BREAKING — FDA refuses to back Pfizer Vax

The staff of the Food and Drug Admin­is­tra­tion on Wednes­day declined to take a stance on whether to back boost­er shots of Pfizer’s Covid-19 vac­cine, say­ing U.S. reg­u­la­tors haven’t ver­i­fied all the avail­able data.

“There are many poten­tial­ly rel­e­vant stud­ies, but FDA has not inde­pen­dent­ly reviewed or ver­i­fied the under­ly­ing data or their con­clu­sions,” they wrote in a 23-page doc­u­ment pub­lished on the agency’s web­site. “Some of these stud­ies, includ­ing data from the vac­ci­na­tion pro­gram in Israel, will be sum­ma­rized dur­ing the Sep­tem­ber 17, 2021 VRBPAC meeting.”

The staff said some obser­va­tion­al stud­ies have sug­gest­ed declin­ing effi­ca­cy of the Pfiz­er vac­cine over time against symp­to­matic infec­tion or against the delta vari­ant, while oth­ers have not.


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