Pfizer and German partner BioNTech have submitted their new COVID-19 booster – that targets the omicron subvariant BA.5 – to the Food and Drug Administration for emergency use authorization, the companies announced Monday.
If the vaccine is authorized, Pfizer has “rapidly scaled up production” to immediately begin distribution “to help protect individuals and families as we prepare for potential and winter surges,” Pfizer CEO Albert Bourla said in a news release.
The new boosters may be available “in a few short weeks” to anyone over the age of 12, said White House COVID-19 coordinator Dr. Ashish Jha in an interview with NBC News.
How the new booster targets omicron subvariant BA.5
The updated booster is a bivalent vaccine containing mRNA from the original SARS-CoV-2 spike protein, which is already present in Pfizer’s first COVID-19 vaccine, combined with mRNA from the spike protein of the omicron BA.4 and BA.5 subvariant.
The BA.5 subvariant makes up nearly 90% of new COVID-19 cases in the U.S., according to the Centers for Disease Control and Prevention.
“Given the ongoing evolution of SARS-CoV-2 and its variants, it’s of great importance that vaccines can be rapidly adapted to the major circulating omicron lineages,” said Dr. Ugur Sahin, BioNTech’s CEO and co-founder.
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.
The company has tested the BA.5-specific vaccine only on mice, so far, and is relying on data from both the BA.1 human trials and the BA.5 mice trials for their submission for authorization.
In the study, eight mice that were given the BA.5 booster dose about 100 days after receiving two doses of Pfizer’s original vaccine generated an immune response.
“To rely only on mouse data (for authorization) would be unprecedented in my knowledge and would certainly raise eyebrows,” said John Moore, a vaccine and virology expert at Weill Cornell Medicine in New York. “It doesn’t mimic the human situation,” where many people were vaccinated more than a year ago and have since been boosted.
In Monday’s release, Pfizer-BioNTech said a clinical study looking at the updated booster in people over 12 will begin this month. A Pfizer spokesperson said data from that trial will be shared with regulators when available.
But Moore isn’t convinced the data will show the BA.5 booster working significantly better than the BA.1 booster, or even the original booster. The public expects the new booster to prevent more infections, he said, but it will probably be only marginally more protective.
“They’re offering the public a shiny toy and they say, ‘look, here’s a new shiny toy, go out and get boosted with it,’” he said. “What if the public realizes the shiny toy doesn’t come with battery included, will that reduce confidence in future vaccines?”
Last week, British drug regulators were the first in the world to authorize an updated version of Moderna’s coronavirus vaccine that includes protection against the original omicron variant, BA.1.
In Monday’s release, Pfizer and BioNTech said they’re also planning to submit their BA.5 booster to European drug regulators in the “coming days.”
Follow Adrianna Rodriguez on Twitter: @AdriannaUSAT.
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