Immune Response and Safety of SARS-CoV-2 mRNA-1273 Vaccine in Patients With Myasthenia Gravis.

Abstract

BACKGROUND AND OBJECTIVES:

Evidence regarding the safety and efficacy of messenger RNA (mRNA) vaccines in patients with myasthenia gravis (MG) after immunosuppressive therapies is scarce. Our aim is to determine whether the mRNA-1273 vaccine is safe and able to induce humoral and cellular responses in patients with MG.

METHODS:

We performed an observational, longitudinal, prospective study including 100 patients with MG of a referral center for MG in our country, conducted from April 2021 to November 2021 during the vaccination campaign. The mRNA-1273 vaccine was scheduled for all participants. Blood samples were collected before vaccination and 3 months after a second dose. Clinical changes in MG were measured using the MG activities of daily life score at baseline and 1 week after the first and second doses. A surveillance of all symptoms of coronavirus disease 2019 (COVID-19) was conducted throughout the study. Humoral and cellular immune responses after vaccination were assessed using a spike-antibody ELISA and interferon gamma release assay in plasma. The primary outcomes were clinically significant changes in MG symptoms after vaccination, adverse events (AEs), and seroconversion and T-cell immune response rates.

RESULTS:

Ninety-nine patients completed the full vaccination schedule, and 98 had 2 blood samples taken. A statistically significant worsening of symptoms was identified after the first and second doses of the mRNA-1273 vaccine, but this was not clinically relevant. Mild AEs occurred in 14 patients after the first dose and in 21 patients after the second dose. Eighty-seven patients developed a humoral response and 72 patients showed a T-cell response after vaccination. A combined therapy with prednisone and other immunosuppressive drugs correlated with a lower seroconversion ratio (OR = 5.97, 95% CI 1.46-24.09, p = 0.015) and a lower T-cell response ratio (OR = 2.83, 95% CI 1.13-7.13, p = 0.024).

DISCUSSION:

Our findings indicate that the mRNA vaccination against COVID-19 is safe in patients with MG and show no negative impact on the disease course. Patients achieved high humoral and cellular immune response levels.

CLASSIFICATION OF EVIDENCE:

This study provides Class IV evidence that patients with MG receiving the mRNA-1273 vaccine did not show clinical worsening after vaccination and that most of the patients achieved high cellular or immune response levels.

• Authors: David Reyes-Leiva, Joaquín López-Contreras, Esther Moga, Francesc Pla-Juncà, Elionor Lynton-Pons, Ricardo Rojas-Garcia, Janina Turon-Sans, Luis Querol, Montse Olive, Rodrigo Álvarez-Velasco, Marta Caballero-Ávila, Álvaro Carbayo, Ana Vesperinas-Castro, Pere Domingo, Isabel Illa, Eduard Gallardo, Elena Cortés-Vicente
• Journal: Neurology(R) neuroimmunology & neuroinflammation (Neurol Neuroimmunol Neuroinflamm) Vol. 9 Issue 4 (07 2022) ISSN: 2332-7812 [Electronic] United States
• PMID: 35728947 (Publication Type: Journal Article, Observational Study, Research Support, Non-U.S. Gov't)
• Copyright: Copyright © 2022 The Author(s). Published by Wolters Kluwer Health, Inc. on behalf of the American Academy of Neurology.

Chemical References

• Antibodies, Viral
• 2019-nCoV Vaccine mRNA-1273

Topics

• 2019-nCoV Vaccine mRNA-1273 (adverse effects, immunology)
• Antibodies, Viral (blood)
• COVID-19 (prevention & control)
• Humans
• Immunity, Cellular
• Immunity, Humoral
• Longitudinal Studies
• Myasthenia Gravis (complications)
• Prospective Studies
• SARS-CoV-2
• T-Lymphocytes (immunology)