The U.S. Food and Drug Administration is preparing to authorize Pfizer Inc and German partner BioNTech SE's COVID-19 vaccine for adolescents aged between 12 and 15 years by early next week, the New York Times reported on Monday, citing federal officials familiar with the agency's plans.
Gloria Tso reports.
Americans as young as 12 years old will be able to get a COVID-19 shot next week.
The New York Times reported Monday that the U.S. Food and Drug Administration (FDA) is preparing to authorize the Pfizer and BioNTech vaccine for teens, citing federal officials familiar with the agency's plans.
The announcement has been highly anticipated, after Pfizer announced in March that their vaccine was found to be safe and effective in 12 to 15-year-olds in a clinical trial.
The vaccine is already cleared in the U.S. for people age 16 and older.
The FDA said its review of expanding the vaccine's emergency use authorization is ongoing, but did not provide further details.
Pfizer declined to comment on the NYT report.
The report added that if the vaccine is approved for 12 to 15-year-olds, the U.S. Centers for Disease Control's vaccine advisory panel will likely meet the following day to review the clinical trial data and make recommendations.
Moderna and Johnson & Johnson are also testing their vaccines in 12 to 18-year-olds, with data from Moderna's trial expected to come soon.
Pfizer and Moderna have launched trials in even younger children age six months to 11 years old.
Both companies have said they hope to be able to vaccinate children under 11 by early next year.
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