An Open Letter to Dr. A.S. Fauci, Director NIAID, NIH

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(Please see the following open letter statement authored by members of the GBS|CIDP Foundation International medical community as referenced.)

As clinician/scientists who have spent careers studying GBS, we are concerned that your statement on the “New Normal” television show about GBS and the COVID vaccine will have unintended consequences. Your statement is already all over the internet with many believing it to be true and acting accordingly.

On the television show, you stated that people who had GBS in the past should avoid the COVID vaccines as they may cause another episode of GBS. GBS was associated with the 1976/1977 swine flu vaccine at a rate of about 1 case/100,000 vaccinees. Since then, the only vaccine associated with GBS has been the flu vaccine at a rate of 1 extra case of GBS/1,000,000 vaccinees, that is, 21 cases when 20 are expected (Salmon et al. Guillain-Barré Syndrome Following Influenza Vaccines Affords Opportunity to Improve Vaccine Confidence. The Journal of Infectious Diseases, jiaa544, In a survey conducted in the Netherlands, people who had GBS in the past were queried about whether they had another GBS episode following seasonal flu vaccine, and the answer was an unequivocal ‘No’ in over 100 recovered GBS persons, many of whom received multiple flu vaccines over many years (Kuitwaard et al. Recurrences, vaccinations and long-term symptoms in GBS and CIDP. JPNS 2009;14:310–315). This study and the published literature does not support the idea that people who had GBS in the past should avoid vaccines in the future (Principi and Esposito. Vaccine-preventable diseases, vaccines and Guillain-Barre’ syndrome. Vaccine 2019;37:5544- 5550 and Hawken et al. Simulation Study of the Effect of Influenza and Influenza Vaccination on Risk of Acquiring Guillain-Barré Syndrome. Emerg Infect Dis 2015;21:224–231). In fact, the CDC recommends that everyone get the flu vaccine as the benefits of the vaccine outweigh the risks of GBS ( Any risk of GBS or that people with past GBS should avoid either the Pfizer-BioNTech COVID-19 Vaccine or the Moderna COVID-19 Vaccine is not listed in the FDA authorized package insert for either product.

To date, no cases of GBS have been associated with the COVID vaccines. However, the number of subjects in the clinical trials is too small to detect such a rare event, if it existed, and surveillance is ongoing. In the meantime, we would urge all to follow national and local guidelines about who should get the vaccine. At this time, there is no reason that those who had GBS in the past cannot get the current COVID vaccines. If they have concerns, they should speak to their local health care professionals.

Sincerely yours,

David R. Cornblath, MD, Johns Hopkins University School of Medicine, Baltimore, MD USA Peter D. Donofrio, M.D., Chair, Medical Advisory Board. GBS/CIDP Foundation

Kenneth C Gorson, MD, Tufts University, Boston, MA USA

Thomas Harbo, MD, PhD, Aarhus University Hospital, Aarhus, Denmark Richard Hughes, MD King’s College, London, UK

Bart C. Jacobs, MD, PhD, Erasmus MC University Medical Hospital, Rotterdam, The Netherlands

Richard A Lewis, MD, Cedars-Sinai Medical Center, Los Angeles, CA USA

Sonja Leonhard, MD, Erasmus MC University Medical Center, Rotterdam, The Netherlands Michael P Lunn, FRCP, PhD National Hospital for Neurology and Neurosurgery, London, UK Eduardo Nobile-Orazio, MD, PhD Milan University, Milan, Italy

Luis Querol, MD, PhD, Hospital de la Santa Creu i Sant Pau, Barcelona, Spain

Pieter A van Doorn, MD, PhD, Erasmus MC, University Medical Hospital, Rotterdam, The Netherlands Hugh Willison, MD, PhD Institute of Infection, Immunity and Inflammation, University of Glasgow, UK