Rare Cases of Guillain-Barré Syndrome Reported in Janssen COVID-19 Vaccine

Johnson & Johnson released a statement providing more information on the risks and benefits of its single-shot COVID-19 vaccine.

The Janssen COVID-19 vaccine is linked to rare cases of Guillain-Barré syndrome, according to a recent news release from Johnson & Johnson. Only an estimated 100 cases among more than 12 million doses have been reported.1,2

The FDA updated its emergency use authorization (EUA) for the Janssen COVID-19 vaccine and provided a warning of the increased risk of Guillain-Barré syndrome for up to 42 days after vaccination.3

In April, the FDA and CDC placed a brief pause on administering the Janssen vaccine following reports of a rare but potentially lethal blood clotting condition called thrombosis with thrombocytopenia syndrome (TTS) in vaccinated individuals. On April 26, the agencies recommended resuming the vaccine after reviewing the known and potential risks and benefits. The FDA has also identified the risk of anaphylaxis and capillary leak, which are reflected in the EUA.

Still, the benefits of the vaccine outweigh the risks.

“Evidence has demonstrated that Johnson & Johnson’s single-shot COVID-19 vaccine offers protection against COVID-19 disease and prevents hospitalization and death, including in countries where viral variants are highly prevalent,” the news release stated.1 “A single-shot vaccine that provides this level of protection represents an important tool in the global fight against COVID-19, as we strive to help end this deadly pandemic.”

Guillan-Barré syndrome is a nervous system disorder that causes the immune system to damage nerve cells, resulting in muscle weakness and may lead to paralysis in severe cases. Johnson & Johnson advised that those who received the single-dose vaccine seek medical attention if they have:1

  • Weakness or tingling sensations, in the legs or arms in particular, that continues to worsen and spread
  • Difficulty walking
  • Difficulty speaking, chewing, swallowing, or moving their face
  • Difficulty with controlling bladder and bowel functions

To report adverse events of the Janssen vaccine to the FDA/CDC Vaccine Adverse Event Reporting System (VAERS), call 1-800-822-7967 or visit https://vaers.hhs.gov/reportevent.html.

The CDC Advisory Committee on Immunization Practices (ACIP) will be investigating the reports but has not yet included Guillain-Barré syndrome as a safety concern on their website.

References

  1. Johnson & Johnson Statement on COVID-19 Vaccine (7/12). News Release. Johnson & Johnson; July 12, 2021. Accessed July 14, 2021. https://www.jnj.com/johnson-johnson-july-12-statement-on-covid-19-vaccine.
  2. Pruitt-Young S. Johnson & Johnson Vaccine Is Linked To Neurological Disorder In Extremely Rare Cases. NPR. July 12, 2021. Accessed July 14, 2021. https://www.npr.org/sections/coronavirus-live-updates/2021/07/12/1015366005/johnson-johnson-vaccine-is-linked-to-neurological-disorder-in-extremely-rare-cas.
  3. Fact Sheet For Healthcare Providers Administering Vaccine (Vaccination Providers) Emergency Use Authorization (EUA) of the Janssen COVID-19 Vaccine To Prevent Coronavirus Disease 2019 (COVID-19). FDA. Revised July 8, 2021. Accessed July 14, 2021. https://www.fda.gov/media/146304/download.