Pfizer Says Trial Shows, COVID-19 Vaccine , Is Safe and Effective
for 5 to 11 Year-Olds.
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.
CNN reports that these are the first such
results released for this age group for
a COVID-19 vaccine in the United States.
CNN also points out that the data from the study has not yet been peer-reviewed or published.
CNN also points out that the data from the study has not yet been peer-reviewed or published.
According to the FDA, once the Pfizer data is submitted, the agency could authorize a vaccine for younger children in a matter of weeks.
According to the FDA, once the Pfizer data is submitted, the agency could authorize a vaccine for younger children in a matter of weeks.
The trial, which included 2,268 participants
ages 5 to 11, used a two-dose regimen
of the vaccine administered 21 days apart.
The trial, which included 2,268 participants
ages 5 to 11, used a two-dose regimen
of the vaccine administered 21 days apart.
A 10-microgram dose, smaller than the 30-microgram dose that has been used for those 12 and older, was administered in the trial.
A 10-microgram dose, smaller than the 30-microgram dose that has been used for those 12 and older, was administered in the trial.
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.
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.
Pfizer said the levels compared well with older
people who received the larger dose, demonstrating a , "strong immune response in this cohort
of children one month after the second dose.".
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.
According to a spokesperson for Pfizer, the trial resulted in no instances of myocarditis, ...
... a type of heart inflammation that
has been linked with mRNA vaccines