United States: As per the reports by the FDA on August twenty-two, it has approved the updated versions of mRNA-based COVID-19 vaccines of Pfizer, BioNTech, and Moderna, mainly aiming to target the KP.2 strain of the virus.
More about the news
The approval involved Pfizer/BioNTech’s Comirnaty and Moderna’s Spikevax for its usage by people aged twelve years and above. Furthermore, its low-dose formulations usage has also been approved for vaccines of six months old to eleven years of age.
The approval is based on various factors, such as a combination of manufacturing, non-clinical, and real-world data, which prove the efficacy and safety of the updated Moderna and Pfizer/BioNTech vaccines.
More about the updated composition
The updated vaccine composition was based on guidance issued in late June by the FDA. As per the FDA’s Vaccines and Related Biological Products Advisory Committee recommendation in June, the vaccine makers made a tailored vaccine to tackle KP.2 variants for its usage in the US at the beginning of the fall of 2024, as Yahoo reported.
It was also updated advice from the FDA’s prior advice issued in June that recommended updated vaccines for the JN.1 strain.
Why the FDA’s updated guidance?
The FDA’s advice earlier was in line with the WHO’s guidelines, which it issued on April 26. However, the FDA also pointed out that after WHO’s guidelines, another subvariant called KP.2 emerged, which dominated the US.
According to the FDA, the KP.2 strain is a JN.1-derived subvariant containing two other mutations providing an advantage to the virus “either in terms of fitness or escape from immunity.”
Availability of new vaccines
Pfizer and BioNTech claim that shipping of an updated formulation would be initiated with their jointly developed COVID vaccine ‘immediately.’
Moreover, they mentioned that the doses would be made available “in the coming days.” Moderna also announced that its vaccine would be available within the same time period as well, as Yahoo reported.
About Novavax’s NVAX, the FDA is yet to announce its decision, which is currently going through a regulatory filing, seeking authorization for its usage of protein-based COVID-19 vaccines for 12-year-olds and above.
After its approval, it would become the only non-mRNA-based vaccine available in the country.