Janet Woodcock, M.D. Acting Commissioner of Food and Drugs – Food and Drug Administration (FDA), and Peter Marks, M.D., PhD. Director – Center for Biologics Evaluation and Research (CBER) shared information about the process and the necessary considerations involved to provide greater clarity to the public about vaccines for children under 12 years of age. Because young children are still growing and developing, it’s important that thorough and robust clinical trials of adequate size are completed to evaluate the safety and the immune response to a COVID-19 vaccine among younger children. Children are not small adults and issues that may be addressed in pediatric vaccine trials can include whether there is a need for different doses or different strength formulations of vaccines already used for adults. Read more.
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 must 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 children under 12 years of age 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.
Until the FDA authorizes or approves a vaccine for children under 12 years of age Tribal communities, it’s especially important that parents and others who interact closely with children under 12 years of age get vaccinated, wear masks, and follow other recommended precautions so that we can protect those who cannot yet protect themselves through vaccination. Remember, getting your COVID-19 vaccine is an Act of Love to your Tribe! For more information on COVID-19 vaccines visit the NIHB COVID-19 Tribal Resource Center.