Pfizer announced Friday their COVID-19 vaccine has proven to be more than 90% effective in children ages 5 to 11.
In documents submitted to the FDA, the drugmaker said sixteen children in the Pfizer/BioNTech trial who were given a placebo got COVID-19, compared with three who received the vaccine.
With nearly 2.300 children in the trial, and more than twice as many given the vaccine than placebo, that equates to better than 90% efficacy.
FDA advisors are scheduled to meet Tuesday to vote on whether to recommend the vaccine for that age group.
The study did not show any new safety concerns, but both Pfizer and Moderna vaccines have been linked to rare cases of heart inflammation, called myocarditis, particularly in young men.
Pfizer suggested the rate of myocarditis in the 5 to11 age group was likely to be lower than in 12 to 15 year olds. It also estimated that the number of COVID-related hospitalizations prevented by vaccination was many times the number of potential cases of myocarditis.
If the FDA authorizes the vaccine for children 5 to 11 years old, CDC advisors will meet on Nov. 2 and 3 to make recommendations on how the shots should be administered.