Immunocompromised individuals discuss monoclonal antibody treatment options with their health care provider, says FDA
The U.S. Food and Drug Administration (FDA) is now allowing the use of an additional dose of both the Pfizer-BioNTech COVID-19 Vaccine and the Moderna COVID-19 Vaccine for certain immunocompromised individuals.
The new rule is made specifically for solid organ transplant recipients or those who are diagnosed with conditions that are considered to have an equivalent level of immunocompromise.
“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,” said Janet Woodcock, M.D, acting FDA commissioner. “Today’s action allows doctors to boost immunity in certain immunocompromised individuals who need extra protection from COVID-19.
Last month, the U.S. Food and Drug Administration approved the Pfizer-BioNTech COVID-19 Vaccine and became the first such vaccine to receive such approval.
The affected group of people have a reduced ability to fight infections and other diseases, and they are especially vulnerable to infections, including COVID-19, according to the FDA, adding that a third vaccine dose may provide them with an additional layer of protection.
These patients should also be counseled to maintain physical precautions to help prevent COVID-19, it said, and close contacts of immunocompromised persons should get vaccinated, as appropriate for their health status, to provide increased protection.
“We are excited about the FDA’s announcement regarding the use of boosters for people who are immunocompromised. We will be following today’s [Advisory Committee on Immunization Practices] ACIP meeting closely in order to provide additional guidance on who will benefit most from an additional dose,” said Dr. Leisha Nolen, Utah Department of Health (UDOH) state epidemiologist. “We are working to calculate the size of this population, but we currently have a large supply of vaccine in the state, and providers have the ability to order additional doses if needed.”
The FDA previously stated that other individuals who are fully vaccinated are adequately protected and do not need an additional dose of COVID-19 vaccine.
The Centers for Disease Control and Prevention’s (CDC’s) ACIP is scheduled to meet Friday to discuss further clinical recommendations regarding immunocompromised individuals.