Oct. 29, 2021 – FDA Authorizes Comirnaty for Children 5 to 11:

On October 29, 2021, 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 allow children between the ages of five and eleven to receive a pediatric dose of the vaccine. The agency’s decision is based on the unanimous recommendation of the Vaccines and Related Biological Products Advisory Committee, which voted 17-0 to recommend authorizing use of the vaccine in this population at their meeting on October 26, 2021. The two-dose vaccination series showed 90.7 percent efficacy in preventing COVID-19 in children between the ages of five and eleven, which is similar to the vaccine’s performance in adults between the ages of 16 and 25. The vaccine formulation that was studied for children is a smaller dose (10 micrograms for children vs. 30 micrograms for adults) that was administered three weeks apart. Importantly, no serious side effects occurred in the vaccine’s safety study, which included approximately 3,100 children between the ages of five and eleven.

Following the FDA’s authorization, the U.S. Centers for Disease Control (CDC) is expected to meet in the next week to approve the use of the Pfizer-BioNTech vaccine in children If approved, children could receive the vaccine as soon as Wednesday, November 3, 2021.

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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