Federal health agencies will temporarily stop using Johnson & Johnson’s one-dose vaccine after six women developed blood clots, including one who died, according to officials and a new report Tuesday.
The Food and Drug Adminstration announced the pause, saying there’ve been a half-dozen reports of a “rare & severe type of blood clot” in patients who received the vaccine.
“Right now, these adverse events appear to be extremely rare,” the agency tweeted in a joint statement tweeted in a joint statement with the Centers for Disease Control and Prevention.
Those affected were six women, between the ages of 18 and 48, who developed the clots within about two weeks of vaccination, The New York Times reported.
One died and a second in Nebraska was hospitalized in critical condition. The feds hope the pause will serve as a strong signal to states to do the same.
About 9 million more doses have shipped to states, according to the Centers for Disease Control and Prevention.AP
The feds hope the pause will serve as a strong signal to states to do the same.
“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 agency’s Advisory Committee on Immunization Practices will meet Wednesday to discuss the cases and the FDA also has also launched an investigation.
Members of the military inoculate people with the now-paused Johnson & Johnson COVID-19 vaccine.(AP Photo/Matt Rourke)
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.
While the move was described as a recommendation to health providers nationwide, the federal government will pause administration of the jab at all federally-run vaccination sites, The Times reported.
The pause could significantly complicate US inoculation efforts as many states face a surge in new cases and seek to address vaccine hesitancy.
Regulators in other countries are concerned about a similar issue with another vaccine, developed by AstraZeneca and Oxford University researchers. AP
Regulators in other countries are concerned about a similar issue with another vaccine, developed by AstraZeneca and Oxford University researchers, according to the newspaper.
That concern has raised the number of anti-vaxxers, even though the AstraZeneca jab has not been approved for use in the US, The Times noted.
In the US, most of the vaccine supply comes from Pfizer/BioNTech and Moderna, which together deliver more than 23 million doses a week of their two-shot vaccines.
There have been no significant safety concerns about those inoculations.