An empty glass vial containing 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, March 3 (Jaclyn Nash, National Museum of American History via Reuters)
WASHINGTON – Top U.S. health officials believe Pfizer’s COVID-19 vaccine could be licensed for children ages 5 to 11 in late October, two sources familiar with the situation said Friday.
The timeline is based on the hope that Pfizer, which developed the shot with Germany’s BioNTech, will have enough data from clinical trials to apply for emergency use authorization for this age group of the Food and Drug Administration. from the United States later this month, according to sources. dit.
They anticipate that the FDA could make a decision on whether the shot is safe and effective in younger children within three weeks of the U.S. filing.
The leading infectious disease expert in the United States, Dr. Anthony Fauci, outlined the calendar during an online town hall meeting attended by thousands of officials at the National Institutes of Health on Friday, according to one source.
A second source familiar with the situation said the FDA envisioned a similar timeline for Pfizer. If Pfizer ships to the U.S. in late September and the data supports it, “by October, the first few weeks of October … the Pfizer product will probably be ready,” Fauci said, according to the source.
Fauci said Moderna will take about three more weeks than Pfizer to collect and analyze its data on children ages 5 to 11, according to the source. According to the source, he estimated that a decision on the firing of Moderna could take place around November.
The second source said Fauci’s chronology for Modern seemed “optimistic.”
NIH officials did not immediately comment on Fauci’s remarks.
Pfizer has said it would have data on children ages 5 to 11 ready in September and would plan to apply for a U.S. soon after. Earlier, federal health regulators, including Fauci, suggested that an FDA decision could be reached in November or later.
Modern on Thursday told investors they were expecting data from their children’s study later this year.