Emergency use authorization for the COVID-19 vaccine in children younger than 12 years old could come in the early to midwinter, an FDA official told NBC.
Pfizer and Moderna have said their clinical trials on younger children will provide results potentially as early as October, according to CNN, and then they will apply to the FDA for emergency use authorization.
Consideration by the FDA could take several weeks once the application is received, which means authorization could come around the end of the calendar year or early 2022.
The timeline may be worrisome for some parents as the delta variant of the coronavirus is spreading around the country, causing spikes in infections and hospitalizations, just as schools plan to reopen for the fall.
The vast majority of cases are in people who are not vaccinated.
Currently, the Pfizer vaccine is available to anyone aged 12 and up with an emergency use authorization from the FDA. The Moderna and the Johnson and Johnson vaccine are both authorized for emergency use in anyone 18 and up.
Pfizer and Moderna launched their vaccine trials in younger children in March. Johnson and Johnson is also working on a clinical trial of their vaccine in younger children.
The Food and Drug Administration is asking for four to six months of safety follow-up information for the clinical trials involving kids 12 and younger, NBC reported. Just two months of follow-up data was requested for the clinical trials in adults.
The extra follow-up data could be used to help the process of applying for full FDA approval of the COVID-19 vaccine.
Pfizer and Moderna both have formally applied for full authorization of their COVID-19 vaccine in Americans 18 and older.