Pfizer vaccine could prevent tens of thousands of cases in 5-11-year-olds, FDA panel told
Vaccinating children aged five to 11 would prevent tens of thousands of cases of Covid-19 over a six-month period, according to data presented to a panel of US advisory experts who are debating whether to recommend doing so.
The data, which was presented by Pfizer to the committee and backed up by a similar analysis by the Food and Drug Administration, suggested that the benefits of vaccinating younger children would far outweigh the risks.
The panel will vote later on Tuesday on whether to recommend that the FDA authorise the BioNTech/Pfizer vaccine for such young children. If it does so, the FDA is likely to give the green light within days, making the US the first country to approve Pfizer for that age group.
William Gruber, Pfizer’s senior vice-president of vaccine research and development, told the committee: “The observed [adverse event] profile in the study did not suggest any safety concerns for vaccination of children five to less than 12 years of age.”
Analyses by Pfizer and the FDA suggested that vaccinating younger children would prevent between 45,000 and 60,000 Covid-19 infections for every 1m children who received the vaccine over a six-month period, assuming the virus is as prevalent as it is now. This would stop over 200 hospitalisations and a handful of deaths in that time.
The models suggest that rolling out the Pfizer vaccine for five to 11-year-olds could cause about 200 cases of heart inflammation, though this would not be expected to lead to any deaths.
Speaking at the start of the meeting, Fiona Havers, a doctor at the Centers for Disease Control and Prevention, said that infection rates among younger children had been rising through the summer.
“In total, there have been more than 1.9m cases of Covid-19 reported in this age group, and starting in July and August this year there was a sharp increase in cases in this age group,” she told the panel. Children aged five to 11 currently make up 10.6 per cent of US cases, but only 8.7 per cent of the population, she added.
Health experts say extending jabs to the 28m children in the age group represents a crucial 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 the company 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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