The U.S. Food and Drug Administration has added a new warning to Johnson & Johnson’s single-dose COVID-19 vaccine. The FDA reports about 100 cases of the rare autoimmune disorder Guillain-Barré among 12.8 million J&J vaccine recipients in the U.S. The cases were mostly in men aged 50 and older, with one death reported. The FDA said in a statement the benefits of the vaccine still clearly outweigh the risks. A recent study by the Cleveland Clinic found over 99.7% of people hospitalized with COVID-19 were unvaccinated.