The FDA and CDC have lifted the pause on Johnson & Johnson's COVID-19 vaccine in the U.S., determining that the benefits of the shot outweigh potential risks.
Several states, including Texas, Nevada and Massachusetts have resumed using the shot.
The CDC's vaccine advisory panel voted April 23 to recommend the U.S. resume use of the vaccine with a warning label stating the risk of rare but potentially dangerous blood clots.
Johnson & Johnson has agreed to add a warning label to the vaccine and has agreed on the language for a potential label with the FDA, according to Joanne Waldstreicher, Johnson & Johnson's chief medical adviser, said at the CDC's advisory panel meeting.
The FDA said there have been nine new confirmed cases of the rare blood-clotting disorder, called cerebral venous sinus thrombosis, or CVST, bringing the total number of confirmed cases to 15. All have occurred in women between the ages of 18 and 59. Three of the women have died, and seven are hospitalized, a CDC scientist said during the meeting.
Additional potential cases of CVST are being reviewed, including some in men, The New York Times reported. A CDC scientist also said there was one case in a 25-year-old man in a clinical trial.
CVST is a disorder in which blood clots, often in the brain, are combined with low levels of platelets. The overall risk of developing CVST after a Johnson & Johnson vaccine is extremely low, CDC officials said. Women between 30 and 39 years old appear to be at the greatest risk, with 11.8 cases of CVST reported per million doses given. There have been seven cases per million doses among women between 18 and 49 years old, according to the Times.
The FDA said it and the CDC have conducted extensive outreach to providers to ensure they're aware of the potential for adverse events after Johnson & Johnson's shot and know how to manage CVST.
CDC scientists projected April 23 that if Johnson & Johnson vaccinations resume for all adults, 26 to 45 cases of CVST would be expected in the next six months, the Times reported. They also forecasted 600 to 1,400 fewer COVID-19-related deaths during the same period.
More articles on pharmacy:
8 key COVID-19 vaccine administration errors
Patient groups to HHS: Do these 5 things to lower drug costs
1 dose of Pfizer, AstraZeneca COVID-19 vaccines cuts infection 65%, UK studies find