FDA Review Says Pfizer Vaccine Safe for Children Aged 5-11

If the FDA approves, then Pfizer would become the first vaccine authorised for that age group.

Image used for representational purposes only. 

(File Photo)

American scientists at the Food and Drug Administration (FDA) said on Friday, 22 October, that the benefits of inoculating children aged between 5 and 11 with the Pfizer/BioNTech COVID-19 vaccine clearly outweighed the risks, The Washington Post reported.

Pfizer also stated on Friday that the vaccine had a 90.7% efficacy against COVID-19 in a clinical trial for children belonging to the above-mentioned age group.

A panel of experts will meet and discuss on Tuesday, 26 October, on whether or not the FDA should be recommended to provide authorisation for vaccinating children with Pfizer.

If the FDA does end up approving this, then Pfizer would be the first vaccine authorised for this age group.

Vaccinations could start as early as November, Reuters added. Anthony Fauci, Chief Medical Advisor to United States President Joe Biden, said the same in an interview to ABC News on Sunday.

"If all goes well, and we get the regulatory approval and the recommendation from the CDC, it's entirely possible if not very likely that vaccines will be available for children from 5 to 11 within the first week or two of November."

Both the Pfizer/BioNTech and Moderna vaccines have, as a side effect, shown signs of contributing to a rare case of heart inflammation called myocarditis, most likely in young men.

Pfizer, however, stated that based on its own clinical trials, the rate of myocarditis in children aged between 5 and 11 was less likely compared to the rate in 12-15 year olds who receive the vaccine, partly due to the reduced dose injected in the younger group.

The 5-11 year olds are to be given a third of the vaccine dose that is given to those who are 12 years and older.

(With inputs from The Washington Post, ABC News and Reuters.)