COVID-19 Vaccine For Children Under 12 Could Be Available In Winter
By Jason Hall
July 16, 2021
NBC News reports the FDA is hoping to then quickly gain full approval of the vaccine for the age group in order to bring relief to parents unable to vaccinate their children.
Some families remain hesitant given the vaccines are currently under emergency use authorization, but haven't been given full FDA approval.
Full approval of the vaccines by the FDA may limit those concerns.
COVID-19 vaccines are currently authorized for individuals ages 12 and older in the United States, but none have received full approval as of Friday (July 16).
Both Moderna and Pfizer-BioNTech began distributing COVID-19 vaccines for children under the age of 12 in March and FDA officials plan to review both drug companies' applications after receiving follow-up results.
The regulatory agency is aiming for a 4 to 6-month window for follow-up data for vaccinated children under the age of 12, an FDA official confirmed.
Clinical trials in adults required just two months of follow-up data. However, the additional data may speed up the process of gaining full approval, as six months of follow-up data is needed for a biologics license application (BLA).
Both Pfizer and Moderna have previously applied for full licensure of their respective vaccines for adults and an FDA official confirmed granting full approval is the agency's top priority.