The US Food and Drug Administration (FDA) today, Friday, approved Pfizer-BioNTech and Moderna coronavirus boosters for all adults, a move that will make booster doses available to all people from 18 years and older.
Pfizer asked for permission last week, citing the results of a Phase 3 clinical trial with more than 10,000 participants, as it found the third dose to be safe and effective. Moderna applied for leave on Wednesday.
“The FDA has decided that the data now available support the extension of the Moderna and Pfizer – BioNtech vaccine boost to people 18 years of age and older,” said Dr. Peter Marks, director of FDA research.
The approval comes about two months late because scientists advising the FDA rejected the administration’s initial plans to start distributing booster doses to all adults on September 20, citing a lack of data. Moderna resubmitted its application just two days ago and the two companies finally announced the decision this morning.
“This booster dose comes at a critical time as we enter the winter months and face increasing numbers of coronavirus cases and hospital admissions,” said Stéphane Bancel, CEO of Moderna.
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Source From: Capital
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