FDA panel backs Pfizer Covid-19 vaccine for 5- to 11-year-olds
US government advisers have recommended allowing children aged five to 11 to receive the BioNTech/Pfizer Covid-19 vaccine, paving the way for the US to become the first county to authorise the vaccine for younger children.
Scientists on a US Food and Drug Administration advisory panel voted overwhelmingly on Tuesday in favour of allowing Pfizer to supply its vaccine to this age group, with 17 votes in support and one abstention.
The vote clears the path for a further expansion of the US vaccine rollout, and could help ease the burden on schools, where cases have been on the rise in recent weeks.
While no one on the panel voted against the move, several said they were concerned by the idea that this might lead to vaccine mandates for children.
“I see this as a personal choice and equity question and not a mandate for all,” said Michael Nelson, professor of medicine at the University of Virginia.
Many scientists on the panel said they were concerned about the possible side-effects for younger children, since that group is not at significant risk of suffering severe Covid-19.
Others however were persuaded by data presented by both Pfizer and the FDA that showed vaccinating five- to 11-year-olds could stop tens of thousands of infections over a six-month period.
Kathrin Jansen, Pfizer’s head of vaccine research and development, welcomed the positive recommendation by the committee. “Covid-19 is an ongoing threat for the more than 28m young children in this age group in the US, as they remain at risk for this infection,” she said.
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.”
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