Follow the Science Regarding COVID-19 Vaccines for Children
The U.S. FDA announced on September 10, 2021, 'Parents need to remember that the COVID-19 vaccines currently being studied in younger children are not necessarily the same vaccine doses that were authorized for individuals 12 years and older or approved for individuals 16 years of age and older—different dosing regimens are being investigated.'
'It is important for the clinical trials to be completed before vaccinating young kids,' stated Janet Woodcock, M.D., Acting Commissioner, and Peter Marks, M.D., Ph.D., Director, with the FDA.
The FDA confirmed it would take the following steps to ensure the safety and efficacy of COVID-19 related products for children:
- First, vaccine manufacturers have reported that the necessary clinical trials involving children as participants are currently underway. Some have stated that they are still enrolling, and some are still administering doses or following participants. This process is expected to include a follow-up period of at least two months to allow for proper safety monitoring following the administration of vaccine doses for at least half of the clinical trial vaccine recipients.
- Once the manufacturers complete the relevant portion of their clinical trials, they have to analyze the data from the studies to understand how safe the vaccine is and how well it works in the clinical trial participants. The FDA will work closely with each manufacturer to ensure this data analysis is robust and meets regulatory standards. After manufacturers analyze their clinical trial data, they will compile the information and may request an emergency use authorization (EUA) or submit for approval a biologics license application (BLA), as appropriate, for this young population to the FDA.
- When a completed request for EUA or approval has been received by the FDA, the agency will carefully, thoroughly, and independently examine the data to evaluate benefits and risks and be prepared to complete its review as quickly as possible, likely in a matter of weeks rather than months. However, the agency’s ability to rapidly review these submissions will depend partly on the quality and timeliness of the submissions by manufacturers.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines, and other biological products for human use and medical devices.