Pfizer-BioNTech COVID-19 vaccine safe for patients with familial Mediterranean fever
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The Pfizer-BioNTech mRNA vaccine for COVID-19 is safe for patients with familial Mediterranean fever, according to data published in Rheumatology.
The researchers additionally concluded that patients with the disease can receive the vaccine via the same guidelines as the general population.
“Evidence suggests a possible association between the COVID-19 vaccine and autoimmune disease flares or new onset of various autoinflammatory manifestations, such as pericarditis and myocarditis,” Ilan Ben-Zvi, MD, head of the Department of Internal Medicine F at the Sheba Medical Center, in Tel-Hashomer, Israel, told Healio. “Naturally, these autoinflammatory-like side effects raise concerns regarding the safety of mRNA-based vaccines in individuals with autoinflammatory diseases, where the vaccine might trigger attacks or result in an increased rate of side effects.”
To examine the safety of mRNA-based COVID-19 vaccines in familial Mediterranean fever — which the researchers described as “the prototypic autoinflammatory disease” — the researchers conducted a retrospective study in which patients with familial Mediterranean fever seen at the Sheba Medical Center were recruited at random. Researchers screened 1,136 electronic health records of patients with a presumed diagnosis, among whom 478 fulfilled the criteria for familial Mediterranean fever diagnosis and were aged 18 years or older with no record of additional rheumatic diseases.
A total of 273 patients who had received at least one dose of the vaccine chose to take part in the study. In all, 95% of the participants had received two doses of the Pfizer-BioNTech vaccine and 4.7% had received one dose.
The researchers conducted phone interviews with participants to gather data on disease flares after vaccination and side effects that occurred within 1 month of vaccination. Patients were asked about specific post-vaccination adverse events, including the need for medical attention due to flares and changes in disease management.
According to the researchers, the rate of local adverse events was comparable between the first and second dose. Systemic events were significantly more common after the second dose — at 50.4% — than after the first — 26% (P < .05). Specifically, fatigue — 18% vs. 38% (P < .05) — muscle pain — 12% vs. 27% (P < .05) — and fever — 8% vs. 17% (P < .05) — were all more common after the second dose.
In all, 68 patients reported a familial Mediterranean fever attack in the month following vaccination, with no significant difference in attack rates between first and second doses. The most common areas of attack were the abdomen and joints. There were no reported cases of pericarditis. Eight patients who experienced attacks sought emergency medical evaluation, while six required hospitalization and seven needed an increase in their typical colchicine dose, the authors wrote.
“Overall, our results show that the vaccine is safe for patients with familial Mediterranean fever (FMF),” Ben-Zvi said. “These results can reassure rheumatologists to recommend the administration of mRNA-based vaccine to FMF patients according to local guidelines applicable to the general population.”
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