On Thursday, a Food and Drug Administration official said that the emergency approval for COVID-19 vaccines in children under 12 could come in early to midwinter.
An awaited approval for parents across the US, who wish to get their children safely vaccinated now that schools are re-opening everywhere, the final green flag for the COVID-19 vaccines to be administered on children below the age of 12 is expected to come in the approaching months.
A full approval by the FDA is pending, partially since the agency is awaiting the results of the trials conducted by both Pfizer and Moderna, who are currently vaccinating volunteers under the age of 12. The trial results are expected in the fall, and it will take FDA officials time to review the drug companies’ applications.
In light of the fast-spreading variants and an increase in cases globally, Israel began administering vaccines to children above 12, hoping to innoculate them as they join schools once again, but for children below the age of 12, approvals may come in later. The FDA is asking for four to six months of safety follow-up data for kids under age 12. Just two months of follow-up data was required for the clinical trials in adults.
Meanwhile, the CDC states on its website “everyone 12 years and older should get a COVID-19 vaccination to help protect against COVID-19.”