Safety and humoral response rate of inactivated and mRNA vaccines against SARS-CoV-2 in patients with Multiple Sclerosis
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Date
2022
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Abstract
Background: Safety and effectiveness outcomes in Multiple Sclerosis (MS) patients receiving different disease- modifying therapies (DMT) and different types of vaccines against SARS-CoV-2 are limited. Growing evidence coming mainly from Israel, Europe and North America using mRNA and adenoviral vector vaccines has been published. Objectives: To assess the safety and humoral response of inactivated virus and mRNA vaccines against SARS-CoV- 2 in patients with MS. Methods: Ongoing, multicentric, prospective, observational study performed between February and September 2021. Humoral response (antibodies against spike-1 protein) was determined at least 4 weeks after the complete schedule of anti-SARS-CoV-2 vaccines. Categorical outcome (positive/negative) and total antibody titres were recorded. Adverse events supposedly attributable to vaccination (AESAV) were collected. Results: 178 patients, 68% women, mean age 39.7 ±11.2 years, 123 received inactivated (Coronavac-Sinovac), 51 mRNA (Pfizer-BioNtech), and 4 adenoviral vector vaccines (CanSino n =2, Jonhson&Johnson-Jannsen n =1, Oxford-AstraZeneca n =1). Six patients had a history of COVID-19 before vaccination. Overall humoral response was observed in 66.9% (62.6% inactivated vs. 78.4% mRNA, p =0.04). Positive anti-S1-antibodies were observed in 100% of patients with no DMT (n =3), 100% with interferon/glatiramer-acetate (n =11), 100% with teriflunomide/dimethyl-fumarate (n =16), 100% with natalizumab (n =10), 100% with alemtuzumab (n =8), 90% with cladribine (n =10), and 88% with fingolimod (n =17), while 43% of patients receiving antiCD20 (n =99) were positive (38% inactivated vaccine vs. 59% mRNA vaccine, p =0.05). In the multivariate analysis including antiCD20 patients, the predictors for a positive humoral response were receiving the mRNA vaccine (OR 8.11 (1.79–36.8), p =0.007) and a lower number of total infusions (OR 0.44 (0.27–0.74) p =0.002. The most frequent AESAV was local pain (14%), with 4 (2.2%) patients experiencing mild-moderate relapses within 8 weeks of first vaccination compared to 11 relapses (6.2%) within the 8 weeks before vaccination (Chi-squared 3.41, p =0.06). Discussion: A higher humoral response rate was observed using the mRNA compared to the inactivated vaccine, while patients using antiCD20 had a significantly lower response rate, and patients using antiCD20 and fingolimod had lower antibody titres. In this MS patient cohort, inactivated and mRNA vaccines against SARS-CoV-2 appear to be safe, with no increase in relapse rate. This information may help guidelines including booster shots and types of vaccines in selected populations.
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Multiple sclerosis, Vaccine, COVID-19, SARS-CoV-2, Humoral response, Inactivated virus, mRNA