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FDA Panel to Consider Updating COVID-19 Jabs for New Virus Strains
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Shares of COVID-19 vaccine developers rose on Monday after the FDA issued briefing documents for its Vaccines and Related Biological Products Advisory Committee (VRBPAC) meeting on Jun 5 to consider the selection of the 2024-2025 formula for COVID-19 vaccines.
In this meeting, members of the VRBPAC will discuss whether to update the currently authorized COVID-19 vaccines to target the JN.1 variant. This was also recommended by a World Health Organization (WHO) advisory committee on Apr 26.
The FDA pointed out that post the WHO recommendation, another subvariant named KP.2 has become the dominant strain in the country since the end of April. Per the agency, this new strain is a JN.1-derived subvariant that contains two new additional mutations. Per the agency, the KP.2 subvariant provides an advantage to the virus ‘either in terms of fitness or escape from immunity’.
In the VRBPAC meeting, panel members will likely discuss whether to update the vaccines with the JN.1 or KP.2 strains. The FDA documents state that while a JN.1-variant targeting vaccine could also be effective against the KP.2 strain, the agency is concerned that the virus’ continuous evolution could lead to further divergence from the JN.1 variant.
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 the KP.3 and JN.1.7 subvariants, respectively.
Post the release of the briefing documents, shares of Novavax (NVAX - Free Report) , Moderna (MRNA - Free Report) and Pfizer (PFE - Free Report) rose 21.2%, 3.7% and 2.3%, respectively, on Jun 3. All these companies are currently the only ones who market an authorized/approved COVID-19 vaccine and are already in the process of updating their respective COVID-19 vaccines.
Novavax largely benefitted from the release of these briefing documents. In April, NVAX stated that it plans to be ready for the 2024-2025 vaccination season with a JN.1 updated protein-based COVID-19 vaccine. Management has been developing and manufacturing this vaccine at risk to ensure a well-interrupted supply of vaccine shots ahead of the upcoming vaccination season.
Compared with Pfizer and Moderna, Novavax was not able to reap the benefits of the pandemic due to a delayed launch of its COVID-19 vaccine. During last year’s vaccination season, sales of Novavax also suffered due to delayed approval of its vaccine formulation and product launch. Some investors and analysts pointed out that with Novavax’s early participation in the upcoming vaccination season, it could capitalize on the opportunity.
However, a variation in vaccine strain from the WHO-recommended strain could also pose a challenge for COVID-19 vaccine makers, especially Novavax, as it makes a more traditional protein-based shot that takes longer to manufacture. The FDA has also pointed out that Pfizer and Moderna’s vaccines, which are based on mRNA technology, can be developed more quickly when compared to Novavax’s protein-based COVID vaccine.
Since 2022, the FDA’s VRBPAC has been holding similar meetings to select the COVID-19 virus strains 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, the VRBPAC members unanimously recommended updating the COVID-19 vaccines to target the Omicron XBB lineage, which was then the dominant variant strain in the country.
The vaccine makers are suffering a heavy beatdown in product sales and market value as COVID-19 cases have significantly dropped compared with the last couple of years. Though the rising COVID-19 infection cases could somewhat revive demand for vaccine boosters, a substantial gain in revenues and profits that was observed at the peak of the pandemic — is unlikely.
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FDA Panel to Consider Updating COVID-19 Jabs for New Virus Strains
Shares of COVID-19 vaccine developers rose on Monday after the FDA issued briefing documents for its Vaccines and Related Biological Products Advisory Committee (VRBPAC) meeting on Jun 5 to consider the selection of the 2024-2025 formula for COVID-19 vaccines.
In this meeting, members of the VRBPAC will discuss whether to update the currently authorized COVID-19 vaccines to target the JN.1 variant. This was also recommended by a World Health Organization (WHO) advisory committee on Apr 26.
The FDA pointed out that post the WHO recommendation, another subvariant named KP.2 has become the dominant strain in the country since the end of April. Per the agency, this new strain is a JN.1-derived subvariant that contains two new additional mutations. Per the agency, the KP.2 subvariant provides an advantage to the virus ‘either in terms of fitness or escape from immunity’.
In the VRBPAC meeting, panel members will likely discuss whether to update the vaccines with the JN.1 or KP.2 strains. The FDA documents state that while a JN.1-variant targeting vaccine could also be effective against the KP.2 strain, the agency is concerned that the virus’ continuous evolution could lead to further divergence from the JN.1 variant.
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 the KP.3 and JN.1.7 subvariants, respectively.
Post the release of the briefing documents, shares of Novavax (NVAX - Free Report) , Moderna (MRNA - Free Report) and Pfizer (PFE - Free Report) rose 21.2%, 3.7% and 2.3%, respectively, on Jun 3. All these companies are currently the only ones who market an authorized/approved COVID-19 vaccine and are already in the process of updating their respective COVID-19 vaccines.
Novavax largely benefitted from the release of these briefing documents. In April, NVAX stated that it plans to be ready for the 2024-2025 vaccination season with a JN.1 updated protein-based COVID-19 vaccine. Management has been developing and manufacturing this vaccine at risk to ensure a well-interrupted supply of vaccine shots ahead of the upcoming vaccination season.
Compared with Pfizer and Moderna, Novavax was not able to reap the benefits of the pandemic due to a delayed launch of its COVID-19 vaccine. During last year’s vaccination season, sales of Novavax also suffered due to delayed approval of its vaccine formulation and product launch. Some investors and analysts pointed out that with Novavax’s early participation in the upcoming vaccination season, it could capitalize on the opportunity.
However, a variation in vaccine strain from the WHO-recommended strain could also pose a challenge for COVID-19 vaccine makers, especially Novavax, as it makes a more traditional protein-based shot that takes longer to manufacture. The FDA has also pointed out that Pfizer and Moderna’s vaccines, which are based on mRNA technology, can be developed more quickly when compared to Novavax’s protein-based COVID vaccine.
Since 2022, the FDA’s VRBPAC has been holding similar meetings to select the COVID-19 virus strains 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, the VRBPAC members unanimously recommended updating the COVID-19 vaccines to target the Omicron XBB lineage, which was then the dominant variant strain in the country.
The vaccine makers are suffering a heavy beatdown in product sales and market value as COVID-19 cases have significantly dropped compared with the last couple of years. Though the rising COVID-19 infection cases could somewhat revive demand for vaccine boosters, a substantial gain in revenues and profits that was observed at the peak of the pandemic — is unlikely.