Table 5.

Research agenda for future COVID‐19 vaccine studies in RMD patients proposed by the task force^*

Conduct clinical efficacy and laboratory‐based immunogenicity studies in RMD patients following vaccination, especially for AIIRD patients receiving certain immunomodulatory therapies (e.g., methotrexate, abatacept, JAK inhibitors, rituximab, mycophenolate, GCs).

Optimize response to primary vaccination and supplemental/booster dose by considering timing related to intentional short‐term cessation of certain immunomodulatory therapies (e.g., methotrexate, subcutaneous abatacept, JAK inhibitors, mycophenolate) to optimize vaccine response.

Evaluate risk of disease flare, disease worsening, and systemic reactogenicity following COVID‐19 vaccination in RMD patients, by disease and in relation to background immunomodulatory therapies.

Directly compare vaccines and vaccine platforms for the above efficacy, immunogenicity, and safety outcomes: notable given the potential for some COVID‐19 vaccines to achieve the minimum threshold for the FDA's EUA yet have seemingly lower vaccine efficacy based on large clinical trials in non‐RMD patients.

Conduct long‐term follow‐up for durability and magnitude of vaccine protection in relation to various immunomodulatory medications, and as new SARS–CoV‐2 strains emerge.

Assess benefits and timing of additional COVID‐19 vaccine administration (i.e., booster doses).

Generate real‐world evidence (e.g., large pragmatic trial or observational studies) embedded in routine clinical practice to study the above topics, especially to promote large‐scale safety surveillance.

Establish a biorepository with associated clinical data infrastructure to facilitate future COVID‐19 (and possibly other) vaccine‐related research in RMD patients, considering the future potential to identify laboratory‐based correlates of protection relevant for individual patients.

Identify laboratory‐based serologic testing to identify patients with a suboptimal response to COVID‐19 vaccination who might be candidates for additional booster doses or need to repeat the vaccination series.

Evaluate the impact of coadministration of the COVID‐19 vaccine given concurrently with other, non–live‐virus vaccines (e.g., shingles, influenza, pneumococcal) on vaccine immunogenicity and tolerability.

Optimize approaches to address vaccine hesitancy for high‐risk RMD patients who are reticent or unwilling to undergo vaccination, with particular attention to vulnerable populations (e.g., underrepresented racial/ethnic groups).

Identify COVID‐19 vaccine–induced immune parameters (immunogen‐specific neutralizing antibody levels, total immunogen‐specific antibody levels or isotypes, T cell immunity, innate immunity) or host determinants that are predictive of successful host response to vaccine, as reflected by protection from infection or mitigation of morbidity during subsequent infection.

Conduct large epidemiology studies of COVID‐19 outcomes (e.g., using large administrative databases of health plans, electronic health record data [e.g., the ACR RISE registry], or other data sources or methods) and examine the role of AIIRD disease features, treatments, and vaccination. While risk factors for incident disease may be shaped by confounding and unmeasured variability in exposure, examining outcomes conditioning on incident COVID‐19 diagnosis may be more fruitful.

^*RMD = rheumatic and musculoskeletal disease; AIIRD = autoimmune and inflammatory rheumatic disease; GCs = glucocorticoids; FDA = US Food and Drug Administration; EUA = Emergency Use Authorization; ACR = American College of Rheumatology; RISE = Rheumatology Informatics System for Effectiveness.