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Thursday, July 08, 2021 5:31:54 PM
Pfizer Plans to Request FDA Nod for Covid Booster in August
By Robert Langreth
July 8, 2021, 4:00 PM CDT
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Pfizer Inc. plans to request U.S. emergency authorization in August for a third booster dose of its Covid-19 vaccine, based on early data showing that it can sharply increase immune protection against the coronavirus.
The company has received initial data from an early human study showing that a third dose of its existing coronavirus vaccine is safe and can raise neutralizing antibody levels by 5 to 10 fold compared with the original vaccine, Pfizer research head Mikael Dolsten said in an interview.
Once more data is in hand, Pfizer plans to ask the FDA to authorize a booster shot that could be given six to eight months after the original two doses, Dolsten said. The drugmaker is also talking with regulators in other countries and the European Union about the new results, he said. Pfizer produces the vaccine in partnership with BioNTech SE.
Dolsten said the company is going public with its plans because the early data looks convincing and because of increasing concern about mutations of the virus, including the ultra-transmissible delta variant that is spreading in numerous countries.
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