Pfizer Declares COVID-19 Vaccine Safe and Triggers Antibody Response for 5-11 Age Group—Is there a Rush?

Pfizer Declares COVID-19 Vaccine Safe and Triggers Antibody Response for 5-11 Age Group---Is there a Rush?

Pfizer and BioNTech announced results from their Phase 2/3 clinical trial demonstrating what they report is a favorable safety profile combined with significant neutralizing antibodies in children age 5 to 11 using a two-dose regimen of 10 µg administered 21 days apart. Using a dose a third of the size for those 12 years and up, the company reports that the antibody response was comparable to those in a previous study investigating the vaccine use in people 16 to 25 years of age immunized with 30 µg doses. Pfizer reported in its press release that the dose was “carefully selected as the preferred dose for safety, tolerability, and immunogenicity in children 5 to 11 years of age.” These results represent the very first data set from a pivotal trial involving the COVID-19 vaccine BNT162b2 in this age group.

With 2,286 participants between the ages of 5-11, TrialSite suggests Pfizer will make an assertive move to file for an emergency use authorization (EUA) in the forthcoming weeks while also bundling the data for regulatory submission around the world. The company will make the argument that although efficacy is not established yet, safety and comparable antibody respo...

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