Pfizer Submits Clinical Trial Data To FDA For Third Dose...
Pfizer and BioNTech 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 shot 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.”
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