Pfizer Inc. has asked US regulators to authorize its Covid-19 vaccine for emergency use in children under 5, an effort to extend protection against the virus to the nation’s youngest.
The drugmaker and BioNTech SE have finalized their ongoing application to the Food and Drug Administration for emergency use authorization of their vaccine in children ages 6 months to 4 years, the companies said in a statement Wednesday. The vaccine partners began the submission process in February.
Pfizer and BioNTech announced in late May that a three-shot regimen was highly effective and elicited a strong immune response in children under 5, according to early results from a long-awaited trial that is likely to pave the way for infants and young children get immunized
The preliminary analysis found that the vaccine was 80.3% effective in preventing covid infections among young children, with 10 infections occurring among all participants. Final results will be determined once all 21 children enrolled in the study have been infected, according to the companies.
In February, Pfizer and BioNTech launched an ongoing review of trial data from 1,678 children under the age of 5. The three-dose vaccine regimen was well tolerated, with a similar safety profile to placebo, and most side effects were mild or moderate.
The full submission includes data on the product’s safety, efficacy, and ability to elicit an immune response. Children under 5 years of age received a series of three doses, each 3 micrograms, or 1/10 the amount given to adults.
With the filing now complete, attention will turn to an upcoming FDA advisory committee meeting on June 15. The expert panel will meet to discuss the risks and benefits of Pfizer-BioNTech and Moderna Inc. vaccines in younger children, and provide a recommendation to U.S. regulators on whether or not they should be licensed for use in emergency.
Pfizer said the companies also plan to submit the data to the European Medicines Agency and other regulators around the world.
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