US to authorize Pfizer vaccine for ages 12-15 early next week
The US Food and Drug Administration is preparing to authorize the Pfizer/BioNTech Covid vaccine for adolescents between ages 12 and 15 years by early next week, the New york times reported on Monday, citing federal officials familiar with the agency’s plans.
An approval is highly anticipated after the drugmakers said in March that the vaccine had been found to be safe, effective and produced robust antibody responses in 12- to 15-year-olds in a clinical trial.
Responding to a Reuters request for comment, the FDA said its review of expanding the vaccine’s emergency use authorization was continuing, but it did not provide further details.
The vaccine has already been cleared in the United States for people age 16 and above.
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