Gardasil 9 HPV Vaccine

HPV9 Vaccines Coming to Latin America

Karen McClorey Hackett — Tue, 11 Feb 2025 09:15:41 +0000

Reviewer:

Over the past decade, human papillomavirus (HPV) vaccinations have prevented thousands of cervical cancer cases worldwide.

Beginning in July 2025, the enhanced 9-valent HPV vaccine will become more available in the Region of the Americas.

The Pan American Health Organization (PAHO) Revolving Fund announced on February 7, 2025, that the general availability of the 9-valent HPV vaccine will be easier and more affordable for Latin American countries.

This PAHO initiative is expected to help immunization programs access tools to protect their populations against the most prevalent genotypes in cervical cancer and reduce the overall burden of HPV-related diseases. The HPV9 vaccine has five more valencies than its previous version (quadrivalent) against the genotypes.

This is an essential PAHO program since, in 2022, more than 78,000 women were diagnosed with cervical cancer, and about 40,000 died from this preventable disease in the Americas.

Furthermore, mortality rates are three times higher in Latin America and the Caribbean as compared to North America, Canada, and the United States.

In a press release, Santiago Cornejo, Executive Manager of PAHO's Regional Revolving Funds, commented, "By working together, we can make life-saving vaccines more accessible to all and continue the goal of eliminating cervical cancer by 2030."

Currently, the HPV9 vaccine is recommended for the entire population from 9 to 26 years of age, depending on the immunization schedules of each country.

The PAHO Elimination Initiative seeks to end more than 30 diseases by 2030, including cervical cancer, using vaccination as a key tool. The goal is to vaccinate 90% of girls before the age of 15 with at least one dose of the HPV vaccine.

The PAHO Revolving Fund allows countries to combine their purchasing power to negotiate better prices and ensure a permanent and timely supply of their vaccines and other related inputs. This approach reduces costs and simplifies the procurement process for participating countries.

WHO prequalifies all vaccines included in the PAHO Revolving Fund portfolio or a reference authority. It seeks to offer quality, safe health technologies that meet technical criteria.

In the United States, Merck's GARDASIL 9® vaccine is the leading HPV vaccine. In 2025, it is generally available for boys and girls at health clinics and pharmacies.

Sub Title:

HPV9 vaccine is US FDA approved in 2025

References:

Americas will be able to access the HPV9 vaccine from mid-2025 through the PAHO Revolving Fund

Analysis of the situation of cervical cancer in the Region of the Americas

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Reduce Cervical Cancer in the Americas with One HPV Dose

Karen McClorey Hackett — Mon, 30 Sep 2024 18:21:18 +0000

Reviewer:

Robert Carlson, MD

A recent report on cervical cancer in the region of the Americas published by the Pan American Health Organization (PAHO) urges countries to implement innovations in cervical cancer prevention, testing, and treatment to achieve the elimination goals by 2030.

The Latin America and the Caribbean region accounts for 80% of all cases in the Americas and 84% of deaths, making it the region with the second-highest rates of cervical cancer cases and deaths in the world, after Africa.

The primary cause of cervical cancer is persistent infection with high-risk types of human papillomaviruses (HPV), which can be prevented through vaccination.

According to the new PAHO report, while 32 of 35 countries of the Americas have introduced the HPV vaccine into their national immunization schedules, coverage varies widely from less than 10% to over 80%.

To tackle this variance, PAHO recommends implementing strategies to increase coverage, such as switching to a one-dose schedule.

“While increasing HPV vaccination coverage is key to eliminating cervical cancer, countries of the Americas must also urgently step up efforts to shift from conventional PAP to HPV testing and improve cancer treatment,” stated Dr. Anselm Hennis, Director of Noncommunicable Diseases and Mental Health at PAHO, in WHO press release on September 26, 2024.

As of September 2024, 21 of 35 countries are implementing communications campaigns to raise awareness around the HPV vaccine. Countries should also strengthen vaccine delivery strategies, ensure outreach efforts for those in hard-to-reach areas, and work alongside ministries of education to encourage school vaccination with at least one dose of HPV vaccine by age 15.

In 2020, member states of the World Health Organization (WHO) adopted the Strategy to Accelerate the Elimination of Cervical Cancer as a Public Health Problem.

The WHO strategy outlines three objectives for 2030: 90% HPV vaccination coverage in girls by the age of 15, 70% screening coverage of women with high-performance tests by the ages of 35 and 45 years, and 90% treatment of precancerous lesions and management of invasive cancer cases (known as the 90-70-90 targets).

As of September 2024, six licensed HPV vaccines protect males and females against cancers caused by HPV. These bivalent, quadrivalent, and nonavalent HPV vaccines are available in 140 countries.

In the United States, the CDC updated HPV vaccination schedules in 2024.

Sub Title:

HPV vaccinations offered at pharmacies and clinics in 2024

Reference:

PAHO - HPV vaccinations - Sept 2024

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Northern Texas Leads Lower HPV Vaccination Rate

Karen McClorey Hackett — Mon, 09 Sep 2024 21:44:24 +0000

Reviewer:

Robert Carlson, MD

Since human papillomavirus (HPV) vaccines were first recommended in the United States in 2006, uptake rates increased for most of the years.

Recent data indicates that HPV vaccination rates have recently stalled around 62%, with some states reporting variable rates segmented by urban and rural counties.

According to an Original Investigation published by the JAMA Network Open, northern Texas's counties and health service regions (HSR) have a higher incidence of HPV-related cancers and lower HPV vaccination rates than elsewhere in the state.

'Some counties and HSRs in west, east, and south Texas are doing well in vaccination coverage, whereas others are lagging,' stated these researchers.

Published on September 5, 2024, this study found that across 254 counties and 8 HSRs in Texas, HPV vaccination series initiation rates, up-to-date status, and the incidence of HPV-related cancer varied widely.

According to the National Immunization Survey-Teen in 2022, the estimated HPV vaccination coverage among teenagers aged 13 to 17 years in Texas is 58.5%, which ranks Texas 48th in the U.S.

These researchers reported that the mean 2021 to 2022 county-level HPV vaccination series initiation estimates ranged from 6.3% to 69.1% for females and 7.0% to 77.6% for male children and teenagers aged 9 to 17.

Up-to-date estimates of Texas county-level vaccination were generally lower than initiation estimates, ranging from 1.6% to 30.4% for females and 2.1% to 34.8% for male children and teenagers.

This data confirms previous studies' findings that Texas has one of the lowest HPV vaccination rates in the U.S. Other states with lower overall vaccination rates include Mississippi, Alaska, Kentucky, and Oklahoma.

In most cases, HPV goes away on its own and does not cause any health problems, says the Texas Department of State Health Services. But when HPV does not go away, it can lead to serious health problems, including cancer.

With the Vaccines for Children (VFC) program, the cost of HPV vaccinations should not be a concern in Texas or any state. The HPV vaccine is available to all uninsured or underinsured males and females between the ages of 9 and 18 through the Texas VFC program.

The U.S. CDC recently wrote, 'Healthcare providers should make strong recommendations for all routine vaccines and verify that adolescents, particularly those eligible for the VFC program, are up to date with all recommended vaccines.'

In Texas, HPV vaccines are offered at health clinics and pharmacies.

Sub Title:

Texas ranks 48th in HPV vaccinations

References:

Human Papillomavirus Vaccination and Human Papillomavirus–Related Cancer Rates

US CDC HPV vaccinations 2022

National Immunization Survey-Teen, United States, 2023

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US CDC HPV vaccination trends 2024

HPV Cancer Vaccinations Stall for Second Year

Karen McClorey Hackett — Fri, 23 Aug 2024 20:49:31 +0000

Reviewer:

Robert Carlson, MD

New data published by the U.S. Centers for Disease Control and Prevention (CDC) indicates that Human papillomavirus (HPV) vaccination coverage among adolescents in the United States did not increase.

Published in the Morbidity and Mortality Weekly Report (73(33);715–721) on August 22, 2024, the CDC's National Center for Immunization and Respiratory Diseases data shows that HPV vaccinations decreased slightly last year, reaching 61.4% in 2023, lower than the 62.6% reported in 2022.

This is concerning because HPV vaccines are a crucial public health tool in preventing most cervical cancers in women.

Worldwide, cervical cancer is the fourth most common cancer among women.

HPV vaccination has been reported to prevent about 92% of HPV-attributable cancers.

Contrary to this CDC-reported trend, Merck announced in late July 2024 that its HPV vaccine products experienced sales increases.

Merck confirmed a 4% growth in the market-leading GARDSAIL / GARDASIL 9 HPV vaccines primarily due to higher sales in the U.S.

As of August 23, 2024, HPV vaccines remain available for eligible people at most clinics and pharmacies in the U.S.

Furthermore, the CDC's Vaccines for Children program provides recommended vaccines at no cost to eligible children and adolescents. Overall, vaccination coverage among VFC-eligible adolescents remained stable last year.

Sub Title:

Vaccination can prevent HPV cancers

References:

Human Papillomavirus Vaccination Coverage Among Adolescent Girls Aged 13–17 Years

National Vaccination Coverage Among Adolescents Aged 13–17 Years — National Immunization Survey-Teen, United States, 2023

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US CDC HPV vaccination trends August 2024

Childhood Immunizations Stalled in 2023

Karen McClorey Hackett — Mon, 15 Jul 2024 16:59:12 +0000

Reviewer:

Robert Carlson, MD

The latest World Health Organization (WHO) and UNICEF estimates of national immunization coverage highlight the need for vaccination catch-up, recovery, and system-strengthening efforts.

The WHO announced today the global childhood immunization coverage stalled in 2023, leaving 2.7 million additional children un- and under-vaccinated compared to 2019.

More than half of unvaccinated children live in 31 countries.

“The latest trends demonstrate that many countries continue to miss far too many children,” said UNICEF Executive Director Catherine Russell in a press release on July 15, 2024.

“Closing the immunization gap requires a global effort, with governments, partners, and local leaders investing in primary healthcare and community workers to ensure every child gets vaccinated and that overall healthcare is strengthened.”

According to the findings, the number of children who received three doses of the vaccine against diphtheria, tetanus, and pertussis (DTP) in 2023 – a key marker for global immunization coverage – stalled at 84% (108 million).

However, the number of children who did not receive a single dose of the vaccine increased from 13.9 million in 2022 to 14.5 million in 2023.

Additionally, 6.5 million children did not complete their third dose of the DTP vaccine, which is necessary to achieve disease protection in infancy and early childhood.

The new data also highlight some brighter spots in immunization coverage.

The steady introduction of new and underutilized vaccines, including for human papillomavirus, meningitis, pneumococcal, polio, and rotavirus disease, continues to expand the breadth of protection, particularly in the 57 countries supported by Gavi, the Vaccine Alliance.

Sub Title:

2.7 million additional children un- and under-vaccinated compared to 2019

Reference:

WHO - Global childhood immunization levels stalled in 2023

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by Varun Kulkarni

Some Seniors Get HPV Too

Karen McClorey Hackett — Wed, 10 Jul 2024 13:48:04 +0000

Reviewer:

Robert Carlson, MD

According to a new study from FAIR Health, those aged 65 and older were the group with the most significant increase (23.8%) in sexually transmitted disease (STD) diagnoses from 2020-2023.

Among the other FAIR Health findings, people 65 and older had the most significant increase (32.2%) in human papillomavirus (HPV) diagnoses.

Furthermore, 21.9% of HPV cases occurred among patients aged 55 to 64.

However, Fair Health's data did not disclose if these HPV cases were in adults who had been vaccinated, when they were vaccinated, or were unvaccinated.

Based on data analysis from FAIR Health’s repository of over 47 billion commercial healthcare claim records, the study results were announced on July 8, 2024.

In a press release, FAIR Health President Robin Gelburd stated, “It is central to FAIR Health’s mission to use our vast repository of claims data to provide data on public health concerns and support research by others."

"We hope this information brings greater clarity to the incidence of STDs.”

The FAIR Health findings are consistent with data recently released by the U.S. Centers for Disease Control and Prevention (CDC), showing rising rates of STDs among people aged 55 and older from 2012 to 2022.

The CDC's HPV vaccination schedule for 2024 includes a three-dose HPV series (0, 1-2, 6 months) for persons who initiate vaccination at ages 15 through 45 years and for immunocompromised persons.

The 9-valent HPV vaccine has been U.S. FDA approved for years and protects against HPV types 16 and 18, which cause about 66% of cervical cancers and most other HPV-attributable cancers in the U.S., and five additional cancer-causing types, which account for about 15% of cervical cancers. It also protects against HPV 6 and 11, which cause most anogenital warts. says the CDC.

FAIR Health is a national, independent nonprofit organization.

Sub Title:

HPV diagnoses increase in those over 65 years of age

References:

Fair Health study - July 8, 2024

CDC HPV vaccination schedule 2024

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Seniors

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Fair Health - percentage of patients with STD diagnoses from 2020 to 2023

Should Schools Offer HPV Vaccinations

Karen McClorey Hackett — Fri, 24 May 2024 16:48:24 +0000

Reviewer:

Robert Carlson, MD

Holly Lutmer PharmD

A recent study suggests that providing vaccinations at school can effectively reduce preventable cancers. School-based vaccination programs have successfully demonstrated value in reducing influenza and meningitis.

In a cluster randomized PrevHPV clinical trial involving 91 municipalities, it was found that offering free human papillomavirus (HPV) vaccinations to students on school premises consistently and significantly increased vaccination coverage.

Published by the JAMA Open Network on May 23, 2024, this Original Investigation did not find a significant increase in HPV vaccination rates after training general practitioners or educating and motivating adolescents and their parents.

Furthermore, at-school vaccination was shown to have a similar magnitude of effectiveness among both sexes.

While most media attention has been focused on reducing cervical cancer in women, vaccinating men has been shown to reduce other cancers. This study found HPV-related cancers occurred in unvaccinated men (57 vs 26), which translated into a 54% risk reduction.

According to Nancy Lapid, reporting for Reuters on May 23, 2024, vaccinated males had lower rates of any HPV-related cancer and of head and neck cancers (3.4 and 2.8 cases, respectively, per 100,000 vaccinated patients, compared with 7.5 and 6.3, respectively, per 100,000 unvaccinated patients).

This new study is scheduled for presentation at the upcoming American Society of Clinical Oncology meeting on May 31, 2024.

A recent example is Rio Grande City Consolidated Independent School District in Texas, where a school-based vaccination program dramatically improved HPV vaccination rates. Initiation rates increased to 65.5%–69%, and completion rates increased to 41.5%–43.1% in 2019.

Previously, Dr. Katharine Price, a medical oncologist with the Mayo Clinic Comprehensive Cancer Center, commented in March 2024 that while HPV-related throat cancer is often curable, prevention is best.

Throat cancer is the most common HPV-associated cancer in men, and the rate of infection continues to increase.

"It's much better to get a vaccine that's safe, that has no long-term side effects or complications than to go through surgery, radiation, chemotherapy," says Dr. Price.

As of late May 2024, HPV vaccines are generally available at most clinics and pharmacies in the U.S.

Sub Title:

HPV vaccination reduces throat cancer rates in men

References:

Effectiveness of a School- and Primary Care–Based HPV Vaccination Intervention

American Society of Clinical Oncology meeting

UTMB School-Based HPV Vaccination Program

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by Elena We

Oral Cancer Month Encourages More HPV Vaccinations

Karen McClorey Hackett — Mon, 22 Apr 2024 16:11:48 +0000

Reviewer:

Robert Carlson, MD

Holly Lutmer PharmD

In April 2024, the United States observes the 15th Annual Oral Cancer Awareness Month, which emphasizes the significance of preventing human papillomavirus (HPV)- related oral cancers.

Projections estimate an upward trend for the next decade, with predictions greater than 30,000 oral cancer cases annually by 2029.

Research shows that more than 90% of oropharyngeal cancer cases are linked to HPV 16.

As of 2023, oropharyngeal and oral cavity cancers impact far more men than women.

Health agencies such as the Centers for Disease Control and Prevention (CDC) have identified several tactics to reduce sexually transmitted oral cancers, such as vaccination.

While most young people are offered the HPV vaccine, uptake has recently plateaued in the U.S.

According to the U.S. CDC, the percentage of children who have received one or more HPV vaccine doses increased with age:

7.3% among children ages 9–10 years,
30.9% among children ages 11–12 years,
48.8% among children ages 13–14 years, and
56.9% among children ages 15–17 years.

Specifically, girls (42.9%) were more likely than boys (34.6%) to have received one or more HPV vaccine doses as of 2022.

"This Oral Health Month, we are urging parents to educate themselves on the benefits of the HPV vaccine, many of which people may not already be aware of," commented Kelly Palmateer, Oral Health Program Manager at Prince Edward Public Health, in a press release on April 17, 2024.

"Parents want to give their children the best start in life, and this (HPV) vaccine gives them the chance to invest in their child's future health."

The good news regarding the HPV vaccination market segment is that it is expanding.

The leading HPV vaccine reached the billion-dollar revenue milestone in late 2023, reporting a 27% increase from last year's fourth quarter.

Furthermore, pharmacists in most states administer HPV vaccines to patients, though some states may have age restrictions.

In 2024, it is commonplace for pharmacies on main-street to provide influenza, pneumococcal, and herpes zoster vaccination services.

And as cancer-prevention awareness increases, so should HPV vaccinations.

With six HPV vaccines already approved in 2024 and several innovative HPV vaccine candidates in development, access to cancer-preventing vaccines looks very promising.

Sub Title:

HPV vaccine protects against HPV16

References:

Current State of Oropharyngeal Cancer Prevention and Treatment

Human Papillomavirus Vaccination Coverage in Children Ages 9–17 Years: United States, 2022

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US CDC HPV vaccine uptake data 2022

$600 Million Cancels Cervical Cancer with One HPV Dose

Karen McClorey Hackett — Wed, 06 Mar 2024 22:25:50 +0000

Reviewer:

Robert Carlson, MD

World-class leaders have taken a bold step towards eliminating cervical cancer once and for all. Nearly $600 million in new funding has been pledged to expand vaccine coverage and strengthen screening and treatment programs.

The Global Cervical Cancer Elimination Forum: Advancing the Call to Action aims to eradicate this preventable cancer.

The Global Cervical Cancer Elimination Forum has played a crucial role in catalyzing national and global momentum to end this preventable disease.

Vaccination against human papillomavirus (HPV), the leading cause of cervical cancer, has successfully prevented the vast majority of cases and offers a clear path to elimination.

Dr. Chris Elias, President, Global Development, Bill & Melinda Gates Foundation, commented in the WHO press release on March 5, 2024, "HPV vaccines are a miracle of modern medicine, yet too many girls in low- and middle-income countries do not have access to them."

"There is no reason why women should die from cervical cancer when a vaccine to prevent it exists."

"With the addition of WHO's guidance for a one-dose HPV vaccine schedule, cervical cancer elimination is within reach. Now is the time for governments and partners around the world to increase HPV vaccine access and protect future generations from cervical cancer."

In a significant shift, the World Health Organization's (WHO) 2022 global recommendation for one-dose HPV vaccine schedules significantly reduced barriers to scaling up vaccination programs.

It has been reinforced by a similar recommendation in the Americas Region in 2023.

Furthermore, the WHO's Regional Office for Africa has just followed suit with its recommendation for countries in the region to adopt the single-dose vaccination schedule.

To date, 37 countries have reported switching or intent to switch to a one-dose HPV regimen.

As of March 2024, there are six licensed HPV vaccines, including Cervavac and Gardasil 9®.

In the United States, the Centers for Disease Control and Prevention says HPV vaccination is administered as a two-dose series (0, 6-12 months) for most persons who initiate vaccination at ages 9 through 14. A three-dose series (0, 1-2, 6 months) for persons who start vaccination at ages 15 through 45 and for immunocompromised persons.

The new funding includes but is not limited to $180 million from the Bill & Melinda Gates Foundation, $10 million from UNICEF, and $ 400 million from the World Bank.

Sub Title:

HPV Vaccination Core to Global Cervical Cancer Elimination

References:

Global Cervical Cancer Elimination Forum: Advancing the Call to Action

US CDC Administering HPV Vaccine

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Location Impacted HPV Vaccinations in 2022

Karen McClorey Hackett — Sat, 17 Feb 2024 14:24:46 +0000

Reviewer:

Robert Carlson, MD

Did you know that Human papillomavirus (HPV) vaccination can help prevent sexually transmitted infections in both men and women?

Unfortunately, many young people living in the 'country' remain under-immunized against HPV cancers.

A new report (NCHS Data Brief No. 495, February 2024) published by the U.S. Centers for Disease Control and Prevention (CDC) sheds light on this issue.

It reveals that only a certain percentage of children (38.6%) aged between 9 and 17 years have received at least one dose of the HPV vaccine by 2022. The report also highlights the social and health characteristics of the vaccinated children.

Remember, the CDC says people can start their HPV vaccination at age 9 in the U.S., but it is usually given to children between 11 and 12.

The percentage of children who have received one or more HPV vaccine doses varied by location.

Children living in metropolitan areas were about 40% more likely to have received one or more HPV vaccine doses than those living in non-metropolitan areas, 30%.

While the CDC did not offer a reason behind this significant difference, and most HPV vaccine costs are covered by insurance, recent studies have identified that non-metropolitan areas have different points of view than those living in big cities.

A Pew Research Center report issued in 2023 highlighted the urban-rural divide in voting preferences continues to be a significant factor in America.

According to the CDC, HPV vaccination prevents and controls genital warts, precancerous lesions, and certain cancers, such as cervical, vaginal, vulvar, anal, penile, and oropharyngeal.

In the United States, HPV vaccination has been recommended for girls since 2006 and for boys since 2011. During 2024, HPV vaccines are offered at health clinics and pharmacies in the U.S.

Sub Title:

Vaccination prevents and controls HPV cancers

References:

Human Papillomavirus Vaccination Coverage in Children Ages 9–17 Years: United States, 2022

Pew: Urban, suburban, rural in 2022

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US CDC - NCHS Data Brief No. 495 - February 2024

Ten Years Later, HPV Vaccination Remains Very Protective

Karen McClorey Hackett — Tue, 05 Sep 2023 14:09:20 +0000

Reviewer:

Robert Carlson, MD

After the introducing of Human Papillomavirus (HPV) vaccines in 2006, real-world studies have demonstrated decreases in the prevalence of specific HPV types and reduced rates of cervical lesions and cancer in vaccinated populations, wrote the American Academy of Pediatrics (AAP).

On September 5, 2023, the AAP stated the accumulated safety data from extensive postmarketing surveillance and epidemiologic studies conducted from 2009 through 2021 across 13 countries have been consistent with the safety profile in clinical trials.

These post-licensure results and the results from long-term follow-up extensions of clinical trials, including the study described herein, continue to support the favorable benefit-risk profile of HPV vaccination.

The complete study is posted at this AAP link.

"These data highlight the importance of GARDASIL 9® in the prevention of certain HPV-related cancers and diseases later in life," said Dr. Eliav Barr, senior vice president, head of global clinical development, and chief medical officer, Merck Research Laboratories, in a Merck press release on September 5, 2023.

"HPV-related cancers and diseases are a significant public health issue. These strong study results serve as a reminder that we need to do everything we can to expand and recover vaccination rates globally to help protect all eligible people from certain HPV-related cancers."

This is essential cancer prevention news since HPV will infect most sexually active males and females in their lifetime, writes the U.S. CDC.

For most people, there is no way to know who has HPV, except for cervical cancer, as there is no routinely recommended screening to detect HPV-related cancers.

GARDASIL 9 targets HPV types that cause approximately 80% of cervical cancers. Additionally, HPV is responsible for causing genital warts and certain types of vulvar, vaginal, and anal cancers.

For most people, HPV, a sexually transmitted disease, clears on its own, but it could lead to certain cancers and other diseases for those who don't clear the virus.

In the U.S., GARDASIL 9 is indicated for use in females 9 through 45 years of age for the prevention of cervical, vulvar, vaginal, anal, oropharyngeal and other head and neck cancers caused by HPV Types 16, 18, 31, 33, 45, 52, and 58; cervical, vulvar, vaginal, and anal precancerous or dysplastic lesions caused by HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58; and genital warts caused by HPV Types 6 and 11.

GARDASIL 9 is also indicated for use in males 9 through 45 years of age for the prevention of anal, oropharyngeal, and other head and neck cancers caused by HPV Types 16, 18, 31, 33, 45, 52, and 58; anal precancerous or dysplastic lesions caused by HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58; and genital warts caused by HPV Types 6 and 11.

The oropharyngeal and head and neck cancer indication is approved under accelerated approval based on its effectiveness in preventing HPV-related anogenital disease. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. The confirmatory trial is ongoing.

GARDASIL 9 is contraindicated in individuals with hypersensitivity, including severe allergic reactions to yeast, or after a previous dose of GARDASIL 9 or GARDASIL® [Human Papillomavirus Quadrivalent (Types 6, 11, 16, and 18) Vaccine, Recombinant].

Globally, there are several authorized HPV vaccines.

Disclosure: Funding for this research was provided by Merck Sharp and Dohme LLC, a subsidiary of Merck and Co, Inc., Rahway, NJ.

Sub Title:

HPV vaccines available in September 2023

References:

Ten-Year Follow-up of 9-Valent Human Papillomavirus Vaccine: Immunogenicity, Effectiveness, and Safety

Long-Term Follow-up Data on Sustained Immunogenicity and Safety for GARDASIL®9 Published in Pediatrics

US CDC HPV

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AAP HPV study Sept. 2023

Is One HPV Vaccine Dose Enough Cancer Protection?

Karen McClorey Hackett — Wed, 30 Aug 2023 19:22:37 +0000

Reviewer:

Robert Carlson, MD

When the World Health Organization (WHO) updated its recommendations for the human papillomavirus (HPV) vaccine in late 2022, it stated that a single-dose schedule could provide a comparable efficacy and durability of cancer protection compared to a two-dose regimen.

Since sexually transmitted HPV causes more than 95% of cervical cancer, many countries sought independent clinical research to support the WHO's revised recommendation.

During 2023, several research papers have been published offering insights behind the WHO's HPV vaccination schedule change.

On August 28, 2023, BMC Medicine published a research article: Global impact and cost-effectiveness of one-dose versus two-dose human papillomavirus vaccination schedules: a comparative modeling analysis that supports this one-dose schedule under certain assumptions.

Using three independent HPV transmission models, these researchers estimated the long-term health benefits and cost-effectiveness of one-dose versus two-dose HPV vaccination in 188 countries.

Under the scenarios where a single HPV vaccine dose confers more than 30 years of protection or 80% efficacy with lifelong protection, routine one-dose HPV vaccination provides the majority of health benefits to the two-dose program while simplifying vaccine delivery, reducing costs and circumventing vaccine supply constraints.

The second dose may be cost-effective if there is a shorter duration of protection from one dose, cheaper vaccine and vaccination delivery strategies, and a higher burden of cervical cancer.

These modeling results were fairly consistent when projected from three independent transmission dynamic models used in nine countries.

The outcomes of this comparative modeling analysis contribute to the extensive evidence base, including emerging evidence from the single-dose HPV vaccine trials and observational studies, which would benefit policymakers when they consider HPV vaccination in their populations, wrote these researchers.

"The HPV vaccine is highly effective for the prevention of HPV serotypes 16 & 18, which cause 70% of cervical cancer," said Dr. Alejandro Cravioto, WHO SAGE Chair, in a press release in 2022.

"SAGE urges all countries to introduce HPV vaccines and prioritize multi-age cohort catch-up of missed and older cohorts of girls."

"These recommendations will enable more girls and women to be vaccinated and thus prevent them from having cervical cancer and all its consequences throughout their lifetimes."

In the U.S., HPV accounts for about 14 million new infections annually.

The Centers for Disease Control and Prevention (CDC) updated its HPV vaccination schedule in 2023. The CDC recommends routine vaccination of preteens at ages 11 or 12 years. The vaccination series can be started at age nine years, if appropriate.

And HPV vaccinations may be given simultaneously with other vaccines, says the CDC.

Various HPV vaccines are available in 2023 in the U.S. at health clinics and pharmacies and globally.

Sub Title:

HPV vaccination reduces cervical cancer risk

References:

Global impact and cost-effectiveness of one-dose versus two-dose HPV vaccination schedules: a comparative model

A single dose of quadrivalent HPV vaccine is highly effective against HPV genotypes 16 and 18 detection in young pregnant women

Human papillomavirus vaccines: WHO position paper, December 2022

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by Toshiaki Tanaka

Many Unvaccinated Men Infected with HPV

Karen McClorey Hackett — Wed, 16 Aug 2023 13:13:26 +0000

Reviewer:

Robert Carlson, MD

The number of human papillomavirus (HPV) infections in women has been well documented, but less is known about this cancer-causing virus's prevalence in men.

A new study published today in The Lancet Global Health (September 2023 early release) estimates the frequency of men harboring genital HPV infections.

These resarchers estimated the overall HPV prevalence of any type among men was 31% (95% CI 27–35), with study-specific prevalences ranging from 1% to 84%

And the overall prevalence of high-risk (HR) HPV was 21% (95% CI 18–24), with study-specific prevalences ranging from 1% to 75%. HPV-16 was the most frequent HR-HPV type at 5%.

Furthermore, HPV prevalence in men peaked in the group aged 25–29 years.

These estimates are consistent with the hypothesis that sexually active men, regardless of age, are at risk of HPV-related morbidity and are a reservoir of sexually transmissible HPV infection, wrote these resarchers.

Globally in men, as in women, the most common oncogenic and preventable HPV type is HPV-16.

Additionally, this study identified the protection from various HPV vaccines.

The pooled prevalence was 7% (95% CI 6–8) for the HPV types found in the two-valent vaccine, 11% (95% CI 9–13%) for the four-valent vaccine, and 16% (95% CI 14–18%) for the nine-valent vaccine.

These HPV vaccines are available in different countries globally.

Incorporating HPV vaccination for adolescent males into national immunization schedules can be further considered as vaccine supplies allow and single-dose strategies are assessed, suggest these researchers.

In the U.S., the Centers for Disease Control and Prevention (CDC) endorses HPV vaccinations for young men in the 2023 vaccine schedule. The nine-valent HPV vaccine is recommended in the U.S. and is often available at health clinics and community pharmacies.

HPV accounts for about 14 million new infections annually in the U.S., reports the CDC.

These HPV estimates are based on a systematic review of published prevalence surveys and unpublished data from study authors.

Declaration of interests - The Cancer Epidemiology Research Program received sponsorship for grants from Merck (which produced HPV vaccines) and HPV test kits at no cost from Roche for research purposes.

Sub Title:

HPV vaccines prevent cancer in men and women

References:

Estimates of genital human papillomavirus prevalence among men: a systematic review and meta-analysis

US CDC - HPV Vaccination Recommendations 2023

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HPV, vaccinations

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Fact checked:

Wednesday, August 16, 2023 - 05:30

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by Keith Johnston

mRNA Vaccine Candidates Target HPV Cancers

Karen McClorey Hackett — Fri, 05 May 2023 17:40:23 +0000

Reviewer:

Robert Carlson, MD

Holly Lutmer PharmD

For more than a decade, researchers have been developing vaccines that use messenger RNA (mRNA) to treat cancer, though none have been approved by the U.S. Food and Drug Administration (FDA), wrote Edward Winstead.

On April 26, 2023, the U.S. National Cancer Institute published an article that confirmed a few studies had compared mRNA cancer vaccine candidates using different technologies.

A recent non-human study developed and compared three mRNA vaccine formulations designed to treat cancers caused by human papillomavirus (HPV) infections, such as cervical and some head and neck cancers.

In the head-to-head comparison, researchers found all three experimental vaccines eradicated HPV-related cancers in the mice, reported the NCI.

In fact, a single dose of any of the three vaccines made tumors in the mice go away, Jamile Ramos da Silva, Ph.D., of the University of São Paulo, and her colleagues reported in Science Translational Medicine on March 3, 2023.

In most of the mice, cancer did not come back.

Although there are vaccines to prevent HPV infections and the cancers that result, these vaccines do not treat cancers caused by existing HPV infections.

Building on this work, a new study compared two vaccines with different formulations of nonreplicating mRNA—one used modified mRNA and the other unmodified mRNA.

The third vaccine in the study was a self-amplifying mRNA vaccine.

Each vaccine delivers mRNA instructions for making an engineered protein called gDE7.

Cells that take up the vaccine produce this protein, which trains the immune system to recognize and attack cells with a protein from HPV-16 called E7. This protein interacts with other proteins in cells to drive cancer progression.

Not only were all three vaccines effective, but they also outperformed two other treatments—a DNA-based gDE7 vaccine and a gDE7 protein-based vaccine—in the same mouse model, the researchers reported.

"We learned from our studies that all three mRNA platforms can potentially be used in future studies in humans," said study co-leader Norbert Pardi, Ph.D., of the University of Pennsylvania Perelman School of Medicine, who investigates mRNA vaccines.

The researchers focused on HPV-related cancers partly because current treatments are not optimal.

For example, while many cervical cancers initially respond to standard treatments, these cancers often stop responding to therapies at some point, and the disease frequently returns.

Oropharyngeal cancer is a type of head and neck cancer that occurs in the back of the throat and is caused by HPV.

Moreover, these researchers wrote that many people diagnosed with HPV-related cancers in the next few decades would have been past the age at which vaccination is recommended when the preventive vaccines became available or lacked access.

In the meantime, mRNA vaccine candidates are being evaluated in people with HPV-related cancers.

One active clinical trial is testing a personalized mRNA vaccine in combination with an immune checkpoint inhibitor in patients with advanced head and neck cancer.

That vaccine is mRNA-4157, manufactured by Moderna Inc.

This mRNA-based individualized, therapeutic personalized cancer vaccine targets 20 tumor-associated antigens expressed by the patient's cancer cells.

And recent studies indicate currently available HPV vaccines can curtail a throat cancer epidemic.

Throat (Oropharyngeal) cancer incidence is rapidly rising due to HPV 16 infection.

Throat cancer's leading risk factor is the number of sexual partners. Those with six or more lifetime oral-sex partners are 8.5 times more likely to develop oropharyngeal cancer.

For any vaccine to be effective, it must be first administered.

In the U.S., coverage with one or more HPV vaccine doses in boys and girls was over 75% in 2021, an increase of 1.8% from 2020.

As of May 5, 2023, various HPV vaccines are offered at clinics and pharmacies in the U.S.

For other sexually transmissible diseases (chlamydia, gonorrhea, herpes), vaccine development news is posted by Precision Vaccinations.

are

Sub Title:

HPV vaccination prevents throat cancer

References:

mRNA Vaccines Show Promise for Treating HPV-Related Cancers

Oropharyngeal Cancer Epidemic and Human Papillomavirus

U.S. National Vaccination Coverage Among Adolescents - 2022

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Young Adults

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HPV, vaccinations

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Fact checked:

Friday, May 19, 2023 - 19:15

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U.S. CDC throat cancer vaccine May 2023

Which Sexually Transmitted Disease is Vaccine-Preventable

Karen McClorey Hackett — Fri, 21 Apr 2023 16:26:02 +0000

Reviewer:

Robert Carlson, MD

Holly Lutmer PharmD

While several sexually transmitted diseases (STDs) lack preventive vaccines, such as herpes, HIV, and chlamydia, cervical cancer is a disease that can be prevented with an effective vaccine.

Furthermore, real-world data indicates only one dose is needed to protect certain women from this cancer.

Announced on April 20, 2023, a new study funded by the Bill and Melinda Gates Foundation and in collaboration with the Massachusetts General Hospital (MGH) and the Republic of Kenyan Ministry of Health confirmed a single dose of a Human Papillomavirus (HPV) vaccine was highly efficacious in preventing persistent infections of the virus over three years.

This randomized, multicenter, double-blind, controlled clinical trial included 2,275 women between the ages of 15-20, who were randomly assigned to receive either a single dose of the bivalent or nonavalent HPV vaccine or the control vaccine.

Over the 36-month study period, participants were regularly tested for HPV DNA, with cervical and vaginal swabs routinely collected. The results showed that the single dose of both the bivalent and nonavalent HPV vaccines was highly efficacious, with a vaccine efficacy of 98%.

Additionally, the nonavalent vaccine had a vaccine efficacy of 96% for the nine types of HPV it targets.

"This study provides important evidence that a single dose of HPV vaccine can be highly effective in preventing persistent infections and, ultimately, cervical cancer," commented Lead Investigator Dr. Ruanne Barnabas of the MGH in a press release on April 20, 2023.

"A single-dose vaccination schedule could go a long way in addressing this deadly inequity."

Since December 2022, eight countries have announced switching to a one-dose HPV schedule following updated guidance from the World Health Organization (WHO).

The WHO's Strategic Advisory Group of Experts on Immunization evaluated the evidence and supported a single-dose schedule for certain women.

In 2023, SAGE recommends updating dose schedules for HPV as follows: