The Food and Drug Administration (FDA) has authorized a third dose of Pfizer-BioNTech’s and Moderna’s COVID-19 vaccines for administration in certain individuals with weakened immune systems.
“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,” Acting FDA Commissioner Dr. Janet Woodcock said in a news release.
The FDA announced that individuals with weakened immune systems, similar to those who have received solid organ transplants, have a reduced ability to fight infections and are more likely to become infected with viruses including COVID-19.
The agency based its decision on information that showed that a booster dose of the vaccines may increase protection against COVID-19 among those with weakened immune systems, including patients with cancer.
“Today’s action allows doctors to boost immunity in certain immunocompromised individuals who need extra protection from COVID-19,” Woodcock said. “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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