United States Health Officers believe that the Covid-19 Vaccine Pfizer Inc.
can be authorized for children aged 5-11 years at the end of October, two sources familiar with the situation on Friday.
The timeline was based on expectations that the Pfizer, who developed a shot with Germany’s Bontech, would have enough data from clinical trials to find emergency use permits (EUA) for the age group from the US (FDA) towards the end of this month, said the source.
They anticipate the FDA can make a decision about whether the shot is safe and effective in younger children within three weeks after the submission of EUA.
US Top Infectious Disease Expert Anthony Fauci describes the schedule during the online city hall meeting attended by thousands of staff at the National Institutes of Health (NIH) on Friday, according to one source.
The second source familiar with the situation said that the FDA anticipated a similar timeline for Pfizer.
If the Pfizer sends EUA at the end of September, and the data supports its use, “When we arrive in October, the first few weeks …
Pfizer products are likely to be ready,” Fauci said, according to The Fauci, according to the source.
Fauci said that Moderna Inc.
is likely to take around three weeks longer than Pfizer to collect and analyze the data in children aged 5-11, according to sources.
He estimates that decisions about moderna shots can come around November, according to the source.
The second source said the Fauci timeline for modern appeared “optimistic.” The official did not immediately comment on Fauci’s comments.
Pfizer said that it would have data in children aged 5-11 ready in September and plan to submit to EUA shortly after that.
Previously, federal health regulators, including Fauci, had suggested that the FDA decision might come in November or newer.
Moderna on Thursday told investors that it expects data from their children’s study at the end of the year.
US decision on Pfizer Covid-19 shots for children aged 5-11 can come in October: Source
