ACR COVID-19 Vaccine Clinical Guidance

Summary of Recommendations

ACR COVID-19 Vaccine Clinical Guidance for Patients with Rheumatic and Musculoskeletal Diseases
Updated 2/11/22

The American College of Rheumatology (ACR) has updated its vaccine clinical guidance for patients with rheumatic and musculoskeletal diseases (RMD). While each patient is unique, ACR’s COVID-19 Vaccine Clinical Guidance Task Force developed recommendations as a framework for addressing disease management within the context of vaccination against the SARS-CoV-2 virus.

The ACR guidance is not designed to replace the judgment of rheumatology care providers or overrule the values and preferences of their patients.

The task force members noted that the guidance is provided as part of a ‘living document,’ recognizing rapidly evolving evidence and the need for continuous monitoring of information about available mRNA vaccines and other types of COVID-19 vaccines in development. The guidance should be considered conditional or provisional. For additional details, click here.

Key Takeaways

COVID-19 Risk Factors

• Autoimmune inflammatory rheumatic diseases (AIIRD) patients (e.g., RA, PsA, axSpA, gout, lupus, vasculitis) are at a higher risk for COVID-19 hospitalization and worse outcomes compared to the general population.
• Based on their COVID-19 risk, AIIRD patients should be a priority group for vaccine access before the general population of similar age and sex.

Vaccine Considerations

Regardless of whether they have had COVID-19 itself, people who are moderately or severely immunocompromised from an immune-compromising condition, like autoimmune inflammatory rheumatic diseases, or who take immunosuppressant medications to treat it should be vaccinated. These recommendations apply to those aged 5 and older for the Pfizer/BioNTech vaccine , which is authorized for those ages, and to those ages 12 and older for the Moderna vaccine , which is authorized for those ages.

• For patients not yet vaccinated, either of the mRNA vaccines is recommended over the single dose J&J vaccine. There is no recommendation for one mRNA vaccine over another.
• Based on the evidence to date, there is no reason to expect that adverse effects from the vaccines will outweigh the benefits to RMD patients.
• There are no known additional contraindications to COVID-19 vaccines beyond known allergies to the vaccine’s ingredients.
• Rheumatology patients taking systemic immunosuppressive medications may experience a lesser response to a COVID-19 vaccine and the protection may not last as long as in the general population. Nevertheless, the vaccine is still very likely to provide meaningful protection, and RMD patients should be vaccinated.
• A third dose of Pfizer-BioNTech COVID-19 vaccine (age>= 12 years) or Moderna COVID-19 vaccine (age>=18 years) is recommended at least 28 days after the completion of the 2-dose mRNA vaccine series for patients receiving any immunosuppressive or immunomodulatory therapy, except for hydroxychloroquine.
• There is a theoretical risk that AIIRD patients may experience a disease flare after getting a COVID-19 vaccine, but the benefits of the vaccine’s protection outweigh the risks.
• Healthcare providers should not routinely order any lab testing (e.g., antibody tests for IgM and/or IgG to spike or nucleocapsid proteins) to assess immunity to COVID-19 post-vaccination, nor to assess the need for vaccination in a yet-unvaccinated person.

Medication Timing

• It may be helpful to alter the timing of the following medications, in consultation with a rheumatologist, when following a COVID-19 vaccination schedule:
  • methotrexate, mycophenolate, cyclophosphamide
  • JAK inhibitors - baricitinib (Olumiant) tofacitinib (Xeljanz), upadacitinib (Rinvoq)
  • abatacept (Orencia), rituximab (Rituxan, Ruxience, Truxim)

Assuming that disease is stable, do not use acetaminophen or NSAIDs 24 hours prior to vaccination (no restrictions on use post vaccination to treat symptoms).

The purpose of doing so would be to maximize vaccine response; there were no safety concerns raised related to medication or vaccine timing.

Booster Doses and Timing

Except for glucocorticoids and anti-cytokine therapies (IL-17, IL-12/23, IL-23, IL-1R, IL-6R), hold all immunomodulatory or immunosuppressive medications for 1-2 weeks after booster vaccination, assuming disease activity allows. Patients on rituximab or other anti-CD20 medications should discuss the optimal timing with their rheumatology provider before proceeding with booster vaccination.

ACR is now recommending that people who are immunosuppressed also receive a booster shot in addition to the “primary” series, in alignment with guidelines from the Centers for Disease Control and Prevention . Boosters differ from primary vaccines in dosage.

• Those who received all three Moderna vaccines should get a booster at least five months after the third vaccine.
• Those who received Pfizer/BioNTech vaccines and are aged 12 to 17 should get a booster after five months; people 18 and older should get a fourth vaccine after five months.
• Those who received a first J&J vaccine and followed it with either a J&J or mRNA booster at least two months later should receive a booster two months after the second shot.

Post-Exposure Treatments

The ACR recommendations also address treatment with monoclonal antibodies for those immunocompromised individuals who have been exposed to the virus. However, neither of these treatments has been authorized for use by the Food & Drug Administration against the omicron variant, which is currently the predominant strain of the virus circulating in the United States, because they have been found to be largely ineffective against this variant. Other therapies, however, are still available.

ACR recommends that high-risk immunocompromised patients receive treatment with monoclonal antibodies — when they are available and effective — once they have been exposed to the coronavirus or once they begin showing symptoms.

Bottomline

Following COVID-19 vaccination, RMD patients should continue to follow all public health guidelines, including mask-wearing, hand hygiene, physical distancing, and other preventive measures. For more information about COVID-19 vaccine safety, risks and medication interactions, click here.