FDA authorizes mRNA vaccine booster dose for immunocompromised people

Aug. 13, 2021

The U.S. Food and Drug Administration (FDA) amended the emergency use authorizations (EUAs) for both the Pfizer-BioNTech and Moderna COVID-19 vaccines, allowing the use of a third dose for solid organ transplant recipients or those who are diagnosed with conditions that are considered to have an equivalent level of immunocompromise.

The Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices is scheduled to meet Friday to discuss further clinical recommendations regarding immunocompromised individuals.

“The FDA evaluated information on the use of a third dose of the Pfizer-BioNTech or Moderna vaccines in these individuals and determined that the administration of third vaccine doses may increase protection in this population. These patients should be counseled to maintain physical precautions to help prevent COVID-19. In addition, close contacts of immunocompromised persons should get vaccinated, as appropriate for their health status, to provide increased protection to their loved ones,” the agency said.

The FDA also recommended that immunocompromised individuals discuss monoclonal antibody treatment options with their healthcare provider should they contract or be exposed to COVID-19, noting that one authorized product includes its use for preventative (prophylaxis) treatment after being exposed to SARS-CoV-2.

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