Safety of the BNT162b2 mRNA COVID-19 vaccine in patients with familial Mediterranean fever

Abstract

Objectives 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. The objective of this study was to assess the safety of an mRNA-based BNT162b2 anti-COVID-19 vaccine in individuals with familial Mediterranean fever (FMF), a prototypic autoinflammatory disease. Methods Patients participating in this study fulfilled the criteria for diagnosis of FMF, were older than 18 years, and received at least one dose of the vaccine. Data on baseline characteristics, features of FMF, post-vaccination side effects, and disease flares were acquired using electronic medical files and telephone interviews. Results A total of 273 FMF patients were recruited for the study. More than 95% were vaccinated with two doses of the vaccine. The rates of local reactions following the first and second vaccine doses were 65.5% and 60%, respectively, and 26% and 50.4%, respectively, for systemic adverse events. These rates are lower than those reported for the general population from real-world and clinical trial settings. Postvaccination FMF activity remained stable in most patients. None of the patients reported an attack of pericarditis or myocarditis, considered the most serious vaccine-associated adverse events. Patients with a more active FMF disease and patients harboring the M694V mutation had a significantly higher rate of post-vaccination systemic side effects and attacks. Conclusion The BNT162b2 mRNA Covid-19 vaccine is safe in patients with FMF. Our results support the administration of this vaccine to FMF patients according to guidelines applicable to the general population.

A single‐center COVID‐19 vaccine experience with CoronaVac and BNT162b2 in familial Mediterranean fever patients

“…Likewise, most common adverse events in our study were fever, malaise, local pain/arm pain and arthralgia. When FMF attacks were considered, we observed that 22.2% of BNT162b2 recipients and 19.4% of CoronaVac recipients reported suffering from a FMF attack within 1 month after any vaccine dose, which was similar to the results of the study of Shechtman et al,18 who reported that approximately 19% of their patients had suffered from a FMF attack with 1 month after a BNT162b2 dose.Polack et al22 reported up to 83% local adverse events and up to 59% systemic events in 43 548 BNT162b2 recipients. As for CoronaVac, 0-28 day incidence of all adverse events were reported TA B L E 2…”

“…Similarly, in our study, patients with adverse events/FMF attacks had increased frequency of canakinumab use, nearly reaching statistical significance. When taken into consideration with results of Shechtman et al, 18 this finding may imply disease activity may actually be related to increased rates of vaccine‐related adverse events/FMF attacks, since canakinumab is an agent selected in patients with high disease activity despite colchicine treatment. Our results did not imply any significant other relation between demographics, remaining clinical characteristics, history of prior COVID‐19 infection and occurrence of adverse events/FMF attacks.…”

“…Fatigue, headache, myalgia, arthralgia, fever and nausea‐vomiting were the most common adverse events reported by Haslak et al 17 Similarly, Peet et al 16 most commonly reported fatigue, myalgia, fever, headache and localized symptoms. Shechtman et al 18 evaluated BNT162b2 safety among 273 adult FMF patients, reporting 65.5% local and 26% systemic adverse events after the first dose and 60% local and 50.4% systemic adverse events after the second dose. The most common adverse events were local reaction/pain, fatigue, myalgia and fever.…”

“…Additionally, Li et al 25 indicated an increased rate of vaccine‐related hospitalizations due to side effects in subjects with a history of COVID‐19 infection prior to vaccination. Shechtman et al 18 reported adverse events and FMF attacks following vaccination were more common in FMF patients with higher disease activity and increased colchicine and canakinumab use. Similarly, in our study, patients with adverse events/FMF attacks had increased frequency of canakinumab use, nearly reaching statistical significance.…”

“…Haslak et al 17 reported an acceptable safety profile in children and young adults with auto‐inflammatory diseases, the majority of whom were FMF patients. In a recent study, Shechtman et al 18 reported no increased safety signal after BNT162b2 in adult FMF patients with an increase in systemic adverse events after the second dose. However, comprehensive data regarding safety of different COVID‐19 vaccine types, effects of a booster dose or history of COVID‐19 infection prior to vaccination are still missing.…”