FDA to approve Pfizer vaccine for kids 12-15, report says


By Trisha Roy | Reuters

The U.S. Food and Drug Administration is preparing to authorize Pfizer Inc and German partner BioNTech SE’s COVID-19 vaccine for children ages 12 to 15 by early next week, the New York Times reported Monday, citing federal officials familiar with the agency’s plans.

An approval is highly anticipated after the drugmakers said in March that the vaccine was 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 is ongoing, but did not provide further details.

The vaccine has already been cleared in the United States for those 16 and older.

Pfizer declined to comment on the NYT report.

The U.S. Centers for Disease Control Director Rochelle Walensky said last month that the vaccine could be approved by mid-May.

If an approval for the 12- to 15-year-olds is granted, the CDC’s vaccine advisory panel will likely meet the following day to review the clinical trial data and make recommendations for the vaccine’s use in adolescents, the report added.

A potential approval of the vaccine would boost the country’s immunization drive and help allay fears of parents anxious to protect their children from COVID-19.


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