The panel joined FDA in endorsing a third dose of Pfizer-BioNTech and Moderna vaccines for moderately to severely immunocompromised patients.
The Advisory Committee on Immunization Practices (ACIP) concluded there was insufficient evidence to recommend an additional dose for immunocompromised recipients of Janssen’s COVID-19 vaccine.
The ACIP panel described the third dose of vaccine as part of a primary series of shots rather than a booster. Moderately to severely immunocompromised patients ages 12 and older would be eligible for a third dose of the Pfizer-BioNTech vaccine. The eligibility criteria for Moderna vaccine recipients is similar but applies to those 18 and older.
The immunocompromised persons described in the recommendation have an increased risk of hospitalization, breakthrough disease and death from COVID-19.
The ACIP shared the FDA’s recommendation of a third dose for patients who had undergone solid organ transplantation or who were diagnosed with conditions leading to a similar impairment of immune function.
ACIP member Dr. Helen Keipp Talbot explained that stance by noting that the recommendation applies to “a very specific population in the U.S. who was not able to mount an appropriate immune response to the normal two doses.” She added: “This is a very specific population, and [the recommendation] is not meant for the entire U.S. population.”
Other patients who would be eligible include those with have received CAR-T cell or hematopoietic stem cell transplants and those with moderate to severe primary immunodeficiency or advanced or untreated HIV. Patients receiving high doses of corticosteroids or other immunosuppressing drugs would also be eligible.
Talbot stressed the importance of sharing vaccine doses worldwide and proactively addressing areas with low vaccination rates.
The Global Liver Institute (GLI) applauded the decisions from the FDA and CDC’s Advisory Committee on Immunization Practices. “This is great news for the seven million immunocompromised Americans, many of whom had no to little protective immune response to the standard one- and two-dose vaccine regimens and so faced risks similar to those who had chosen to take no vaccination at all, or worse, since COVID-19 infection raises our risks of severe effects from infection, including hospitalization and death,” said GLI CEO and President Donna R. Cryer, in a statement.
In the U.S., the Delta variant has sparked a dramatic increase in COVID-19 infections. The volume of cases has increased 700% since July 1.
Filed Under: Infectious Disease