FDA Staff Says Pfizer Shot for Children Under 5 Safe and Effective
Preliminary data indicated it was 80.4 percent effective
Sunday, Food and Drug Administration (FDA) staff said the coronavirus (COVID-19) vaccine made by Pfizer and its German partner, BioNTech, for children younger than 5 is effective in producing a virus-blocking response and did not raise safety concerns, a prelude to a crucial review this week by the agency's independent advisers.
The analysis by FDA scientists was released ahead of a meeting Wednesday of the agency’s independent experts, who will consider a request for emergency use authorization for the Pfizer-BioNTech vaccine in the youngest children. It will also review a request from Moderna to use its vaccine in children younger than 6. FDA staff Friday said Moderna's shot for infants and young children was safe and effective.
After the advisers make their recommendations, the FDA will decide whether to follow the panel's advice, which it often does. If the agency clears the vaccines, and the Centers for Disease Control and Prevention (CDC) signs off, the shots could be available beginning next week.
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