FDA could authorize vaccines for children in midwinter

Emergency authorization for COVID-19 vaccines in children under 12 could come in early to midwinter, says FDA official.

Arutz Sheva Staff ,

Pfizer injection
Pfizer injection
Flash 90

Emergency authorization for COVID-19 vaccines in children under 12 could come in early to midwinter, a Food and Drug Administration official said Thursday, according to NBC News.

One sticking point for some families who remain hesitant, the official said, is that the vaccines currently in use are administered under emergency use authorization and have not been given full approval by the FDA. Full approval, if it comes quickly after the emergency round, could alleviate that concern.

COVID-19 vaccines have only been authorized for people ages 12 and up in the US to this point, after the FDA in May approved the vaccines for 12-15-year-olds.

Both Moderna and Pfizer-BioNTech launched trials of their COVID-19 vaccines for kids under 12 in March. Results are expected in the fall, and it will take FDA officials time to review the drug companies' applications, according to NBC News.

The regulatory agency is asking for four to six months of safety follow-up data for kids under age 12, the FDA official said. Just two months of follow-up data was required for the clinical trials in adults.

Pfizer said in a statement to NBC News it anticipates results on its clinical trials in kids ages 5 to 11 sometime in September, and then could apply for emergency use authorization. "Data for kids 2 and under 5 could arrive soon after that," the company said, adding that results on kids ages 6 months up to 2 years may not be released until October or November.



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