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FDA Approves Pfizer & Moderna's Updated COVID-19 Jabs
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The FDA, on Aug 22, approved/authorized the updated mRNA-based COVID-19 vaccines of Pfizer (PFE - Free Report) /BioNTech (BNTX - Free Report) and Moderna (MRNA - Free Report) that target the KP.2 strain of the virus.
While the agency approved Pfizer/BioNTech’s Comirnaty and Moderna’s Spikevax for use in individuals aged 12 years of age and older, it granted emergency use authorization (EUA) to low-dose formulations of these vaccines for use in individuals aged six months through 11 years.
These approvals/authorizations are based on a combination of manufacturing, non-clinical and real-world data, which supported the efficacy and safety of the updated Moderna and Pfizer/BioNTech vaccines. These updated vaccines are manufactured using a similar process as previous formulations of these vaccines.
The updated vaccine composition is based on guidance from the FDA issued in late June.
In June, the FDA's Vaccines and Related Biological Products Advisory Committee recommended that vaccine makers make an updated COVID vaccine tailored to the KP.2 strain for use in the United States beginning in the fall of 2024
This guidance is also an update on the FDA’s prior advice issued in early June that recommended updating the COVID-19 vaccines to target the JN.1 strain.
Why the FDA Amended its Guidance?
The FDA’s prior advice was in line with the recommendation issued by a World Health Organization (WHO) advisory committee on Apr 26. However, the FDA pointed out that post the WHO recommendation, another subvariant named KP.2 has become the dominant strain in the country.
Per the agency, the KP.2 strain is a JN.1-derived subvariant that contains two new additional mutations that provide an advantage to the virus ‘either in terms of fitness or escape from immunity.’ Although this variant is no longer the most dominant one in the country, the updated vaccine shots are also effective against other strains within the JN.1 lineage, like the currently dominating KP.3.1.1 and KP.3 variants.
Commercial Availability of the Updated Vaccines
PFE and BNTX claim that they will begin shipping the updated formulation of their jointly developed COVID vaccine ‘immediately’ and that doses will be available ‘in the coming days.’ Moderna also announced that its vaccine will be available around the same timeframe.
What about Novavax?
The FDA is yet to announce its decision on Novavax’s (NVAX - Free Report) regulatory filing that seeks authorization for the use of its updated protein-based COVID-19 vaccine for use in individuals aged 12 years and older. If approved, it will be the only non-mRNA-based vaccine available in the country.
The Novavax vaccine is also the only COVID-19 vaccine that has been formulated to target the JN.1 strain. Unlike mRNA-based vaccines, protein-based vaccines require a lot more time for development and manufacturing. However, management claims that the vaccine is also effective against other strains like KP.2.3, KP.3, KP.3.1.1 and LB.1.
Stock Price Performance
Despite the FDA’s approval of mRNA-based vaccines, stocks of all vaccine-makers fell during trading on Thursday. Post the announcement, shares of Pfizer, BioNTech and Moderna were down 0.9%, 2.0% and 6.5%, respectively. These dips in stock prices of vaccine-makers were likely due to already declining demand for COVID-19 vaccines following the end of the pandemic.
Novavax’s shares fell nearly 8% the same day due to the delay in regulatory approval. An extended delay could likely give an edge to its competitors, resulting in the company losing market share in an already declining market.
Our Take
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 recent rises in COVID-19 infection cases in the United States could somewhat revive demand for vaccines, a substantial gain in revenues and profits that was observed at the peak of the pandemic — is unlikely.
Since 2022, the FDA has been approving/authorizing different compositions of the COVID-19 vaccines for each vaccination season, which is akin to seasonal influenza vaccines. The FDA approved/authorized bivalent COVID-19 vaccines for the 2022-2023 season, which could target the original and Omicron BA.4/BA.5 variants of the virus. For the last vaccination season, agency officials approved/authorized vaccines to target the Omicron XBB lineage, which was then the dominant variant strain in the country.
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FDA Approves Pfizer & Moderna's Updated COVID-19 Jabs
The FDA, on Aug 22, approved/authorized the updated mRNA-based COVID-19 vaccines of Pfizer (PFE - Free Report) /BioNTech (BNTX - Free Report) and Moderna (MRNA - Free Report) that target the KP.2 strain of the virus.
While the agency approved Pfizer/BioNTech’s Comirnaty and Moderna’s Spikevax for use in individuals aged 12 years of age and older, it granted emergency use authorization (EUA) to low-dose formulations of these vaccines for use in individuals aged six months through 11 years.
These approvals/authorizations are based on a combination of manufacturing, non-clinical and real-world data, which supported the efficacy and safety of the updated Moderna and Pfizer/BioNTech vaccines. These updated vaccines are manufactured using a similar process as previous formulations of these vaccines.
The updated vaccine composition is based on guidance from the FDA issued in late June.
In June, the FDA's Vaccines and Related Biological Products Advisory Committee recommended that vaccine makers make an updated COVID vaccine tailored to the KP.2 strain for use in the United States beginning in the fall of 2024
This guidance is also an update on the FDA’s prior advice issued in early June that recommended updating the COVID-19 vaccines to target the JN.1 strain.
Why the FDA Amended its Guidance?
The FDA’s prior advice was in line with the recommendation issued by a World Health Organization (WHO) advisory committee on Apr 26. However, the FDA pointed out that post the WHO recommendation, another subvariant named KP.2 has become the dominant strain in the country.
Per the agency, the KP.2 strain is a JN.1-derived subvariant that contains two new additional mutations that provide an advantage to the virus ‘either in terms of fitness or escape from immunity.’ Although this variant is no longer the most dominant one in the country, the updated vaccine shots are also effective against other strains within the JN.1 lineage, like the currently dominating KP.3.1.1 and KP.3 variants.
Commercial Availability of the Updated Vaccines
PFE and BNTX claim that they will begin shipping the updated formulation of their jointly developed COVID vaccine ‘immediately’ and that doses will be available ‘in the coming days.’ Moderna also announced that its vaccine will be available around the same timeframe.
What about Novavax?
The FDA is yet to announce its decision on Novavax’s (NVAX - Free Report) regulatory filing that seeks authorization for the use of its updated protein-based COVID-19 vaccine for use in individuals aged 12 years and older. If approved, it will be the only non-mRNA-based vaccine available in the country.
The Novavax vaccine is also the only COVID-19 vaccine that has been formulated to target the JN.1 strain. Unlike mRNA-based vaccines, protein-based vaccines require a lot more time for development and manufacturing. However, management claims that the vaccine is also effective against other strains like KP.2.3, KP.3, KP.3.1.1 and LB.1.
Stock Price Performance
Despite the FDA’s approval of mRNA-based vaccines, stocks of all vaccine-makers fell during trading on Thursday. Post the announcement, shares of Pfizer, BioNTech and Moderna were down 0.9%, 2.0% and 6.5%, respectively. These dips in stock prices of vaccine-makers were likely due to already declining demand for COVID-19 vaccines following the end of the pandemic.
Novavax’s shares fell nearly 8% the same day due to the delay in regulatory approval. An extended delay could likely give an edge to its competitors, resulting in the company losing market share in an already declining market.
Our Take
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 recent rises in COVID-19 infection cases in the United States could somewhat revive demand for vaccines, a substantial gain in revenues and profits that was observed at the peak of the pandemic — is unlikely.
Since 2022, the FDA has been approving/authorizing different compositions of the COVID-19 vaccines for each vaccination season, which is akin to seasonal influenza vaccines. The FDA approved/authorized bivalent COVID-19 vaccines for the 2022-2023 season, which could target the original and Omicron BA.4/BA.5 variants of the virus. For the last vaccination season, agency officials approved/authorized vaccines to target the Omicron XBB lineage, which was then the dominant variant strain in the country.