NEW YORK. — Scientists at the US Food and Drug Administration (FDA) said on Friday that the likely benefits of giving the Pfizer PFE.N/BioNTech BNTX.O COVID-19 vaccine to 5 to 11-year-olds clearly outweigh the risks of rare cases of heart inflammation.
Earlier on Friday, the vaccine makers said their shot showed 90.7% efficacy against the coronavirus in a clinical trial of children 5 to 11 years old.
The details were in briefing documents published ahead of a meeting of a panel of outside experts scheduled to vote on Tuesday whether to recommend the FDA authorize the shots for the young age group.
If the FDA authorizes the Pfizer/BioNTech immunization for children 5 to 11 years old, it would be the first COVID-19 vaccine for the age group and shots could be available in the United States in early November.
Both the Pfizer/BioNTech and Moderna Inc MRNA.O vaccines have been linked to rare cases of heart inflammation called myocarditis, especially in young men.
The FDA staff said that, assuming the number of myocarditis cases observed in the younger age group would be similar to that seen in 12 to 15-year-olds, the number of COVID-19 related hospitalizations prevented would outnumber myocarditis-related hospitalizations in most scenarios analyzed.
If the FDA authorizes the vaccine for 5 to 11-year-olds, a group of advisers to the US Centers for Disease Control and Prevention (CDC) will meet on Nov. 2-3 to make recommendations to the agency on how the shots should be administered.
Most states wait for the CDC to sign off on recommendations for vaccines before they begin administering shots.
Pfizer suggested in its own briefing documents that the rate of myocarditis in the age group was likely to be lower than observed in vaccinated 12 to 15-year-olds, in part because the younger children were given a lower dose.
The 5 to 11-year-olds were given two shots of a 10-microgram dose, a third of what was given to people 12 years and older.
Sixteen children in the trial who had received a placebo got COVID-19, versus three who were vaccinated, Pfizer said in briefing documents submitted to the FDA. — Reuters
