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When will children under 12 be vaccinated for Covid?

Trials in school age children show as much as efficiency as in adults, Dr Fauci has said

Gino Spocchia
Monday 13 September 2021 19:04 BST
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Former FDA commissioner says vaccines likely for kids ‘by halloween’

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More than 178 million Americans have been fully immunised against Covid since the first dose was administered in December last year, but that figure does not include children under 12-years-old.

School aged children aged five to 11 are awaiting US Food and Drug Administration (FDA) approval of the Moderna and Pfizer shots which have been administered to Americans aged 12 and above. Experts say this could be soon.

Dr Scott Gottlieb, a former FDA commissioner and author of “Uncontrolled Spread: Why Covid-19 Crushed Us and How We Can Defeat the Next Pandemic”, told CBS’s “Face the Nation” on Sunday that it would be a matter of weeks for children aged below 12 to get approval.

“[The] FDA has said it's going to be a matter of weeks, not months, in terms of their evaluation of that clinical data to make a determination whether they're going to authorise vaccines for kids aged five to 11,” said Dr Gottlieb.

“I interpret that to mean perhaps four weeks, maybe six weeks. But I think in a best-case scenario, given that timeline they've just laid out, you could potentially have a vaccine available to children aged five to 11 by Halloween.”

While no timeline has been put on the approval by the FDA, the director of the US Centres for Disease Control and Prevention, Dr Rochelle Walensky, said on Monday that her agency was working with “urgency” to finalise a vaccine for young children.

She added during an appearance on NBC’s “Today Show” that she wanted authorisation to happen “in the fall”, that all younger children could be vaccinated “by the end of the year”.

“We’re waiting for the companies to submit the data to the FDA, we're anticipating that will happen in the fall,” said Dr Walensky. “We will look at that data from the FDA, from the CDC, with the urgency that we all feel for getting our kids vaccinated and we're hoping by the end of the year”.

Dr Gottlieb said on Sunday that Pfizer would be able to handover its findings from clinical trials in children aged below 12 to the FDA by the end of September, and that it would be filed with the body “very quickly”.

“If everything goes well, the Pfizer data package is in order, and FDA ultimately makes a positive determination, I have confidence in Pfizer in terms of the data that they've collected. But this is really up to the the Food and Drug Administration to make an objective determination,” Dr Gottlieb said.

Dr Anthony Fauci, the US chief medical adviser and director of the National Institute of Allergy and Infectious Diseases (NIAID), told CNN last month that he was confident that the trials would show as much efficiency in young children as in adults.

"I don't think there's going to be any question that this is going to be effective in the children at that younger age. I have no doubt about that," Dr Fauci said.

Parents were warned by the FDA on Friday not to ask health providers to vaccinate children before authorisation from the body, and full results from clinical trials, because “children are not small adults”.

“Issues that may be addressed in paediatric vaccine trials can include whether there is a need for different doses or different strength formulations of vaccines already used for adults,” the FDA, which could not give a date for authorisation, added.

Vaccinating children against Covid, who according to CBS account for about a quarter of all infections in the US, will improve the rate of vaccinations among the whole population — which currently stands at 53.8 per cent.

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