Top US health officials believe that Pfizer Inc.’s COVID-19 vaccine could be licensed for children ages five to 11 by the end of October, two sources familiar with the situation said Friday.
The schedule is based on the expectation that Pfizer, which developed the injection with Germany’s BioNTech, will have enough clinical trial data to request emergency use authorization (EUA) for that age group from the US Food and Drug Administration. the US (FDA) towards the end. this month, sources said.
Pfizer to Submit COVID-19 Vaccine Approval for Children Up to 5 Years in the Coming Weeks
They anticipated that the FDA could make a decision on whether the vaccine is safe and effective in younger children within three weeks of the EUA’s submission.
The decision to authorize a vaccine for younger children is eagerly anticipated by millions of Americans, particularly parents whose children started school in recent weeks amid a wave of infections fueled by the Delta variant.
America’s leading infectious disease expert Dr. Anthony Fauci outlined the schedule during an online public meeting attended by thousands of National Institutes of Health (NIH) staff members on Friday, according to one of the sources. A second source familiar with the situation said the FDA anticipated a similar schedule for Pfizer.
If Pfizer submits its USA by the end of September, and the data supports its use, “by the time we get to October, the first two weeks of October … the Pfizer product will probably be ready,” Fauci said, according to the source.
One step closer to vaccination for children
Fauci said Moderna Inc will likely take about three weeks longer than Pfizer to collect and analyze its data on children ages five to 11, according to the source. He estimated that a decision on taking Moderna could come around November, according to the source. The second source said Fauci’s schedule for Moderna seemed “optimistic.”
Officials from Pfizer, Moderna and NIH did not immediately comment.
Pfizer has previously said it would have data on children ages five to 11 ready in September and plans to submit it for a USA shortly thereafter. Previously, federal health regulators, including Fauci, had suggested that the FDA’s decision could come in November or later. Moderna told investors on Thursday that it expected data from its children’s study by the end of the year.
Earlier on Friday, the FDA said it would work to quickly approve COVID-19 vaccines for children once companies submit their data. He said he would consider applications based on a faster route to authorize the seizure for emergency use.
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Such an emergency authorization requires companies to submit two months of safety data on trial participants, compared to the six months required to obtain the full license.
Pfizer partner BioNTech told Der Spiegel that it also hopes to apply for global authorization for the COVID-19 vaccine in children as young as five in the coming weeks and that preparations for a launch were underway.