FDA Expected to Authorize COVID-19 Vaccine Booster Doses for Immunocompromised Patients

The FDA is soon expected to recommend that individuals with compromised immune systems receive a booster shot of either the Pfizer or Moderna COVID-19 vaccine, which could begin as soon as this weekend.

During an appearance on NBC’s ”Today” show on Thursday, Director of the National Institute of Allergy and Infectious Diseases, Anthony Fauci, MD, said that COVID-19 booster shots will be recommended for patients with weakened immune systems who are already vaccinated, according to an Associated Press report. Fauci added that he expects the recommendation for booster shots to come “imminently.”

This patient population includes those who have received an organ transplant and take immune-suppressing drugs, as well as those with diseases that attack the immune system, such as various types of blood cancers.

The decision could address concerns that immunocompromised individuals lack the ability to mount a significant defense against COVID-19 and its variants. In an article published in the New England Journal of Medicine, investigators warned that persistent COVID-19 infections in immunocompromised individuals could result in novel SARS-CoV-2 variants of concern. The partial immune response observed in these patients can create an environment for immune selection of evolutionary variants, according to the authors.

“The medical community needs to develop more precise guidelines for monitoring, treating and preventing COVID-19 infections in immunosuppressed patients to reduce both the risk to these patients and the potential emergence of variants of concern,” said Larry Corey, MD, virologist at Fred Hutchinson Cancer Research Center and leader of the COVID-19 Prevention Network, in a press release.

For other vaccinated groups considered high-risk, such as the elderly, data are being gathered to assess whether or when protection goes “below a critical level” Fauci said on “The Today Show,” and “that’s when you’re going to be hearing about the implementation of boosters” for other groups.

He added that boosters will currently not be offered to any groups other than those who are immunosuppressed, but Fauci said “inevitably there will be a time when we’ll have to get boosts” because ” no vaccine, at least not within this category, is going to have an indefinite amount of protection,” the Associated Press reported.

On Friday, a CDC advisory panel will meet to discuss considerations for COVID-19 booster doses as cases of the Delta COVID-19 variant surge throughout the United States. The CDC Advisory Committee on Immunization Practices meeting will also discuss additional doses for immune compromised individuals.