Las Vegas, Nevada 2021-10-22 08:52:00 –
so New document Pfizer, posted prior to the main meeting of the U.S. Food and Drug Administration’s Vaccine Advisors, states that the vaccine is safe and 90.7% effective against symptomatic COVID-19 in children aged 5-11 years. increase.
In this study of approximately 2,000 children, there were 3 COVID-19 cases in the vaccinated group and 16 cases in the placebo group. In the trial, twice as many children as placebo were vaccinated.
Pfizer / BioNTech is seeking an FDA emergency use authorization for a 10 microgram dose 2-dose regimen for children aged 5-11 years. The two doses are given at 3-week intervals.
Last month, Pfizer released details of a Phase 2/3 trial showing that the COVID-19 vaccine is safe and exhibits a “strong” antibody response in children aged 5-11 years. The study included 2,268 participants aged 5-11 years. Responses were measured by examining blood neutralizing antibody levels and comparing those levels to controls aged 16-25 years who were given a double dose regimen at a larger dose of 30 micrograms. .. Pfizer said levels were often compared to older people who received higher doses and showed “a strong immune response in this cohort of children one month after the second dose.”
The FDA’s Vaccine and Related Biopharmaceutical Advisory Board will meet on October 26 to discuss whether to recommend vaccines for approval between the ages of 5 and 11.
If approved, this will be the first COVID-19 vaccine for infants. The Pfizer / BioNTech vaccine is approved for people over the age of 16 and has EUA for people between the ages of 12 and 15.