Covid: Pfizer asks FDA for approval of vaccine for five year olds

Agency will review data in weeks after data from trials on school age children submitted

Gino Spocchia
Thursday 07 October 2021 16:06
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Pfizer has formally asked the US Food and Drug Administration (FDA) for authorisation of its Covid vaccine for Americans aged five to 11.

If approved, the shot could become available within weeks and boost the number of Americans immunised against Covid.

The pharmaceutical firm found in trials that children should receive a third of the dose given to adults.

Thursday’s announcement follows pressure from parents for vaccinations to open up for school-age children, most of whom have returned to classrooms for the first time in a year.

An expert panel will publicly debate the evidence from Pfizer’s trials on 26 October, with a final decision likely not long after.

Pfizer said in a series of tweets that it had “officially submitted our request to US FDA for Emergency Use Authorisation (EUA) of our Covid vaccine in children 5 to

“With new cases in children in the US continuing to be at a high level, this submission is an important step in our ongoing effort against Covid”.

“We’re committed to working with the FDA with the ultimate goal of helping protect children against this serious public health threat.”

More than 28 million Americans would be protected from the virus if the EUA is granted, although it requires further review by the US Centres for Disease Control and Prevention (CDC).

The CDC will recommend – or decline – the shots for those aged five to 11 after looking at Pfizer’s data.

Pfizer said there were no serious side effects in the 2,268 volunteers aged five to 11 who were given the lower dosage during trials, although its study was not large enough to find extremely rare side effects.

Dr Scott Gottlieb, a former FDA commissioner who sits on Pfizer’s board, suggested to CNBC last week that the Covid shots for children could come by Halloween.

While cases of Covid are falling throughout the US, the levels of infection remain high and many experts are cautious about the impact of winter on case numbers.

Additional reporting by The Associated Press.

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