Pfizer and BioNTech SE finalised their rolling application to the Food and Drug Administration for emergency-use authorization of their vaccine in kids ages 6 months through to 4 years old, the companies said in a statement on Wednesday. The vaccine partners began the submission process in February.
In February, Pfizer and BioNTech launched a rolling review of data from the trial of 1,678 children under the age of 5. The three-dose vaccine regimen was well tolerated, with a safety profile similar to that of the placebo, and most side effects were mild or moderate. The full submission includes data on the product’s safety, efficacy and ability to prompt an immune response. Children under the age of 5 were a given of series of three doses, each 3 micrograms, or 1/10th the amount given to adults.
With the submission now complete, attention will turn to a forthcoming FDA advisory committee meeting on June 15. The panel of experts will convene to discuss the risks and benefits of the Pfizer-BioNTech and Moderna Inc. vaccines in the youngest children, and provide a recommendation to U.S. regulators as to whether or not they should be cleared for emergency use.
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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