FDA: ‘Additional Dose For Immunocompromised’

August 14, 2021

The U.S. Food and Drug Administration amended the emergency use authorizations for the Pfizer and Moderna Covid-19 vaccines to “allow for the use of an additional dose in certain immunocompromised individuals, specifically, solid organ transplant recipients or those who are diagnosed with conditions that are considered to have an equivalent level of immunocompromise.”

The FDA noted that the “action does not apply to people who are not immunocompromised.”

“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,” said Acting FDA Commissioner Dr Janet Woodcock.

“Today’s action allows doctors to boost immunity in certain immunocompromised individuals who need extra protection from Covid-19. 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..

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