The Pfizer COVID-19 vaccine is nearly 91% effective against symptomatic illness in children ages 5-11, according to new data released Friday ahead of a key FDA advisory meeting on Tuesday.
The vaccine also appeared safe, with none of the children experiencing a rare side effect of heart inflammation known as myocarditis. If allowed in children aged 5-11, the Pfizer vaccine will be given in a smaller one-third dose.
This efficacy estimate comes from the company’s clinical trial of 2,268 children in which some children received a placebo and some children received the Pfizer vaccine. During the trial, 16 children who received the placebo injections developed COVID-19. Only three children who received the real vaccine developed COVID-19.
A small number of the children who were vaccinated and later developed COVID-19 experienced much fewer and milder symptoms than the unvaccinated children. For example, none of the vaccinated children developed a fever, while a majority of the unvaccinated children developed a fever with other symptoms.
None of the children had serious side effects. Many had typical symptoms such as injection site pain, fatigue and headache.
FDA advisers will meet Tuesday to vote on whether or not to approve the vaccine. From there, the FDA itself and the CDC will have to sign — a process that could take several days — before shots can become available to children nationally.
– Sony Salzman from ABC News