Rate of Recurrent Guillain-Barré Syndrome After mRNA COVID-19 Vaccine BNT162b2 | Demyelinating Disorders | JAMA Neurology | JAMA Network
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Table.  Patients Who Have Been Previously Diagnosed With GBS and Hospital Visits Following COVID-19 Vaccine Administrationa
Patients Who Have Been Previously Diagnosed With GBS and Hospital Visits Following COVID-19 Vaccine Administrationa
1.
Israeli Ministry of Health. Coronavirus (COVID-19) vaccines. Accessed April 30, 2021. https://www.health.gov.il/UnitsOffice/HD/PH/epidemiology/td/docs/365_Corona.pdff.
2.
Centers for Disease Control and Prevention. COVID-19 vaccines for people with underlying medical conditions. Accessed April 27, 2021. https://www.cdc.gov/coronavirus/2019-ancov/vaccines/recommendations/underlying-conditions.html.
3.
Vellozzi  C, Iqbal  S, Broder  K.  Guillain-Barre syndrome, influenza, and influenza vaccination: the epidemiologic evidence.   Clin Infect Dis. 2014;58(8):1149-1155. doi:10.1093/cid/ciu005PubMedGoogle ScholarCrossref
4.
Martín Arias  LH, Sanz  R, Sáinz  M, Treceño  C, Carvajal  A.  Guillain-Barré syndrome and influenza vaccines: a meta-analysis.   Vaccine. 2015;33(31):3773-3778. doi:10.1016/j.vaccine.2015.05.013PubMedGoogle ScholarCrossref
5.
Lunn  MP, Cornblath  DR, Jacobs  BC,  et al.  COVID-19 vaccine and Guillain-Barré syndrome: let’s not leap to associations.   Brain. 2021;144(2):357-360. doi:10.1093/brain/awaa444PubMedGoogle ScholarCrossref
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    .Decision-makers must not stop the vaccination programs against COVID-19
    Calixto Machado, MD, PhD, FAAN | Institute of Neurology and Neurosurgery, Havana, Cuba
    Guillain-Barré Syndrome (GBS) is an acute, post-infectious immune-mediated polyradiculoneuropathy typically arising a few days to 6 weeks after bacterial or viral infections, including Campylobacter jejuni, Haemophilus influenzae, Mycoplasma pneumoniae, influenza, Epstein-Barr virus, cytomegalovirus, and more recently, Zika virus.1,2
    The possibility of SARS-CoV-2 driving a global spike in GBS has unsurprisingly been eagerly monitored, with many cases and small series already published asserting a causal link. However, a surge in GBS cases after the SARS-CoV-2 pandemic has not been detected as it happened in the Zika virus pandemic. 2 Moreover, several reports have tried to correlate COVID-19 vaccines with GBS.
    Nonetheless, Thus far, there has been no evidence of an increased risk of GBS resulting from either COVID-19 infection or COVID-19 vaccines. It is as yet not possible to conclude any significant association between COVID-19 vaccination and GBS.1
    The history of medicine has many examples of reluctances to vaccination programs, in some cases based on proved evidence like the “swine flu” vaccines in the US at the end of the 1970s, causing the program to be halted.3 Regarding the autism spectrum disorders (ASD), beliefs that the measles-mumps-rubella (MMR) vaccine causes autism still persist, leading to lower vaccination levels, despite several authors demonstrating no link between the MMR vaccine and ASD.2
    It is also curious that a significant percentage of the population in the US is currently reluctant to receive COVID-19 vaccines, many times without a convincing explanation. Most COVID-19 vaccinations are based on the SARS-CoV-2 spike protein. The SARS-CoV-2 messenger RNA (mRNA) vaccines BNT162b2 (Pfizer-BioNTech) and mRNA-1273 (Moderna) have each shown more than 90% efficacy in preventing COVID-19 disease and 100 % for averting a severe illness.4
    The vaccination effort against this terrible pandemic is the most extensive mass vaccination campaign ever undertaken. Therefore, it is inevitable that thousands of sporadic cases of GBS or another rare neurological disease caused by other factors will appear temporally associated with COVID-19 vaccination. But, as any statistician can confirm, this cannot be considered causal.1
    In medicine, there is always a premise: the risk-benefit balance. COVID-19 vaccination programs have extensively shown that vaccines are the most potent weapons to defeat this disease until now. Decision-makers must not stop the vaccination programs unless there is clear evidence of a genuine excess of cases that have been carefully calculated. Even then, only if it is of sufficient magnitude to exceed the benefits of vaccination.1

    References
    1. Lunn MP, Carr AC, Keddie S, Pakpoor J, Pipis M, Willison HJ. Reply: Guillain-Barre syndrome, SARS-CoV-2 and molecular mimicry and Ongoing challenges in unravelling the association between COVID-19 and Guillain-Barre syndrome and Unclear association between COVID-19 and Guillain-Barre syndrome and Currently available data regarding the potential association between COVID-19 and Guillain-Barre syndrome. Brain. 2021;144(5):e47.
    2. Ophir Y, Jamieson KH. Intentions to use a novel Zika vaccine: the effects of misbeliefs about the MMR vaccine and perceptions about Zika. J Public Health (Oxf). 2018;40(4):e531-e537.
    3. Langmuir AD. Guillain-Barré Syndrome: The Swine Influenza Virus Vaccine Incident in the United States of America, 1976–77: Preliminary Communication. 1979;72(9):660-669.
    4. (CDC) CfDCaP. In: Centers for Disease Control and Prevention; 2021: https://www.cdc.g
    CONFLICT OF INTEREST: None Reported
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    Research Letter
    September 1, 2021

    Rate of Recurrent Guillain-Barré Syndrome After mRNA COVID-19 Vaccine BNT162b2

    Author Affiliations
    • 1Health Division, Maccabi Healthcare Services, Tel Aviv, Israel
    • 2Internal Medicine and Infectious Diseases, Maccabi Healthcare Services, Haifa, Israel
    JAMA Neurol. Published online September 1, 2021. doi:10.1001/jamaneurol.2021.3287

    On December 20, 2020, Israel initiated a national vaccination program against COVID-19. National and international vaccine guidelines did not preclude patients who have previously been diagnosed with Guillian-Barré Syndrome (GBS) from receiving the COVID-19 vaccine.1,2 However, previous association between vaccines and GBS raises the level of caution and hesitancy among clinicians and patients regarding administering the vaccine.3-5 The aim of this study was to establish rates of GBS relapse among Pfizer-BioNTech BNT162b2 vaccine receivers.

    Methods

    We performed a descriptive retrospective cohort study in the second largest health maintenance organization in Israel, Maccabi Healthcare Services (MHS), serving more than 2.5 million members, representing a quarter of the Israeli population. MHS has a nationwide centralized database, spanning more than 20 years, that includes extensive clinic and hospital diagnoses as well as vaccine registries. Data from the medical records were retrieved for all members who were recorded as having an International Classification of Diseases, Ninth Revision (ICD-9) diagnosis code for GBS (code 357.0). To ensure that the correct patients with GBS diagnosis were identified, manual review of the electronic medical record was conducted of all cases. The criterion for a GBS case was a diagnosis given by a hospital neurology department. Data collected included information regarding GBS, vaccine administration, medical care encounters, and hospital visits after receiving at least 1 vaccine dose. The study was approved by the MHS institutional review board (0029-21-MHS).

    Results

    Seven hundred two cases of GBS were identified between 2000 and 2020. Three hundred thirty-seven (48%) were women and the mean (SD) age was 53 (18) years. Of these patients, 579 had received 1 vaccine dose and 539 received 2 doses. A median (IQR) of 108 (82 to 122) days’ follow-up was obtained after the first vaccine administration and 90 (64 to 100) after the second. Of 40 patients who received only 1 dose of vaccine, 38 had COVID-19 previously and needed only 1 dose according to Israeli Ministry of Health guidelines.1

    Forty-eight of 579 patients were seen in a hospital (Table). Twenty-four had visited the emergency department and were released after less than 24 hours for transient non-neurologic concerns and the others needed admission for a variety of conditions. Only 5 were referred to the hospital for neurological concerns. Two patients had paresthesia, 1 patient had several months' duration of tremor, and 1 patient was evaluated for a seizure. They were released from the emergency department within a few hours without further medical observation. The fifth patient had a history of previously diagnosed GBS and was treated with plasmapheresis with no residual neurological symptoms. The patient had progressive leg weakness and paresthesia that started shortly after receiving the first vaccine dose, which lasted for several weeks. Several days following administration of the second vaccine dose, the patient was admitted to the hospital. The clinical picture and electrodiagnostic evidence were suggestive of sensorimotor demyelinating polyneuropathy. The patient was treated with plasmapheresis in the hospital and, by the day of discharge, had a significant improvement in her lower limb weakness and only minor proximal weakness without any sensory disturbance.

    Discussion

    To our knowledge, this is the first study assessing safety of messenger RNA COVID-19 vaccine in previously diagnosed cases of GBS. In this cohort study, which included 702 patients, only 1 needed short medical care for relapse of previous syndrome, which represents a minimal risk.

    The study has limitations. First, it relies on medical records and diagnosis. However, a meticulous medical record inspection was conducted to validate all cases. Second, this study included only hospital visits, which may underestimate other symptoms that presented only in the community. Nevertheless, any significant serious neurologic concern would probably have been evaluated in a hospital setting.

    The Israeli Ministry of Health and national immunization guidelines did not include a history of GBS as a precaution or contraindication to receiving the COVID-19 vaccine, and our study supports this approach.

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    Article Information

    Accepted for Publication: August 5, 2021.

    Published Online: September 1, 2021. doi:10.1001/jamaneurol.2021.3287

    Corresponding Author: Shirley Shapiro Ben David, MD, Maccabi Healthcare Services, Hamered 27, Tel Viv 6812509, Israel (shirley.shap@gmail.com).

    Author Contributions: Dr Shapiro Ben David had full access to all of the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis.

    Concept and design: Shapiro Ben David.

    Acquisition, analysis, or interpretation of data: All authors.

    Drafting of the manuscript: All authors.

    Critical revision of the manuscript for important intellectual content: Rahamim-Cohen.

    Supervision: Rahamim-Cohen.

    Conflict of Interest Disclosures: None reported.

    References
    1.
    Israeli Ministry of Health. Coronavirus (COVID-19) vaccines. Accessed April 30, 2021. https://www.health.gov.il/UnitsOffice/HD/PH/epidemiology/td/docs/365_Corona.pdff.
    2.
    Centers for Disease Control and Prevention. COVID-19 vaccines for people with underlying medical conditions. Accessed April 27, 2021. https://www.cdc.gov/coronavirus/2019-ancov/vaccines/recommendations/underlying-conditions.html.
    3.
    Vellozzi  C, Iqbal  S, Broder  K.  Guillain-Barre syndrome, influenza, and influenza vaccination: the epidemiologic evidence.   Clin Infect Dis. 2014;58(8):1149-1155. doi:10.1093/cid/ciu005PubMedGoogle ScholarCrossref
    4.
    Martín Arias  LH, Sanz  R, Sáinz  M, Treceño  C, Carvajal  A.  Guillain-Barré syndrome and influenza vaccines: a meta-analysis.   Vaccine. 2015;33(31):3773-3778. doi:10.1016/j.vaccine.2015.05.013PubMedGoogle ScholarCrossref
    5.
    Lunn  MP, Cornblath  DR, Jacobs  BC,  et al.  COVID-19 vaccine and Guillain-Barré syndrome: let’s not leap to associations.   Brain. 2021;144(2):357-360. doi:10.1093/brain/awaa444PubMedGoogle ScholarCrossref
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