FDA panel to consider updating COVID-19 vaccines for new virus strains

Shares of COVID-19 vaccine developers rose Monday after the FDA released briefing materials for the June 5 Vaccines and Related Biological Products Advisory Committee (VRBPAC) meeting to review the selection of the 2024-2025 formula for COVID-19 vaccines.

At this meeting, VRBPAC members will discuss whether currently authorized COVID-19 vaccines should be updated to target the JN.1 variant. This was also recommended by a World Health Organization (WHO) advisory committee on April 26.

The FDA pointed out that following WHO’s recommendation, another sub-variant called KP.2 has become the dominant strain in the country since late April. According to the agency, this new strain is a subvariant derived from JN.1 that contains two additional new mutations. According to the agency, the KP.2 subvariant provides an advantage to the virus “either in terms of fitness or evasion of immunity.”

At the VRBPAC meeting, panel members will likely discuss whether vaccines should be updated with the JN.1 or KP.2 strains. FDA documents indicate that while a vaccine targeting the JN.1 variant could also be effective against the KP.2 strain, the agency is concerned that continued evolution of the virus could lead to further divergence from the variant JN.1.

The latest CDC data (as of May 26) shows that the KP.2 strain was the most prevalent, accounting for nearly 28.5% of COVID-19 cases in the United States. It was followed by 12.7% and 9.2% for sub-variants KP.3 and JN.1.7 respectively.

Publish the publication of information documents, sharing of Novavax NVAX, Modern mRNA and Pfizer The PFE increased by 21.2%, 3.7% and 2.3% respectively on June 3. All of these companies are currently the only ones marketing an authorized/approved COVID-19 vaccine and are already in the process of updating their respective COVID-19 vaccines.

Novavax has benefited greatly from the publication of these information documents. In April, NVAX said it planned to be ready for the 2024-2025 vaccination season with an updated protein-based COVID-19 vaccine JN.1. Management developed and manufactured this risky vaccine to ensure a well-interrupted supply of vaccines before the next vaccination season.

Compared to Pfizer and Moderna, Novavax has not been able to reap the benefits of the pandemic due to the delayed launch of its COVID-19 vaccine. During last year’s vaccination season, Novavax’s sales also suffered due to the delay in approval of the vaccine formulation and product launch. Some investors and analysts pointed out that with Novavax’s early participation in the upcoming vaccination season, it could take advantage of this opportunity.

However, a variation in the vaccine strain from the WHO-recommended strain could also pose a challenge to COVID-19 vaccine makers, particularly Novavax, as it is a more traditional vaccine-based shot. of proteins which take more time to produce. The FDA also pointed out that Pfizer and Moderna’s vaccines, based on mRNA technology, can be developed more quickly than Novavax’s protein-based COVID vaccine.

Since 2022, the FDA’s VRBPAC has held similar meetings to select strains of the COVID-19 virus for the 2022-2023 and 2023-2024 fall seasons. The committee recommended bivalent COVID-19 vaccines for the 2022-2023 season, which could target the original and Omicron BA.4/BA.5 variants of the virus. Last year, VRBPAC members unanimously recommended updating COVID-19 vaccines to target the Omicron XBB lineage, which was then the dominant variant strain in the country.

Vaccine makers are experiencing a sharp decline in product sales and market value as COVID-19 cases have declined significantly compared to the past two years. Although rising COVID-19 infection cases could somewhat revive demand for vaccine boosters, a substantial gain in revenue and profits seen during the height of the pandemic is unlikely.

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