Pfizer asks FDA for approval to give Covid vaccine to children aged 12 to 15

The vaccine is currently authorised for people aged 16 years and older

Danielle Zoellner
New York
Friday 09 April 2021 21:13

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Pfizer has requested the Food and Drug Administration (FDA) to clear its Covid-19 vaccine to be used in children aged 12 to 15.

The request, if approved, would amend the company's initial emergency use authorisation from the FDA, which allowed for the Covid-19 vaccine to be used in those aged 16 years and older.

The pharmaceutical giant revealed last week that Phase 3 clinical trials of its Covid-19 vaccine showed the jab was safe and 100 per cent effective in children aged 12 to 15, but the findings have yet to be peer-reviewed. 

Whether a Covid-19 vaccine would be safe in children has been one of the leading questions experts face as the United States aims to achieve herd immunity against the coronavirus. Vaccinating children was a necessary step to this goal, but initial vaccine trials focused on adults due to their higher risk of severe disease if they contracted Covid-19.

All three vaccines with emergency use authorisation from the FDA – Pfizer, Moderna, and Johnson & Johnson – were approved for American adults. But pharmaceutical companies were now researching the vaccine’s impact on children.

“The hope of starting to vaccinate this age group before the start of the next school year,” Pfizer CEO Albert Bourla said in a statement following the release of the company’s Phase 3 clinical trial results.

Already one-third of the United States population has received at least one dose of a Covid-19 vaccine, according to data released by the Centers for Disease Control and Prevention (CDC). The country was administering about three million vaccines per day, and Mr Biden indicated that any adult who wants a vaccine appointment would be able to access one by 19 April.

The potential of expanding Covid-19 vaccine eligibility to children comes as there have been reports of the virus spreading due to youth sports and high schools in Michigan and Minnesota. Michigan Governor Gretchen Whitmer has called for a two-week hiatus to high schools and youth sports due to the surge. 

Although children were less likely to become severely ill from the virus, they could still transmit it to unvaccinated adults.

Dr Rochelle Walensky, the CDC director, has indicated that the virus transmitting from younger adults and children could be why the country was seeing a current surge in infection rates and new hospitalisations. The US was averaging about 64,000 new infections per day, which was a 2 per cent increase from the previous seven-day average.

Pfizer was currently the only vaccine with emergency use authorisation for children aged 16 and 17. Both Moderna and Johnson & Johnson were undergoing clinical trials to study safety and efficacy in children.

The FDA would now review Pfizer's request to extend vaccine eligibility in the coming weeks.

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