Drugmaker has submitted data to FDA, will file with European safety agencies amid hopes of speedy approval
Pfizer and BioNTech announced on Tuesday that they had submitted data to the Food and Drug Administration that the companies said showed that their coronavirus vaccine is safe and effective in children ages 5 to 11, the New York Times reports.
The companies said that they would submit a formal request to regulators to allow a pediatric dose of their vaccine to be administered in the United States in the coming weeks. Similar requests will be filed with European regulators and in other countries.
The announcement, coming as U.S. schools have resumed amid a ferocious Delta wave, brings many parents another step closer to the likelihood of a Covid vaccine for their children.
Just over a week ago, Pfizer and BioNTech announced favorable results from their clinical trial with more than 2,200 participants in that age group. The F.D.A. has said that it will analyze the data as soon as possible.
The companies said last week that their vaccine had been shown to be safe and effective in low doses in children ages 5 to 11, offering hope to parents in the United States who are worried that a return to in-person schooling has put children at risk of infection.
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