FDA authorizes 3rd COVID vaccine dose for immunocompromised [Updated]

Enlarge / A pharmacist holding a vial of the undiluted Pfizer-BioNTech vaccine for COVID-19. (credit: Getty | JEAN-FRANCOIS MONIER)

Update 8/13/2021 9:30 am ET: Just before midnight on Thursday, the Food and Drug Administration updated the emergency use authorizations for both the Pfizer/BioNTech and Moderna COVID-19 vaccines, allowing immunocompromised people to receive a third dose of vaccine at least 28 days following the two-dose regimen to further boost protection. The FDA said the change applied specifically to "solid organ transplant recipients or those who are diagnosed with conditions that are considered to have an equivalent level of immunocompromise."

In a statement, Acting FDA Commissioner Janet Woodcock said, The country has entered yet another wave of the COVID-19 pandemic, and the FDA is especially cognizant that immunocompromised people are particularly at risk for severe disease. After a thorough review of the available data, the FDA determined that this small, vulnerable group may benefit from a third dose of the Pfizer-BioNTech or Moderna Vaccines."

Woodcock further emphasized that, for now, only certain immunocompromised people need an additional dose. "As we've previously stated, other individuals who are fully vaccinated are adequately protected and do not need an additional dose of COVID-19 vaccine at this time. The FDA is actively engaged in a science-based, rigorous process with our federal partners to consider whether an additional dose may be needed in the future." Health officials expect that booster shots may be needed for the general population at some point in the future, but it's unclear when.

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