WASHINGTON -- Injections of Johnson & Johnson's single-dose coronavirus vaccine came to a sudden halt in much of the country Tuesday when federal health agencies called for a pause in the vaccine's use after 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 7 million people in the United States have received Johnson & Johnson shots so far, and about 9 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."
Speaking at the White House, Dr. Anthony Fauci, the nation's top expert on infectious disease, said the pause would allow the FDA and the CDC to investigate the clotting cases and "to make physicians more aware of this."
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While the move was framed as a recommendation to health practitioners, the impact was immediate. By Tuesday afternoon, virtually every state and the District of Columbia had announced a pause in Johnson & Johnson vaccine injections, including Arkansas.
The Arkansas Department of Health says vaccination clinics with the Johnson & Johnson vaccine are canceled, but ones offering the Pfizer or Moderna vaccines will continue as planned.
Gov. Asa Hutchinson urged Arkansans to continue to get vaccinated, and said the state has the supply to meet the demand even with the Johnson & Johnson vaccine on pause.
"No one should slow down and say, 'well, because of this, I'm going to wait,'" Hutchinson said at his weekly briefing on the virus. "Don't wait, get the vaccine now. It is critically important."
Arkansas has 63,000 doses of the Johnson & Johnson vaccine on hand, 178,000 doses of Moderna and 245,000 of Pfizer.
The Georgia Department of Public Health also announced a pause of the vaccine.
One of Georgia's largest school districts -- Atlanta Public Schools -- canceled a coming mass vaccination event for teachers that was to have used the Johnson & Johnson vaccine. The school system said the April 21 event was being scrapped because of Tuesday's news, The Atlanta Journal-Constitution reported.
In Missouri, Dr. Randall Williams, director of the state's Department of Health and Senior Services, said in a news release that Missouri also decided to pause use of the Johnson & Johnson vaccine out of "an abundance of caution."
"We anticipate having more information shortly to make further decisions about overall vaccine distribution in light of this new development and will continue to update citizens who have been vaccinated with the J&J vaccine after the advisory committee meets at the federal level tomorrow," Williams said.
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 FDA, said at a news conference Tuesday that the pause was expected to last only "a matter of days," although she said the time frame depends on "what we learn in the next few days." 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 FDA and CDC will jointly examine possible links between the vaccine and the disorder, and determine whether the FDA 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 CDC's outside vaccine advisory committee has been scheduled for today.
LOST SUPPLY
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, Marks drew a connection between the two vaccines, saying the cases involving rare blood clots were very similar.
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. 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.
The White House said there's enough vaccine to continue giving shots at the current pace. "This announcement will not have a significant impact on our vaccination plan," said Jeff Zients, the White House covid-19 response coordinator, in a statement.
Pfizer and Moderna supplies will be adequate to satisfy U.S. demand, said one official who spoke on condition of anonymity, as signs emerge that the U.S. is beginning to shift from a shortage of shots to a shortage of willing recipients.
The U.S. expects to have received enough doses from Pfizer and Moderna by the end of May to fully vaccinate 200 million people. It expects enough doses from those companies by the end of July to vaccinate another 100 million.
'VERY LOW' RISK
Federal officials are concerned that doctors may not be trained to spot or treat the rare disorder if recipients of the vaccine develop symptoms of it. They said Tuesday morning that a standard treatment for blood clots -- use of an anticoagulant drug -- could be dangerous or even fatal in such cases.
Schuchat, the CDC official, said the risk of dangerous blood clots was "very low" for people who received Johnson & Johnson's 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.
In a statement, Johnson & Johnson said, "We have been working closely with medical experts and health authorities, and we strongly support the open communication of this information to health care professionals and the public."
The company also said it was reviewing these cases with European health authorities. "We have made the decision to proactively delay the rollout of our vaccine in Europe," the company said in its statement.
In the United States alone, 300,000 to 600,000 people a year develop blood clots, according to CDC data. But the particular blood-clotting disorder the vaccine recipients developed, known as cerebral venous sinus thrombosis, is extremely rare. Schuchat described the condition as "a severe strokelike illness linked to low platelet counts."
All of the women developed the illness within about one to three weeks of vaccination, with a median time of nine days. The Nebraska woman who is now hospitalized is in her late 40s and developed blood clots two weeks after her shot, state health officials said.
Government experts are concerned that the blood clots are linked to an immune system response triggered by the vaccine. Federal officials said there was broad agreement in the senior ranks of the administration about the need to pause use of the vaccine while the cases are investigated.
Marks said the federal government was not issuing an order to suspend the vaccine, adding that health providers may decide that for a particular patient, the benefits of a shot outweigh the risks. "We're not going to stop that provider from administering the vaccine because it could be right," he said.
States have been using the vaccine in a broad range of settings, including at mass vaccination sites and on college campuses. The vaccine's one-shot approach has proved popular, and officials have directed it to transient, rural and isolated communities where following up with a second dose is more complicated.
It is common for regulators to investigate "safety signals" in new vaccines and other medical products. Very often, the signals prove not to be of concern. But the concerns about Johnson & Johnson's vaccine mirror concerns about AstraZeneca's, which European regulators began investigating last month after some recipients developed blood clots.
AstraZeneca and Johnson & Johnson use the same platform for their vaccines, a virus known as an adenovirus. On Tuesday, the Australian government announced that it would not purchase Johnson & Johnson vaccines, citing Johnson & Johnson's use of an adenovirus. But there is no obvious reason adenovirus-based vaccines in particular would cause rare blood clots associated with low platelet levels.
The Australian government has said that Pfizer will now be the recommended vaccine for those 50 years and younger but that the AstraZeneca vaccine will still play a key role in the country's vaccination drive.
"The most vulnerable people in our community are not just over 50, they are actually a lot older than that," Prime Minister Scott Morrison said last week. "The AstraZeneca vaccine is well-suited to address those critical vulnerable groups."
AstraZeneca has not yet applied for an emergency use authorization in the United States.
The Moderna and Pfizer vaccines use a different technology to produce immunity.
Information for this article was contributed by Noah Weiland, Sharon LaFraniere and Carl Zimmer of The New York Times; by Josh Wingrove of Bloomberg News (WPNS); by Erin Cunningham and Siobhan O'Grady of The Washington Post; and by Zeke Miller, Lauran Neergaard, Matthew Perrone, Mike Stobbe, Emily Wagster Pettus, Karen Matthews, Jill Bleed, Linda A. Johnson, Sophia Eppolito, Denise Lavoie, Kate Brumback, Jeff Martin and Heather Hollingsworth of The Associated Press.