US FDA Deviates From WHO's COVID-19 Vaccine Advice

When the World Health Organization (WHO) recently announced its recommendations for updating COVID-19 vaccines, many scientists focused on the continued evolution of the SARS-CoV-2 coronavirus and its potential impact on vaccine efficacy. 

Since late 2019, several virus variants have been detected since the initial identification.

On April 26, 2024, the WHO Technical Advisory Group on COVID-19 Vaccine Composition stated that the virus is expected to continue evolving from JN.1 and advised the use of a monovalent JN.1 lineage as the antigen in future formulations of COVID-19 vaccines.

This WHO advice greatly influences the global rollout of COVID-19 vaccines. To date, the WHO has issued 13 COVID-19 vaccines Emergency Use Listing.

On June 13, 2024, the U.S. Food and Drug Administration (FDA) stated it has continued to monitor the circulating strains of SARS-CoV-2.  

Based on the most current available data and the recent rise in COVID-19 cases in the U.S., the agency has further determined that the preferred JN.1-lineage for the COVID-19 vaccines (2024-2025 Formula) is the KP.2 strain, if feasible.  

This FDA determination is a change from last week's vaccine advisory meeting.

On June 6, 2024, the FDA initially advised the manufacturers of the licensed and authorized COVID-19 vaccines that the COVID-19 vaccines (2024-2025 Formula) for use in the U.S. beginning in fall 2024 should be monovalent JN.1 vaccine.

The FDA's change is intended to ensure that the COVID-19 vaccines (2024-2025 Formula) more closely match currently circulating SARS-CoV-2 strains.  

FDA stated in a media release that it has communicated this change to the manufacturers of the licensed and authorized COVID-19 vaccines. The agency does not anticipate that a change to KP.2 will delay the availability of the vaccines in the U.S.

Following the FDA's announcement, Novavax, Inc., a global company advancing protein-based vaccines with its Matrix-M™ adjuvant, announced that it had submitted an amendment to its Emergency Use Authorization to the FDA for its updated JN.1 COVID-19 vaccine (NVX-CoV2705) for individuals aged 12 and older. 

Novavax wrote on June 14, 2024, that its submission aligns with guidance from the U.S. FDA, the European Medicines Agency, and the WHO to target the JN.1 lineage this fall.

Novavax's JN.1 vaccine has recently demonstrated broad cross-neutralizing antibodies against multiple variant strains, including KP.2 and KP.3, indicating the potential to protect against forward drift variants.

Numerous countries currently deploy Novavax's COVID-19 vaccine.