Emergency use authorization for COVID-19 vaccines

Emergency use authorization for COVID-19 vaccines

By
Deb Balzer

October 26, 2021

a diverse group of school aged children, tweens, wearing face masks and carrying backpacks, walking together with several feet between them

The Food and Drug Administration's (FDA) Advisory Committee is meeting to discuss a request from Pfizer to amend its emergency use authorization to allow the use of its COVID-19 vaccine in children 5–11.

"An emergency use authorization is a mechanism that exists within the Food and Drug Administration to provide accelerated availability and use of any medical device, or medication or vaccine, during emergency situations, such as during a pandemic," says Dr. Nipunie Rajapakse, a pediatric infectious diseases physician with Mayo Clinic Children's Center. "This allows these (devices, medications or vaccines) to be used more quickly than the usual process with full approval."

Watch: Dr. Nipunie Rajapakse explains emergency use authorization.

Journalists: Sound bites with Dr. Nipunie Rajapakse are in the downloads at the end of the post. Please courtesy: "Nipunie Rajapakse, M.D. / Pediatric Infectious Diseases/ Mayo Clinic."

Data submitted for review must show the vaccine is safe and effective. For an emergency authorization to be issued for a vaccine, the FDA must determine that the known and potential benefits outweigh the known and potential risks of the vaccine. Dr. Rajapakse says safety is the highest priority.

"The FDA review for emergency use authorization requires the company to submit safety and efficacy data, especially for vaccines that are reviewed in detail to make sure that anything that receives emergency use authorization is safe and effective for use in the population," Dr. Rajapakse says.

Vaccines with emergency use authorization by the FDA include:

Pfizer COVID-19 vaccine for children ages 12–15.
Moderna COVID-19 vaccine.
Johnson & Johnson COVID-19 vaccine.

The Pfizer COVID-19 vaccine for adults was the first to gain FDA approval. The Pfizer vaccine was previously available under an FDA emergency use authorization. This emergency use authorization followed rigorous testing that included thousands of clinical trial participants.

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Information in this post was accurate at the time of its posting. Due to the fluid nature of the COVID-19 pandemic, scientific understanding, along with guidelines and recommendations, may have changed since the original publication date.

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