Pfizer said it has selected lower dosages of its COVID-19 vaccine for Phase 2/3 portions of its clinical trial involving kids younger than 11 than the volume given to shot recipients ages 12 and older. For children ages 5-11 the vaccine will be given at a 10 microgram (ug) dose level, while those younger than 5 down to 6 months will receive a 3 ug dose level.
The shots will continue to be given in a two-dose regimen. Currently, the FDA has granted emergency use authorization to Pfizer for its COVID-19 two-dose vaccine in people ages 12 and older. Everyone 12 and over receives two doses of 30 ug each given three weeks apart.
A spokesperson told FeedLine.net in a statement that the lower dosages were determined "based on the safety, tolerability and immunogenicity from our Phase 1 study."
COVID-19 VACCINE TRIALS INVOLVING KIDS 5 AND UP BEGINS
"We take a deliberate and careful approach to help us understand the safety and how well the vaccine can be tolerated in younger children," Dr. Bill Gruber, M.D., senior vice president of Clinical Research and Development at Pfizer, said. "Children younger than 12 make up a significant portion of the total global population and can develop COVID-19 disease, and also can spread the virus to others. If successful, we believe vaccinating children will help further protect our communities and contribute to the evolving herd immunity."
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The next phase of the study is aiming to enroll up to 4,500 participants at more than 90 clinical sites in the U.S., Finland, Poland and Spain, the spokesperson said.
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