U.S. Calls for Pause of J&J Shot on Clots, Roiling Rollout

U.S. Calls for Pause of J&J Shot on Clots, Roiling Rollout
John Lauerman, Angelica LaVito and Riley Griffin
·5 min read

(Bloomberg) --

U.S. health officials are probing a rare blood-clot complication tied to Johnson & Johnson’s Covid-19 vaccine and have urged a pause in its use as they determine how best to recognize and manage it.

Six women between the ages of 18 and 48 who received the shot developed a severe form of blood clotting in the brain called cerebral venous sinus thrombosis with low levels of blood platelets. At least one died, and a second was in critical condition, Peter Marks, head of the Food and Drug Administration’s Center for Biologics Evaluation and Research, said in a Tuesday briefing.

A key reason for the pause, FDA officials said, is that the normal treatment for clots, the blood-thinner heparin, could make the disorder worse, or even kill a patient. Those vaccinated a month ago are at low risk, but people who got it in the last couple of weeks should be on the lookout for headache, leg pain, abdominal pain and shortness of breath, said Anne Schuchat, principal deputy director at the Centers for Disease Control and Prevention.

“We expect it to be a matter of days for this pause,” the FDA’s Janet Woodcock said at the briefing. The delay gives health officials time to review the situation and make sure doctors who see the clotting syndrome know how to respond, Marks said.

More than 6.8 million doses of the single-shot J&J vaccine have been administered in the U.S. through Monday. Jeff Zients, the White House Covid-19 response coordinator, said the delay won’t have a significant impact on the Biden administration’s vaccination plans.

Meanwhile, a number of states on Tuesday said they would follow the recommendation. New York plans to immunize people who were supposed to receive J&J’s shot with Pfizer’s vaccine at state-run mass vaccination sites. Virginia said it will reschedule appointments.

Walgreens Boots Alliance Inc. and CVS Health Corp., which have been administering the shot in drugstores, both said they would pause immediately.

Crucial Juncture

The decision comes at a crucial juncture in the U.S. vaccination effort, which has gained speed in recent weeks at the same time a worsening outbreak driven by coronavirus variants grips the upper Midwest. It could boost vaccine hesitancy in the U.S. and heighten worry about vaccines globally after similar issues caused delays with AstraZeneca Plc’s shot.

Schuchat emphasized at the briefing that the clotting events with low platelet counts are not being seen with Pfizer Inc.-BioNTech SE vaccine and the Moderna Inc. shot.

J&J shares fell 2.2% to $158.15 at 12:55 p.m. in New York trading.

No definitive cause for the disorder has yet been determined, according to Marks, who said it was very similar to blood clotting incidents seen with the AstraZeneca Plc vaccine. It may be tied to an immune response after vaccination that leads to an activation of platelets and clotting, he said.

The J&J shot has been popular due to its single dose while the Pfizer and Moderna vaccines require two doses spaced several weeks apart. Many of the J&J doses in the U.S. have been targeted to harder-to-reach populations through the federal government’s distribution program that works through pharmacies, federally qualified health centers and other locations.

“We are recommending a pause in the use of this vaccine out of an abundance of caution,” the CDC and the FDA said in a joint statement Tuesday. The CDC will convene a meeting Wednesday of its Advisory Committee on Immunization Practices to review the cases and assess their potential significance.

The FDA will review the CDC assessment as it also investigates these cases, according to the statement.

J&J has recently begun shipments to the European Union. The bloc’s drugs regulator, the European Medicines Agency, didn’t immediately respond to a request for comment. J&J said in a statement that it’s decided to delay the rollout of its vaccine in Europe.

The EMA said Friday that it is assessing blood clots in people who received the J&J vaccine, after four serious cases of unusual clots accompanied by low blood platelets, one of which was fatal, emerged.

On Friday afternoon, FDA spokesperson Abby Capobianco said in an emailed statement that the agency hadn’t found a causal relationship between the J&J vaccine and the six cases of thromboembolic events, and was continuing its assessment of the cases

“Our analysis of the data will inform the potential need for regulatory action,” she said. The agency had shared information with the EMA, which became “the basis” of the EU probe, she said.

Asked Monday if further analysis had determined a causal relationship, the FDA declined to comment.

Collecting Information

A handful of vaccination sites in Georgia, Colorado and North Carolina temporarily stopped administering the J&J vaccine last week in the wake of adverse reactions, including nausea and fainting. Such side effects are typical of vaccination, health authorities said at the time.

“Analysis by the CDC did not find any safety issues or reason for concern,” the North Carolina Department of Health and Human Services said Friday in a statement. “The CDC recommends continuing to administer the vaccine.”

That same day, J&J said in a statement that it was collecting information, assessing adverse events, and sharing reports with the FDA and other health agencies.

“There is no greater priority than the safety and well-being of the people we serve,” the company said. “This is part of the established process to inform health authorities’ comprehensive surveillance programs that monitor the overall safety of medicines, as well the vaccines authorized for use against this pandemic.”

(Updates with share price in the ninth paragraph.)

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