The US Food and Drug Association says the benefits outweigh the risks for administering the Pfizer COVID-19 vaccine to children.
Scientists at the U.S. Food and Drug Administration (FDA) said on Friday, October 22, that the likely benefits of giving the Pfizer/BioNTech COVID-19 vaccine to 5 to 11-year-olds clearly outweigh the risks of reported rare cases of heart inflammation.
Earlier on Friday, the vaccine makers announced that their shot showed 90.7% efficacy against the coronavirus in a clinical trial of children 5 to 11 years old. The details were contained in briefing documents published ahead of a meeting of a panel of outside experts scheduled to vote on Tuesday whether to recommend the FDA authorise the shots for the younger age group.
Should the FDA authorise the Pfizer/BioNTech immunization for children 5 to 11 years old, it would be the first COVID-19 vaccine available for the age group and shots could be available in the United States as early as November.
Both the Pfizer/BioNTech and Moderna Inc 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 hospitalisations prevented would outnumber myocarditis-related hospitalizations in most scenarios analysed.
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.
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