FDA allows additional COVID-19 vaccine dose for immunocompromised

The US Food and Drug Administration (FDA) have amended the emergency use authorisations (EUAs) for both the COVID-19 Vaccine Moderna and Pfizer-BioNTech’s Comirnaty^® to allow the use of an additional dose in certain immunocompromised patients, specifically solid organ transplant recipients or those who are diagnosed with conditions that are considered to have an equivalent level of immunocompromise. This action does not apply to people who are not immunocompromised.

“The country has entered yet another wave of the COVID-19 pandemic, and the FDA is especially cognisant that immunocompromised people are particularly at risk for severe disease,” said Acting FDA Commissioner Janet Woodcock. “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.”

“Today’s action allows doctors to boost immunity in certain immunocompromised individuals who need extra protection from COVID-19. As we have 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,” Woodcock added.

The Comirnaty is currently authorised for emergency use in individuals ages 12 and older, and the COVID-19 Vaccine Moderna is authorised for emergency use in individuals ages 18 and older. Both vaccines are administered as a series of two shots. The Pfizer-BioNTech’s vaccine is administered three weeks apart and the  COVID-19 Vaccine Moderna is administered one month apart.

The authorisations for these vaccines have been amended 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 (ages 12 or older for Pfizer-BioNTech) who have undergone solid organ transplantation, or who are diagnosed with conditions that are considered to have an equivalent level of immunocompromise.

The FDA evaluated information on the use of a third dose of the Pfizer-BioNTech or Moderna vaccines in individuals who are immunocompromised in a manner similar to those who have undergone solid organ transplantation and determined that the administration of third vaccine doses may increase protection in this population. According to the FDA, these patients should be counselled to maintain physical precautions to prevent COVID-19. Furthermore, close contacts of immunocompromised persons should get vaccinated, as appropriate for their health status, to provide increased protection to loved ones.

The EUA amendments for the Pfizer-BioNTech COVID-19 vaccine and the COVID-19 Vaccine Moderna were issued to Pfizer Inc. and ModernaTX Inc., respectively.