Pfizer and BioNTech said they have submitted early-stage clinical trial data to the FDA as part of their application seeking U.S. OK of a Covid booster shot.
said Monday they have submitted early-stage clinical trial data to the Food and Drug Administration as part of their U.S. application seeking authorization of a Covid vaccine booster for everyone 16 and older — not just people with weak immune systems.
In a phase one trial, a booster dose of the vaccine generated "significantly higher neutralizing antibodies" against the original coronavirus strain as well as the beta and delta variants, the companies said in a press release. Participants in the trial received a third dose of the two-dose vaccine about eight to nine months after receiving their second shot, they said.
"The data we've seen to date suggest a third dose of our vaccine elicits antibody levels that significantly exceed those seen after the two-dose primary schedule," Pfizer CEO Albert Bourla said in a statement. "We are pleased to submit these data to the FDA as we continue working together to address the evolving challenges of this pandemic."
The companies said late-stage trial results evaluating the third dose are expected shortly and will also be submitted to the FDA and other regulatory authorities worldwide.
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