Pfizer-BioNTech submits new COVID immunization supporter focusing on BA.5 to the FDA for approval

Pfizer and its German partner BioNTech have applied to the Food and Drug Administration for emergency use authorization for their new COVID-19 booster, which targets the omicron subvariant BA.5, the firms revealed Monday.

If the vaccine is approved, Pfizer has “rapidly scaled up production” to begin distribution “to assist safeguard individuals and families as we prepare for potential and winter spikes,” according to Pfizer CEO Albert Bourla.

In an interview with NBC News, the new boosters might be given to everyone over the age of 12 “in a few short weeks,” according to White House COVID-19 coordinator Dr. Ashish Jha.

How the new booster focuses on the omicron subvariant BA.5
The revised booster is a bivalent vaccine that combines mRNA from the original SARS-CoV-2 spike protein, which is already included in Pfizer’s first COVID-19 vaccine, with mRNA from the omicron BA.4 and BA.5 subvariants’ spike proteins.

According to the Centers for Disease Control and Prevention, the BA.5 subvariant accounts for roughly 90% of new COVID-19 cases in the United States.

“Given the continuing development of SARS-CoV-2 and its variations, it’s critical that vaccines can be promptly modified to the primary circulating omicron lineages,” stated BioNTech CEO and co-founder Dr. Ugur Sahin.


What the data shows: BA.1 in humans, BA.5 in mice

Members of the FDA’s advisory panel supported targeting omicron’s BA.4 and BA.5 subvariants in June after Pfizer had already tested a new version of its vaccine against the original omicron variant, BA.1.

Those trials showed a vaccine containing both the BA.1 and the original SARS-CoV-2 strain generated up to a 10-fold increase in neutralizing antibodies against omicron, according to a press release in June.

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