Use of Johnson & Johnson Covid’s one-time vaccine will resume within a few days, but with a warning on the label about the risk of a rare bleeding disorder that has occurred in young women, the Food and Drug Administration said on Friday.
Concerns about the disorder had resulted in a hiatus in vaccine use that had started 10 days earlier.
The FDA has chosen not to limit the use of the vaccine based on age or gender, although some European countries have placed such restrictions on a vaccine manufactured by AstraZeneca due to a similar coagulation disorder.
Federal health officials said information about the disorder was also being made available to vaccination centers, and Dr. Peter Marks, the FDA’s chief vaccine regulator, predicted the shooting could resume by Saturday morning.
The company supported adding the warning label and agreed to its language, said Dr. Joanne Waldstreicher, Chief Medical Officer at Johnson & Johnson. The label states that “most cases” of the coagulation disorder have occurred in women between the ages of 18 and 49.
The suspension came after officials learned that within about two weeks of receiving the vaccine, six women developed a serious disorder that caused blood clots in their brains. One died.
The hiatus was widely viewed as a blow to national and global vaccination efforts and removed an effective vaccine that many states and countries had expected to be used in hard-to-reach places. Unlike the Pfizer-BioNTech and Moderna vaccines, the Johnson & Johnson vaccine only takes one shot and is easier to store and distribute because it does not require extremely cold temperatures.
At a blood clotting advisory panel meeting on Friday, the CDC reported that it had identified a total of 15 cases, including three deaths.
However, the risk is rated as 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 failure to use it would result in more deaths than the coagulation disorder could cause.
The panel voted 10-4 to resume use of the vaccine with the warning label. Some of the panelists who voted “no” wanted a clearer warning about the risk to younger women and the availability of other Covid vaccines that do not appear to pose the same risk.
By lifting the hiatus, states will be able to resume vaccination efforts on hard-to-reach populations such as rural Americans, migrants, and the elderly who are having difficulty leaving their homes. Her access to the vaccine had been blocked by the suspension, leaving about 10 million doses on the shelves.
In Wisconsin, officials said they wanted to use their Johnson & Johnson cans as soon as possible.
“We’ve also heard from a number of vaccinators who say there are a lot of people who don’t like needles,” said Julie Willems Van Dijk, assistant secretary for the State Department of Health. “They just want to get the vaccine for which they need one shot versus two shots.”
Dr. Rochelle P. Walensky, the CDC director, said governors in a number of states have shown great interest in resuming the use of the gunfire.
“They were wondering why we were on pause and they were eager to have this back, to have an opportunity for a single-dose vaccine, for a one-off opportunity,” she said.
Approximately 135.8 million people in the United States have received at least one shot of a coronavirus vaccine. But daily doses are down nearly 13 percent since last week, from a high of an average of 3.38 million daily doses to about 2.95 million.
It’s hard to say what is driving the decline. Even before the use of the Johnson & Johnson vaccine was suspended, shipments had declined due to a factory failure that had ruined millions of doses.
Larry Bergner, the administrator for the Newton County, Missouri health department, with a population of 58,000, said demand fell before the break. He was concerned that the federal government’s decision had hesitated even more people in his area to get the vaccine.
April 23, 2021, 8:08 p.m. ET
“Some tell me that they planned to get vaccinated by J. & J. was stopped, ”said Mr. Bergner. “Now they say they will hold back until they are sure that all vaccines are safe.”
The county had distributed leaflets and called businesses, churches and other community groups to spark interest in a vaccination clinic on Wednesday, but only 14 people showed up. It was actually about twice as much as Mr Bergner expected, he said, although the health department could have handled about 100 shots.
Dr. Walensky said the federal government planned to emphasize the vaccine’s safety to Americans who may be reluctant to take it after the hiatus.
“We need to make exceptional connections with clinicians, like we did last week,” she said. “We already have plans to start this on Monday for public health officials. And then we have to make extraordinary contacts with patients, meet people where they are to educate them. “
She said the CDC spoke to health care providers for young women, including the American College of Obstetricians and Gynecologists. The hiatus and investigation into the rare coagulation disorder should give the public confidence in the vaccine safety monitoring system.
European Union regulators earlier this week did not recommend the age restrictions on Johnson & Johnson shots that some individual countries have imposed on the AstraZeneca vaccine. Johnson & Johnson agreed to include a risk warning for the blood clot and several European countries have resumed use of the blood clot Vaccine, as well as South Africa.
Until a few hours before the break was recommended by American officials, regulators had planned a revision of the FDA’s emergency approval, similar to the one formalized on Friday, with warnings about the blood clots.
However, on April 12, senior health officials decided that the government should take a break while federal agencies and the CDC panel of experts investigated a possible link between the blood clots and the vaccine. They feared a number of cases of the disorder had not been identified and wanted to give those who had just received the vaccine more time to get to the point where infrequent clotting typically occurs.
“As we have done this intense scientific evaluation over the past few days, I think we have become more and more confident about the decision that was made today,” said Dr Janet Woodcock, acting FDA commissioner, on Friday.
In the CDC panel analysis, women between 30 and 39 appear to be at greatest risk with 11.8 cases per million doses. In women between 18 and 49 there were seven cases per million doses.
The clotting condition, which the CDC calls thrombosis with thrombocytopenic syndrome, causes severe blood clots and a tendency to bleed due to abnormally low levels of platelets, a component of blood that is involved in clotting.
The disorder is “rare but clinically severe,” said Dr. Tom Shimabukuro, Assistant Director of the CDC Vaccination Safety Office, at the meeting.
Other potential cases, including some in men, are currently being investigated. A 25-year-old man who was in a clinical trial of the vaccine also developed the disorder.
Symptoms are very similar to a rare syndrome that can be caused by heparin, a widely used blood thinner. This is shared by Dr. Michael Streiff, a hematologist at Johns Hopkins University, joined the panel. Heparin, which is normally used to treat blood clots, shouldn’t be given to these patients, he said.
The symptoms are severe headache, stomach pain, leg pain, or shortness of breath. These problems generally do not appear until about six days after vaccination. Once symptoms appear, treatment should begin as soon as possible, as researchers say it can worsen quickly.
Dr. Marks, the FDA regulator, said the agency recommends blood thinners other than heparin and a blood product called intravenous immunoglobulin, which can help alleviate the immune response causing the problem.
“That seems to reverse that process,” he said.
The researchers suspect that in these rare cases, the vaccine elicits an intense response from the patient’s immune system, which produces antibodies that activate platelets, a blood component needed for clotting. Why this happens in some people is not known, and experts say they haven’t been able to identify any traits or underlying conditions that could make some people susceptible.
Senior US health officials have stressed that the finding of the low number of cases of a rare disorder and the discontinuation of vaccine use indicated that safety precautions were in place to assess risks and raise awareness among doctors and hospitals of the unusual symptoms.
“This pause was essential to our ability to educate the public,” said Dr. José R. Romero, Chair of the Expert Panel of the Advisory Committee on Immunization Practices, on Friday.
A poll released by Ipsos / Axios this week found that the hiatus itself boosted confidence in federal vaccine monitors. 81 percent said the CDC and FDA acted appropriately. The mood was unusually bipartisan. 87 percent of Republicans and 91 percent of Democrats shared this view.
Measuring the impact of the Johnson & Johnson break is difficult Liz Hamel, Vice President, Public Opinion and Research Survey, Kaiser Family Foundation. “They don’t know what vaccine intake would have been like without this break,” she said.
The biggest challenge ahead will be creating messages of confidence in vaccines that will resonate with the public. “We don’t know if there has been any more hesitation, especially among women,” she said.
Benjamin Mueller, Matina Stevis-Gridneff, Julie Bosman, Jan Hoffman, Carl Zimmer and Emily Anthes contributed to the coverage.