ACR recommends fourth dose of COVID-19 mRNA vaccine for patients on immunosuppressants
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The American College of Rheumatology has updated its COVID-19 vaccine clinical guidance for patients with rheumatic diseases to recommend a fourth mRNA vaccine dose in patients receiving immunosuppressive or immunomodulatory therapy.
“It remains important for rheumatology providers to assess the vaccination status of all patients with rheumatic diseases,” Jeffrey Curtis, MD, MPH, chair of the ACR COVID-19 Vaccine Guidance Task Force, and a professor of medicine, epidemiology and computer science at the University of Alabama at Birmingham, said in an ACR press release.
“Initially, it might have been acceptable to just ask a patient if they have been vaccinated,” he added. “There is now more nuance with supplemental and booster dose recommendations that should prompt us to ask patients not only whether they have been vaccinated, but with what, how many times, and how recently.”
In the fifth version of its COVID-19 guidelines, the ACR now recommends that all patients rheumatic disease receive a booster dose following their primary vaccine series, as directed by the CDC. Patients receiving immunosuppressive or immunomodulatory therapy who are expected to mount an inadequate vaccine response should take a third mRNA vaccine dose as part of their primary vaccination series, at least 28 days after their second shot. A booster shot should then be administered 5 months after the completion of the primary series, for a total of four mRNA doses.
This applies to both the Pfizer-BioNTech — approved in people aged 5 years and older — and Moderna — for those aged 18 years and older — formulations. Based on the availability of evidence, the ACR recommends patients try to take the same mRNA vaccine for their third dose as their first two, but may use either if the initial brand is unknown or unavailable.
No additional primary shot for the Johnson & Johnson single-dose Ad26.COV2.S vaccine is approved at this time. However, both the CDC and ACR are now recommending a booster dose of an mRNA vaccine at least two months following the primary Johnson & Johnson shot.
These recommendations for primary vaccination, supplemental dosing and booster doses apply regardless of whether patients have experienced natural COVID-19 infection, according to the ACR.
The new guidance also continues to support the use of pre- and post-exposure prophylaxis with monoclonal antibodies, when available, for high-risk patients with autoimmune and inflammatory rheumatic disease.
The ACR notes that the FDA has limited the use of some monoclonal antibody therapies for being ineffective against the omicron variant. However, for patients with autoimmune and inflammatory rheumatic disease who are at high-risk, the ACR recommends pre-exposure prophylaxis monoclonal antibody treatment — “for instance, tixagevimab co-packaged with cilgavimab [Evusheld, AstraZeneca],” read the new guidelines — if licensed or approved under FDA emergency use authorization.
The ACR has submitted a peer-reviewed manuscript, with additional details on the clinical studies, data and discussion points that impacted the recommendations, for publication to Arthritis & Rheumatology. Once published, the full recommendations will be available on the ACR website.
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