Federal health agencies on Tuesday called for an immediate pause in use of Johnson & Johnson’s single-dose coronavirus vaccine after six recipients in the US 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 hospitalised in critical condition.
Nearly seven million people in the US 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 CDC, said in a joint statement. “Right now, these adverse events appear to be extremely rare.”
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.
Scientists with the FDA and CDC will jointly examine possible links between the vaccine and the disorder and determine whether the FDA should continue to authorise use of the vaccine for all adults or limit the authorisation. An emergency meeting of the CDC’s outside advisory committee has been scheduled for Wednesday.
The move could substantially complicate the US’s vaccination efforts at a time when many states are confronting a surge in new cases.
The vast majority of US’s vaccine supply comes from 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.
It is unclear whether the pause in the use of the Johnson & Johnson vaccine will upset the Biden administration’s plans to deliver enough vaccine to be able to inoculate all adults in the US by the end of May, or whether the demand will be met by the other manufacturers.
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 on 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.
New York Times News Service
