(Reuters) – U.S. health authorities believe Pfizer Inc.’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 German BioNTech, will have enough data from clinical trials to obtain emergency use authorization (US) for this age group of the U.S. Food and Drug Administration (FDA) later this month, sources said.
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 decision on whether to allow 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 caused by the Delta variant.
The leading infectious disease expert in the United States, Dr. Anthony Fauci, outlined the calendar during an online city hall meeting attended by thousands of officials at the National Institutes of Health (NIH) 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. by the end of September and the data supports its use, “by October, the first few weeks of October … the Pfizer product will probably be ready,” Fauci said. at the source.
Fauci said Moderna Inc. will likely 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.”
Pfizer, Moderna and NIH officials did not comment immediately.
Pfizer has previously said it would have data ready for children ages 5-11 in September and planned to ship to the US shortly thereafter. Earlier, federal health regulators, including Fauci, have 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.
Earlier 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 way to authorize the outlet for emergency use.
This emergency authorization requires companies to submit two months of safety data on test participants, compared to the six months required to obtain a full license.
Pfizer partner BioNTech told Der Spiegel that it also hopes to apply for global clearance for the COVID-19 vaccine in children up to five years old in the coming weeks and that preparations for the launch were well under way.
Reports by Marisa Taylor in Washington and Dan Levine in San Francisco; Additional reports from Michael Erman in New Jersey; Edited by Michele Gershberg, Caroline Humer, Aurora Ellis and Rosalba O’Brien