The Food and Drug Administration (FDA) announced revisions to Johnson & Johnson's
Based on an analysis of Vaccine Adverse Event Reporting data, a federal monitoring system for patients and healthcare professionals to report adverse effects from vaccines, there have been 100 preliminary reports of GBS among the 12.5 million doses administered in the United States. Of those reports, 95% were considered serious and required hospitalization, the FDA said. There was also one reported death.
"Although the available evidence suggests an associations between the Janssen vaccine and increased risk of GBS, it is insufficient to establish a causal relationship," the FDA stated, referring to Johnson & Johnson's pharmaceutical arm. The federal agency continued to monties reports of GBS following the vaccinated with the J&J shot.
GBS is a neurological disorder in which the body's immune system damages nerve cells, causing muscle weakness, or in severe cases, paralysis, according to the FDA. An estimated 3,000 to 6,000 Americans develop GBS each year, with most fully recovering from the disorder.
While regulators have found that the chances of developing the condition naturally are low, they appear to be three to five times greater following inoculation with the J&J vaccine than among the general U.S. population, according to the FDA.
Increased risk for GBS has also been observed following other vaccines, including certain seasonal flu vaccines. No relationship has been found between GBS and vaccines developed by Pfizer
The updated fact sheet for the J&J vaccine includes a warning about GBS. Additionally, the fact sheet noted that vaccine recipients should seek medical attention right away if they develop any of the following symptoms after receiving the J&J vaccine: weakness or tingling sensations, especially in the legs or arms, that's 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.
This new safety concern follows J&J's vaccine being linked to rare blood clots with low platelet levels following inoculation, which caused the vaccine's use to be halted for several days while federal regulators investigated the possible connection. The vaccine's fact sheet also warns of this potential side effect on its fact sheet.
Despite the potential risks, the FDA still recommends use of the vaccine, reiterating that all known and potential benefits "clearly outweigh" all known and possible side effects.
Only about 8% of the fully vaccinated population in the U.S. have received the one-dose J&J vaccine, according to Centers for Disease Control and Prevention (CDC) data. By contrast, about 147 million American have been fully vaccinated with either Pfizer-BioNTech or Moderna vaccines, both of which require two doses.
