Exclusive-US May Authorize Pfizer COVID-19 Vaccine For Children 5-11 Years Old In October -sources

(Reuters) – Senior U.S. health officials believe Pfizer Inc’s COVID-19 vaccine could be cleared for children aged 5 to 11 by the end of October, two sources familiar with the situation said on Friday.

The timeline is based on the expectation that Pfizer, which developed the shot with German BioNTech, will have enough clinical trial data to apply for an Emergency Use Authorization (EUA) for this age group. with the United States Food and Drug Administration (FDA) towards the end. this month, the sources said.

They predict that the FDA could decide whether the vaccine is safe and effective in young children within three weeks of the EUA’s submission.

The decision whether or not to allow a vaccine for young children is eagerly awaited by millions of Americans, especially parents whose children have started school in recent weeks amid a wave of infections caused by the Delta variant.

America’s top infectious disease expert Dr Anthony Fauci described the schedule in an online public meeting attended by thousands of National Institutes of Health (NIH) staff on Friday, according to one of the sources. A second source close to the situation said the FDA is planning a similar timeline for Pfizer.

If Pfizer submits its EUA by the end of September and the data supports its use, “by October, the first two weeks of October … the Pfizer product will likely be ready,” Fauci said, according to the source.

Fauci said Moderna Inc will likely take about three weeks longer than Pfizer to collect and analyze its data on children aged 5 to 11, according to the source. He estimated that a decision on the firing of Moderna could be made around November, according to the source. The second source said Fauci’s timeline for Moderna seemed “upbeat”.

Officials from Pfizer, Moderna and NIH did not immediately comment.

Pfizer previously said it would have data on children aged 5 to 11 ready in September and planned to submit them to an EUA shortly thereafter. Previously, federal health regulators, including Fauci, had suggested that an FDA decision could come in November or later. Moderna told investors on Thursday that she expected data from her study on children by the end of the year.

Earlier on Friday, the FDA said it would work to quickly approve COVID-19 vaccines for children here after the companies submit their data. He said he would consider requests based on a faster path to allow firing in an emergency.

Such emergency clearance requires companies to submit two months of safety data on trial participants, compared to six months required for a full license.

Pfizer’s partner BioNTech told Der Spiegel that it also plans to seek global authorization for the COVID-19 vaccine in children as young as five in the coming weeks and that preparations for a launch are underway. on the right track.