FDA Authorizes Additional Dose of the COVID-19 Vaccine for Immunocompromised Populations

The FDA has amended the emergency use authorizations that were issued to both the Pfizer and Moderna COVID-19 vaccines, allowing for an additional dose in a specific population of immunocompromised patients, including those who have received solid organ transplants or have been diagnosed with conditions that are thought to have an equivalent level of immunocompromise, according to a press release.¹

The Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices is set to meet on August 13, 2021, in order to hold discourse concerning further clinical recommendations for individuals who are immunocompromised. However, it was noted that the indicated does not currently apply to individuals who are not immunocompromised. The third dose can be administered at least 28 days after the 2-dose regimen in patients who are aged 18 or older and immunocompromised. Notably, the EUA also enacted the amendments for both vaccines.

“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. 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,” Janet Woodcock, MD, acting commissioner at the FDA, said in a press release. “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.”

It was noted that patients who are currently immunocompromised similarly to those who have received a solid organ transplant have a reduced ability to stave off infection and disease and are susceptible to infections such as the COVID-19 virus. Data regarding the use of a third vaccine dose was evaluated in this population and the FDA determined that the additional dose may increase protection against the virus within this population. In addition for a need to counsel this population to continue taking physical precautions to prevent contracting the virus, it is recommended that those who interact with immunocompromised individuals should be vaccinated in order to provide further protection and decrease risk of spread.

Additionally, the FDA has previously authorized the use of treatment with monoclonal antibodies for adult and pediatric patients who have tested positive for COVID-19 and/or been hospitalized. Although the class of drug can act as a prophylactic treatment, the FDA cautions that this is not a replacement for being vaccinated.

The emergency use authorization was originally issued to both vaccines by the FDA in December 2020 in order to help prevent disease caused by the COVID-19 virus.² Pfizer is authorized to be used in individuals who are ages 12 and up and Moderna can be used in adults aged 18 and older.

References

1. Coronavirus (COVID-19) update: FDA authorizes additional vaccine dose for certain immunocompromised individuals. News release. FDA. August 12, 2021. Accessed August 13, 2021. https://bit.ly/3g0dyJO
2. FDA takes additional action in fight against COVID-19 by issuing emergency use authorization for second COVID-19 vaccine. News release. FDA. December 18, 2020. Accessed August 13, 2021. https://bit.ly/2UcQWOm