US could authorise Pfizer Covid-19 shot for kids aged 5 to 11 in October

Vaccine for younger children is eagerly anticipated by millions, particularly parents whose children started school in recent weeks.
Vaccine for younger children is eagerly anticipated by millions, particularly parents whose children started school in recent weeks.PHOTO: REUTERS

WASHINGTON (REUTERS) - Top US health officials believe that Pfizer's Covid-19 vaccine could be authorised for children aged five to 11 years old by the end of October, two sources familiar with the situation said on Friday (Sept 10).

The timeline is based on the expectation that Pfizer, which developed the shot with Germany's BioNTech, will have enough data from clinical trials to seek emergency use authorisation (EUA) for that age group from the United States Food and Drug Administration (FDA) towards the end of this month, the sources said.

They anticipate the FDA making 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 authorise 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 US infectious disease expert 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", Dr Fauci said, according to the source.

Dr Fauci said that Moderna will likely take about three weeks longer than Pfizer to collect and analyse its data on children age five to 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 Dr Fauci's timeline for Moderna appeared "optimistic".

Officials at Pfizer, Moderna and NIH did not immediately comment.

Pfizer previously said that it would have data on children age five to 11 ready in September and planned to submit for an EUA shortly after. Previously, federal health regulators, including Dr 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.

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 authorise the shot for emergency use.

Such emergency authorisation requires companies to submit two months of safety data on trial participants, versus six months required for full licensing.

Pfizer partner BioNTech told Der Spiegel that it also intends to request authorisation 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.