Vaccine News

The U.S. Food and Drug Administration (FDA) Vaccines and Related Biological Products Advisory Committee (VRBPAC) unanimously voted today to recommend that COVID-19 vaccines be updated to a monovalent JN.1-lineage composition for 2024-2025 and expressed a preference for the JN.1 strain.

As of June 5, 2024, Novavax Inc. stated in a press release that, pending authorization, it expects to be ready for the commercial delivery of a protein-based JN.1 COVID-19 vaccine in the U.S. in September 2024.

Novavax’s JN.1 COVID-19 vaccine has demonstrated broad cross-neutralizing antibodies for various JN.1 descendant viruses, including KP.2 and KP.3.

'We believe updating to the JN.1 lineage or JN.1, as recommended by the World Health Organization and the European Medicines Agency and as unanimously recommended by VRBPAC today, will provide the protection needed this fall against COVID-19,' wrote the company.

'Our most recent nonclinical data have demonstrated that our JN.1 vaccine candidate induces broad neutralization responses to JN.1 lineage viruses including those with the F456L mutation (e.g., JN.1.16), the R346T mutation (e.g., JN.1.13.1), to “FLiRT” variants that contain both mutations such as KP.2, currently the most common circulating variant in the U.S., and to “FLuQE” variants that are increasing in circulation (e.g., KP.3).'

'Our JN.1 vaccine candidate also produces conserved polyfunctional, Th1-biased CD4+ T cell responses to a range of JN.1 lineage variants, including those containing the F456L, R346T, and FLiRT mutations (e.g., KP.2).'

'These responses indicate that our vaccine technology induces broadly neutralizing responses against multiple variant strains, including circulating forward drift variants.'

Based on data presented by vaccine manufacturers today, the VRBPAC acknowledged the advantages of a JN.1 vaccine in providing broad protection against circulating and future strains and the need to minimize confusion in making public health recommendations.

As of June 2024, Novavax's vaccine is the only protein-based, non-mRNA vaccine available in the U.S. Novavax vaccines have been offered by most pharmacies in the U.S.

The U.S. Centers for Disease Control and Prevention (CDC) reported today that Oropouche fever outbreaks occur in 21 countries, including parts of Brazil, Bolivia, Colombia, Peru, Cuba, Ecuador, Panama, and Peru.

As of June 5, 2024, the CDC's Travel Health Advirosy says travelers should seek medical care if they develop high fever, headache, muscle aches, stiff joints, nausea, vomiting, chills, or sensitivity to light during or after travel.

Since it was first isolated in Trinidad and Tobago in 1955, more than half a million Oropouche cases and at least 30 major outbreaks have been reported. However, these data are difficult to quantify due to the lack of diagnosis.

In 2024, the Pan American Health Organization reported over 5,000 confirmed cases of Oropouche in four countries in the Region of the Americas.

This illness can occur in people of any age and is often mistaken for dengue, which is also impacting these populations.

The CDC says Oropouche fever is spread by the bite of infected midges (small flies) and mosquitoes.

Unfortunately, Oropouche infection treatment is supportive, as no specific medications or vaccines are available.

The Centers for Disease Control and Prevention (CDC) says most dengue fever cases in the United States occur in areas where dengue is common, such as U.S. territories and a few states. Dengue virus is found in many tropical parts of the world, including the Caribbean, Central, and South America.

As of June 5, 2024, the CDC has reported over 100 additional dengue cases over the last month, which has increased this year's total to 1,706.

As of week #19 in 2024, Puerto Rico reported the most dengue cases, 1,107, with San Juan reporting 528 of these cases. In 2023, Puerto Rico reported 1,242 dengue cases.

Florida recently confirmed 198 travel-associated dengue cases in 2024, mainly by visitors from Brazil and Cuba. Seven cases of locally acquired dengue were reported from Miami-Dade and Pasco counties.

Additionally, the CDC reported New York's dengue outbreak has reached 119 cases in 2024.

Since the state of Texas has yet to post its dengue cases count for 2024, the CDC's overall total is expected to significantly increase. In 2023, Texas 67 travel-related dengue cases.

Dengue fever is a mosquito-borne, vaccine-preventable disease caused by the dengue virus. However, the WHO-approved dengue vaccines are not commercially offered in the U.S.

The Vaccines and Related Biological Products Advisory Committee (VRBPAC) will meet in an open session on June 5, 2024, to discuss and recommend selecting the 2024- 2025 Formula for COVID-19 vaccines.

VRBPAC has met multiple times since 2022 to discuss the selection of the Formula for COVID-19 vaccines. The U.S. FDA Briefing Document and Agenda for this new meeting were recently posted online. 

The FDA has approved two COVID-19 vaccines for active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals 12 and older. In addition, the FDA currently authorizes three vaccines for use in the U.S. under emergency use authorization.

The U.S. COVID-19 emergency declaration was withdrawn on May 11, 2023.

Available data suggest that the current formula of COVID-19 vaccines should be updated for the anticipated 2024–2025 respiratory virus season in the U.S.

Based on the review of virus epidemiology data indicating the recent dominance of the JN.1 sublineage and data from post-monovalent XBB.1.5 human sera indicating a drop in neutralizing antibody responses against JN.1, the World Health Organization Technical Advisory Group on COVID-19 Vaccine Composition recommended that a monovalent JN.1 lineage component be included in the composition of COVID-19 vaccines (2024-2025 Formula).

This recommendation was made on April 26, 2024, before the dominance of the KP.2 sublineage in the U.S.

Initial neutralization data of various vaccine candidates are now available for both the JN.1 and KP.2 sublineages and will be presented along with current SARS-CoV-2 epidemiologic data for VRBPAC’s consideration.

To digitally attend this meeting, visit this YouTube link tomorrow: https://youtube.com/live/weaKQiFk_98 

The U.S. Centers for Disease Control and Prevention (CDC) published a Morbidity and Mortality Weekly Report that confirmed Guillain-Barré syndrome (GBS) was identified as a potential safety concern following respiratory syncytial virus (RSV) vaccination.

On May 30, 2024, the CDC wrote that 'Findings are consistent with those from trials; reports of GBS (5.0 and 1.5 reports per million doses of Abrysvo and Arexvy vaccine administered, respectively) were more common than expected background rates.

Two deaths among RSV vaccine recipients who had been diagnosed with GBS were reported.

The CDC, the U.S. FDA, and the Centers for Medicare & Medicaid Services are conducting population-based surveillance assessments of RSV vaccine safety and risks for GBS. Findings from these studies will help guide the development of Advisory Committee on Immunization Practices recommendations.

About 10 million older adults have been vaccinated against RSV since August 2023.

As of June 3, 2024, three approved RSV vaccines for adults and one monoclonal antibody for infants are available in the U.S.

According to the Global Polio Eradication Initiative (GPEI), five counties reported new cases involving vaccine-derived poliovirus types.

The GPEI's latest weekly update confirmed Angola reported its second circulating vaccine-derived poliovirus type 2 (cVDPV2) case of 2024, and Chad, the Democratic Republic of the Congo (DRC), Niger, and Nigeria also reported cVDPV2 cases as of May 29, 2024

Additionally, the DRC reported two more cases of circulating vaccine-derived poliovirus type 1.

The World Health Organization (WHO) confirmed in April 2024 that the spread of the poliovirus remained a Public Health Emergency of International Concern and recommended its extension through July 2024 to reduce the risk of the international spread of poliovirus outbreaks.

In May 2024, the U.S. Centers for Disease Control and Prevention (CDC) issued an updated Global Polio Alert - Level 2, Practice Enhanced Precautions Travel Health Notice regarding polio outbreaks and poliovirus detections in 34 countries. 

The African country Angola recently reported two cases of Acute Flaccid Paralysis (AFP). These AFP cases are the first in Angola since the 2019-2020 polio outbreak, which recorded 124 cases.

Furthermore, 36 potential AFP cases are awaiting classification, which may or may not be related to the polio virus.

As of June 2024, both the WHO and CDC recommend polio vaccinations and booster doses for under-immunized people visiting outbreak areas.

In the U.S., IPV vaccines have been offered since 2000, and over 1 billion nOPV2 vaccine doses have been offered in African countries.

Moderna, Inc. today announced that the U.S. Food and Drug Administration (FDA) has approved mRESVIA® (mRNA-1345), an mRNA respiratory syncytial virus (RSV) vaccine, to protect adults aged 60 years and older from lower respiratory tract disease caused by RSV infection.

Stéphane Bancel, Chief Executive Officer of Moderna, commented in a press release on May 31, 2024, "mRESVIA protects older adults from the severe outcomes of RSV infection, and it is the only RSV vaccine available in a pre-filled syringe designed to maximize ease of administration, saving vaccinators' time and reducing the risk of administrative errors."

RSV is a highly contagious seasonal respiratory virus that is a leading cause of lower respiratory tract infections and pneumonia. It causes a particularly large burden of disease in infants and older adults.

Moderna expects to have mRESVIA available for eligible populations by the 2024/2025 RSV season in the U.S. Additionally, Moderna has filed for mRNA-1345 approval with regulators in multiple markets.

As of June 1, 2024, three RSV vaccines and one monoclonal antibody (Beyfortus™) were approved in the U.S.