the AccuVAC-PT007, a protein-based vaccine targeting the E7 oncoprotein of the HPV virus. 

LinKinVax is conducting a first-in-human Phase I/IIa clinical trial with CD40HVac, a new therapeutic vaccine candidate in immuno-oncology targeting dendritic cells against head and neck cancer associated with HPV.

Genexine GX-188E (tirvalimogene teraplasmid) is a DNA therapeutic vaccine fused with encoding both E6 and E7 antigens and the extracellular domain of Flt3L to target and activate dendritic cells. A Multi-Center, Open-label Phase Ib-II Trial of the Combination of GX-188E Vaccination and Pembrolizumab in Patients with Advanced, Non-Resectable HPV-Positive Cervical Cancer.

HPV Vaccine Effectiveness

The JAMA Network published a Research Letter on October 21, 2022, highlighting the importance of timely vaccination against HPV. Vaccination by age 12 is estimated to prevent most lifetime cervical cancers caused by HPV-16/18. However, this benefit decreases by 25% as the vaccination age increases to 16 years.

Lauri E. Markowitz, M.D. Division of Viral Diseases, U.S. CDC Advisory Committee on Immunization Practices presented on June 23, 2022, which summarized: 'There are now data on 1-dose HPV vaccination, including efficacy data from a randomized controlled trial with 18-month follow-up. In addition, long-term follow-up from other studies suggests a good duration of protection (>10 years) with one dose. And Julia Gargano, Ph.D., presented: 'Impact of the US HPV vaccination program on HPV-associated outcomes. Declines in HPV16/18 prevalence have translated into declines in cervical precancer incidence in young women.'

The UK's Joint Committee on Vaccination and Immunisation announced on August 5, 2022, that one HPV dose is as effective as two at preventing cancers caused by HPV in adolescents. Likewise, on April 11, 202, the WHO's Strategic Advisory Group of Experts on Immunization concluded that a single-dose HPV vaccine delivers virus protection comparable to 2-dose schedules.

A systematic review of 138 peer-reviewed studies, published between March 2016 and March 2020, within MEDLINE, EMBASE, and Google Scholar involving 14 years of follow-up data details the impact and effectiveness of GARDASIL through immunization programs in 23 countries across Africa, Asia, Europe, Australia, South America, and North America. The most significant reductions were observed in younger age groups (14-17 years), with up to 73% reduction in CIN3+ among vaccinated females. Consistent with the previous review, declines in the incidence of anogenital warts continue to be observed within vaccine-targeted female age groups, with more significant decreases (up to 88%) observed in younger age groups.

HPV Vaccine Price

The list price for each indicated dose of GARDASIL 9 is about $250, says Merck. The U.S. CDC Vaccine Price List - Vaccines for Children Program - was last updated in September 2022. HPV vaccine prices and discount information are posted at InstantRx™.

HPV Vaccination and HIV

A peer-reviewed study published on October 1, 2022, found MSM with HIV would benefit from Gardasil 9 immunization, particularly the youngest and those with prior gonococcal infection.

HPV News For 2020 - 2023

January 24, 2023 - SSI's Cervavac vaccine became available in India, with an international launch scheduled for 2024.

January 20, 2023 - The Korean Ministry of Food and Drug Safety issued Fast Track Designation for GX-188E.

January 19, 2023 - LinKinVax announced a collaboration to conduct a first-in-human Phase I/IIa clinical trial with CD40HVac, a new therapeutic vaccine candidate against head and neck cancer associated with HPV.

January 11, 2023 - A study published by the American Cancer Society indicates cervical cancer herd immunity may occur in the U.S.

December 13, 2022 - State-owned pharmaceutical company Bio Farma would produce a version of Merck's HPV vaccine in-county.

December 6, 2022 - SQZ Biotechnologies eAPC Therapeutic Candidate for Treatment of HPV16+ Tumors Receives U.S. FDA Fast Track Designation.

November 30, 2022 - The current study is a first-in-human trial to investigate the safety and immunogenicity of an amplivant conjugated to human papillomavirus (HPV) 16-SLP. Amplivant is a molecularly optimized Tolllike receptor 2 ligand that can be covalently conjugated to tumor peptide antigens. In preclinical models, amplivant-adjuvanted synthetic long peptides strongly enhanced antigen presentation by dendritic cells, T cell priming, and induction of effective antitumor responses.

November 23, 2022 - Defence Therapeutics Inc. reported completing its Good Laboratory Practice preclinical studies on the AccuVAC-PT007 vaccine candidate specifically designed to target cervical cancer.

November 21, 2022 - The JAMA published a Research Letter: Cervical Cancer Incidence Among US Women. Between 2001 and 2019, cervical cancer incidence declined or remained stable among US women except for the 30- to 34-year-old age group, whose incidence increased by 2.5% annually after 2012.

November 7, 2022 - Ravinder Dhawan, vice president, and head of the center for observational and real-world evidence, Merck Research Laboratories, stated in a press release, "These real-world data from more than one hundred published studies show decreases in vaccine-type HPV infections and related diseases and are an important reminder that we need to do more to expand vaccination to males and females as part of the global fight to lessen the incidence of certain HPV-related diseases and cancers."

November 2, 2022 - Transgene announced following an interim analysis of its randomized controlled Phase II clinical study comparing TG4001 in combination with avelumab to avelumab alone in patients with HPV16- positive anogenital tumors, the IDMC recommended the study continue. Transgene anticipates the last patient to be randomized in the trial in H1 2024.

October 28, 2022 - China's National Medical Products Administration accepted the application for a clinical trial of an in-housed developed novel adjuvanted recombinant quadrivalent HPV vaccine, REC604a.

October 11, 2022 - PDS Biotechnology Corporation announced expanded interim data in the Phase 2 clinical trial investigating the PDS0101-based triple combination therapy in advanced HPV-positive cancers. Survival data: 66% (19/29) of HPV 16-positive CPI refractory patients in the cohort were alive at a median follow-up of 16 months. Historically, this group has a median overall survival of only 3-4 months.

October 1, 2022 - The Lancet Oncology published and EDITORIAL: HPV vaccination in south Asia: new progress, old challenges.

September 21, 2022 - "The data generated in the CPI refractory arm of the Phase 2 trial investigating the PDS0101-based triple combination in advanced HPV-positive cancers seems compelling and potentially provides a foundation for advancing this program into late-stage clinical development," stated Dr. Frank Bedu-Addo, President and Chief Executive Officer of PDS Biotech.

September 12, 2022 - BMC Health published: Implementation of a provider-focused intervention for maximizing HPV vaccine uptake in young cancer survivors receiving follow-up care in pediatric oncology practices: protocol for a cluster-randomized trial of the HPV PROTECT intervention.

September 3, 2022 - The WHO confirmed Sierra Leone introduced HPV vaccines to protect 153,991 girls from cervical cancer.

August 26, 2022 - The Lancet Infectious Disease published a study: Efficacy, safety, and immunogenicity of an Escherichia coli-produced Human Papillomavirus (16 and 18) L1 virus-like-particle vaccine: end-of-study analysis of phase 3, double-blind, randomized, controlled trial. Interpretation: Xiamen Innovax Biotech Co., Ltd.'s E coli-produced HPV 16 and 18 vaccine was well tolerated and highly efficacious against HPV 16 and 18 associated high-grade genital lesions and persistent infection and would supplement the global HPV vaccine availability and accessibility for cervical cancer prevention.

August 19, 2022 - The LAMA Network published: Prevalence of Human Papillomavirus Infection Among Women Born in the 1990s vs. the 1980s and Association With HPV Vaccination in the USA. A more significant decline in HPV-16/18 infection prevalence among 18- to 20-year-old women during the 2015−2016 period may reflect greater direct and herd protection from broader HPV vaccination coverage.

August 10, 2022 - Jiangsu Recbio Technology Co., Ltd. announced it completed the subject enrollment and first dose vaccination regarding the immuno-bridging study of its recombinant HPV 9-valent vaccine, REC603, in younger age groups and the study to compare the immunogenicity between REC603 and Gardasil® 9. At the same time, follow-up on the subjects of REC603's efficacy trial is being conducted by the clinical protocol.

August 4, 2022 - The BMJ reported - Role of human papillomavirus (HPV) vaccination on HPV infection and recurrence of HPV-related disease after local surgical treatment: systematic review and meta-analysis. Conclusion: HPV vaccination might reduce the risk of recurrence of CIN, in particular when related to HPV16 or HPV18, in women treated with local excision. 

August 1, 2022 - PTI reported Serum Institute of India stated it could supply one crore doses of its Quadrivalent Human Papillomavirus vaccine (qHPV) by December 2022.

July 28, 2022 - Merck announced second-quarter GARDASIL/GARDASIL 9 sales grew 36% to $1.7 billion, primarily driven by strong demand outside of the U.S., particularly in China, which benefited from increased supply.

July 5, 2022 - Scientists from the International Agency for Research on Cancer support the evaluation of the quadrivalent HPV vaccine manufactured by the Serum Institute of India in females and males aged 9–26 years.

June 16, 2022 - The New England Journal of Medicine published the results of a clinical trial funded by the National Cancer Institute that found people living with HIV treated for anal precancerous growths reduced the chance that anal cancer will develop by more than half.

June 16, 2022 - The journal BMC Women Health published - Optimization of a protocol for evaluating antibody responses to HPV vaccination in low-resource settings - This study aimed to optimize an assay to evaluate the long-term durability of HPV vaccine response of adolescent girls. Our results demonstrated more significant immunoglobulin G antibody activity within serum drawn from adolescent girls immunized 36 months prior.

May 31, 2022 - The BMJ published Research - Extension of cervical screening intervals with primary human papillomavirus testing: an observational study of English screening pilot data. Conclusions These data support an extension of the screening intervals regardless of the test assay used: to five years after a negative HPV test in women aged 25-49 years and even longer for women aged 50 years and older. The screening interval for HPV-positive women with negative HPV tests at early recall should be kept at three years.

May 27, 2022 - GSK plc announced a two-dose schedule for the Cervarix [Human Papillomavirus bivalent (types 16, 18) Vaccine, Recombinant)] was approved in China for young women aged 9 to 14. 

May 21, 2022 - The Lancet published a commentary - on HPV vaccination and cervical cancer screening.

May 20, 2022 - Ireland's Minister for Health, Stephen Donnelly, confirmed that the HPV vaccine is free to all women under 25.

May 17, 2022 - Original Research: Human Papillomavirus Vaccine Impact and Effectiveness Through 12 Years After Vaccine Introduction in the United States, 2003 to 2018. Vaccine effectiveness ranged from 60% to 84% during vaccine eras for females and 51% from 2013 to 2016 for males.

May 15, 2022 -  PTI reported the Serum Institute of India sought the Indian government's permission to manufacture and stockpile the indigenously developed Quadrivalent Human Papillomavirus (qHPV) vaccine after the completion of the Phase 2/3 clinical trials to ensure its early availability.

May 12, 2022 - The Kingdom of Eswatini is preparing for the nationwide rollout of HPV vaccines.

May 9, 2022 - Nykode Therapeutics AS announced positive interim results from its Phase 2 VB C-02 trial of VB10.16, its wholly-owned therapeutic cancer vaccine, combined with the PD-L1 inhibitor atezolizumab in patients with HPV16-positive advanced cervical cancer. Interim results from 39 patients with a median follow-up of 6 months show an ORR of 21%—including two patients who achieved a complete response, six who achieved a partial response, and a very high disease control rate of 64%.

May 9, 2022 - MedpageToday reported self-collected menstrual blood samples offered "highly concordant" results with clinician-collected sampling in women who were positive for HPV.

April 28, 2022 - New Jersey-based Merch Inc. announced that GARDASIL and GARDASIL 9 vaccine sales increased by about 59% to $1.5 Billion in the first quarter of 2021.

April 11, 2022 - Merck Canada announced Health Canada approved an expanded indication of GARDASIL®9 in individuals 9 through 45 years of age to prevent infection caused by the HPV types 6, 11, 16, 18, 31, 33, 45, 52 and 58.

April 4, 2022 - Merck reaffirmed its commitment to enable broad equitable access to its HPV vaccines. To support this, the Company recently expanded its vaccines manufacturing facility in Elkton, VA, completing the construction of 120,000 square feet and adding 150 new jobs at the site.

March 30, 2022 - The BMJ published results from an Observational study: National experience in the first two years of primary HPV cervical screening in an HPV-vaccinated population in Australia. Conclusion: Colposcopy referral thresholds need to consider underlying cancer risk. On this basis, women with HPV16/18 in the first round of HPV screening were at higher risk regardless of cytology, even in a previously well-screened population. Conversely, women with HPV types, not 16/18, and negative or low-grade cytology showed a low risk of serious abnormalities but constituted most referrals and could be managed safely with two rounds of repeat HPV testing rather than one. And, HPV16/18 driven referrals were low in HPV-vaccinated cohorts.

March 16, 2022 - The JAMA Network published an Original Investigation - Obstetrics and Gynecology - Trends in Human Papillomavirus–Associated Cancers, Demographic Characteristics, and Vaccinations in the US, 2001-2017. Conclusions and Relevance  In the US, cervical cancer rates have decreased at a population level, especially in younger women. The findings of this study suggest this decrease may be associated with vaccination. Given the increase in oropharyngeal and anal/rectal cancers, particularly in men, it may be essential to highlight vaccination uptake in both sexes.

March 15, 2022 - PDS Biotechnology Corporation announced that the National Cancer Institute had achieved the intended enrollment objective of 30 patients in the NCI-Led Phase 2 clinical trial's checkpoint inhibitor refractory arm evaluation PDS0101 (Versamune®+HPV16mix) in combination with two investigational immune-modulating agents in advanced HPV-associated cancers.

March 11, 2022 - Kenya became the 16th African country to introduce the HPV vaccine into its routine national immunization schedule. The national scale-up program ensures HPV vaccines and other related routine vaccines are available countrywide.

March 11, 2022 - To raise awareness of human papillomavirus and the use of the HPV vaccine to reduce the risk of HPV-related cancers, the ADA Council on Advocacy for Access and Prevention is hosting a three-part webinar series, Preventing HPV Cancers in Action, as part of Oral Cancer Awareness Month.

February 23, 2022 - BMC Women's Health published: Knowledge, attitudes, and perceptions of HPV vaccination among female Korean and Chinese university students.

February 10, 2022 - The Joint Committee on Vaccination and Immunisation is the scientific advisory committee that advises the UK government on matters relating to vaccination and immunization. After reviewing data regarding the dosage of HPV vaccines, they are recommending that the Gardasil 9 vaccine be reduced to a single-dose schedule.  

January 31, 2022 - Th Netherlands Public health institute RIVM confirmed all 10-year-old children would be invited to get vaccinated against HPV. Vaccinating both boys and girls contribute to creating herd immunity," said Jeanne-Marie Hament, RIVM program manager of the National Immunization Program. 

January 26, 2022 - Defence Therapeutics Inc. announced the development of AccuVAC-PT009, a new protein-based HPV vaccine, leading to a humoral response bypassing Gardasil-9 immunogenicity in animals.

January 1, 2022 - A new study - High-Grade Vulvar, Vaginal, and Anal Precancers Among US Adolescents and Young Adults After Human Papillomavirus Vaccine Introduction - found 'Opportunistically-detected high-grade vulvar and vaginal precancers among females aged 15–29 years decreased and anal precancers stabilized in years after the introduction of the HPV vaccine, which is suggestive of the impact of the vaccine on noncervical human papillomavirus cancers.'

December 20, 2022 - IHME published: Cost-effectiveness of HPV vaccination in 195 countries: A meta-regression analysis.

November 29, 2021 - The JAMA Network - Pediatrics published a Research Letter: Human Papillomavirus Vaccination and Trends in Cervical Cancer Incidence and Mortality in the US, which found a 38% decrease in cervical cancer incidence and a 43% decline in mortality among women after HPV vaccination.

November 12, 2021 - A new phase 3 study results were published by The Lancet, which stated, 'The quadrivalent HPV vaccine provides durable protection against anogenital disease related to HPV6, 11, 16, and 18. The results support quadrivalent HPV vaccination in men, including catch-up vaccination.'

November 3, 2021 - The Lancet published: The effects of the national HPV vaccination program in England, UK, on cervical cancer and grade 3 cervical intraepithelial neoplasia incidence: a register-based observational study. Interpretation: We observed a substantial reduction in cervical cancer and incidence of CIN3 in young women after the introduction of the HPV immunization program in England, especially in individuals who were offered the vaccine at age 12–13 years. The HPV immunization program has almost eliminated cervical cancer in women born since Sept 1, 1995.

October 17, 2021 - Xiamen Innovax Biotech Co., Ltd. received an official letter from the World Health Organization confirming that its bivalent human papillomavirus vaccine Cecolin® had been accepted for Prequalification. As a result, it is the first China-manufactured HPV vaccine to receive WHO Prequalification.

October 9, 2021 - Study: Kosovo women's knowledge and awareness of human papillomavirus infection, HPV vaccination, and its relation to cervical cancer. Of 800 questionnaires distributed, 645 were completed and returned (80.6%). Only 0.5% of women were vaccinated against HPV. The majority of respondents (66.4%) did not know about HPV.

October 8, 2021 - The Lancet Oncology published: Vaccine efficacy against persistent human papillomavirus (HPV) 16/18 infection at ten years after one, two, and three doses of quadrivalent HPV vaccine in girls in India: a multicentre, prospective, cohort study. Interpretation - A single dose of HPV vaccine provides similar protection against persistent infection from HPV 16 and 18, the genotypes responsible for nearly 70% of cervical cancers, to that provided by two or three doses.

September 2, 2021 - JAMA Oncology published Orginal Research: Projected Association of Human Papillomavirus Vaccination With Oropharynx Cancer Incidence in the US, 2020-2045. According to the projections of this population-based age-period cohort study, current HPV vaccination rates will have a limited association with overall OPC incidence through 2045 because older individuals who have not yet been vaccinated remain at high risk for OPC. However, reductions in OPC incidence should occur among young and middle-aged adults, the group at the lowest risk of diagnosis.

August 26, 2021 - The JAMA Network published an Original Investigation that found no association between HPV vaccination and primary ovarian insufficiency. Vaccination was not associated with primary ovarian insufficiency in this cohort study of 996,300 girls and women. However, given the rarity of the outcome in this study, the presence of a clinically relevant increase in the diagnosis rate cannot be excluded. The 4HPV vaccine (Gardasil, Merck Sharp, and Dohme) was introduced in the Danish childhood immunization schedule in January 2009. 

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 parents refusing 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 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 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 more than cytology, but evidence from real-life implementation was missing. 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 equal 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 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 decrease 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 Uganda. In addition, 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. IResearchersassessed parental support for implementing social media standards to combat misinformation. in the second study

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: Eliminating 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 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. In addition, the fall in anal HPV16 and 18 may reduce 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 more significant risks for PTD and pPROM and was associated with PROM, neonatal mortality, and maternal and neonatal infectious complications.

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 immunized 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, demonstrating the efficacy of Papilocare® in preventing and treating lesions caused by HPV. As a result, 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 the 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.

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 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 - 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 that '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. In addition, the data showed that 7.3 million HPV vaccine-eligible US adolescents were unvaccinated in 2018.

February 1, 2021 - A new study focused on Oral Human Papillomavirus infections in children during the first six years of life indicates 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 - 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 their 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 worldwide target of 90% of girls vaccinated with the 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 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.'

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.

Clinical Trials

No clinical trials found