WASHINGTON — Top public health officials said Tuesday that they are recommending a pause in the use of a COVID-19 vaccine from Johnson & Johnson “out of an abundance of caution” following six cases of a rare and severe type of blood clot, and states and localities immediately began moving to suspend the vaccine’s use.
Officials with the Food & Drug Administration and the Centers for Disease Control and Prevention said in a media briefing that the occurrence of the symptoms was extremely rare. They said the six cases of the blood-clot condition, out of 6.8 million doses administered, have all involved women between the ages of 18 and 48, and that their symptoms occurred six to 13 days after vaccination.
One woman has died, and another is in critical condition.
Halting additional doses will allow officials to alert health care providers of the potential side effects they may see arise in patients, they said, noting that the blood-clot condition requires a less-common treatment to be resolved safely.
“It was clear to us that we needed to alert the public,” said Anne Schuchat, the CDC’s principal deputy director, adding that the pause will allow the health care community to “learn what they needed to learn about how to diagnose, treat and report” on adverse reactions.
A cascade of states — including Virginia and Missouri — said Tuesday following the federal announcement that they would heed the recommendation and halt any administering of the one-shot J&J vaccine.
The J&J vaccine has been viewed as a critical part of ramping up the U.S. vaccination effort, because it requires just one dose and has less-stringent storage requirements.
But so far, it’s been a small share of the overall doses administered — the 6.8 million doses given as of Monday are among nearly 190 million nationally, according to the CDC’s vaccine tracker. Another 9 million have been shipped to states but not yet administered.
In comparison, 98 million doses of the Pfizer vaccine and 85 million of the Moderna vaccine have been administered, both of which require two shots given weeks apart. The rare blood-clot condition has not been reported following doses of those shots.
Johnson & Johnson has faced challenges in scaling up its vaccine production, and had to discard 15 million doses due to errors at a Maryland manufacturing facility.
The federal announcement comes as demand for vaccines is increasing as states remove eligibility requirements, acting on directions from the Biden administration to make every American eligible for a vaccine by Monday.
Jeff Zients, the White House’s COVID-19 response coordinator, said Tuesday that there is enough supply available of Pfizer and Moderna doses to continue the current pace of 3 million shots per day.
He added that the Biden administration is working with states and federally run vaccine sites to reschedule anyone with a J&J appointment to receive one of the other available shots.
It’s not yet clear how long the pause on J&J doses will last. The FDA’s independent vaccine advisory panel, which authorized each of the three current vaccines, is set to meet on Wednesday to review the cases that led to the federal recommendation.
Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said the pause is “a recommendation” and “not a mandate,” adding that federal officials would not stop a provider from administering the vaccine if a provider and a patient determine that the benefits outweigh the risks.
But most Americans are not getting their vaccine directly from a primary-care provider, and instead are going through federally or state-run vaccination sites, or local pharmacies receiving doses through the government.
The blood-clot condition, known as cerebral venous sinus thrombosis, had combined with low levels of blood platelets in the six cases under scrutiny according to the FDA.
Anyone who has received a J&J vaccine and develops severe headache, abdominal pain, leg pain, or shortness of breath within three weeks after vaccination should contact their health care provider, FDA officials said.
