The safety data for Covid-19 vaccines are reassuring at this stage in myositis and myasthenia

Two internet surveys are exploring the safety profile of Sars-CoV-2 vaccination in autoimmune neuromuscular diseases in particular: Covad has 10,900 participants worldwide, including 1,227 with myositis, and Vacnemus has 1,274 participants in France, including nearly 300 with autoimmune myasthenia.

Their preliminary results show that:

  • 76.5% of patients with myositis report having experienced at least one adverse event, most often moderate (fatigue, body aches, fever), within one week of receiving a dose of Covid-19 vaccine;
  • the absolute risk of major adverse events (dyspnea, severe rash, etc.) and hospitalization was low and similar in the myositis group and in a control group;
  • the absolute risk of major adverse events (dyspnoea, severe rash…) and hospitalisation is low and similar in the myositis group and in a control group;
  • the risk of side effects is higher in patients who have myositis in the days preceding vaccination, or dermatomyositis, or especially myositis associated with at least one other autoimmune disease;
  • 51.7% of vaccine injections in patients with autoimmune myasthenia do not result in any adverse events; this is less than in neuropathy (62.6%), but more than in myopathy (49.8%) or SMN1-related proximal spinal muscular atrophy (45.8%).
  • Side effects reported by myasthenic patients are very often moderate and non-specific (injection site pain, fatigue, headache, muscle pain, etc.);
  • a transient worsening of the myasthenia occurred after 20 out of 578 vaccine injections, with the need for immunoglobulin infusions in only two cases.

Continuation of the two studies should provide longer-term vaccine safety data.

 

COVID-19 Vaccination in Autoimmune Diseases (COVAD) study: Vaccine safety in idiopathic inflammatory myopathies. Gil-Vila A, Ravichandran N, Selva-O’Callaghan A et al. Muscle Nerve. 2022 Oct;66(4):426-437.

 

COVID-19 vaccination in autoimmune disease (COVAD) survey protocol. Sen P, Gupta L, Lilleker JB et al. Rheumatol Int. 2022 Jan;42(1):23-29.

 

Safety of COVID-19 vaccination in a large French cohort of neuromuscular patients: data from the VACNEMUS study. M. Barnay Communication during the Myoloy 2022 international conference.