Johnson & Johnson’s single shot vaccine has been stopped by the Food and Drug Administration. According to the agency there’ve been a half-dozen reports of a “rare & severe type of blood clot” in patients who received the vaccine. The clots were observed along with reduced platelet counts, making the usual treatment for blood clots — the blood thinner heparin — potentially “dangerous.”
Those affected were six women, between the ages of 18 and 48, who developed the clots within about two weeks of vaccination. One died and a second in Nebraska was hospitalized in critical condition. In addition, people are reporting having severe headache, abdominal pain, leg pain or shortness of breath within three weeks after receiving the vaccine.
“We are recommending a pause in the use of this vaccine out of an abundance of caution,” the FDA said. “Treatment of this specific type of blood clot is different from the treatment that might typically be administered.”
Nearly 7 million people in the US have gotten the J&J shot so far. About 9 million more doses have shipped to states, according to the CDC.
The other two authorized vaccines in the US — Pfizer/BioNTech and Moderna — are not affected by the pause.
The FDA added: “CDC will convene a meeting of the Advisory Committee on Immunization Practices (ACIP) 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 this pause. This is important to ensure that the health care provider community is aware of the potential for these adverse events and can plan due to the unique treatment required with this type of blood clot,” it said.