Benefits of giving the Pfizer/BioNTech COVID vaccine to 5 to 11-year-olds clearly outweigh the risks, according to a US drug watchdog.
The assessment by scientists at the country’s Food and Drug Administration (FDA) comes as the makers of the vaccine said it showed 90.7% efficacy against coronavirus in a clinical trial of children in that age group.
A panel of experts is due to vote on Tuesday whether to recommend the FDA authorises the shots for youngsters.
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If given the go-ahead, it would be the first COVID-19 vaccine for the age group and jabs could be available in the US in early November.
Both the Pfizer/BioNTech and Moderna vaccines have been linked to rare cases of heart inflammation called myocarditis, especially in young men.
The FDA said that, assuming the number of myocarditis cases seen in the younger age group would be similar to that seen in 12 to 15-year-olds, the number of COVID hospitalisations prevented would outnumber myocarditis-related ones in most scenarios.
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, partly because the younger children were given a lower dose.
Sixteen children in the trial who had received a placebo got COVID-19, compared with three who were vaccinated, Pfizer said in papers submitted to the FDA.
Because more than twice as many children in the 2,268-participant trial were given the vaccine than placebo, that equated to better than 90% efficacy.
The manufacturers have already said the vaccine provided a robust immune response in the children.
The Pfizer/BioNTech vaccine already has US regulatory authorisation for people who are at least 12-years-old, including full FDA approval in August for those 16 and over.
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Around 190 million people in the US are fully vaccinated, including more than 11 million 12 to 17-year-olds that have received the Pfizer vaccine.
If the FDA approves the vaccine for younger children, a group of experts will meet early next month to make recommendations on how the shots should be administered.