This article has been updated from the original.
The FDA has authorized a booster shot of both the Pfizer-BioNTech and Moderna COVID-19 mRNA vaccines for 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.
On Friday August 13, the CDC’s ACIP officially recommended an additional dose for immunocompromised people. According to CDC Director Rochelle P. Walensky, MD, MPH, “This official CDC recommendation — which follows FDA’s decision to amend the emergency use authorizations of the vaccines — is an important step in ensuring everyone, including those most vulnerable to COVID-19, can get as much protection as possible from COVID-19 vaccination.”
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. Many of these immunocompromised individuals fall under CDC’s list of applicable conditions. The CDC also offered advice to health care providers on talking about a third mRNA vaccine dose with patients who are immunocompromised.
There is not enough data at this time to determine whether immunocompromised people who received the Johnson & Johnson’s Janssen COVID-19 vaccine also have an improved antibody response following an additional dose of the same vaccine, according to the CDC.
LaVarne A. Burton, president and CEO of the American Kidney Fund (AKF), a national patient advocacy organization, said, “AKF urges the CDC and FDA to quickly assess whether those who received the Johnson & Johnson vaccine should also receive a booster shot. While getting the vaccine, and a booster shot, are strongly encouraged for those who are immunocompromised, it is still important for the kidney community to take CDC-recommended precautions, like wearing masks in public places and practicing social distancing, to protect themselves from COVID-19, particularly as cases from the Delta variant surge across the US.”
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 [mRNA shot] 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.
Coronavirus (COVID-19) Update: FDA Authorizes Additional Vaccine Dose for Certain Immunocompromised Individuals [news release]. FDA; August 12, 2021.
Media statement from CDC Director Rochelle P. Walensky, MD, MPH, on Signing the Advisory Committee on Immunization Practices’ Recommendation for an Additional Dose of an mRNA COVID-19 Vaccine in Moderately to Severely Immunocompromised People [news release]. CDC; August 13, 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
American Kidney Fund Commends the CDC, FDA and CMS for Supporting a Booster Shot of the COVID-19 Vaccine for Immunocompromised People [press release]. AKF; August 18, 2021.
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