U.S. federal health agencies began an “immediate pause” in the Johnson & Johnson single-dose coronavirus vaccine rollout.
As six Americans have reportedly developed a rare disorder involving blood clots, one died after receiving the shot.
All six recipients were women between 18 and 48, with symptoms developing six to 13 days after receiving the shot. Doctors typically treat that type of blood clot with heparin, but health regulators noted that it could be dangerous in this case and recommended a different treatment. Federal agencies want a pause in the distribution out of “an abundance of caution.”
“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.”
This was to “ensure that the health care provider community is aware of the potential for these adverse events.”
A statement from Johnson & Johnson said safety was its “number one priority,” and it shared “all adverse event reports” with the health authorities.
It added: “We are aware that thromboembolic events including those with thrombocytopenia have been reported with Covid-19 vaccines. At present, no clear causal relationship has been established between these rare events and the Janssen (J&J) Covid-19 vaccine.”
In the U.S., more than seven million people have already been vaccinated with the Johnson & Johnson coronavirus vaccine; the rarity of developing blood clot disorder is indicated. A million more doses have been ordered.
Fauci said the pause is expected to last a matter of days to a few weeks. He said it gives the FDA and CDC time to investigate the cases, try to understand what’s going on and what the women have in common.
Australia will no longer purchase the Johnson & Johnson vaccine because it “is an adenovirus vaccine, the same type of vaccine as the AstraZeneca vaccine” — which is slapped with a warning against use on people under 50.
Dr. Anne Schuchat of the CDC told reporters Tuesday, “For people who recently got the vaccine within the last couple of weeks, they should be aware to look for any symptoms,” she said. “If you’ve received the vaccine and developed severe headaches, abdominal pain, leg pain, or shortness of breath, you should contact your healthcare provider and seek medical treatment.”