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The Food and Drug Administration (FDA) has authorized the administration of a third dose of the Pfizer-BioNTech COVID-19 Vaccine and the Moderna COVID-19 Vaccine to certain immunocompromised individuals.
A third dose of the Pfizer-BioNTech COVID-19 vaccine (0.3mL) administered at least 28 days following the first 2 doses of this vaccine is authorized for administration to individuals at least 12 years of age who have undergone solid organ transplantation, or who are diagnosed with conditions that are considered to have an equivalent level of immunocompromise.
Similarly, a third dose of the Moderna COVID-19 Vaccine (0.5mL) administered at least 28 days following the first 2 doses of this vaccine is authorized for administration to individuals at least 18 years of age who have undergone solid organ transplantation, or who are diagnosed with conditions that are considered to have an equivalent level of immunocompromise.
Following a thorough review of the available data, the Agency determined that the administration of a third vaccine dose may increase protection in this patient population. The third dose appears to be moderately effective at increasing antibody titers, so patients should still maintain physical precautions to help prevent COVID-19.
The Centers for Disease Control and Prevention’s (CDC’s) Advisory Committee on Immunization Practices will meet today to discuss further clinical recommendations regarding the FDA’s amended authorizations for immunocompromised individuals.
“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,” said Acting FDA Commissioner Janet Woodcock, MD. “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.”
Additional information can be found in the updated Emergency Use Authorization fact sheets for the Pfizer-BioNTech and Moderna COVID-19 vaccines.
Reference
Coronavirus (COVID-19) update: FDA authorizes additional vaccine dose for certain immunocompromised individuals. News release. US Food and Drug Administration. Accessed August 13, 2021. https://www.prnewswire.com/news-releases/coronavirus-covid-19-update-fda-authorizes-additional-vaccine-dose-for-certain-immunocompromised-individuals-301354860.html.
