ACR Updates COVID-19 Vaccine Guidance- April 2021 Save

The ACR COVID-19 Vaccine Clinical Guidance was originally published on February 8, 2021 and updated on March 4, 2021. On April 28, 2021, new recommendations regarding mycophenolate, methotrexate, acetaminophen, and NSAID timing considerations were added.  

Purpose

The purpose of this document is to provide guidance to rheumatology providers on the use of the COVID-19 vaccine and the associated management of rheumatic and musculoskeletal disease patients around the time of vaccination against SARS-CoV-2. These statements were based upon a dearth of high-quality data and are not intended to replace clinical judgment. Modifications made to treatment plans, particularly in complex rheumatic disease patients, are highly disease-, patient-, geography-, and timespecific and, therefore, must be individualized as part of a shared decision-making process. This guidance is provided as part of a ‘living document,’ recognizing rapidly evolving evidence and the anticipated need for frequent updates as such evidence becomes available.

Methods

The North American Task Force panel, consisting of 9 rheumatologists, 2 infectious disease specialists, and 2 public health experts with current or past employment at the Centers for Disease Control (CDC), convened multiple times in December 2020 and January 2021. The Task Force proposed a variety of clinical questions related to COVID-19 vaccination in patients with rheumatic and musculoskeletal diseases (RMD), divided itself into subgroups (i.e., teams), and assigned the clinical questions to the various teams by topic (e.g., vaccine effectiveness, safety). Each team was charged to generate an evidence review covering that topic; the evidence reviews were combined into an evidence summary document that was collated and disseminated to the entire Task Force.

The Task Force reviewed the clinical questions and associated proposed vaccine guidance statements that were evaluated using a well-established method of consensus building (modified Delphi process). This process included two rounds of asynchronous anonymous rating by email and two live webinars including the entire Task Force. Panel members rated their agreement with draft statements using a numeric scoring system, and consensus was determined to be either “moderate” (M) or “high” (H), based on the dispersion in the rating results. To be approved as guidance, median ratings were required to correlate to pre-defined levels of agreement (with median values interpreted as “agreement,” “uncertainty” or “disagreement”) with either moderate or high levels of consensus. For this summary document, several rating statements that were initially separate were combined to facilitate clarity and conciseness.

Results and Conclusion

General considerations related to COVID-19 vaccination in rheumatic and musculoskeletal disease patients are shown in Table 1. Statements more specific to patient groups, as well as general disease- and timing-related considerations, are presented in Table 2. No evidence was found to support a concern regarding the use or timing of immunomodulatory therapies in relation to vaccine safety. Therefore, guidance regarding immunomodulatory medication and vaccination timing (Table 3) was given considering the intent to optimize vaccine response. An important set of guiding principles, foundational assumptions and limitations are mentioned in the Supplemental Table. The ACR is committed to updating this guidance as a ‘living document’ as new evidence emerges.

Recommendations

Table 1: General Considerations Related to COVID-19 Vaccination in Rheumatic and Musculoskeletal Disease Patients

Table 2: Recommendations for Use of the COVID-19 Vaccine in RMD Patients 

Table 3: Guidance Related to the Use and Timing of Vaccination and Immunomodulatory Therapies in Relation to COVID-19 Vaccination Administration in RMD Patients*