The United States Food and Drug Administration is preparing to authorize the COVID-19 vaccine from Pfizer Inc (PFE.N) and its German partner BioNTech SE (22UAy.DE) for adolescents aged 12 to 15 at the start of next week, The New York Times reported on Monday, citing federal officials familiar with the agency’s plans.
Approval is eagerly awaited after drugmakers said in March that the vaccine was found to be safe, effective, and produced robust antibody responses in children 12 to 15 years of age in a clinical trial.
In response to a request for comment from Reuters, the FDA said its review of extending the emergency use authorization for the vaccine was underway, but did not provide further details.
The vaccine has already been licensed in the United States for people 16 years of age and older. (https://reut.rs/3nLH8Fj)
Pfizer declined to comment on the NYT report.
U.S. Centers for Disease Control (CDC) director Rochelle Walensky said earlier in April that the vaccine could be approved by mid-May.
If approval for 12-15 year olds is granted, the CDC’s vaccine advisory committee will likely meet the next day to review clinical trial data and make recommendations for vaccine use in adolescents, the report added. . (https://nyti.ms/3eclRld)
Potential vaccine approval would boost the country’s vaccination campaign and help allay fears of parents concerned about protecting their children from COVID-19.
Moderna Inc (MRNA.O) and Johnson & Johnson (JNJ.N) are also testing their vaccines in children aged 12 to 18, data from Moderna’s trial should be available soon.
Pfizer and Moderna have also started trials in even younger children, aged 6 months to 11 years. The two companies said they hoped to be able to immunize children under 11 by early 2022.
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