FDA Authorizes Additional COVID-19 Vaccine Dose – But Not For Everyone

By the US Food and Drug Administration (FDA) August 13, 2021

The FDA authorization is only for certain immunocompromised individuals. Other fully vaccinated individuals do not need an additional vaccine dose at this time.

Today, the U.S. Food and Drug Administration amended the emergency authorizations (EUAs) for both the Pfizer-BioNTech COVID-19 vaccine and the Moderna COVID-19 vaccine to allow the use of an additional dose in certain immunocompromised individuals, especially solid organ transplant recipients or those who have been diagnosed as having an equivalent level of immunocompromised. The Centers for Disease Control and Prevention’s advisory committee on immunization practices will meet Friday to discuss further clinical recommendations related to immunocompromised individuals. Today’s action does not apply to people who are not immunocompromised.

“The country has entered another wave of the COVID-19 pandemic and the FDA is especially aware that immunocompromised people are at particular risk for serious illness. After a thorough review of the available data, the FDA has determined that this small, vulnerable group could 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 additional protection against COVID-19. As we mentioned before, other individuals who have been 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.”

People who are immunocompromised in a manner similar to those who have had an organ transplant have a reduced ability to fight off infections and other diseases, and they are particularly vulnerable to infections, including COVID-19. The FDA reviewed information on the use of a third dose of the Pfizer-BioNTech or Moderna vaccines in these individuals and determined that the administration of third doses of vaccine may increase protection in this population. These patients should be advised to take physical precautions to help prevent COVID-19. In addition, close contacts of immunocompromised individuals should be vaccinated, depending on their health status, to better protect their loved ones.

It is recommended that immunocompromised individuals discuss monoclonal antibody treatment options with their healthcare provider if they become infected or exposed to COVID-19. The FDA has approved monoclonal antibody treatments for emergency use during this public health emergency for adults and pediatric patients (aged 12 years and older and weighing at least 40 kilograms or approximately 88 pounds) with positive immediate results. SARS-CoV-2 viral tests, and these are at high risk of progressing to severe COVID-19 and/or hospitalization. One approved product includes use for preventive (prophylaxis) treatment after exposure to SARS-CoV-2; however, this product is not a substitute for vaccination.

The Pfizer-BioNTech COVID-19 vaccine is currently approved for emergency use in individuals 12 years of age and older, and the Moderna COVID-19 vaccine is approved for emergency use in individuals 18 years of age and older. Both vaccines are administered as a series of two injections: the Pfizer-BioNTech COVID-19 vaccine is administered three weeks apart and the Moderna COVID-19 vaccine is administered one month apart. The authorizations for these vaccines have been changed to allow an additional or third dose to be administered at least 28 days after the two-dose schedule of the same vaccine to individuals 18 years of age or older (aged 12 years or older for Pfizer). -BioNTech) who have undergone a solid organ transplant, or who have been diagnosed with conditions believed to have an equivalent level of immunocompromised.

The EUA amendments to the Pfizer-BioNTech COVID-19 vaccine and the Moderna COVID-19 vaccine have been issued to Pfizer Inc., respectively. and Moderna TX Inc.