COVID-19 Vaccine Efficacy & Safety Discussed at Town Hall

“This will be enormously important for our immunocompromised patients, and we are thankful to the FDA and CDC for hearing our concerns, recognizing the needs of this population and moving forward,” stated ACR President Dr. David Karp. “We look forward to working with the agencies as they communicate this new recommendation.”

The additional dose of mRNA COVID-19 vaccine should be administered at least 28 days after completion of the primary vaccine series, and patients and providers should stick to the same brand for the third dose, if possible.

Vaccine Safety
In April 2021, the Global Rheumatology Alliance, a group of patients, clinicians and researchers studying the impact of COVID-19 on patients with rheumatic disease, launched a survey of rheumatic disease patients, of whom 2,860 had received at least one COVID-19 vaccine dose. Jean Liew, MD, MS, assistant professor, Division of Rheumatology, Boston University School of Medicine, presented some unpublished data from the patient survey.

Dr. Liew

Among other findings, Dr. Liew shared that 13% of surveyed patients reported experiencing a flare after receiving their first vaccination that lasted at least two days, and 5% reported requiring a medication change to help manage these symptoms. These results are roughly in line with those from a different survey of 1,100 outpatients with systemic rheumatic disease who had received at least one dose of SARS-CoV-2 vaccine, in which about 15% of these patients reported a disease flare post-vaccination.¹³

However, these results may highlight some differences between physician-assessed flares and patient-reported symptoms that may not meet medical criteria for a flare. In the physician-reported EULAR COVAX registry, with data from 1,519 vaccinated patients with rheumatic and musculoskeletal diseases, flare was reported for 5% of the 1,519 vaccinated patients, with severe flare in about 1%.¹⁴ In the VALCOLUP survey of almost 700 patients with lupus, 3% reported a medically confirmed flare. Results from much smaller prospective, physician-reported studies out of Germany and Israel did not document an increased risk of significant disease flare.^4,5

Although it will take more time to understand the true rates of disease flare after vaccination, it’s important to keep emphasizing to patients that rheumatologists can treat any flare symptoms, should they occur, and that the risks from not getting vaccinated are much more significant.

Treatment
Another speaker, Michael R. Anderson, MD, MBA, highlighted monoclonal antibodies as a key therapeutic option, particularly for non-hospitalized COVID-19 patients in an early phase of the disease. Dr. Anderson, a senior advisor in the Office of the Assistant Secretary for Preparedness and Response, U.S. Department of Health & Human Services, Washington, D.C., has performed a key leadership role on the COVID-19 monoclonal antibody therapeutics team.