Pfizer Inc plans to ask U.S. regulators to authorize a booster dose of its COVID-19 vaccine within the next month, the drugmaker's top scientist said on Thursday, based on evidence of greater risk of reinfection six months after inoculation and the spread of the highly contagious Delta variant.
The U.S. Food and Drug Administration and the Centers for Disease Control and Prevention said, however, in a joint statement that Americans who have been fully vaccinated do not need a booster COVID-19 shot at this time.Pfizer's chief scientific officer, Mikael Dolsten, said the recently reported dip in the vaccine's effectiveness in Israel was mostly due to infections in people who had been vaccinated in January or February.
"It's a small data set, but I think the trend is accurate: Six months out, given that Delta is the most contagious variant we have seen, it can cause infections and mild disease," Dolsten said. He stressed that data from Israel and Britain suggests that even with waning antibody levels, the vaccine remains around 95% effective against severe disease.
He said multiple countries in Europe and elsewhere have already approached Pfizer to discuss booster doses, and some may begin administering them before a potential U.S. authorization.Dr.
Pfizer plans to launch soon a placebo-controlled efficacy trial of the booster with 10,000 participants. The study will run throughout the fall, Dolsten said, meaning it will not be completed ahead of the company's filing with the Food and Drug Administration. Because boosters would drive increasing demand for vaccines while much of the world is still unvaccinated, Dolsten said Pfizer is looking at ways to boost production.
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