UPDATED: J&J pauses vaccine rollout as feds probe rare cases of blood clots
The FDA and CDC have jointly decided to stop administering J&J’s Covid-19 vaccine after reviewing data involving six reported US cases of a rare and severe type of blood clot in individuals after receiving the vaccine.
CDC will convene a meeting of its Advisory Committee on Immunization Practices on Wednesday to further review these cases and assess their potential significance. “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,” Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research and Anne Schuchat, Principal Deputy Director of the CDC, said in a joint statement Tuesday morning.
Marks said in a media call that the probable cause may be a similar mechanism seen in other adenovirus vector vaccines, like the AstraZeneca Covid-19 vaccine, which underwent a similar safety review in Europe. He said one person has died and one person is in critical condition from the blood clots. FDA acting commissioner Janet Woodcock added that the timeframe for this review of the J&J vaccine “will be a matter of days.”
J&J said in a statement on Tuesday that it has made the decision to proactively delay the rollout of its vaccine in Europe. “The safety and well-being of the people who use our products is our number one priority,” the company said.
“All six cases occurred among women between the ages of 18 and 48, and symptoms occurred 6 to 13 days after vaccination,” they noted, adding that almost 7 million doses of the vaccine have now been administered in the US. The CDC and FDA said that people who have received the J&J vaccine and who develop severe headache, abdominal pain, leg pain, or shortness of breath 3 weeks after vaccination should contact their health care provider.
Treatment of this specific type of blood clot is different from heparin, which is the treatment that might typically be administered, as in this setting, CDC and FDA said, “administration of heparin may be dangerous, and alternative treatments need to be given.”
Senators on Tuesday began weighing in on what the FDA should do with its review.
I respect the independence of the FDA and their need to evaluate risk. But 6 out of 6.8 million is not a lot, and if they are going to land on “we reviewed the data and everything is fine,” they need to be clear and quick and unequivocal.
— Brian Schatz (@brianschatz) April 13, 2021
Jeff Zients, White House Covid-19 response coordinator, said in a statement that the Biden administration is working with states to reschedule J&J appointments for Morderna or Pfizer vaccines. New York said all appointments for J&J vaccines today at New York State mass vaccination sites will be honored with the Pfizer vaccine.
The news comes as the European Medicines Agency’s safety committee said last Friday that it has initiated a review of four “serious cases of unusual blood clots with low blood platelets,” including one death, reported after people received the J&J vaccine in the US.
As of April 4, EMA said a total of 169 cases of cerebral venous sinus thrombosis (CVST) and 53 cases of splanchnic vein thrombosis were reported to the database, among 34 million people who have been vaccinated with the AstraZeneca vaccine in the EEA and UK. By comparison, the agency noted that for the J&J vaccine, 3 CVST cases were found among 4.5 million vaccinated worldwide, for Pfizer, 35 CVST cases worldwide were found and 54 million received the vaccine in the EEA, and for Moderna, 5 CVST cases worldwide were among 4 million vaccinated in the EEA.
Moderna said in a statement on Tuesday that more than 64.5 million doses of its vaccine have been administered globally and its assessment of the data “does not suggest an association with cerebral venous sinus thrombosis (CVST) or thrombotic events.”
Anne Schuchat, principal deputy director at the CDC, also said on the media call that they are not seeing concerns with these clotting events for the Moderna or Pfizer vaccines.