This article has been updated from the original.
The FDA has authorized a booster shot of both the Pfizer-BioNTech and Moderna COVID-19 vaccines for some immunocompromised adults, such as solid-organ transplant recipients and some patients with cancer.
The emergency use authorizations for these vaccines have been amended to allow for an additional, or third, dose to be administered at least 28 days following the 2-dose regimen of the same mRNA 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, according to an FDA press release.
Various studies, such as a recent study of kidney transplant recipients published in the Journal of the American Society of Nephrology, indicate that immunocompromised individuals and those taking immunosuppressive therapies mount a lower immune response to the current COVID-19 vaccination schedule compared with other individuals.
In late July, the Centers for Disease Control and Prevention (CDC) convened a meeting of the Advisory Committee on Immunization Practices (ACIP) during which Sara Oliver, MD, MSPH, an epidemiologist, reported that 44% of hospitalized breakthrough cases in a US study were immunocompromised patients. Additionally, in small case studies of solid-organ recipients and patients on hemodialysis who had no detectable antibody response to an initial mRNA vaccine series, 33%-50% developed an antibody response to an additional vaccine dose, she reported. In those series, no serious adverse events or acute rejection episodes occurred after the third dose.
The CDC’s ACIP is scheduled to meet on Friday, August 13, to discuss booster doses of Covid-19 vaccines and additional doses for some immunocompromised people, according to a meeting agenda posted online.
In an interview with CNN, Anthony Fauci, MD, Director of the National Institute of Allergy and Infectious Diseases (NIAID) and the Chief Medical Advisor to the President, said:
“When you look at immunocompromised people…they generally don’t get a good immune response [to conventional vaccination]. We think they should get an additional booster sooner rather than later.”
Dr Fauci also noted that it is likely that everyone will need a booster shot at some point in the future because the durability of immune responses to the COVID-19 vaccine appear to diminish over time. Immunocompromised adults have an “imminent” need, he said.
Immunocompromised people comprise approximately 2.7% of US adults, according to the CDC. This statistic includes solid-organ or hematopoietic stem cell transplant recipients and patients with solid tumor and hematologic malignancies, severe primary immunodeficiencies, HIV, and those treated with immunosuppressive medications such as cancer chemotherapy, TNF blockers, certain biologic agents (eg, rituximab), and high-dose corticosteroids.
Coronavirus (COVID-19) Update: FDA Authorizes Additional Vaccine Dose for Certain Immunocompromised Individuals [news release]. FDA; August 12, 2021.
Meeting of the Advisory Committee on Immunization Practices. CDC; August 12, 2021. Accessed on August 13, 2021. https://www.cdc.gov/vaccines/acip/meetings/downloads/agenda-archive/agenda-2021-08-13-508.pdf
FDA poised to OK 3rd vaccine dose for immunocompromised people. NBC News; August 11, 2021. Accessed on August 12, 2021. https://www.nbcnews.com/health/health-news/fda-poised-ok-third-vaccine-dose-immune-compromised-people-n1276602
Oliver S. ACIP Meeting: Data and clinical considerations for additional doses in immunocompromised people. CDC; July 22, 2021. Accessed on August 12, 2021. https://www.cdc.gov/vaccines/acip/meetings/downloads/slides-2021-07/07-COVID-Oliver-508.pdf
FDA expected to authorize Covid-19 vaccine booster shots for some immunocompromised people within the next 48 hours. CNN; August 11, 2021. Accessed on August 12, 2021. https://www.cnn.com/2021/08/11/politics/fda-third-dose-covid-19-vaccine/index.html
Fauci on vaccine boosters for immunocompromised and updated CDC guidance for pregnant women. CBS News; August 12, 2021. Accessed on August 12, 2021. https://www.cbsnews.com/video/fauci-on-vaccine-boosters-for-immunocompromised-and-updated-cdc-guidance-for-pregnant-women/#x
This article originally appeared on Renal and Urology News