Pfizer's Covid-19 Vaccine Nearly 91% Effective In Children Ages 5 To 11

(RTTNews) - Pfizer (PFE) and BioNTech's COVID-19 vaccine showed 90.7% efficacy against the coronavirus in a clinical trial of five to 11 year olds, according to study details released on Friday.

In the trial, three children who were vaccinated got Covid-19 compared to 16 children from the group that received placebo. In the trial, twice as many children received the vaccine as the placebo.

If the FDA approves the Emergency Use Authorization of vaccine for children between 5 and 11, the shots could begin early next month. A two-dose regimen of 10-microgram dose will be administered three weeks apart.

The FDA's Vaccines and Related Biological Products Advisory Committee is scheduled to meet on October 26 to discuss whether to recommend the vaccine for authorization for those ages 5 to 11.

In September, Pfizer and BioNTech had submitted positive data from the Phase 2/3 trial of their COVID-19 vaccine in children 5 to <12 years of age.

The pivotal trial, which included 2,268 participants 5 to <12 years of age, demonstrated a favorable safety profile and elicited robust neutralizing antibody responses using a two-dose regimen of 10 g doses. The results were comparable to those recorded in a previous Pfizer-BioNTech study in people 16 to 25 years of age, who were immunized with 30 g doses.

The companies said the 10 g dose was carefully selected as the preferred dose for safety, tolerability and immunogenicity in children 5 to <12 years of age.