Pfizer Says Trial Shows, COVID-19 Vaccine , Is Safe and Effective <br />for 5 to 11 Year-Olds.<br />On September 20, Pfizer said that a Phase 2/3 trial showed that its COVID-19 vaccine was safe and effective for children ages 5 to 11.<br />CNN reports that these are the first such <br />results released for this age group for <br />a COVID-19 vaccine in the United States.<br />CNN also points out that the data from the study has not yet been peer-reviewed or published.<br />CNN also points out that the data from the study has not yet been peer-reviewed or published.<br />According to the FDA, once the Pfizer data is submitted, the agency could authorize a vaccine for younger children in a matter of weeks.<br />According to the FDA, once the Pfizer data is submitted, the agency could authorize a vaccine for younger children in a matter of weeks.<br />The trial, which included 2,268 participants <br />ages 5 to 11, used a two-dose regimen <br />of the vaccine administered 21 days apart.<br />The trial, which included 2,268 participants <br />ages 5 to 11, used a two-dose regimen <br />of the vaccine administered 21 days apart.<br />A 10-microgram dose, smaller than the 30-microgram dose that has been used for those 12 and older, was administered in the trial.<br />A 10-microgram dose, smaller than the 30-microgram dose that has been used for those 12 and older, was administered in the trial.<br />The 10 microgram dose was carefully selected as the preferred dose for safety, tolerability and immunogenicity in children 5 to 11 years of age, Pfizer news release, via CNN.<br />The 10 microgram dose was carefully selected as the preferred dose for safety, tolerability and immunogenicity in children 5 to 11 years of age, Pfizer news release, via CNN.<br />Pfizer said the levels compared well with older <br />people who received the larger dose, demonstrating a , "strong immune response in this cohort <br />of children one month after the second dose.".<br />Further, the COVID-19 vaccine was well tolerated, with side effects generally comparable to those observed in participants 16 to 25 years of age, Pfizer news release, via CNN.<br />According to a spokesperson for Pfizer, the trial resulted in no instances of myocarditis, ...<br />... a type of heart inflammation that <br />has been linked with mRNA vaccines
