as early as July 13, according to multiple media reports.
Although the FDA is projected to add the new warning to the labeling for the vaccine, the agency still calculates the benefit of vaccination with the J&J product continues to outweigh the risk. Benefits include protection against the Delta variant and serious COVID-19 outcomes.
More than 100 cases of Guillain-Barré reported to the Vaccine Adverse Event Reporting System, a federal program for reporting vaccine issues, spurred the FDA to act.
Men and people older than 50 appear to be at highest risk, according to reports of a July 12 Centers for Disease Control and Prevention statement. The CDC also revealed that most cases occur about 2 weeks following immunization.
Guillain-Barré syndrome often causes muscle weakness and sometimes temporary paralysis. Most people who develop the rare syndrome recover.
Such was not the case for a 57-year-old man, the New York Times reported July 12. He had a history of both a heart attack and stroke in the previous 4 years and died in April after vaccination with the J&J vaccine and developing Guillain-Barré.
The new warning comes in the wake of a number of setbacks for the company’s COVID-19 vaccine. On April 13, the FDA and CDC both recommended a 10-day pause on administration of the J&J vaccine after reports of rare blood clot events emerged. In mid-June, the FDA requested that Johnson and Johnson discard millions of vaccine doses produced at a manufacturing facility in Baltimore.
The mRNA vaccines from Pfizer/BioNTech and Moderna are not affected by the new FDA warning.
The Biden administration is expected to make a formal announcement of the new warning for the Johnson and Johnson vaccine as early as July 13, the Times reports.
A version of this article first appeared on Medscape.com.