FDA reviews COVID-19 vaccines for young children

Sept. 13, 2021

FDA officials, in answer to questions regarding vaccinations for children, say it’s important that the public recognize that because young children are still growing and developing, it’s critical that thorough and robust clinical trials of adequate size are completed to evaluate the safety and the immune response to a COVID-19 vaccine in this population. 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.

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.  

Conducting clinical trials to determine an appropriate vaccine dose in children requires additional work over that done in the adult studies, including ensuring that the vaccine dosage and formulation strength used is the appropriate one from the perspective of safety and generating an immune response. Our multi-disciplinary teams of doctors, scientists, statisticians and other experts will thoroughly assess this complex data in making any determination about COVID-19 vaccines in young children.

Parents may be wondering if they can ask their healthcare providers to go ahead and vaccinate their kids using one of the currently available vaccines outside of the FDA-authorized or approved uses. Parents need to remember that the vaccine doses that are 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—there are different dosing regimens being investigated. It is important for the clinical trials to be completed before vaccinating young kids, so the FDA’s team can conduct a thorough evaluation and ensure the data show that the vaccine under consideration is likely to work to prevent COVID-19 in young children and doesn’t cause unexpected safety issues separate from those that have already been observed in adolescents and adults.

Until we authorize or approve a vaccine for this younger population, 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.

FDA release

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