Vaccine News

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.

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.

The World Health Organization (WHO) today announced that between 24 October and 5 December 2024, the Panzi health zone in Kwango Province of the Democratic Republic of the Congo (DRC) recorded 406 cases of an undiagnosed disease with symptoms of fever, headache, cough, runny nose, and body ache. 

Most cases reported are among children, particularly those under five years of age.

The WHO's Disease Outbreak News wrote on December 8, 2024, that 31 deaths had been registered.

Given the clinical presentation and symptoms reported so far and the number of associated deaths, acute pneumonia, influenza, COVID-19, measles, and malaria are considered potential causal factors, with malnutrition as a contributing factor.

Laboratory tests are underway to determine the exact cause. At this stage, it is also possible that more than one disease is contributing to the cases and deaths.

The WHO says the overall risk level to the affected DRC communities is assessed as high.

At the national level, the risk is considered moderate due to the localized nature of the outbreak within the Panzi health zone in Kwango province. However, the potential for spread to neighboring areas, coupled with gaps in surveillance and response systems, this assessment underscores the need for heightened preparedness. 

At the regional and global levels, the risk remains low at this time.

However, the proximity of the affected area to the border with Angola raises concerns about potential cross-border transmission, and continued monitoring and cross-border coordination will be essential to mitigate this risk. 

The current confidence in the available information remains moderate, as significant clinical, epidemiological, and laboratory data gaps persist.

One aspect of this new WHO report is that there are vaccines available for many of these suspected diseases.

In the Region of the Americas, outbreaks of Oropouche virus disease have occurred historically in the Amazon region in rural and urban communities in Brazil, Colombia, Ciba, Ecuador, French Guiana, Panama, Peru, and Trinidad and Tobago.

On December 5, 2024, the World Health Organization (WHO) issued Disease Outbreak News regarding the current outbreak.

As of late November 2024, a total of 11,634 confirmed Oropouche cases, including two deaths, have been reported in the Region of the Americas across ten countries and one territory: Bolivia, Brazil, Canada, Cayman Islands, Colombia, Cuba, Ecuador, Guyana, Panama, Peru and the United States of America.

In the USA, the Florida Department of Health published its Arbovirus Surveillance Update 48 on November 30, 2024, revealing 90 travel-associated Oropouche fever cases have been reported this year in travelers to Cuba.

The WHO's News report highlights the need to strengthen epidemiological and entomological surveillance and reinforce the population's preventive measures.

This advice is crucial due to the expansion of the virus's transmission area and the growing need to understand better the disease spectrum, including possible new transmission routes. Oropouche is spread primarily by the bite of infected midges (small flies) and mosquitoes.

While it is unknown if Oropouche can be spread by sex, travelers to outbreak areas should take precautions during travel and for six weeks after returning to the USA from abroad.

According to the U.S. CDC, these vectors could affect the general population and vulnerable groups, such as pregnant women, their fetuses, and newborns.

Unfortunately, there are no Oropouche preventive vaccines available in 2024.

Based on available information, the WHO assesses the overall public health risk posed by the Oropouche virus as high at the regional level and low at the global level. Based on the current information on this event, WHO advises against applying travel or trade restrictions.

The U.S. CDC today published a Morbidity and Mortality Weekly Report that confirmed Nirsevimab (Beyfortus™), a U.S. FDA-approved monoclonal antibody that protects infants and young children against severe respiratory syncytial virus (RSV) infection, experienced significant uptake in New York City (NYC).

Among infants born in NYC during the recommended nirsevimab administration period for the 2023–24 RSV season and who reportedly received nirsevimab, 37% of Vaccines for Children (VFC)–eligible and 45% of non–VFC–eligible infants received it within the first 7 days of life.

These authors wrote on December 5, 2024, 'Ensuring birthing hospital VFC enrollment and establishing protocols to offer nirsevimab to eligible infants before hospital discharge might increase nirsevimab administration within the first week of life.'

Furthermore, Beyfortus has been found to be very protective.

On November 26, 2024, a study published by The Pediatric Infectious Disease Journal concluded that in immunized infants, RSV-positive bronchiolitis was less frequent and less severe, with a significantly reduced hospitalization length than in nonimmunized infants, producing substantial healthcare cost savings.