Health Alert
INCREASED RISK OF GUILAIN BARRE SYNDROME FOLLOWING J&J VACCINE ADMINISTRATION

The Delaware Division of Public Health (DPH) is issuing this health alert to advise the medical community that on July 12, 2021, the U.S. Food and Drug Administration (FDA) amended the emergency use authorization (EUA) for the Janssen (Johnson & Johnson) COVID-19 vaccine for the prevention of coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) to include a warning of the possible increased risk of a rare neurological complication known as Guillain-Barré syndrome (GBS).

Summary

Reports of adverse events following use of the Janssen COVID-19 Vaccine under emergency use authorization suggest an increased risk of GBS during the 42 days following vaccination.

One case of GBS was reported in a vaccinated participant in the Johnson & Johnson Janssen COVID-19 vaccine clinical trial (compared to one GBS case among those who received placebo). Of the 12.5 million Americans who received this vaccine, about 100 people reported having GBS in the Vaccine Adverse Event Reporting System (VAERS). Of these reports, 95 of them were serious and required hospitalization, and there was one reported death.

To date, no cases of GBS have been reported following vaccination in participants in the mRNA COVID-19 vaccine clinical trials. With few exceptions, the independent Advisory Committee on Immunization Practices (ACIP) general best practice guidelines for immunization do not include a history of GBS as a precaution to vaccination with other vaccines.

Background

Anyone can develop GBS, but people older than 50 are at greatest risk. In addition, about two-thirds of people who get GBS do so several days or weeks after they have been sick with diarrhea or a lung or sinus illness. Infection with the bacteria Campylobacter jejuni, which causes gastroenteritis (including symptoms of nausea, vomiting and diarrhea), is one of the most common risk factors for GBS. People also can develop GBS after having the flu or other infections such as cytomegalovirus and Epstein Barr virus, and GBS has been reported following infection with COVID-19 as well. On very rare occasions, people develop GBS in the days or weeks after getting a vaccination.

GBS is an acquired demyelinating polyneuropathy that often begins in the lower extremities and ascends over time with loss of reflexes, causing muscle weakness, or in the most severe cases, paralysis. Diagnosis is often made by lumbar puncture demonstrating albuminocytologic dissociation within cerebral spinal fluid, however electromyography in the setting of a consistent clinical picture may also be diagnostic. Often, GBS is reversible. Treatment with plasma exchange or intravenous immune globulin (IVIG) is indicated for most patients with GBS because these treatments accelerate recovery.

Reporting

GBS is a reportable event in Delaware. 

DHSS/DPH, requests clinicians report all GBS cases, including those that can be associated to a recent vaccination.

Promptly report suspected (without waiting for laboratory confirmation) and confirmed cases of any notifiable disease to the DPH Office of Infectious Disease Epidemiology (OIDE) at 302-744-4990 (normal business hours) or 1-888-295-5156 (outside of normal business hours), fax to 302-223-1540, or email to reportdisease@delaware.gov. 

You may also complete a Notifiable Disease Report PDF Form and mail the form as directed, fax the form to DPH at 302-223-7540, or email to reportdisease@delaware.gov. The form and list of notifiable diseases can be found online at https://dhss.delaware.gov/dhss/dph/dpc/rptdisease.html.

Reporting enables appropriate public health follow-up for your patients, helps identify outbreaks, and provides a better understanding of disease trends in Delaware.

All Delaware physicians, laboratories and other health care providers are required by regulations to report patients with conditions, either lab-confirmed or clinical diagnoses, to OIDE as listed at Reportable Diseases in Delaware - Delaware Health and Social Services - State of Delaware.

Recommendations

For Clinicians:

1. Maintain a high index of suspicion for symptoms that might represent GBS in patients who have received the J&J COVID-19 vaccine, within the past 42 days, including but not limited to lower extremity weakness, difficulty with ambulation, or other unexplained neurologic complaints.
2. Report adverse events to VAERS, including serious and life-threatening adverse events and deaths in patients following receipt of COVID-19 vaccines as required under the Emergency Use Authorizations for COVID-19 vaccines.

Additional Information

FDA EUA for Janssen Vaccine: https://www.fda.gov/media/146304/download