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Pause in immunosuppressive treatment results in improved immune response to SARS-CoV-2 vaccine in autoimmune patient: a case report
  1. Basil Golding,
  2. Youri Lee,
  3. Hana Golding,
  4. Surender Khurana
  1. Center for Biologics Evaluation and Research (CBER), Food and Drug Administration (FDA), Silver Spring, Maryland, USA
  1. Correspondence to Dr Surender Khurana, FDA, Silver Spring, MD 20993, USA; Surender.Khurana{at}

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Patients on immunosuppressive drugs have been excluded from studies of SARS-CoV-2 mRNA vaccines’ (mRNA-BNT162b2 and mRNA-1273) clinical trials that resulted in their Emergency Use Authorization in the USA and Europe. Since the initiation of the global vaccination campaign, it became apparent that patients on immunosuppressive drugs may not generate optimal immune response following vaccination.1 Prednisone and mycophenalate are potent inhibitors of immune responses. Prednisone acts at many levels of immunity including the innate and adaptive responses, whereas mycophenalate mainly targets T and B cells.2 These and other immunosuppressive drugs used to treat patients with autoimmune disorders and organ transplant patients were shown to significantly curtail antibody responses following SARS-CoV-2 mRNA vaccines.3–5

We report on a 75-year-old male patient with an underlying autoimmune disorder, myasthenia gravis, which was controlled after receiving high doses of prednisone and mycophenalate for 9 months. At his first SARS-CoV-2 vaccination, he was receiving 7.5 mg prednisone on alternate days and 3 g mycophenalate daily (figure 1A). He received two doses of Moderna mRNA-1273 vaccine with a 4-week interval between doses. Neutralisation titres were measured using a pseudovirus neutralisation assay (PsVNA) as described previously.6 No SARS-CoV-2 neutralising antibodies were detected in plasma at 4 weeks after the second mRNA-1273 …

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  • Handling editor Josef S Smolen

  • Contributors SK and HG designed the research. BG and HG provided clinical specimens and unblinded clinical data. YL and SK performed the research. SK, HG and BG contributed to writing.

  • Funding Supported by FDA’s Medical Countermeasures Initiative (MCMi) grant #OCET 2021-1565 to SK.

  • Disclaimer The funders had no role in study design, data collection and analysis, decision to publish or preparation of the manuscript. The content of this publication does not necessarily reflect the views or policies of the Department of Health and Human Services, nor does mention of trade names, commercial products or organisations imply endorsement by the US government.

  • Competing interests None declared.

  • Patient and public involvement Patients and/or the public were involved in the design, or conduct, or reporting, or dissemination plans of this research. Refer to the Methods section for further details.

  • Provenance and peer review Not commissioned; externally peer reviewed.