The United States could offer Pfizer Inc's Covid-19 vaccine for children aged between 5 and 11 years by the end of October, according to reports.
The officials have arrived at the timeline, hoping that Pfizer, which developed the vaccine with Germany's BioNTech, will be able to present the complete data from clinical trials by then.
Emergency use authorization (EUA) will be sought from the US Food and Drug Administration (FDA) towards the end of this month, two sources told Reuters news agency.
More From Reuters:
They anticipate the FDA could make a decision on whether the shot is safe and effective in younger children within three weeks of the EUA submission.
The decision on whether 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 driven by the Delta variant.
Top U.S. infectious disease expert Dr. Anthony Fauci outlined the timetable during an online town hall meeting attended by thousands of staff at the National Institutes of Health (NIH) on Friday, according to one of the sources. A second source familiar with the situation said that the FDA anticipated a similar timeline for Pfizer.
If Pfizer submits its EUA by the end of September, and the data support its use, "by the time we get to October, the first couple of weeks of October... the Pfizer product will likely be ready," Fauci said, according to the source.
Fauci said that Moderna Inc will likely take about three weeks longer than Pfizer to collect and analyze its data on children age 5-11, according to the source. He estimated that a decision on the Moderna shot could come around November, according to the source. The second source said Fauci's timeline for Moderna appeared "optimistic."
Officials at Pfizer, Moderna and NIH did not immediately comment.
Pfizer has previously said that it would have data on children age 5-11 ready in September and planned to submit for an EUA shortly after. Previously, federal health regulators, including Fauci, have suggested that an FDA decision might come in November or later. Moderna on Thursday told investors it expected data from its children's study by the end of the year.
Emergency Authorization
Earlier on Friday, the FDA said it would work to approve the COVID-19 vaccines for children quickly once the companies submitted their data. It said it would consider applications based on a faster path to authorize the shot for emergency use.
Such emergency authorization requires companies to submit two months of safety data on trial participants, versus six months required for full licensure.
Pfizer partner BioNTech told Der Spiegel that it also expects to request authorization globally for the COVID-19 vaccine in children as young as five over the next few weeks and that preparations for a launch were on track.
