Vaccine News

Merck today announced plans to initiate clinical development of a new investigational multi-valent human papillomavirus (HPV) vaccine designed to provide broader protection against multiple HPV types.

Separately, the company also plans to conduct clinical trials to evaluate the efficacy and safety of a single-dose regimen of GARDASIL®9 compared to the approved three-dose regimen.

“Evidence continues to emerge showing the importance of GARDASIL and GARDASIL 9 to public health,” said Dr. Eliav Barr, senior vice president, head of global clinical development, and chief medical officer, Merck Research Laboratories, in a press release on March 13, 2024.

“These significant investments build upon our leadership and, importantly, provide the opportunity to further impact the global burden of certain HPV-related cancers and diseases.”

Merck announced in February 2024 that GARDASIL/GARDASIL 9 vaccine sales reached about $8.9 Billion; 

The World Health Organization (WHO) recommends vaccinating against HPV to prevent infections and associated cancers.

As of March 2024, the WHO has listed 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. 

Furthermore, the WHO and the United Kingdom have endorsed the single-dose regimen.

An observational, cross-sectional cohort study was published on March 5, 2024, investigating the source of an ongoing mpox outbreak in the Democratic Republic of the Congo (DRC).

The study also evaluated how the mpox virus (MPXV) clade I spread in the city of Kamituga. This non-peer-reviewed study included data from 2022 to January 2024.

These researchers reported a staggering 21,630 suspected MPXV cases and 1,003 deaths. Around 85% of the deaths recorded during this period were children under 15 years of age.

This MPXV clade I outbreak marks an important change as transmission routes now appear to be expanding to include heterosexual activity, wrote these researchers.

The DRC reported the first mpox MPXV clade I cases in humans in 1970.

"The mpox situation in the DRC is deeply alarming, and the lack of tests for both mpox and HIV means it's unclear just how bad the mpox situation is and what the underlying comorbidities are," said Dr. Ayoade Alakija, who is Chair of the Board at FIND, in a press release on March 12, 2024.

The May 2022 MPVX clade II global outbreak caused global concern, primarily among men. The outbreak caused 93,497 cases in 118 locations.

As of March 5, 2024, there have been 32,063 confirmed mpox cases and 58 deaths in the U.S.

Throughout the clade II outbreak, the JYNNEOS® ((MVA-BN®, IMVAMUNE®) vaccine has been deployed in most impacted countries.

On December 7, 2023, the U.S. CDC published a Health Alert Network Health Advisory stating that JYNNEOS is expected to have similar vaccine effectiveness (VE) against MPXV clade I, as seen with clade II.

The CDC's vaccine committee reported in October 2023 that JYNNEOS's VE against mpox clade II ranges from 36%–75% for 1-dose vaccination and 66%–89% for 2-dose vaccination. 

The European CDC reported in December 2023 that real-world JYNNEOS VE data is lacking.

Scientists from Duke-NUS Medical School (Duke-NUS) have developed a new approach using the Zika virus to destroy brain cancer cells and inhibit tumor growth while sparing healthy cells.

Using Zika virus vaccine candidates developed at Duke-NUS, the team discovered how these strains target rapidly proliferating cells over mature cells—making them an ideal option to target fast-growing cancerous cells in the adult brain.

Zika virus is one such option in early development. The Duke-NUS team used Zika virus live-attenuated vaccine (ZIKV-LAV) strains, which are "weakened" viruses with limited ability to infect healthy cells but can still increase and spread within a tumor mass.

"We selected Zika virus because it naturally infects rapidly multiplying cells in the brain, allowing us to reach cancer cells that are traditionally difficult to target. Our ZIKV-LAV strains also replicate themselves in brain cancer cells, making this a living therapy that can spread and attack neighboring diseased cells," said Dr. Carla Bianca Luena Victorio, first author of the paper and Senior Research Fellow at the Cancer & Stem Cell Biology Programme at Duke-NUS, in a press release on March 8, 2024.

Their study's findings, published in the Journal of Translational Medicine in February 2024, potentially offer a new treatment alternative for brain cancer patients who currently have a poor prognosis.

Glioblastoma multiforme is the most common malignant brain cancer, with more than 300,000 patients diagnosed annually worldwide. Survival rates for such patients are poor (around 15 months), mainly due to the high incidence of tumor recurrence and limited treatment options.

For such patients, oncolytic virotherapy—or the use of engineered viruses to infect and kill cancer cells—may address the current therapeutic challenges.

Separately, several Zika vaccine candidates are conducting clinical research as of March 2024.

A preventive vaccine targeting Zika is in demand since 36,738 Zika cases were reported in 2023.

In the Americas, the highest proportion of Zika cases was reported in Brazil (35,041), followed by Bolivia, Belize, Columbia, Paraguay, and Venezuela. 

The New Jersey Department of Health (NJDOH), which has already confirmed one measles case in 2024, recently announced it is investigating eight suspected mumps cases in Hunterdon County, northwest New Jersey.

Mumps can become very serious and start with fever, headache, muscle aches, tiredness, and loss of appetite. Later, it appears as a swelling of the salivary glands or puffy cheeks and a tender, swollen jaw.

As of  February 29, 2024, a total of 50 mumps cases have been reported by 21 U.S. jurisdictions, some related to international travel.

Last year, 436 mumps cases were reported in the U.S.

NJDOH is urging everyone to be aware of the symptoms of these highly contagious viruses and to stay up to date with the measles, mumps, and rubella (MMR) vaccinations.

The MMR vaccine is a very effective way to avoid these illnesses.

“As a physician and mom, I understand what keeping your kids and your family healthy is like. The best way to keep you and your loved ones safe is to get the MMR shot. If you or your family have not gotten the shot, now is the time,” said Acting Health Commissioner Dr. Kaitlan Baston in a press release on March 5, 2024.

“These viruses are incredibly contagious, so if you suspect you may have measles, mumps, or rubella, it is important to call ahead before visiting any health care provider or facility so they can take special precautions.” 

The cost of MMR vaccination is generally covered by insurance, and various vaccines are available at community pharmacies.

Many people are looking forward to Spring 2024, but the respiratory season still affects children's health in the United States.

On March 8, 2024, the U.S. CDC published an updated national outlook on respiratory diseases. According to the report, influenza percent positivity has remained stable compared to the previous week, but there have been flu outbreaks in some areas of the country.

In addition, last week, ten children died from influenza.

As of week #9 of 2024, the CDC has identified 103 influenza-associated pediatric deaths using underlying cause-of-death codes J09–J18. During the 2022-2023 flu season, 182 children died from influenza infections.

The vaccination status of these children was not disclosed.

The CDC continues to recommend a seasonal flu shot for anyone older than six months and suggests speaking with a doctor, nurse, or pharmacist about flu shot options (egg, cell, nasal) in March 2024.

Since the Respiratory Syncytial Virus (RSV) season began in the United States in Florida last year and peaked over the winter months, pregnant women have had two immunization options available to protect their future infants.

In August 2023, the CDC recommended Beyfortus™ (Nirsevimab-alip), a single-dose, long-acting monoclonal antibody offering passive immunization, to protect infants aged <8 months against RSV-associated lower respiratory tract infection in their first RSV season.

The other option is maternal vaccination.

On March 7, 2023, the U.S. CDC's Morbidity and Mortality Weekly Report offered encouraging news.

The CDC confirmed that Beyfortus was 90% (95% CI = 75%–96%) effective against RSV-associated hospitalization in infants in their first RSV season.

However, Beyfortus's effectiveness is expected to decrease after receipt because of antibody decay.

In clinical trials, nirsevimab remained highly efficacious against RSV-associated lower respiratory tract infection in infants through 150 days, consistent with an extended half-life of 63–73 days.

This early estimate supports the current CDC recommendation for the prevention of severe RSV disease in infants.

As of January 2024, among females with an infant <8 months, 40.5% reported that their infant received nirsevimab. An additional 21.7% said that they plan to get nirsevimab for their infant.

The European Centre for Disease Prevention and Control (ECDC) today reported a significant surge in sexually transmitted infections (STIs) across Europe.

The latest Annual Epidemiological Reports on STIs in the European Union/European Economic Area (EU/EEA), published on March 7, 2024, reveal a sharp increase in reported STI cases in 2022 compared to the previous year.

Gonorrhea cases rose by a staggering 48%, syphilis by 34%, and chlamydia by 16%. This is a concerning trend that requires immediate action to prevent further escalation, wrote the ECDC.

ECDC Director Andrea Ammon expressed deep concern over the rising STI rates in a press release: "Addressing the substantial increases in STI cases demands urgent attention and concerted efforts."

"Testing, treatment, and prevention lie at the heart of any long-term strategy."

While no approved vaccines for these STIs exist, the United Kingdom (U.K.) has launched an innovative immunization program targeting gonorrhea.

In 2023, the U.K.'s JCVI considered the evidence presented regarding program cost-effectiveness and likely impact on gonorrhea epidemiology.

The committee agreed that a targeted program should be initiated using the 4CMenB vaccine (Bexsero®) to prevent gonorrhea in those at most significant risk of infection.

It is essential for individuals offered vaccination to understand that real-world studies have estimated that the 4CMenB vaccine is effective against gonorrhea between 32.7% and 42%.

Therefore, although vaccination would be expected to reduce the chance of becoming infected with gonorrhea, it would not eliminate the possibility.

Vaccinated individuals could expect to have some reduction in their own risk of contracting gonorrhea.

However, the JVCI wrote that the main benefit of a vaccination program is expected to be at the community level, with a significant reduction in the overall number of cases.