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FDA says robust safety data needed before COVID-19 vaccine approval for kids

Christian Fernsby ▼ |
As schools around the country are re-opening for in-person learning and families are returning to their busy school year schedules, we know many parents are anxious about the pandemic and protecting their children, Acting FDA Commissioner Janet Woodcock and Peter Marks director of the FDA’s Center for Biologics Research and Evaluation said.

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"Many parents have questions about COVID-19 and when vaccines will be available for children younger than 12 years of age.

"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.

"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. As regulators, we recognize we have an important task ahead of us that will require us to act expeditiously while undertaking an extremely meticulous and thoughtful review once we receive requests to authorize a COVID-19 vaccine for emergency use or submissions for approval of a COVID-19 vaccine for this population.

"We know there have been questions and public commentary on the process surrounding vaccines for young children, so we think it’s important to share information about the process and the necessary considerations involved to provide greater clarity to the public about this effort.

"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.

"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.

"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." ■

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