YOUNGSTOWN, Ohio (WKBN) – COVID-19 vaccines are on the horizon for children, and the U.S. Food and Drug Administration is working to make sure parents and caregivers are confident in their safety.
“Many of our team at the FDA are parents and grandparents themselves, and our team shares the same concerns as many in our country about protecting our loved ones from COVID-19,” wrote Acting Commissioner Janet Woodcock, M.D. and Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Research and Evaluation. “We are therefore also eager to see COVID-19 vaccines available for young children. We also know that we all share the interest in making sure this process is done with safety at top of mind.”
FDA officials promise that they will be meticulous and conduct a thoughtful review once they receive requests to authorize COVID-19 vaccines for emergency use or approval for children.
They warn that because children are still growing, robust clinical trials of an “adequate size” need to be completed to evaluate safety and immune response. Researchers are looking into the need for different doses and strengths as compared to adult formulations.
Steps the FDA will take to ensure the safety and efficacy of these 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 about 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 complete the analysis of 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 review these submissions rapidly will depend in part on the quality and timeliness of the submissions by manufacturers.
Once a decision to authorize or approve a vaccine for a younger population has been made, the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices will meet to discuss further clinical recommendations.
“Just like you, we are eager to see our children and grandchildren vaccinated against COVID-19 as soon as possible. We have to let the science and data guide us. The FDA is working around the clock to support the process for making COVID-19 vaccines available for children,” Woodcock and Marks wrote.
Until vaccines are approved for children, it’s important for those who interact with children under 12 to get vaccinated, wear masks, and follow other recommended precautions.