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U.S. Calls for Pause on Johnson & Johnson Vaccine After Blood Clotting Cases – The New York Times

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https://www.nytimes.com/2021/04/13/us/politics/johnson-johnson-vaccine-blood-clots-fda-cdc.html

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WASHINGTON — Injections of Johnson & Johnson’s single-dose coronavirus vaccine came to a sudden halt in much of the country on Tuesday after federal health agencies called for a pause in the vaccine’s use following the emergence of a rare blood clotting disorder in six recipients.

All six were women between the ages of 18 and 48 and all developed the illness within one to three weeks of vaccination. 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 about 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.”

While the move was framed as a recommendation to health practitioners, the impact was immediate. 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. New York, Connecticut, Nebraska and several other states quickly followed suit.

The federal government temporarily halted administration of the shots by the U.S. military, providers at federally-run sites and CVS and Walgreens, two pharmacy giants that participate in a federal vaccination program, officials said.

Dr. Janet Woodcock, the acting commissioner of the F.D.A., said at a news conference Tuesday that the pause was only expected to last “a matter of days,” although she said the time frame depends on “what we learn in the next few days.” Dr. Schuchat said at the same briefing that the pause was enacted in part to “prepare the health care system to recognize and treat patients appropriately.”

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 modify the authorization, possibly limiting it to certain population groups. An emergency meeting of the C.D.C.’s outside vaccine advisory committee has been scheduled for Wednesday.

The move could 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 has not been authorized for emergency use in the United States. At the news conference, Dr. Marks drew a connection between the two vaccines, saying the cases involving rare blood clots were very similar.

The vast majority of the vaccine supply in the United States comes from two other manufacturers, Pfizer-BioNTech and Moderna, which together deliver more than 23 million doses a week of their two-shot vaccines. Federal officials stressed Tuesday that 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.

Mark D. Levine, a New York City councilman, lamented on Twitter that the pause would be a “huge setback” for the city’s vaccination program, which he said relies “entirely on J & J” to inoculate the homebound, reach small private doctors’ offices and supply mobile vaccination vans.

“NYC now has the biggest messaging challenge yet in vaccination,” he wrote. “We have to do everything possible to avoid a collapse in confidence in vaccination overall.”

Jeffrey D. Zients, the White House Covid-19 response coordinator, said Tuesday the pause “will not have a significant impact” on the nation’s vaccination program, and that the administration will still “reach every adult who wants to be vaccinated.”

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