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 be resumed by Saturday morning.
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 8 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 10-4 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 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 United States have received at least one shot of a coronavirus vaccine. But daily doses have fallen by almost 13% since last week, from a peak of 3.38 million daily doses on average to about 2.95 million. It is difficult to say what is driving the decrease. Even before use of the Johnson & Johnson vaccine was paused, shipments had dipped because of a factory error that had ruined millions of doses. Walensky said the federal government planned to emphasize the vaccine’s safety to Americans who might be hesitant to take it after the pause.
“We have to do extraordinary outreach to clinicians, as we have been doing this past week,” she said. “We already have plans to start that on Monday, to public health officials. And then we have to do extraordinary outreach to patients, to meet people where they’re at, to educate them.” She said the CDC had talked to health providers for young women, including the American College of Obstetricians and Gynecologists. The pause and investigation into the rare clotting disorder, she added, should give the public confidence in the system used to monitor vaccine safety.
In the CDC panel analysis, women between 30 and 39 appear to be at greatest risk, with 11.8 cases per 1 million doses given. Among women 18 to 49, there have been seven cases per 1 million doses. The clotting condition, which the CDC is calling thrombosis with thrombocytopenic syndrome, causes severe blood clots and a tendency to bleed at the same time, because of abnormally low levels of platelets, a blood component involved in clotting. The disorder is “rare but clinically serious,” Dr. Tom Shimabukuro, deputy director of the CDC’s immunization safety office, said at the meeting.
Additional potential causes, including some in men, are being reviewed. A 25-year-old man who participated in a clinical trial of the vaccine also developed the disorder. Symptoms closely resemble a rare syndrome that can be caused by heparin, a widely used blood thinner, Dr. Michael Streiff, a hematologist at Johns Hopkins University, told the panel. Heparin, typically used to treat blood clots, should not be given to these patients, he said.
The symptoms include severe headaches, abdominal pain, leg pain or shortness of breath. Those problems generally do not set in before about six days after the vaccination. Once the symptoms occur, treatment should begin as soon as possible, because it can worsen rapidly, researchers say. Marks, the FDA regulator, said the agency was recommending blood thinners other than heparin, and a blood product called intravenous immune globulin, which can help ease the immune reaction causing the problem. “That appears to reverse this process,” he said.
Researchers suspect that in these rare cases, the vaccine causes an intense reaction by the patient’s immune system, which churns out antibodies that activate platelets, a blood component needed for clotting. Why this occurs in some people is not known, and experts say that they have so far been unable to identify traits or underlying conditions that may make some people susceptible. A poll released this week from Ipsos/Axios found that the pause itself boosted confidence in federal vaccine monitors, with 81% saying that the CDC and the FDA acted appropriately. The sentiment was unusually bipartisan, with 87% of Republicans and 91% of Democrats sharing that view.
Measuring the impact of the Johnson & Johnson pause is tricky, said Liz Hamel, vice president of public opinion and research survey at the Kaiser Family Foundation. “You don’t know what the trajectory of the vaccine uptake would have been in the absence of this pause.” The biggest challenge ahead, she noted, will be the creation of vaccine-confidence messages that resonate with the public. “We don’t know whether it has increased hesitancy among women in particular,” she said.