Table 3.
Recommendations for primary and supplemental dosing of the COVID‐19 vaccine in RMD patients*
| Statement domain | Guidance statement | Level of task force consensus |
|---|---|---|
| Clinical practice | RMD and AIIRD patients should receive COVID‐19 vaccination, consistent with the age restriction of the EUA and/or FDA approval.† | Strong |
| Clinical practice | RMD patients without an AIIRD who are receiving immunomodulatory therapy should be vaccinated in a similar manner as described in this guidance as AIIRD patients receiving those same treatments. | Moderate |
| Vaccine effectiveness/safety | For AIIRD patients who are not yet vaccinated, either of the mRNA vaccines is recommended over the Johnson & Johnson vaccine. There is no recommendation for one mRNA vaccine over another.† | Moderate |
| Vaccine effectiveness | For a multidose primary vaccine, AIIRD patients should receive the second dose of the same vaccine, even if there are nonserious adverse events associated with receipt of the first dose, consistent with timing described in CDC guidelines (32). | Strong |
| Clinical practice | RMD and AIIRD patients who completed the primary COVID vaccine series of 3 doses and are expected to have mounted an inadequate vaccine response should receive supplemental doses (e.g., ≥2 additional boosters, for a total of 5 doses) as recommended by the CDC for immunocompromised individuals. ‡ | Strong |
| Clinical practice | For patients who previously completed the mRNA COVID‐19 vaccine series an mRNA vaccine supplemental dose of either type (Pfizer or Moderna) is preferred. | Moderate |
| Clinical practice | Primary vaccination, supplemental dosing, and booster doses should be given regardless of whether patients have experienced natural COVID‐19 infection. | Strong |
| Clinical practice | Health care providers should not routinely order any laboratory testing (e.g., antibody tests for IgM and/or IgG to spike or nucleocapsid proteins) to assess immunity to COVID‐19 postvaccination, nor to assess the need for vaccination in an as‐yet‐unvaccinated person.§ | Strong |
| Public health | Following COVID‐19 vaccination, RMD patients should continue to follow all public health guidelines regarding physical distancing and other preventive measures.¶ | Strong |
| Clinical practice | For high‐risk AIIRD patients, pre‐exposure prophylaxis monoclonal antibody treatment is recommended when available, if licensed or approved under FDA EUA. # | Moderate |
| Clinical practice/public health | Household members and other frequent close contacts of AIIRD patients should undergo COVID‐19 vaccination when available to them to facilitate a “cocooning effect” that may help protect the AIIRD patient. | Moderate |
| Vaccine effectiveness/disease‐related | While vaccination would ideally occur in the setting of well‐controlled AIIRD, except for AIIRD patients with life‐threatening disease (e.g., in the ICU for any reason), COVID‐19 vaccination should occur as soon as possible for those for whom it is being recommended, irrespective of disease activity and severity. | Strong |
Boldface text indicates updates that were added to the version 5 summary document in early 2022. RMD = rheumatic and musculoskeletal disease; EUA = Emergency Use Authorization; AAIRD = autoimmune and inflammatory rheumatic disease; ICU = intensive care unit.
Age ≥6 months as of June 19, 2022.
The timing of booster shot intervals is somewhat vaccine‐dependent. For both the Moderna and Pfizer mRNA vaccines, a booster shot is recommended ≥3–4 months after completion of the 3‐dose primary vaccine series. The recommended interval for those having received the Johnson & Johnson vaccine is ≥2 months (ref. 47 ).
Given uncertainties in the interpretation of laboratory testing following vaccination as it would impact clinical decision‐making, the panel reaffirmed this statement in Version 4 of this guidance document.
The task force discussed the possibility of recommending additional and more sustained public health measures for patients with AIIRD. After deliberation, they did not elect to exceed current public health authority guidance given uncertainties about the clinical effectiveness of vaccination in such patients. The appropriateness for continued preventive measures (e.g., masking, physical distancing) should be discussed with patients as their rheumatology providers deem appropriate.
High risk is defined as moderately to severely compromised immune systems in individuals who may not mount an adequate immune response to COVID‐19 vaccination. Note that the US Food and Drug Administration (FDA) authorization and Centers for Disease Control and Prevention (CDC) recommendations will be influenced based upon the dominant variants of SARS–CoV‐2 circulating in the US ( http://www.fda.gov/news‐events/press‐announcements/coronavirus‐covid‐19‐update‐fda‐limits‐use‐certain‐monoclonal‐antibodies‐treat‐covid‐19‐due‐omicron ). At the time of this update, neither bamlanivimab and etesevimab (administered together) nor casirivimab and imdevimab are licensed or available under FDA EUA given their lack of activity against the omicron variant, the dominant strain circulating in the US. See Supplementary Table 5 for further details (on the Arthritis & Rheumatology website at http://onlinelibrary.wiley.com/doi/10.1002/art.42372 ).