FDA Update: Additional COVID-19 Vaccine Dose Authorized For Certain Immunocompromised Individuals

The U.S. Food and Drug Administration (FDA) amended the emergency use authorizations (EUAs) on Aug. 12 for the Pfizer-BioNTech and Moderna COVID-19 Vaccines to allow for "an additional, or third, dose to be administered at least 28 days following the two-dose regimen of the same vaccine" to individuals 18 years of age or older for the Moderna COVID-19 Vaccine, and individuals 12 years of age or older for the Pfizer-BioNTech COVID-19 Vaccine, "who have undergone solid organ transplantation, or who are diagnosed with conditions that are considered to have an equivalent level of immunocompromise."

"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 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. 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."

The FDA is also recommending that immunocompromised individuals discuss monoclonal antibody treatment options with their health care provider(s) should they contract or be exposed to COVID-19. The FDA has authorized monoclonal antibody treatments for emergency use in "adults and pediatric patients (ages 12 and older weighing at least 40 kilograms or about 88 pounds) with positive results of direct SARS-CoV-2 viral testing, and who are at high risk for progressing to severe COVID-19 and/or hospitalization."

Read the full FDA news release. Access additional guidance and patients and clinician vaccination resources on ACC's COVID-19 Hub.

Clinical Topics: Cardiovascular Care Team, Prevention, Novel Agents

Keywords: ACC Advocacy, COVID-19, SARS-CoV-2, Vaccines, Vaccination, Antibodies, Monoclonal, United States Food and Drug Administration, Immunocompromised Host, Emergency Service, Hospital, Hospitalization


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