Top US health officials believe that Pfizer Inc. (PfE.N.) COVID-19 The vaccine could be authorized for children aged 5-11 by the end of October, two sources familiar with the situation said on Friday.
The timeline is based on the hope that Pfizer, which developed the shot with Germany’s BioNTech (22UAy.DE), will have the clinical approval to obtain emergency use authorization (EUA) for that age group from the US Food and Drug Administration. There will be enough data from the trials. FDA) later this month, sources said.
They estimate that the FDA can make a decision within three weeks of submitting the EUA whether the shot is safe and effective in young children.
The decision to authorize a vaccine for young children has been eagerly awaited amid a wave of infections prompted by millions of Americans, especially parents whose children started school in recent weeks. delta version.
Top US infectious disease expert Dr. Anthony Fauci outlined the timetable during an online town hall meeting attended by thousands of staff at the National Institutes of Health (NIH) on Friday. A second source familiar with the situation said the FDA had anticipated a similar timeline for Pfizer.
If Pfizer submits its EUA by the end of September, and the data supports its use, “by the time we get to October, the first few weeks of October … the Pfizer product will be ready,” Fauci said, of according to source.
Fauci said Moderna Inc. (mRNA.o) will take about three weeks longer than Pfizer to collect and analyze its data on children ages 5-11, according to the source. He speculated that the decision on Moderna Shot could come around November, according to the source. Another source said Fauci’s timeline for Moderna appeared “optimistic.”
Officials from Pfizer, Moderna and NIH did not immediately comment.
Pfizer previously said it would have data on children aged 5-11 years ready in September and plans to submit it to the EUA shortly. Previously, federal health regulators, including Fauci, have suggested the FDA’s decision could come in November or later. Moderna told investors on Thursday that it expects data from its children’s studies by the end of the year.
Earlier on Friday, the FDA said it would work to quickly approve COVID-19 vaccines for children after companies submitted their data. It said it would consider applications based on the fast path to authorize the shot for emergency use.
Such emergency authorization requires companies to submit two months of safety data on trial participants, while a full license requires six months.
Pfizer partner BioNTech told Der Spiegel that it also expects to request authorization globally for a COVID-19 vaccine in children under five in the next few weeks and launch preparations are on track. Was.
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