COVAX Data Show Similar COVID-19 Vaccine Safety Between General Public, Patients With RMD

New COVAX data revealed the safety profiles of COVID-19 vaccines in patients with inflammatory rheumatic and musculoskeletal disease (I-RMD) was comparable with patients with non-inflammatory RMD (NI-RMD) and the general population.

“These are valuable findings which will support discussions about the safety and benefit/risk ratio of COVID vaccination for people with RMDs,” according to a statement from the European Alliance of Associations for Rheumatology (EULAR), which launched the international COVAX patient registry last year. “The information will also be useful for the development of new and updated recommendations.”

Rheumatologists were asked to report as many cases as possible of patients who had received a COVID vaccine and whether they had experienced side effects.

Data from 5121 people in 30 countries with RMD who received at least 1 dose of a COVID-19 vaccine was collected between February and July 2021.

The majority of patients (70%) were female. The mean (SD) age was 61.6 years (15.2) with 56% of cases being over age 60. The I-RMD group made up 90% of cases and the NI-RMD group made up the other 10%.

The most common I-RMDs were rheumatoid arthritis, axial spondyloarthritis, and psoriatic arthritis, and the most common NI-RMDs were osteoarthritis and osteoporosis.

According to the study published in Annals of the Rheumatic Diseases, most people with either type of RMD tolerated vaccination well, with rare reports of I-RMD flare (4.4%) and very rare reports of serious adverse events (SAEs) (0.6%).

“Interestingly, in clinical trials of mRNA, inactivated and non-replicating vector vaccines against SARS-CoV-2 in the general population, the pooled rates of SAEs were very similar to our study, ranging from 0.4% to 0.6% in the vaccine group, and from 0.5% to 0.6% in the control group, suggesting that these SAEs are not necessarily causally related to the vaccine and might be coincidental observations,” the study authors noted.

Among those with I-RMDs, 54% were taking a conventional synthetic disease-modifying antirheumatic drug, 42% were on biological DMARDs, and 35% were taking immunosuppressant medicines for their RMD (glucocorticoids, mycophenolate, azathioprine). More than 98% of people included in the study were able to continue their normal medication with no changes.

The majority received the Pfizer/BioNTech vaccine (70%), followed by AstraZeneca/Oxford (17%) and then Moderna (8%). Only 1% of participants had 3 doses during the time frame, 74% had 2 doses, and 25% had 1 dose. The most common side effects were short-lived reactions to the vaccine injection and, once they were fully vaccinated, there was a low rate of COVID-19 infections in people with RMD (I-RMD, 0.7%; NI-RMD, 1.1%).

“These findings should provide reassurance to rheumatologists and vaccine recipients and promote confidence in SARS-CoV-2 vaccine safety in I-RMD patients,” the authors said.

Reference

Machado PM, Lawson-Tovey S, Strangfeld A, et al. Safety of vaccination against SARS-CoV-2 in people with rheumatic and musculoskeletal diseases: results from the EULAR Coronavirus Vaccine (COVAX) physician-reported registry. Ann Rheum Dis. Published online December 31, 2021. doi:10.1136/annrheumdis-2021-221490