Use of the one-shot Johnson & Johnson Covid vaccine will resume within days, but with a warning added to its label about the risk for a rare blood-clotting disorder that has occurred among young women, the Food and Drug Administration announced on Friday.
Concerns about the disorder had led to a pause in the use of the vaccine that began 10 days earlier.
The FDA decided against limiting the vaccine’s use by age or gender, although some European countries have imposed such restrictions on a vaccine made by AstraZeneca because of a similar clotting disorder.
Federal health officials said information about the disorder would also be provided at vaccination sites, and Dr Peter Marks, the FDA’s top vaccine regulator, predicted that the shots could resume.
The company supported adding the warning label and agreed on its language, said Dr Joanne Waldstreicher, the chief medical officer at Johnson & Johnson. The label notes that “most cases” of the clotting disorder have occurred in women between 18 and 49 years old.
The suspension came after officials learned that six women had developed a severe disorder that led to blood clots in their brains within about two weeks of receiving the vaccine. One died.
The pause was widely considered a blow to national and global vaccination efforts and removed an effective vaccine that many states and countries had counted on to deploy in hard-to-reach places. Unlike the vaccines made by Pfizer-BioNTech and Moderna, Johnson & Johnson’s vaccine requires only one shot and is easier to store and distribute because it does not require extremely cold temperatures.
At an advisory panel meeting about the blood-clotting issue on Friday, the CDC reported that it had identified a total of 15 cases, including three deaths.
But the risk is considered extremely small — nearly eight million Americans have received the Johnson & Johnson vaccine — and the panel decided that the vaccine’s benefits far outweighed its risks. The panel also concluded that failing to use it would lead to more deaths than the clotting disorder might cause.
The panel voted 10 to 4 to resume use of the vaccine with the warning label. Some of the panel members who voted “no” wanted a more prominent warning about the risk to younger women and the availability of other Covid vaccines that do not appear to pose the same risk.
Lifting the pause will allow states to restart vaccination efforts among hard-to-reach populations like rural Americans, migrants and elderly people who have difficulty leaving their homes. Their access to the vaccine had been hampered by the suspension, which left roughly 10 million doses sitting on shelves.
In Wisconsin, officials said they intended to begin using their Johnson & Johnson doses as soon as possible.
“We have also heard from a number of vaccinators who say that there are lots of people who don’t like needles,” said Julie Willems Van Dijk, the deputy secretary of the state health department. “They just want to get the vaccine that requires them to have one shot versus two shots.”
Dr Rochelle P. Walensky, the CDC director, said governors in a number of states had expressed intense interest in resuming use of the shots.
“They wondered why we had paused, and they were anxious to have this back, have an opportunity for a single-dose vaccine, for a one-and-done possibility,” she said.
About 135.8 million people in the US have received at least one shot of a coronavirus vaccine. But daily doses have fallen by almost 13 per cent since last week, from a peak of 3.38 million daily doses on average to about 2.95 million. Even before use of the Johnson & Johnson vaccine was paused, shipments had dipped because of a factory error.
New York Times News Service
