ACR recommends booster 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 third dose of the mRNA vaccine in those receiving immunosuppressive or immunomodulatory therapy.
The updates follow recent recommendations from the CDC that certain immunocompromised patients receive a third dose of Pfizer or Moderna’s mRNA vaccine for COVID-19. The new ACR recommendations include guidance on timing of the third dose, a preference for the use of mRNA vaccines in patients who have not yet been vaccinated, and a notation of the FDA emergency use authorization (EUA) for post-exposure prophylaxis using monoclonal antibody treatment among patients who are exposed to COVID-19, including most vaccinated patients with rheumatic disease.
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“I’m tremendously pleased that the ACR COVID-19 Vaccine Clinical Guidance Task Force was able to quickly mobilize and respond to the new CDC guidance surrounding supplemental dosing against COVID-19,” Jeffrey Curtis, MD, MPH, the task force’s chair and a professor of medicine, epidemiology and computer science at the University of Alabama at Birmingham, said in an ACR press release. “The updated information from the ACR addresses not only booster vaccination but also other important and practical issues facing rheumatology providers and their patients related to the pandemic.”
Timing the third dose and holding medication
According to the updated guidelines, patients on immunosuppressive or immunomodulatory therapy should receive a third dose of the Pfizer-BioNTech — for patients aged 12 years or older — or Moderna — for those aged 18 years or older — mRNA COVID-19 vaccine at least 28 days after the second dose. Providers should attempt to match the third dose to the type — Pfizer or Moderna — received in the primary series. However, switching is permitted if that is not feasible, according to the new guidelines.
In addition, providers should counsel their patients to hold certain immunomodulatory or immunosuppressive medications for 1 to 2 weeks following the booster dose, if disease activity allows. Exceptions to this guidance include glucocorticoids and anti-cytokine therapies, including most biologic agents.
The ACR task force did not achieve consensus on whether anti-cytokine medications, such as TNF inhibitors and others including interleukin-17, IL-12/23, IL-23, IL-1R, IL-6R antagonists, meaningfully impair vaccine response to a degree that would warrant their temporary interruption. As such, none of the recommendations currently cover whether to temporarily hold or to continue these treatments at the time of booster vaccination.
Patients using rituximab (Rituxan; Genentech, Biogen) or other anti-CD20 medications should discuss appropriate timing with their provider before receiving a third dose.
According to the press release, “some practitioners” measure CD19 B cells as a tool to time the booster and subsequent rituximab dosing.
For those who elect to dose without such information, or for whom such measurement is not available or feasible, the ACR recommends giving the third dose 2 to 4 weeks prior to the next anticipated rituximab dose.
On monoclonal prophylaxis and mRNA preference
In a change to its original COVID-19 vaccine guidelines, which expressed no preference between the three vaccines currently available in the United States, the ACR now recommends that currently unvaccinated patients receive either the Pfizer or Moderna vaccines. This preference in favor of the mRNA products over Johnson & Johnson’s single-dose Ad26.COV2.S vaccine is driven by the fact that there is currently no authorization for J&J booster doses. Although this may change in the future, the ACR said.
In addition, due to current uncertainties regarding the safety of providing an mRNA booster to patients who have already received the single-dose J&J vaccine, the ACR’s task force did not achieve consensus regarding recommending supplemental mRNA doses to those who received the Ad26.COV2.S vaccine.
The new guidelines also note the FDA’s recent EUA for , called REGEN-COV, as a post-exposure prophylaxis for COVID-19 in high-risk adults and children aged 12 years and older weighing at least 40 kg. According to the ACR, those at high risk for developing severe COVID-19 include those receiving immunosuppressive or immunomodulatory therapy other than hydroxychloroquine.
“Patients who have been exposed to an individual with COVID-19 should ask their provider whether this treatment would be beneficial as an additional precautionary measure,” read the ACR press release, in part. “Prophylaxis with REGEN-COV is not a substitute for vaccination against COVID-19.”
The updated guidelines also reaffirm the ACR’s previous position that providers refrain from routinely ordering any laboratory testing to examine COVID-19 immunity post-vaccination, or to assess the need for vaccination in unvaccinated individuals. According to the task force, this position stems from reported uncertainties in the interpretation of laboratory testing following vaccination.
Lastly, the updated guidance maintains the importance of patients continuing to follow public health recommendations, including social distancing, following vaccination.
“Although the guidance is issued in light of the best evidence available, the science regarding COVID-19 vaccination as it affects the practice of rheumatology is undergoing rapid evolution,” Curtis said in the press release. “We need direct evidence such as that from randomized trials to inform the best practices of what we can do to protect our patients from SARS-CoV-2.”
Reaction to FDA Pfizer approval
In addition to the updated clinical guidelines, the ACR on Monday released a statement from its president applauding the FDA’s full approval of the Pfizer mRNA vaccine.
That vaccine, now branded as Comirnaty, has been authorized under an EUA since December 2020.
“The American College of Rheumatology applauds the FDA for prioritizing the vaccine approvals and recognizing the unique needs of the immunocompromised over the past week,” ACR President David Karp, MD, PhD, said in a statement.
“Real-world data has shown that patients with rheumatic diseases have worse outcomes than the general population when becoming ill with COVID-19,” he added. “We are hopeful the FDA’s formal approval of the Pfizer vaccine will help Americans feel more confident in the safety and efficacy of mRNA technology and will encourage them to pursue vaccination to reduce their risk of developing COVID-19 disease.”
Perspective
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I’m very pleased that we have approval for the third vaccine for our immunosuppressed patients. We continued to have unvaccinated immunosuppressed patients come into our office on a daily basis despite our educational efforts and current guidelines.
I’m very concerned for the health and welfare of all our patients. It is an ethical dilemma on how to handle unvaccinated patients and to protect the remainder of our immunosuppressed patients. The new vaccination recommendations help protect those who need it the most, but we still have to work on solutions to the remainder of the dilemma on an individual basis in our own clinics.
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