FDA Amended the Emergency Use Authorizations (EUAs) for COVID-19 Vaccines

August 18, 2021: Joint Statement from HHS Public Health and Medical Experts on COVID-19 Booster Shots

FDA Authorizes Additional Vaccine Dose for Certain Immunocompromised Individuals:
On Aug. 12, 2021, the Food and Drug Administration (FDA) revised both Pfizer and Moderna COVID-19 Vaccine Emergency Use Authorization fact sheets to include guidance on administering an additional dose in certain immunocompromised individuals.

The Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices (ACIP) recommended that people whose immune system are moderately to severely compromised receive an additional dose of mRNA COVID-19 vaccine at least 28 days after an initial two-dose mRNA series (Pfizer or Moderna).

ACIP’s recommendation includes people with a range of conditions, such as recipients of organ or stem cell transplants, people with advance or untreated HIV infection, active recipients of treatment for cancer, people who are taking some medications that weaken the immune system, and others. A full list of conditions can be found on CDC’s website: https://www.cdc.gov/coronavirus/2019-ncov/vaccines/recommendations/immuno.html.

The additional dose should be the same vaccine product as the initial two-dose mRNA COVID-19 vaccine series (Pfizer-BioNTech or Moderna). If the mRNA COVID-19 vaccine product given for the first two doses is not available, the other mRNA COVID-19 vaccine product may be administered. A person should not receive more than three mRNA COVID-19 vaccine doses.

It’s important to note that an additional dose is only recommended for individuals who are moderately or severely immunocompromised —CDC does not recommend additional doses or booster shots for any other population at this time.

Currently, there are insufficient data to support the use of an additional mRNA COVID-19 vaccine dose after a single-dose Janssen COVID-19 vaccination series in immunocompromised people. FDA and CDC are actively working to provide guidance on this issue.

Immunocompromised individuals may discuss with their health care provider whether getting an additional dose is appropriate for them. If their health care provider is not at a site administering vaccines, these individuals can self-attest and receive the additional dose wherever vaccines are offered.

For more information, please visit : https://www.cdc.gov/vaccines/covid-19/clinical-considerations/covid-19-vaccines-us.html.