FDA panel considers Pfizer Covid-19 vaccines for 5-11 year olds

A Food and Drug Administration advisory panel will consider whether the US should become the first country in the world to green light the BioNTech/Pfizer vaccine for children aged between 5 and 11 years.

Scientists at the agency have said the protection from Covid-19 offered by the jab to children would “clearly outweigh” the risk of myocarditis, a heart problem that has been reported in rare instances after vaccination.

On Tuesday external advisers will review the evidence and make a recommendation to US authorities on whether to proceed with the rollout of shots for five to 11 year olds — a process the Biden administration has said could begin within weeks.

Health experts say extending jabs to the 28m children in the age group represents a key step towards boosting immunity levels in the US, where just 57 per cent of the population is fully vaccinated. But vaccine hesitancy among some parents could slow that effort, they warned.

“In the US, many children have had their life on hold because they have been unable to be vaccinated and there is not enough vaccine uptake in the population above 12 years [of age] to prevent cases recognised in schools from disrupting in-person learning,” said Amesh Adalja, a senior scholar at the Johns Hopkins Center for Health Security in Baltimore.

“Vaccinating this group will be a significant step towards increased immunity in the population.”

Pfizer said the US was the first country where it had sought regulatory authorisation for its Covid-19 vaccine for five to 11 year olds.

A study by Pfizer found the BioNTech/Pfizer vaccine is 90 per cent effective at preventing symptomatic infection with Covid-19 in five to 11 year olds when administered in “kid-sized” doses, equivalent to a third of the size of an adult shot. It also demonstrated the “safety and tolerability” of the vaccine for the age group, the company said last week.

More than 6.3m children in the US have been diagnosed with Covid-19 since the start of the pandemic, with weekly numbers of new cases peaking at 252,000 in early September, according to the American Academy of Pediatrics.

Children are less vulnerable to severe illness than adults. There were 637 deaths of people aged under 18 years reported in the US during the pandemic, according to the Centers for Disease Control and Prevention.

“We like to say low risk does not mean no risk,” said Sara Goza, a physician and former AAP president.

“We expect to see some vaccine hesitancy around Covid-19 and paediatricians are ready, willing and able to talk to parents and children about this vaccine and why we think it’s important.”

About a third of parents told a Kaiser Family Foundation survey they would vaccinate their five to 11 year old children “right away”, while a quarter said they would definitely not vaccinate their kids. The remainder said they would either wait and see or only vaccinate their children if required.

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