Vaccine News

The U.S. CDC announced today that it supports the new Dosing Interval and Schedule for the Bexsero® MenB-4C Vaccine based on the Updated Recommendations of the Advisory Committee on Immunization Practices in October 2024.

On December 12, 2024, the CDC's MMWR (73(49);1124–1128) recommended MenB-4C as a 2-dose series with doses administered at intervals of 0 and 6 months for healthy adolescents and young adults aged 16–23 based on shared clinical decision-making and as a 3-dose series with doses administered at 0, 1–2, and 6 months for persons aged ≥10 years at increased risk.

This news is very relevant for teenagers and college students as real-world evidence suggests that Bexsero provides cross-protection against gonorrhea, a sexually transmitted disease.

For example, the U.K.'s Joint Committee on Vaccination and Immunisation recommended a routine targeted vaccination program in 2023 using the 4CMenB to prevent gonorrhea. 

The U.S. NIH recently announced the antiviral drug tecovirimat, known commercially as TPOXX®, did not reduce the time to lesion resolution or have an effect on pain among adults with mild to moderate clade II mpox and a low risk of developing severe disease.

A planned interim analysis at 75% of the current study's target enrollment showed no difference in the time to lesion resolution between participants treated with tecovirimat compared with those who received a placebo.

This finding is based on an interim data analysis from an international clinical trial called the Study of Tecovirimat for Mpox (STOMP). 

Considering these definitive findings, the study's Data Safety and Monitoring Board recommended stopping further enrollment of participants who were being randomized to tecovirimat or placebo. 

At the Board's request, an additional assessment was performed. Based on the study design and available data, there was less than a 1% chance that the study would show that tecovirimat would be effective if it were to complete enrollment and follow-up.

"The initial STOMP findings provide valuable insight to inform clade II mpox medical countermeasures and underscore the critical importance of conducting well-designed randomized clinical trials during infectious disease outbreaks," said NIAID Director Jeanne Marrazzo, M.D., M.P.H., in a media release on December 10, 2024.

"Before 2022, no treatment candidate had been studied in people with mpox, and this trial is a critical step in our systematic evaluation of existing antivirals like tecovirimat while pursuing novel antivirals and antibody-based mpox therapeutics."

The Food and Drug Administration initially approved SIGA Technologies, Inc.'s Tecovirimat to treat smallpox.

Mpox is caused by a virus that spreads mainly through close contact. Two virus types, clades I and II, have been identified and are historically present in Central and West Africa.

A clade II subtype virus caused a global mpox outbreak in 2022, and the virus continues to circulate at low levels.

In 2024, the World Health Organization declared a Clade I outbreak in Central and East African countries a public health emergency of international concern.

Travel-related cases of clade I mpox have been reported internationally, and the first reported case in the United States was diagnosed on November 15, 2024.

The U.S. CDC has issued a Level 2 travel advisory regarding the Mpox outbreak.

According to a study published in The BMJ, the rate of essential childhood vaccinations has recently decreased in the U.K. The vaccination schedule in England protects children against 15 vaccine-preventable diseases, and vaccines are administered from ages 8 weeks to 14 years.

Published on December 11, 2024, these researchers analyzed vaccination rates at general practices for MMR, rotavirus, pneumococcal conjugate booster, and a six-in-one shot that includes diphtheria, tetanus, and polio vaccinations. 

For example, the estimated cumulative number of 5-year-olds susceptible to measles infection over the study period increased 15-fold in the least deprived group.

This study revealed that vaccination rates in England have declined steadily since 2013, with few in the routine vaccination schedule. For all childhood vaccinations studied, the uptake rates in England did not exceed the WHO recommended threshold of 95% in the more deprived populations.

As of December 12, 2024, the U.S. CDC says that when visiting the U.K., one should be aware of current health issues such as measles.

The U.S. FDA confirmed the 188th Meeting of the Vaccines and Related Biological Products Advisory Committee (VRBPAC) will be conducted on December 12, 2024,

The Briefing Document for this digital meeting states the VRBPAC will meet in open session to discuss considerations for Respiratory Syncytial Virus [RSV] vaccine safety in pediatric populations. The FDA wrote, "The observed imbalance in severe/very severe cases of RSV LRTI in the mRNA-1345 and mRNA-1365 vaccine development program among 5-month to <8-month-old recipients of mRNA-1345 (15 μg) and mRNA-1365 (15 μg) has uncertain implications for the ongoing and future pediatric development of other non-live attenuated RSV vaccines."

Moderna's mRNA-1345 is an investigational RSV vaccine with a single mRNA sequence encoding for a stabilized prefusion F glycoprotein. The vaccine uses the same lipid nanoparticles (LNPs) as in the Moderna COVID-19 vaccines. The F glycoprotein is on the virus's surface and is required for infection by helping the virus enter host cells. It exists in two states: prefusion and postfusion. The prefusion conformation is a significant target of potent neutralizing antibodies and is highly conserved across both RSV-A and RSV-B subtypes.

The draft Agenda overview is as follows:

1. Clinical and Nonclinical Aspects of RSV Vaccine Safety in Young Children.
2. Review of Investigational RSV (mRNA-1345) and RSV/hMPV (mRNA-1365) Vaccines in Infants and Children < 2 Years.
3. Imbalance in Severe RSV Cases in a Clinical Trial of an RSV Vaccine in Infants and Young Children.
4. Committee Discussion of Considerations for RSV Vaccine Safety in Pediatric Populations.

The FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with disabilities. This is the YouTube link.

Advisory committees provide independent expert advice to the FDA on broad scientific topics or specific products to help the agency make sound decisions based on the available science. Advisory committees make non-binding recommendations to the FDA, which generally follows the recommendations but is not legally bound to do so.

The U.S. Department of State today issued a Level 2: Exercise Increased Caution, Travel Advsiory for the Republic of Costa Rica.

As of December 10, 2024, the State Department confirmed that visitors to Costa Rica should exercise increased caution due to various crimes targeting tourists.

If you travel to Costa Rica, enroll in the Smart Traveler Enrollment Program to receive digital aalerts, making locating you in an emergency easier. Additionally, the U.S. Embassy in San José is located at Calle 98, Via 104, Pavas.

This advisory provides essential information for Costa Rica's expanding tourism industry. Over 1.5 million tourists visited Costa Rica in early 2024, a 14% increase from the same period in 2023.

From a health perspective, mosquito-transmitted Chikungunya, Dengue, Malaria, and Zika viruses have been confirmed and vary by location in 2024. For example, there have been:

Over 29,700 Dengue cases, 40 Chikungunya infections, and 25 Zika cases have been reported this year, primarily in Costa Rica's mountains.

"Zika, Chikungunya, and Dengue Mosquitoes (Aedes aegypti and Aedes albopictus) generally bite from Dawn to Dusk each day," commented Duellyn Pandis, DNP, MS, APRN, FNP-C, Certificate in Travel Health®.

"They may also be active in well-lit areas. They prefer to bite legs, hands, faces, necks, and ears. Protect yourself using appropriate repellants such as DEET and Permethrin for those diseases that are not vaccine-preventable," added Pandis, President & CEO of Passport Health of Tampa Bay.

The U.S. CDC suggests that future visitors to Costa Rica speak with a travel vaccine expert at least one month before traveling abroad about disease protection options. Travel vaccines are available in health clinics and pharmacies in 2024.

The World Health Organization (WHO) today announced the 43rd situation report for the multi-country outbreak of mpox, including countries in the African Region and some countries in the Eastern Mediterranean Region.

As of December 9, 2024, most (>95%) of suspected mpox cases in all African countries except the Democratic Republic of the Congo are tested, so only confirmed cases are reported.

The highlights of this 26-page report are as follows:

• The Emergency Committee under the International Health Regulations was unanimous in expressing the view that the ongoing upsurge of mpox still meets the criteria of a public health emergency of international concern (PHEIC) and that the event continues to constitute a PHEIC and issued revised temporary recommendations to this effect.
• Since the last situation report, two additional countries have confirmed travel-related cases of mpox due to clade Ib MPXV for the first time: Canada and the United States of America. The U.S. case is a male adult in California who reported a recent history of travel to locations in East Africa.
• In late November 2024, the United Kingdom notified WHO of a fifth case of mpox in Leeds due to clade Ib MPXV.
• One country, Angola, has reported mpox cases for the first time.

Regarding preventive vaccines, following the vaccination workshop in early November 2024, countries are submitting updated vaccination plans. As of December 2024, 1,678,000 additional mpox vaccine doses are available for shipment.

In addition to Bavarian Nordic's JYNNEOS® (MVA-BN®) vaccine, the WHO added LC16m8 to the Emergency Use Listing in November 2024. A single dose of the Japan-based vaccine is administered via a multiple-puncture technique using a bifurcated needle.

In the U.S., the JYNNEOS vaccine is commercially available at various clinics and pharmacies.

The Pan American Health Organization (PAHO) is conducting a briefing on the current state of dengue, Oropouche, and avian flu in the Region of the Americas. These Arthropod-borne viruses pose a significant public health threat, with a notable expansion in their geographic spread.

Recently, the Oropouche virus has also expanded in certain countries, such as Cube, and avian flu has been reported in birds, mammals, and humans along the northern flyway.

On December 10, 2024, at 10:00 a.m. EST, via Zoom with prior registration, the PAHO will provide an update on the situation of these viruses and recommendations for 2025.

Since 2003, the Americas have faced an unprecedented increase in dengue outbreaks in 2024, with over 12.6 million infections and 7,713 related fatalities, marking a record year. 

In the United States, the CDC reported that 52 jurisdictions, led by California, Florida, New Jersey, New York, and Puerto Rico, had reported 7,858 dengue cases this year. According to local reporting, dengue may have become endemic in Puerto Rico and Miami, Florida.

As of December 9, 2024, no dengue vaccine is available in the U.S.