FDA warns of an increased risk of Guillain-Barré Syndrome following vaccination with the J&J vaccine

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The Food and Drug Administration today revised the Janssen COVID-19 vaccine fact sheet for healthcare providers to include a warning of an observed increased risk of Guillain-Barré Syndrome following vaccination with the Johnson & Johnson vaccine, according to an FDA spokesperson. 

GBS is a neurological disorder in which the body's immune system damages nerve cells, causing muscle weakness, or in the most severe cases, paralysis. 

Based on an analysis of Vaccine Adverse Event Reporting (VAERS) data, there have been 100 preliminary reports following vaccination with the Janssen vaccine after approximately 12.5 million doses administered. Of these reports, 95 of them were serious and required hospitalization, the FDA official said. There has been one reported death. 

Reports of GBS after receipt of the J&J/Janssen COVID-19 vaccine in the VAERS – a self-reporting system – are rare, but do likely indicate a small possible risk of this side effect following this vaccine, the Centers for Disease Control and Prevention said by statement. These cases have largely been reported about two weeks after vaccination and mostly in males, many aged 50 years and older, the CDC said.  

The warning in the Fact Sheet for Healthcare Providers Administering Vaccine notes that reports of adverse events suggest an increased risk of GBS. 

Each year in the United States, an estimated 3,000 to 6,000 people develop GBS. Most people fully recover from the disorder, the FDA said. GBS has also been observed at an increased rate associated with certain other vaccines, including certain seasonal influenza vaccines and a vaccine to prevent shingles. 

However, no similar risk has been identified with the Moderna and Pfizer-BioNTech COVID-19 vaccines, the FDA and CDC said. Available data show over 321 million doses of the Pfizer and Moderna vaccines administered in the United States. 

Although the available evidence suggests an association between the Janssen vaccine and increased risk of GBS, it is insufficient to establish a causal relationship, the FDA said.

This issue will be discussed as part of an upcoming Advisory Committee on Immunization Practices meeting, said the CDC, though no date has been given for the upcoming meeting.

The Fact Sheet for Recipients and Caregivers notes that vaccine recipients should seek medical attention right away if they develop any of the following symptoms after receiving the Janssen COVID-19 vaccine: weakness or tingling sensations, especially in the legs or arms, that is worsening and spreading to other parts of the body; difficulty walking; difficulty with facial movements, including speaking, chewing or swallowing; double vision or inability to move eyes; or difficulty with bladder control or bowel function.

The CDC said in a statement: "COVID-19 vaccine safety is a top priority for the federal government, and we take all reports of health problems following COVID-19 vaccination very seriously. CDC and FDA are monitoring reports of Guillain-Barré Syndrome after receiving Johnson & Johnson's Janssen (J&J/Janssen) COVID-19 vaccine. GBS is a neurological disorder in which the body's immune system damages nerve cells, causing muscle weakness or in the most severe cases paralysis. Each year in the United States, an estimated 3,000 to 6,000 people develop GBS; it is typically triggered by a respiratory or gastrointestinal infection. Most people fully recover from GBS." 

WHY THIS MATTERS

The CDC and FDA continue to promote vaccination for anyone 12 years and older, as the Biden Administration struggles with its goal to get 70% of the population vaccinated.

The FDA has evaluated the available information for the Janssen COVID-19 vaccine and continues to find the known and potential benefits clearly outweigh the known and potential risks, the spokesperson said.

People who are fully vaccinated are protected from severe disease and death, including from the variants currently circulating in the country, such as Delta, according to the CDC and FDA. Virtually all COVID-19 hospitalizations and deaths are among those who are unvaccinated. 

Currently, the FDA and the CDC are not recommending a booster shot for Americans who have been fully vaccinated. The FDA, CDC and the National Institutes of Health are engaged in a science-based, rigorous process to consider whether or when a booster might be necessary, they said.

THE LARGER TREND

This is the latest setback for the J&J vaccine. When it received emergency use authorization in February, it was touted for being a one-shot vaccine. It did not require the two shots that the Pfizer and Moderna vaccines did.

In April, the FDA and CDC paused use of the J&J vaccine due to rare blood-clotting concerns. Use resumed later that month after the FDA and CDC determined that the benefits of being vaccinated against COVID-19 outweighed the risks.

In May, the CDC reported 11 more cases of serious blood clots among Americans who received the Johnson & Johnson COVID-19 vaccine, bringing the total number of cases at that time to 28 out of about 8.7 million, an uptick from the 17 cases that were recorded as of April 25.

No blood-clotting cases were linked to the Pfizer or Moderna vaccines.

Twitter: @SusanJMorse
Email the writer: susan.morse@himssmedia.com