Vaccine News

A recent study published by the journal Cell Host & Microbe shows that gender-neutral vaccination can achieve population-level human papillomavirus (HPV) immunity.

Published on November 1, 2023, this study evaluated the long-term effect of community-randomized gender-neutral and girls-only HPV vaccination on the ecology of the remaining oncogenic HPVs among young adult women vaccinated as early adolescents.

These researchers observed a significant depletion of high-oncogenicity vaccine-targeted HPV types 16/18/31/45 in gender-neutral and girls-only vaccination communities four years post-vaccination.

However, this depletion was consistent eight years post-vaccination only among gender-neutral vaccination communities.

'Our most important finding, however, was the significantly increased (PFDR = 1.1 × 10−8) oncogenic HPVs ecological diversity from 4 to 8 years post-vaccination exclusively in gender-neutral vaccination communities despite the clearance of the vaccine-targeted types in these communities.'

'This rising ecological diversity of the oncogenic HPVs in gender-neutral vaccination communities with a stronger herd immunity compared with girls-only vaccination communities is likely the first recorded sign of ecological niche occupation by the non-vaccine-targeted HPV post-population-level vaccination,' wrote these researchers.

Previously, the Lancet Global Health released a report in September 2023 report showing that almost 33% of men over the age of 15 were infected with at least one genital HPV type, and 20% are infected with one or more high-risk or oncogenic HPV types.

Additionally, a study published by the Journal of Infectious Diseases on October 12, 2023, found genital HPV infections within two years in about 40% (CI:33.4-48.4) of unvaccinated young women who started a new heterosexual relationship. 

In the United States, about 76% of adolescents have received one or more HPV vaccine doses by 2022.

As of November 11, 2023, various HPV vaccines are available at most clinics and pharmacies.

The U.K.'s Joint Committee on Vaccination and Immunisation (JCVI) today advised the government of a new, routine targeted vaccination program to prevent gonorrhea. 

On November 10, 2023, the JCVI announced it had agreed that a targeted program should be initiated using the 4CMenB (Bexsero®) vaccine for the prevention of gonorrhea in those who are at most significant risk of infection.

The JCVI advice is that Bexsero should be offered on an opportunistic basis through specialist sexual health services, which have the experience in assessment and identification of those who are at increased risk of infection with bacterial sexually transmitted infections (STI).

The U.S. Food and Drug Administration (FDA) initially approved Bexsero (Meningococcal Group B Vaccine) for intramuscular injection in 2015. 

In the U.S., Bexsero is generally available at health clinics and pharmacies.

As of November 2023, no vaccines are approved by the FDA or European Medicines Agency for preventing gonorrhea infection.

The U.S. Centers for Disease Control and Prevention (CDC) reported about 710,000 cases of Gonorrhea in 2021, making it the second most common STI in the U.S.

In addition, the CDC announced on April 11, 2023, that gonorrhea rates increased by more than 4%, reaching 710,151 in 2022. 

According to the U.S. Centers for Disease Control and Prevention (CDC), during the 2022–23 school year, nationwide vaccination coverage among kindergarten children was about 93% for common vaccines, similar to that in the 2021–22 school year.

However, last year's data was lower than the 94% coverage in the 2020–21 school year and lower still than the 95% coverage during the 2019–20 school year.

On November 10, 2023, the CDC announced two concerning trends.

The overall percentage of children with an exemption increased from 2.6% during the 2021–22 school year to 3.0% during the 2022–23 school year, the highest exemption rate ever reported in the United States.

Overall, the percentage of children with a vaccine exemption increased in 40 states and D.C. 

Nonmedical exemptions account for about 90% of reported exemptions and approximately 100% of the increase in the national exemption rate. 

Furthermore, from the 2019–20 to the 2021–22 school year, national coverage with state-required vaccines among kindergartners declined from 95% to approximately 93%, ranging from 92.7% for DTaP to 93.1% for polio.

And the National measles, mumps, and rubella (MMR) coverage among kindergarten students remained below the Healthy People 2030 target of 95% for the third consecutive year.

Nationally, 2-dose MMR coverage was 93.1% (range = 81.3% [Idaho] to ≥98.4% [Mississippi]).

While there have been a few measles outbreaks in the U.S. this year, several countries, such as India, continue reporting significant measles outbreaks in late 2023.

Various MMR vaccines remain available at most clinics and pharmacies in the U.S. A January 2023 IQVIA study showed that 60-70% of all flu vaccines are administered at pharmacies during late 2022.

To address the declines in routine immunization coverage across the lifespan, the CDC launched the Let's Routine Immunizations on Schedule for Everyone (RISE) initiative earlier in 2023 and provides a broad range of communication and enhanced technical assistance, including back-to-school campaigns.

Vaxcyte, Inc. today announced that the first participants were dosed in a Phase 1/2 clinical study for VAX-31, a 31-valent pneumococcal conjugate vaccine (PCV) candidate designed to prevent invasive pneumococcal disease (IPD) in adults.

Vaxcyte stated it expects to announce topline data from the Phase 1/2 study in the second half of 2024.

"We are pleased to initiate the first adult clinical study of VAX-31, which is the broadest-spectrum PCV to enter the clinic, with the potential to protect against approximately 95 percent of IPD circulating in the U.S. adult population," said Grant Pickering, Chief Executive Officer and Co-founder of Vaxcyte, in a press release on November 9, 2023.

"Leveraging the foundation established by our lead PCV candidate, VAX-24, we believe we have an opportunity to deliver a best-in-class PCV franchise that provides the broadest spectrum of coverage and improved immune responses compared to the standard-of-care in adults today."

The VAX-31 Phase 1/2 clinical study is a randomized, observer-blind, active-controlled, dose-finding clinical study designed to evaluate the safety, tolerability, and immunogenicity of VAX-31 compared to Prevnar 20® in healthy adults aged 50 and older.

Pneumococcal disease (PD) is an infection caused by Streptococcus pneumoniae bacteria. It can result in IPD, including meningitis and bacteremia, and non-invasive PD, including pneumonia, otitis media, and sinusitis. 

The U.S. National Center for Health Statistics Mortality Surveillance reported on October 27, 2023, that most respiratory disease deaths were recently related to pneumonia, not COVID-19 or influenza. Precision Vax posts additional PCV vaccine and candidate news. 

The U.S. CDC's pneumococcal vaccine schedules were updated in 2023.

The Lancet Oncology recently published a Commentary by Hitt Sharma and colleagues reporting findings from a pivotal phase 2/3 human papillomavirus (HPV) prophylactic vaccine trial.

Their article, published on November 7, 2023, showed that two doses of a quadrivalent virus-like particle (VLP) vaccine targeting HPV types 6, 11, 16, and 18 (CERVAVAC®; Serum Institute of India) induced non-inferior antibody responses in girls and boys aged 9–14 years compared with a quadrivalent HPV vaccine licensed worldwide and targeting the same HPV types (Gardasil®) given in three doses to women aged 15–26 years, an age group in which strong clinical efficacy has been shown.

The authors also reported no significant differences in adverse events between the vaccines.

It is the first vaccine manufactured in India to receive licensure by the Drugs Controller General of India.

As of November 9, 2023, there are several HPV vaccines licensed globally.

In the U.S., HPV vaccinations for women began in 2006 and for men in 2011. On August 25, 2023, the U.S. CDC reported that in 2022, 76% of people aged 13–17 had received one or more HPV vaccine doses. 

The current U.S. CDC HPV schedule was updated in 2023.

While most people assume Zika virus outbreaks ended a few years ago, new data from the Pan American Health Organization (PAHO) clearly indicates that Zika remains a significant health risk.

As of November 8, 2023, the PAHO dashboard reported 28,267 Zika cases from countries in the Americas, primarily in Central and South America.

The leading countries reporting Zika outbreaks are led by Brazil, with over 26,000 cases, followed by Bolivia, Belize, Columbia, Paraguay, and Venezuela.

In the United States, Puerto Rico's Weekly Report on Arboviral Diseases shows 33 probable Zika cases this year and 20 cases in 2022.

Zika is primarily spread to people by the bite of a mosquito infected with the virus, but it can also be passed during sex from a person infected with Zika.

Furthermore, Congenital Zika-associated syndrome is a set of anomalies (microcephaly) seen in infants born to mothers with a history of gestational Zika fever.

The U.S. CDC recommends that pregnant women and couples planning a pregnancy within the next three months consult with a healthcare provider before visiting an area reporting a Zika outbreak.

As of November 2023, there are no approved Zika vaccines.

Clover Biopharmaceuticals, Ltd. announced today that it has completed the Biologic License Application (BLA) submission for its seasonal influenza vaccine (AdimFlu-S) to the Brazilian Health Regulatory Agency.

Upon approval, Clover will work with its local partner to commercialize AdimFlu-S, a quadrivalent split-inactivated vaccine containing hemagglutinin from four influenza virus strains (A and B).

If approved in Brazil, Clover's AdimFlu-S would have access to the Southern Hemisphere market.

Brazil is a vital vaccine market strategically. The country has the world's second-largest seasonal influenza vaccine market. Its market size is expected to surpass US$1 billion over the next five years.

"The BLA submission of AdimFlu-S in Brazil is another step towards our goal of becoming a global leader in the respiratory vaccine space and builds upon Clover's prior experience enrolling over 10,000 people in clinical trials across Brazil and South America," said Joshua Liang, Chief Executive Officer, and Executive Director of Clover, in a press release on November 6, 2023.

"By leveraging our unique globalization capabilities, we will continue expanding to other countries and regions to diversify our sales and maximize our impact on public health." 

 As of September 2023, AdimFlu-S has been listed in 26 provinces and municipalities in China. 

Clover's diverse pipeline of candidates includes potential treatments that could significantly reduce the burden of vaccine-preventable diseases and make more diseases preventable.  

In the United States, 145.42 million influenza vaccine doses (egg-based, nasal, cell-based) had been distributed in the U.S. as of October 28, 2023,