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Jan. 3, 2021 – FDA Amends Comirnaty EUA to Expand Vaccine and Booster Eligibility

On January 3, 2021, the U.S. Food and Drug Administration (FDA) amended the Emergency Use Authorization for the Pfizer-BioNTech COVID-19 vaccine (marketed as Comirnaty) to expand access to the vaccine and vaccine boosters for children and young adults. The FDA’s amendment includes the following changes:

  • Expands eligibility for the COVID-19 vaccine booster to include individuals between the ages of 12 and 15;
  • Shortens the time that individuals must wait before receiving a vaccine booster from six months to five months after completion of the primary vaccination series; and
  • Allows immunocompromised children between the ages of 5 and 11 to receive a third dose of the vaccine at least 28 days following completion of the two-dose primary vaccination series.

These changes will allow greater COVID-19 vaccine and booster availability for children and young adults as the Omicron variant spurs a surge in cases and hospitalizations across the country, particularly among the pediatric population. While today’s action by the FDA only applies to Comirnaty, the agency continues to review safety and efficacy data for the other COVID-19 vaccines and will amend the EUAs for those vaccines as necessary.

If you have additional questions about your eligibility for a COVID-19 vaccine or a vaccine booster, review our COVID-19 Vaccine Eligibility Guide for the latest information.

FDA Authorizes First Vaccine Booster for Children 5-11

On May 17, 2022, the U.S. Food and Drug Administration (FDA) amended the Emergency Use Authorization (EUA) for the Pfizer-BioNTech COVID-19 vaccine (marketed as Comirnaty) to authorize the use of a single booster dose for children between the ages of five and eleven. The FDA authorized the administration of this booster at least five months after the completion of the primary vaccination series with the same vaccine.

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R.T. Asked: When Can I Get the COVID-19 Booster After Receiving Monoclonal Antibodies?

“When should immunocompromised patients get their second COVID-19 vaccine booster after receiving monoclonal antibodies? We are getting conflicting information from doctors, the news, medical literature, and hospitals on whether it is safe to receive a COVID-19 vaccine or vaccine booster after receiving monoclonal antibodies and whether doing this will reduce the efficacy of the vaccine. We are in a quandary, not knowing what to do.”

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