The Food and Drug Administration and the Centers for Disease Control are recommending a pause on the Johnson & Johnson Covid vaccine after reports of what the agencies characterize as an “extremely rare” blood clot.
The FDA and the CDC will review “six reported U.S. cases of a rare and severe type of blood clot in individuals after receiving the J&J vaccine,” out of 6.8 million doses administered, according to a statement from Peter Marks, the FDA’s director, Center for Biologics Evaluation and Research, and Anne Schuchat, principal deputy director of the CDC.
“FDA will review that analysis as it also investigates these cases. Until that process is complete, we are recommending a pause in the use of this vaccine out of an abundance of caution,” they said. “This is important, in part, to ensure that the health care provider community is aware of the potential for these adverse events and can plan for proper recognition and management due to the unique treatment required with this type of blood clot.”
They said that right now, “these adverse events appear to be extremely rare.”
In February, the Johnson & Johnson vaccine was the third authorized for emergency use, following Pfizer and Moderna. The J&J vaccine has the advantage of requiring only a single dose for effectiveness.
The FDA and CDC said that in the six cases, a type of blood clot called cerebral venous sinus thrombosis was seen in combination with low levels of blood platelets. All of the cases occurred among women between the ages of 18 and 48, and the symptoms occurred 6 to 13 days after vaccination.
The report comes just as state and federal officials are expanding vaccination access, with President Joe Biden announcing last week that all adults will be eligible to receive the doses as of April 19. But there also have been concerns that a significant share of the population will not take the vaccine, as health officials hope to reach herd immunity to curb the spread of the virus.
Jeff Zients, the White House Covid response coordinator, said that the announcement “will not have a significant impact on our vaccination plan: Johnson & Johnson vaccine makes up less than 5 percent of the recorded shots in arms in the United States to date.” He said that the U.S. had secured enough Pfizer and Moderna doses for 300 million Americans. He said that they have “more than enough” supply to continue the current pace of 3 million vaccinations per day and meet Biden’s goal of 200 million vaccinations on his 100th day in office, April 30.
Johnson & Johnson said that it also will “proactively delay” the rollout of the vaccine in Europe.
“We have been working closely with medical experts and health authorities, and we strongly support the open communication of this information to healthcare professionals and the public,” the company said.
On CNBC, Kavita Patel, a primary case physician and NBC News medical contributor, called it a “devastating blow” to the Johnson & Johnson vaccine rollout and that it would have a “ripple effect” in the effort to curb the virus.