Johnson & Johnson’s single-dose coronavirus vaccine after six recipients in the United States developed a rare disorder involving blood clots within about two weeks of vaccination.
All six recipients were women between the ages of 18 and 48. One woman died and a second woman in Nebraska has been hospitalized in critical condition.
Nearly seven million people in the United States have received Johnson & Johnson shots so far, and roughly nine million more doses have been shipped out to the states, according to data from the Centers for Disease Control and Prevention.
“We are recommending a pause in the use of this vaccine out of an abundance of caution,” Dr. Peter Marks, director of the Food and Drug Administration’s Center for Biologics Evaluation and Research, and Dr. Anne Schuchat, principal deputy director of the C.D.C., said in a joint statement. “Right now, these adverse events appear to be extremely rare.”
On a media call later on Tuesday morning, Dr. Marks said that “on an individual basis, a provider and patient can make a determination whether or not to receive the vaccine” manufactured by Johnson & Johnson.
While the move was framed as a recommendation to health practitioners in the states, the federal government is expected to pause administration of the vaccine at all federally run vaccination sites. Federal officials expect that state health officials will take that as a strong signal to do the same. Within two hours of the announcement, Gov. Mike DeWine of Ohio, a Republican, advised all health providers in his state to temporarily stop giving Johnson & Johnson shots. In New York, the health commissioner, Dr. Howard Zucker, said the state would halt the use of the vaccine statewide while federal officials evaluate the safety risks. Appointments for Johnson & Johnson’s shot on Tuesday at state mass sites would be honored with Pfizer doses, Dr. Zucker said.
The authorities in New Jersey, Connecticut, Massachusetts, Maryland, Nebraska, Georgia, Indiana, Texas and Virginia also said that they would follow the call from federal health agencies.
Scientists with the F.D.A. and C.D.C. will jointly examine possible links between the vaccine and the disorder and determine whether the F.D.A. should continue to authorize use of the vaccine for all adults or limit the authorization.
In the media call, federal health officials tried to reassure recipients of Johnson & Johnson’s vaccine while at the same time describing symptoms that they should watch out if they received a shot within the past month.
Dr. Schuchat said that the risk of dangerous blood clots is “very low” for people who received the vaccine more than a month ago.
“For people who recently got the vaccine within the last couple of weeks, they should be aware, to look for any symptoms. If you receive the vaccine and develop severe headaches, abdominal pain, leg pain or shortness of breath, you should contact your health care provider and seek medical treatment,” she said. She emphasized that an emergency meeting of the C.D.C.’s outside advisory committee, which has been scheduled for Wednesday, to discuss how to handle the vaccine in the future is made up of independent experts.
Dr. Janet Woodcock, acting commissioner of the Food and Drug Administration, said she expects the pause in distributing and administrating the vaccine will last for “a matter of days” while officials investigate the cases. Officials also stressed that no serious safety problems have emerged with either of the other two federally authorized vaccines, developed by Pfizer-BioNTech and Moderna.
The move could substantially complicate the nation’s vaccination efforts at a time when many states are confronting a surge in new cases and seeking to address vaccine hesitancy. Regulators in Europe and elsewhere are concerned about a similar issue with another coronavirus vaccine, developed by AstraZeneca and Oxford University researchers. That concern has driven up some resistance to all vaccines, even though the AstraZeneca version has not been authorized for emergency use in the United States.
The vast majority of the nation’s vaccine supply comes from two other manufacturers, Pfizer-BioNTech and Moderna, which together deliver more than 23 million doses a week of their two-shot vaccines. There have been no significant safety concerns about either of those vaccines.
But while shipments of the Johnson & Johnson vaccine have been much more limited, the Biden administration had still been counting on using hundreds of thousands of doses every week. In addition to requiring only a single dose, the vaccine is easier to ship and store than the other two, which must be stored at extremely low temperatures.
Jeffrey D. Zients, the White House Covid-19 response coordinator, said Tuesday the pause “will not have a significant impact” the Biden administration’s plans to deliver enough vaccine to be able to inoculate all 260 million adults in the United States by the end of May. With the Johnson & Johnson setback, federal officials expect there will only be enough to cover fewer than 230 million adults. But a certain percentage of the population is expected to refuse shots, so the supply may cover all the demand.
Mr. Zients said the administration will still “reach every adult who wants to be vaccinated” by the May 31 target.
Federal officials are concerned that doctors may not be trained to look for the rare disorder if recipients of the vaccine develop symptoms of it. The federal health agencies said Tuesday morning that “treatment of this specific type of blood clot is different from the treatment that might typically be administered” for blood clots.
“Usually, an anticoagulant drug called heparin is used to treat blood clots. In this setting, administration of heparin may be dangerous, and alternative treatments need to be given,” the statement said.
In a news release, Johnson & Johnson said: “We are aware that thromboembolic events including those with thrombocytopenia have been reported with Covid-19 vaccines. At present, no clear causal relationship has been established between these rare events and the Janssen Covid-19 vaccine.” Janssen is the name of Johnson & Johnson’s division that developed the vaccine.
In the United States alone, 300,000 to 600,000 people a year develop blood clots, according to C.D.C. data. But the particular blood clotting disorder that the vaccine recipients developed, known as cerebral venous sinus thrombosis, is extremely rare.
All of the women developed the condition within about two weeks of vaccination, and government experts are concerned that an immune system response triggered by the vaccine was the cause. Federal officials said there was broad agreement about the need to pause use of the vaccine while the cases are investigated.
The decision is a fresh blow to Johnson & Johnson. Late last month, the company discovered that workers at a Baltimore plant run by its subcontractor had accidentally contaminated a batch of vaccine, forcing the firm to throw out the equivalent of 13 million to 15 million doses. That plant was supposed to take over supply of the vaccine to the United States from Johnson & Johnson’s Dutch plants, which were certified by federal regulators earlier this year.
The Baltimore plant’s certification by the F.D.A. has now been delayed while inspectors investigate quality control issues, sharply reducing the supply of Johnson & Johnson vaccine. The sudden drop in available doses led to widespread complaints from governors and state health officials who had been expecting much bigger shipments of Johnson & Johnson’s vaccine this week than they got.