coronavirus

FDA Warning for Guillain–Barre Syndrome and the Johnson & Johnson COVID-19 Vaccine

A Statement from the Foundation Global Medical Advisory Board

The Washington Post and New York Times published on July 12, 2021 articles of a report by the FDA regarding cases of purported GBS after receiving the Johnson and Johnson COVID 19 vaccine.  Approximately 100 reports of suspected GBS were experienced by 12.8 million subjects who received this vaccine.  The cases were more common in men and patients above the age of 50.

It is important to understand that the reporting system used was the VAERS system (Vaccine Adverse Event Reporting System). This is a passive reporting system whereby patients, families and health care providers can report a case of GBS.  In past studies, patients were reported as having GBS when the disease was later determined to be another disorder.  Further analysis of the data will be necessary to determine if all of the patients truly developed GBS.

The CDC will be conducting shortly a meeting of their Advisory Committee on Immunization Practice  to analyze the data thoroughly.  The Foundation will be attending this meeting on behalf of the GBS patient community. As this time, the FDA states there is not enough information to establish a causal relationship between the J&J vaccine and cases of GBS.

The FDA has reiterated its stance that the known and potential benefits of the J&J vaccine clearly outweigh the known potential risks of the vaccine.  The GBS/CIDP Foundation supports this stance.   One must keep in mind that the vaccine is highly effective against COVID 19 and the delta variant.  Approximately one third of adults in the United States have not been vaccinated and cases of COVID 19 have increased in several states.

More than 100 million adults in the United States have received the Pfizer and Moderna vaccines and no increased incidence of GBS has been found after those vaccinations.

No data exists to advise patients who have had GBS in the past to avoid the Covid 19 vaccines including the J&J vaccines.  If a patient has received any of the vaccines and developed symptoms of weakness, numbness, or gait difficulty he or she should seek immediate care.

COVID-19 Vaccines and the GBS|CIDP Community

The GBS|CIDP Foundation is committed to sharing the most accurate information from the world’s leading experts, many from our Global Medical Advisory Board. The COVID-19 situation changes daily and we will continue to share updates that are vetted by the experts in GBS. In addition, we are in regular contact with the FDA representing the patient voice in the top-level decision-making. We understand that there are many opinions creating confusion so please consider the source of your information before drawing conclusions.  As always, all decisions should be made with your personal physician based on your own health.

The information below is the most up to date available on Covid-19, vaccines, and the GBS|CIDP Community.

GMAB Statement on Vaccine Boosters and the GBS|CIDP Community

September 28, 2021

(This statement is provided by the GBS|CIDP Foundation Global Medical Advisory Board.  We also encourage you to contact your healthcare provider about whether it would be a good idea for you to have a third COVID19 vaccine dose.)

There has been much discussion about third shots or “booster shots” of certain COVID19 vaccines for individuals who are “immunocompromised.” GBS and CIDP and immune-mediated disorders. This means the immune system works incorrectly by attacking components of a person’s nerves (in GBS this occurs on a one-time basis; in CIDP this occurs on a recurring or continuing basis). Individuals with GBS or CIDP are not immunocompromised. “Immunocompromised” or “immunosuppressed” are terms that refer to situations where the immune system does not do its basic job of recognizing and fighting off infections (such as viruses). There is no evidence that persons who have or have had GBS or CIDP are immunocompromised simply on the basis of these disorders.

Some patients with CIDP may be immunocompromised secondary to medications given to them to treat their disease. This may be the case with prednisone or other cortisocteroids. Other medications that can suppress the immune system include Imuran (azathioprine), Cellcept (mycophenolate mofetil, methotrexate, Cytoxan (cyclophosphamide), and Rituxan (rituximab). If you are currently taking any of these medications (or have recently taken them) you should speak to your provider about whether you might be a candidate for an additional COVID19 vaccine dose. If you receive plasmapheresis or plasma exchange on a long-term, ongoing basis, you should speak to your provider about this as well.

Intravenous immunoglobulin (IVIG) or subcutaneous immunoglobulin (SCIG) do not suppress the immune system. If you are receiving either of these treatments you are not at increased risk of infection and there is no need for a third dose of vaccine.


Global Medical Advisory Boar (GMAB) Statement on Vaccines

October 13th, 2021

COVID19 vaccines are different from flu vaccines. We are not seeing evidence that COVID19 vaccines are more likely to cause GBS, even in individuals who have had GBS brought on by other vaccines. Therefore, we do not see prior GBS as a reason not to get a COVID19 vaccine. 


Rate of Recurrent Guillain-Barré Syndrome After mRNA COVID-19 Vaccine BNT162b2, (Jama Neurology)

September 1st, 2021

https://jamanetwork.com/journals/jamaneurology/fullarticle/2783708


Third dose of Vaccination for Immune Suppressed Patients

August 19, 2021

A statement from our Global Medical Advisory Board

On August 12th, the FDA authorized that a third dose of COVID-19 mRNA vaccines (Pfizer and Moderna) may be given to patients who are moderately or severely immunocompromised.  Patients who are considered immune-suppressed are those who are under active treatment for solid tumors or hematologic malignancies, solid tumor transplantations, stem cell transplantation, primary immune deficiencies, advance HIV infection, and patients who are receiving treatment with high dose corticosteroids such a prednisone, chemotherapy, and other biologic immunosuppressive agents. Immunoglobulin products including IVIG and SCIG are not immunosuppressive, and therefore patients with CIDP or GBS that are treated with only IVIG or SCIG do not meet the FDA’s recommendation for third vaccination at this time.

COVID-19 vaccines are safe and effective.  The GBS/CIDP global medical advisory board encourages eligible patients to proceed with booster vaccines in accordance with the FDA recommendations, and we encourage patients to discuss their immune status with their physician to determine if they meet the FDA’s vaccination recommendations.  If a patient received the first and second dose of vaccination without serious adverse effect, it is highly likely that a 3rd vaccination will also be well tolerated. Pfizer is approved for ages 12 years and older and Moderna for 18 years and older. Patients who have received a single dose of the Johnson & Johnson vaccine are not recommended to receive additional doses of vaccine at this time.


FDA Warning for Guillain–Barre Syndrome and the Johnson & Johnson COVID-19 Vaccine

July 13, 2021

A Statement from the Foundation Global Medical Advisory Board

The Washington Post and New York Times published on July 12, 2021 articles of a report by the FDA regarding cases of purported GBS after receiving the Johnson and Johnson COVID 19 vaccine.  Approximately 100 reports of suspected GBS were experienced by 12.8 million subjects who received this vaccine.  The cases were more common in men and patients above the age of 50.

It is important to understand that the reporting system used was the VAERS system (Vaccine Adverse Event Reporting System). This is a passive reporting system whereby patients, families and health care providers can report a case of GBS.  In past studies, patients were reported as having GBS when the disease was later determined to be another disorder.  Further analysis of the data will be necessary to determine if all of the patients truly developed GBS.

The CDC will be conducting shortly a meeting of their Advisory Committee on Immunization Practice  to analyze the data thoroughly.  The Foundation will be attending this meeting on behalf of the GBS patient community. As this time, the FDA states there is not enough information to establish a causal relationship between the J&J vaccine and cases of GBS.

The FDA has reiterated its stance that the known and potential benefits of the J&J vaccine clearly outweigh the known potential risks of the vaccine.  The GBS/CIDP Foundation supports this stance.   One must keep in mind that the vaccine is highly effective against COVID 19 and the delta variant.  Approximately one third of adults in the United States have not been vaccinated and cases of COVID 19 have increased in several states.

More than 100 million adults in the United States have received the Pfizer and Moderna vaccines and no increased incidence of GBS has been found after those vaccinations.

No data exists to advise patients who have had GBS in the past to avoid the Covid 19 vaccines including the J&J vaccines.  If a patient has received any of the vaccines and developed symptoms of weakness, numbness, or gait difficulty he or she should seek immediate care.

Statement on Vaccines and GBS

June 18, 2021

There is no evidence at the present time to suggest that ANY of the vaccines is associated with GBS in any significant numbers (with data only on AZ, Pfizer and Moderna from the UK). Multiple international surveillance systems are looking specifically for GBS as it is designated an Adverse Event of Special Interest, deemed so because of the small associated risks with influenza vaccines, as reported over many years. There are enough data to exclude any risk of GBS after vaccination to exclude a link at a rate of 1 per 100000 vaccines, but very large numbers of data need to be collated and carefully analysed to detect a risk at 1 per million vaccines where the background rate of GBS is 1 case per 50000 people per year, and higher in the older populations initially selected for vaccination.

At present, despite many millions of vaccinations in countries with extensive vaccination programmes such as the UK and the USA, no link has been identified. The risk of death or long term complications from COVID in adults still far exceeds the risk of any possible risk of GBS by several orders of magnitude.


Statement from the GMAB

May 24, 2021

The Foundation is in daily communication with our Global Medical Advisory Board with regard to news and updates on vaccination efficacy as it relates to GBS|CIDP and variants such as MMN.  The information below is the most current guidance available, and we will post updates on this page, if and when they become available. Please refer to the Centers for Disease Control for more information. https://www.eu-patient.eu/.


Ask The Experts Epsiode 9 – COVID-19 Vaccines and the GBS|CIDP Community

Featuring Dr. Peter Donofrio, Chairman of the Global Medical Advisory Board

Interested in viewing more Ask the Experts episodes? Visit https://www.gbs-cidp.org/ask-the-expert-videocast/


Foundation Global Medical Advisory Board statement on COVID vaccines for CIDP and MMN

January 21, 2021

No instances of CIDP or MMN were seen during clinical trials of the two vaccines. Neither the Centers for Disease Control and Prevention (CDC) nor the Food and Drug Administration (FDA) recommends against administration of the Covid 19 vaccine in patients with CIDP or MMN. One must keep in mind that the Covid Vaccine has only been used for 3-4 months outside of the clinical trials. While it is too early to offer definitive scientific statements on long-term adverse effects of the vaccines in CIDP or MMN, the early observations are reassuring. There is no scientific reason to think that the vaccine will cause problems in those patients with CIDP or MMN.

The CDC has also provided guidance on administration of the vaccine in patients that receive immunoglobulin therapies. The CDC has stated that administration of COVID-19 vaccines either simultaneously with or at any interval before or after receipt of an antibody-containing product (such as IVIG) is unlikely to substantially impair development of a protective antibody response. Thus, there is no recommended minimum interval between antibody therapies not specific to COVID-19 treatment and COVID-19 vaccination. More information can be found here – https://www.cdc.gov/vaccines/covid-19/info-by-product/clinical-considerations.html.


Dr. A.S. Fauci Corrects Previous Statement Regarding COVID-19 Vaccines & GBS

January 15, 2021

As a follow up to the Foundation’s published article from Dec. 20, 2020, “An Open Letter to Dr. A.S. Fauci, Director NIAID, NIH,” on January 15, 2021, Neurology Today published the following article “No Excess Risk for Neurologic Events Observed to Date from COVID-19 Vaccines.”  

Read the full article…

Persons who have previously had GBS may receive an mRNA COVID-19 vaccine

December 26, 2020

Please see the full article at https://www.cdc.gov/coronavirus/2019-ncov/vaccines/recommendations/underlying-conditions.html


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

Posted on December 20, 2020

(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,  https://doi.org/10.1093/infdis/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 (https://www.cdc.gov/vaccinesafety/concerns/guillain-barre-syndrome.html). 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

FDA approved package insert for Pfizer-Biontech COVID-19 vaccine, no mention of GBS as risk

Posted on December 17, 2020

This information is a public document and has been forwarded to the Foundations by our key opinion leaders in the GBS medical community. Of note, there is no mention of GBS in the vaccine insert, not as a risk nor as a vaccine to avoid for those who have had GBS or CIDP or are getting treated for CIDP. 


Statement from Professor Lunn in Reference to Newest Research on COVID-19, GBS, and Vaccines

Posted on December 15, 2020

In reaction to recent research published in Brain (click here to read more), Professor Lunn has offered this guidance in regards to our community:

One vaccine is not the same as another. The only reason that one advises against flu vaccine in someone with GBS is if they actually had GBS in the 6 week window after a flu vaccine and then only out of an abundance of caution which is not based on any real science.

The rate of GBS after flu vaccine in all assessed years after 1976 has been about 1 per million and no study has linked vaccination to recurrence of GBS or CIDP.

COVID vaccine is nothing like flu vaccine.
COVID doesn’t cause GBS  in any significant number if at all and there is no reason to suspect the vaccine would cause it.

Statement attributed to:
Professor Michael Lunn MA MBBS FRCP PhD
Consultant Neurologist and Professor of Clinical Neurology
National Hospital for Neurology and Neurosurgery
Queen Square, London

New Study Reveals No Association Between COVID-19 and Guillain-Barré Syndrome

Posted on December 14, 2020

A UK based epidemiological study, linked below, has found no causal association between COVID-19 infection and Guillain-Barré syndrome. This means that GBS developing at the same time or close to that of COVID-19 is most likely coincidental. A number of peripheral nerve world leading experts have also written a separate commentary, linked below, in light of this study to explain there is no reason for the COVID-19 vaccine to cause GBS, and that any cases that do occur around the time of vaccination are again most likely coincidental (as cases occur at around 1 per 100,000 people per year). They stress the importance of recognising this fact, and therefore not interrupting the COVID-19 vaccination programme when sporadic cases of GBS occur which will be inevitable.

Read full articles

Epidemiological and cohort study finds no association between COVID-19 and Guillain-Barré syndrome

No association between COVID-19 and Guillain-Barré syndrome


A statement from the GBS|CIDP Foundation International Global Medical Advisory Board, November 2020

Posted on December 4, 2020

The GBS|CIDP Foundation has received many questions about COVID-19 and its relationship to Guillain-Barré syndrome and CIDP. It is important to emphasize that presently we have no information on potential cause and effect. One must keep in mind that COVID-19 became known to most of us in March of this year and it is now November. We have limited data to draw a relationship between the virus and neurologic illness based on 8 months of observation. So far, there does not appear to be a high increase in GBS or CIDP following COVID infections. Even if there were a higher incidence, management would be preventative using frequent handwashing, physical distancing, and quarantining in the appropriate situation. If a patient developed GBS or CIDP after a COVID infection (or vaccine), the treatment would be the same as a patient who was not infected by the COVID virus (or vaccine).

There is no data so far to support that patients with prior GBS or CIDP are more prone to develop an infection with COVID.

In the past few weeks, 3 pharmaceutical companies have announced preliminary data on the protective effect of Covid vaccines. The protective effect of all of the vaccines is greater than 90% which is impressive  for a viral vaccine. The data is preliminary. It has not been fully reviewed by experts in the field of vaccine epidemiology or the FDA. The vaccines, if protective, will not be available for widespread use until late spring 2021. There are 4 more pharmaceutical companies working a vaccines for Covid 19 prevention.

The GBS|CIDP Foundation has also received questions about the safety of these COVID vaccines but this needs to be further investigated.  It would be appropriate at this time to summarize the stance of the GBS|CIDP Foundation regarding the seasonal flu vaccination.

Studies on the safety of flu vaccinations showed that for every 1,000,000 people who receive a flu vaccine, there is 1 (one) additional case of GBS. Normally in 1,000,000 people, there would be 20 cases of GBS (2/100,000) but if they all receive the flu vaccine, there would be 21. Who is the one person who got their GBS from the vaccine versus the 20 who would have gotten GBS anyway is not known. Thus, the GBS|CIDP Foundation advocates for receiving the yearly seasonal flu vaccination in the fall of each year. We can easily quantitate the benefits of 1,000,000 people getting the flu vaccine in terms of deaths/hospitalizations/days off work. Those benefits far outweigh the very small risk of GBS in patients who receive the flu vaccine (again 1 extra case for every 1,000,000 people vaccinated).

For more information on GBS and vaccination please see the CDC statement here: https://www.cdc.gov/vaccinesafety/concerns/guillain-barre-syndrome.html

Foundation Global Medical Advisory Board statement on COVID vaccines for CIDP and MMN

No instances of CIDP or MMN were seen during clinical trials of the two vaccines. Neither the Centers for Disease Control and Prevention (CDC) nor the Food and Drug Administration (FDA) recommends against administration of the Covid 19 vaccine in patients with CIDP or MMN. One must keep in mind that the Covid Vaccine has only been used for 4-6 weeks outside of the clinical trials and it is too early to offer scientific statements on long-term adverse effects of the vaccine in CIDP or MMN. Even though there is no long term data yet, there is no scientific reason to think that the vaccine will cause problems in those patients with CIDP or MMN. It is suggested to avoid vaccination in the week following IVIg, as this may potentially lessen the efficacy of the vaccination.

Dr. A.S. Fauci Corrects Previous Statement Regarding COVID-19 Vaccines & GBS

As a follow up to the Foundation’s published article from Dec. 20, 2020, “An Open Letter to Dr. A.S. Fauci, Director NIAID, NIH,” on January 15, 2021, Neurology Today published the following article “No Excess Risk for Neurologic Events Observed to Date from COVID-19 Vaccines.”  

Read the full article…

Persons who have previously had GBS may receive an mRNA COVID-19 vaccine

Adults of any age with certain underlying medical conditions are at increased risk for severe illness from the virus that causes COVID-19. mRNA COVID-19 vaccines may be administered to people with underlying medical conditions provided they have not had a severe allergic reaction to any of the ingredients in the vaccine. The following information aims to help people in the groups listed below make an informed decision about receiving the mRNA COVID-19 vaccine.

COVID-19 Vaccination Considerations for Persons with Underlying Medical Conditions

Please see the full article at: https://www.cdc.gov/coronavirus/2019-ncov/vaccines/recommendations/underlying-conditions.html