New Delhi: Pfizer Covid-19 vaccine could be authorised in the US for children aged 5-11 years by October end, Reuters reported Saturday.
Quoting two sources familiar with the matter, the report said Pfizer is expected to have "enough data from clinical trials" to seek emergency use authorisation from the US Food and Drug Administration for the said age group by the end of September.
Pfizer has developed its Covid vaccine in collaboration with Germany's BioNTech.
The sources also told Reuters that the FDA could decide if the vaccine is safe for 5-11 years olds within three weeks of receiving the appeal for EUA.
With schools reopening in the US, at a time when the Delta variant of the coronavirus triggering a wave of infections, many children are now contracting Covid across the country.
As of Tuesday this week, as many as 2,396 children had been hospitalised, according to data shared with media by the US Department of Health and Human Services.
Over 750,000 pediatric Covid cases were added between August 5 and September 2, the American Academy of Pediatrics has said.
In such a scenario, a decision on a vaccine for children and below-18 teens is eagerly awaited.
Top infectious disease expert Dr Anthony Fauci, who is also the chief medical advisor at White House, is said to have outlined the timetable during a virtual town hall meeting attended by thousands of staff at the National Institutes of Health on Friday, according to the Reuters report.
Quoting Fauci, one of the two sources mentioned above told Reuters: "If Pfizer submits its EUA by the end of September, and the data support its use, 'by the time we get to October... the Pfizer product will likely be ready."
Pfizer and NIH have not made any comment on this yet.
Earlier, the FDA said on Friday it would work on approval to Covid-19 vaccines for children quickly once the drug firms submitted their data, the report said.
For EUA, companies are required to submit two months' safety data on trial participants.
According to the report, Pfizer had previously said it would have data on 5-11 years age group ready in September.