When can I get my vaccine? Will the vaccine make me have a flare of my lupus? Which vaccine is going to be best for me? If your practice is like mine, these questions have been occupying your clinic staff ever since the U.S. Food & Drug Administration gave emergency use authorization to the Pfizer and Moderna vaccines for COVID-19.
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At the beginning of the pandemic last year, the questions surrounding COVID-19 related to whether patients with rheumatic and musculoskeletal diseases would be more susceptible to SARS-CoV-2 or whether their illness would be more severe. In response, the ACR COVID-19 Clinical Guidance task forces published expert opinion, informed by the emerging scientific literature, on the care of both adults and children with autoimmune or autoinflammatory rheumatic diseases who have been exposed to or who have contracted COVID-19. These documents have been revised as new data emerged and have been accessed thousands of times since they appeared on the COVID-19 section of our website.
Now, all of the questions posed by both patients and providers revolve around vaccination. Is it safe for patients with altered immune systems to receive these vaccines, particularly those employing the novel mRNA technology? Will patients who already make their own autoantibodies to nucleic acids or phospholipids have an adverse reaction to a vaccine containing just those two constituents? Could receiving the vaccine exacerbate their underlying disease? Will the vaccine be effective in patients with autoimmune and rheumatic diseases? Will our patients need to hold or modify their disease-modifying anti-rheumatic drug therapies before or after they are vaccinated?
‘Proceeding at our own version of Operation Warp Speed, the task force worked … to craft practical guidance for members. The guidance documents were approved by the ACR Board in early February.’ —Dr. Karp
To provide answers to these and many other questions raised by our members, a COVID-19 Vaccine task force was created last fall, just as the outstanding results of the phase 3 clinical trials were being released. A call for volunteers went out, and Jeff Curtis, MD, University of Alabama at Birmingham, was selected to lead this effort. Members of the task force included other rheumatologists, infectious disease specialists and experts in vaccines.
Proceeding at our own version of Operation Warp Speed, the task force worked through December and January, analyzing the data on the COVID-19 vaccines as well as the literature on other vaccines administered to patients with rheumatic diseases. They used a modified Delphi process to rank 72 statements regarding vaccine safety, efficacy and interaction with medications, and craft practical guidance for members. The guidance documents were approved by the ACR Board in early February.
An online Town Hall was held to discuss these recommendations with our membership. We have found this to be a great mechanism for getting information into our providers’ hands quickly and with confidence. It was reassuring to know we can recommend COVID-19 vaccination to all our patients with few restrictions and few concerns over medication use.
Like all of our COVID-19 guidance, this is a living document, with constant monitoring of the literature and updates whenever significant new information emerges.
COVID-19 Vaccine Immunology
One amazing thing about rheumatology is how quickly our researchers respond to new challenges. Just as the Phase 3 clinical trial results were announced, researchers around the country began designing ambitious translational and clinical research projects to understand the immunology of COVID-19 vaccines in patients with rheumatic diseases. As these plans unfolded, it was clear that collaboration among the groups doing these studies would benefit all involved.
On Dec. 18, 2020, just one week after the Emergency Use Authorization of the Pfizer vaccine, the ACR hosted a COVID-19 Vaccine Consortium online. I was thrilled to see almost 100 people from the U.S., Europe, Mexico, Australia and New Zealand attend this virtual work in progress.
Viewers of the webinar heard from several speakers whose projects were recently described in a special edition of The Rheumatologist, and I suggest everyone look at the exciting work being proposed. These studies will help us understand how patients with autoimmune and rheumatic diseases respond to the vaccines at a very detailed level, including B cell biology and serological protection from infection. We will learn if our patients have adverse effects from the vaccine. The effects of different medications used to treat rheumatology patients on vaccine efficacy will be determined. Some studies will create biorepositories so other investigators can perform their own assays on vaccinated patient specimens.
In addition to serving as a focal point for investigators to share ideas, data and specimens, the ACR can help researchers understand the effect of COVID-19 infection or vaccination in patients with rheumatic diseases. The Rheumatology Research Foundation funded several special COVID-19 studies under an accelerated mechanism last year. Foundation President S. Louis Bridges Jr., MD, PhD, remarked, “As more funds for COVID-related research become available at the Foundation, we hope to fund studies focused on long-term safety and effectiveness of various COVID-19 vaccines in patients with rheumatic diseases, as well as COVID’s long-term consequences and impact on healthcare delivery to our patients.”
What About Other Vaccines?
While COVID-19 is the most important infectious disease we are facing right now, it is not the only one that concerns us or our patients. Last year, the dynamic daughter-father duo of rheumatology, Cassandra (Cassie) Calabrese, DO, and Leonard H. Calabrese, DO, both of the Cleveland Clinic, wrote to the Executive Committee and challenged ACR members to become active proponents in the vaccination of their patients. This is extremely important because our patients’ altered immune systems and the medications they take put them at higher risk of infections, such as influenza, pneumococcal pneumonia and herpes zoster. However, we don’t have published guidelines on the safety and efficacy of these vaccines in any condition except rheumatoid arthritis.
This past year, the ACR Quality of Care Committee convened a panel of experts under the leadership of Eliza Chakravarty, MD, Oklahoma Medical Research Foundation, to create guidelines for all vaccines in the different diseases we treat. Although speed is of the essence for the COVID-19 guidance document, the general vaccine guideline will follow our formal process of extensive literature review, generation of PICO questions (i.e., P=patient, problem or population; I=intervention; C=comparison; and O=outcome) and group assessments of the data on vaccine safety and efficacy. This process is anticipated to take up to 18 months, but it will ultimately result in a source we can look to for years.
As the current COVID-19 pandemic has shown, effective vaccines are essential tools for both public health and the personal health of our patients, in whom infections occur more often and with greater severity than in the general population. The ACR is working hard to be sure our members have all the right information to keep their patients safe.
David R. Karp, MD, PhD, is chief of the Division of Rheumatic Diseases and the Harold C. Simmons Chair in Arthritis Research at UT Southwestern Medical Center, Dallas, and the ACR’s 84th president.