FDA Authorizes Additional COVID-19 Vaccine Dose for Immunocompromised Individuals

Today, the U.S. Food and Drug Administration (FDA) amended its emergency use authorizations (EUAs) for the Pfizer-BioNTech COVID-19 Vaccine and the Moderna COVID-19 Vaccine to allow for the administration of an additional vaccine dose in certain immunocompromised individuals, including solid organ transplant recipients or those diagnosed with conditions that are considered to have an equivalent level of immunocompromise.

The FDA evaluated available data on the use of a third dose of the Pfizer-BioNTech or Moderna vaccines in immunocompromised individuals, finding that the administration of an additional dose may increase protection in this vulnerable population. Patients should be counseled to maintain physical precautions to help prevent COVID-19, according to the FDA.

The U.S. Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) convened a meeting today to review clinical recommendations relative to the additional COVID-19 vaccine dose among immunocompromised individuals. The CDC ACIP, following FDA’s amended EUA, unanimously recommended that an additional dose of COVID-19 vaccine be administered to people with moderately to severely compromised immune systems after an initial two-dose vaccination series. CDC Director Dr. Rochelle Walensky signed off on the ACIP recommendation this afternoon.

Additional information from the FDA on additional doses for immunocompromised persons is available here.