YAHOO! FINANCE – The FDA, on Aug 22, approved/authorized the updated mRNA-based COVID-19 vaccines of Pfizer PFE/BioNTech BNTX and Moderna MRNA 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.
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“The 2024 revenue guidance includes $8.5 billion in potential combined revenues for Paxlovid and Comirnaty.” –MSN.COM, AUG 20, 2024
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.’
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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 …