Aug. 12, 2021 – FDA Authorizes Third Dose of mRNA Vaccine for Certain Patients:

On August 12, 2021, the U.S. Food and Drug Administration (FDA) amended the Emergency Use Authorizations (EUA) for the Pfizer-BioNTech and Moderna COVID-19 vaccines to allow certain patients to receive an additional dose of those vaccines. The EUAs for these vaccines now allow solid organ transplant recipients and individuals who are equivalently immunocompromised to receive a third dose of either the Pfizer-BioNTech or Moderna mRNA vaccines. The agency stated that this patient population is at heightened risk for developing severe COVID-19 symptoms due to their compromised immune systems and that a third vaccine dose will help them maintain a strong antibody response against COVID-19. In addition to allowing patients with compromised immune systems to access a third dose of an mRNA vaccine as a preventive measure, the FDA also advised these patients to discuss monoclonal antibody treatment options with their health care provider if they have been exposed to the coronavirus.

If a patient with a compromised immune system receives a third dose of an mRNA vaccine, it should be the same vaccine that they received in their primary vaccination series and it should be administered at least 28 days after the prior dose. The FDA clarified that the agency is currently engaging in a rigorous process to evaluate whether fully vaccinated adults who are not immunocompromised will benefit from an additional dose of an mRNA vaccine.

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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