(RxWiki News) The US Food and Drug Administration (FDA) has added a new warning to go with one of the approved COVID-19 vaccines.
The warning notes that some cases of Guillain-Barré Syndrome (GBS) have been observed in people who received the Johnson & Johnson (Janssen) COVID-19 vaccine.
This risk will now be noted in fact sheets that come with the one-dose Johnson & Johnson vaccine. The same risk has not been observed with the other two approved COVID-19 vaccines from Pfizer and Moderna.
The FDA reported that roughly 12.5 million doses of the Johnson & Johnson vaccine had been administered. Of those, 100 doses were linked to GBS in recipients. One of the recipients who developed GBS died, and 95 had to go to the hospital.
According to the Washington Post, most of the GBS cases linked to the vaccine were in men over age 50. Symptoms tended to be reported around two weeks after getting the vaccine.
Most people fully recover from GBS. This autoimmune disorder, which affects up to 6,000 people per year in the US, occurs when the immune system attacks the nerves. This condition can result in muscle weakness and paralysis in some cases.
The FDA noted that other vaccines, such as the flu vaccine, have been linked to a slightly increased risk of GBS.
Despite this new warning, the FDA maintains that the benefits of the Johnson & Johnson vaccine outweigh the potential risks.
"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 in a press release. "No similar signal has been identified with the Moderna and Pfizer-BioNTech COVID-19 vaccines."
Vaccination remains the best way to prevent COVID-19. If you have questions about COVID-19 vaccines, speak with your health care provider.
