Washington: The Pfizer (PFE.N)/BioNTech COVID-19 vaccine showed 90.7% efficacy against the coronavirus in a clinical trial of children 5 to 11 years old, the US drugmaker said.
Among more than 2,200 children in this age group, 1,500 of whom received the active vaccine, only 19 came down with COVID-19. The three children infected with COVID-19 after vaccination generally had a few, mild symptoms, such as cough, sore throat and headache, and reported no fevers; while the 16 infected in the placebo group suffered more symptoms, with 10 enduring fevers.
The Food and Drug Administration posted its analysis of Pfizer’s data ahead of a public meeting next week to debate whether the shots are ready for the nation’s roughly 28 million children ages 5 to 11. The agency will ask a panel of outside vaccine experts to vote on that question.
In their analysis, FDA scientists concluded that in almost every scenario the vaccine’s benefit for preventing hospitalizations and death from COVID-19 would outweigh any serious potential side effects in children. But agency reviewers stopped short of calling for Pfizer’s shot to be authorized.
The agency will put that question to its panel of independent advisers next Tuesday and weigh their advice before making its own decision.
On Tuesday, the first of two independent review panels will examine data from Pfizer-BioNTech’s trials in 5- to 11-year-olds and decide whether the vaccine’s benefits outweigh its risks in that age group. Children in this age group would receive one-third of the adult dose given in two shots at least three weeks apart.
The FDA commissioner would then have to sign off on the shots, along with an advisory committee for Centers for Disease Control and Prevention, scheduled to meet Nov. 2 and 3, and then the CDC director.
