[ad_1]
An empty glass vial that contained the first five doses of the Pfizer / BioNTech COVID-19 vaccine administered in the United States on December 14, 2020, is seen after being donated to the collection of the Smithsonian’s National Museum of American History in Washington, DC, the 3 of March. (Jaclyn Nash, National Museum of American History via Reuters)
WASHINGTON – Senior U.S. health officials believe Pfizer’s COVID-19 vaccine could be cleared for children aged 5 to 11 by the end of October, two sources familiar with the matter said on Friday.
The timeline is based on the expectation that Pfizer, which developed the shot with Germany’s BioNTech, will have enough clinical trial data to apply for emergency use authorization for this age group from the United States Food and Drug Administration towards the end of this month, the sources mentioned.
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.
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 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 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 schedule for Moderna appeared “optimistic.”
NIH officials did not immediately comment on Fauci’s remarks.
Pfizer said it would have data on children ages 5 to 11 ready in September and plan 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.
Pictures
Related stories
More stories that might interest you
[ad_2]
Source link