- The Food and Drug Administration is adding a new safety warning for Johnson & Johnson's coronavirus vaccine after reports of very rare cases of a neurological condition called Guillain-Barré following immunization, the regulator said Monday.
- The warning will be the second added to the J&J vaccine, use of which in the U.S. was temporarily paused in April due to concerns over an unusual and uncommon blood clotting syndrome. The FDA and Centers for Disease Control and Prevention reviewed those cases and decided to resume the shot's rollout because the benefits outweighed the risks.
- The FDA reached a similar conclusion with this newly identified side effect and still supports use of J&J's vaccine. But the added caution could further impact use of the single-dose shot just as the Biden administration is pushing to lift vaccination rates. The government missed a goal of getting 70% of adults at least one shot by July 4, and is testing out new ideas like door-to-door campaigns to reach unvaccinated people.
J&J's vaccine was once viewed as a crucial tool in the U.S. vaccination campaign. But multiple setbacks during the shot's rollout have left it as a third option behind vaccines from Pfizer and Moderna. The temporary pause in April appeared to increase public doubts around J&J's vaccine, just as supplies of the other two greatly expanded.
Distribution was further slowed in the months following as tens of millions of doses made at a Baltimore factory run by contractor Emergent Biosolutions were contaminated due to a manufacturing mix-up.
Use of the shot has since trailed off, as has the overall rate of vaccinations administered each day in the U.S. News of the second safety warning could further complicate public health officials' messaging around the vaccine, despite the side effect's low frequency.
Guillain-Barré, a rare autoimmune condition affecting the peripheral nerves, has been reported in about 100 cases out of the approximately 12.5 million doses administered to date. Ninety-five of those cases were serious and required hospitalization. One death was reported, the agency said. Those cases typically occurred within two weeks of receiving the shot and were seen primarily in men, many over age 50, according to the FDA's statement.
The regulator added that the findings were enough to "suggest an association" between the vaccine and an increased risk of the disease, but not to "establish a causal relationship."
Between 3,000 to 6,000 cases of Guillain-Barré occur each year in the U.S., according to the FDA, and most people fully recover. The condition has also been associated with vaccines for the seasonal flu and shingles, the regulator said.
In a July 12 statement, J&J said the rate of Guillain-Barré in people given its vaccine "exceeds the background rate by a small degree."
The FDA and CDC are closely monitoring for side effects following vaccination with coronavirus shots, parsing reports from the hundreds of millions of doses given to date for potential red flags.
J&J's vaccine uses a non-replicating virus to deliver DNA coded to produce the coronavirus' distinctive "spike" protein to human cells, which in turn spurs an immune response that has been proven to prevent COVID-19 in people who receive the shot.
Pfizer's and Moderna's vaccines use small fat particles to deliver another type of genetic material to trigger production of the protein. Their vaccines haven't been linked to cases of Guillain-Barré, although both have been associated with rare cardiac side effects.