The Food and Drug Administration and Centers for Disease Control and Prevention are calling for a pause in the use of the Johnson & Johnson COVID-19 vaccine while they look into safety concerns about the single-dose shot.
The move comes after six women “developed a rare disorder involving blood clots” approximately two weeks after receiving the vaccine. One woman died and another is in critical condition.
As of 4/12, 6.8m+ doses of the J&J vaccine have been administered in the U.S. CDC & FDA are reviewing data involving 6 reported U.S. cases of a rare & severe type of blood clot in individuals after receiving the vaccine. Right now, these adverse events appear to be extremely rare
— U.S. FDA (@US_FDA) April 13, 2021
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.
— U.S. FDA (@US_FDA) April 13, 2021
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.
— U.S. FDA (@US_FDA) April 13, 2021
While the move is framed as a recommendation to health practitioners in the states, the federal government is expected to pause administration of the vaccine at all federally run vaccination sites. Federal officials expect that state health officials will take that as a strong signal to do the same.
Scientists with the Food and Drug Administration and C.D.C. will jointly examine possible links between the vaccine and the disorder and determine whether the F.D.A. should continue to authorize use of the vaccine for all adults or limit the authorization. An emergency meeting of the C.D.C.’s outside advisory committee has been scheduled for Wednesday, officials said. […]
In the United States alone, 300,000 to 600,000 people a year develop blood clots, according to C.D.C. data. But the particular blood clotting disorder that the vaccine recipients developed, known as cerebral venous thrombosis, is extremely rare. All of the women developed the condition between six and 16 days of vaccination, and government experts are concerned that an immune system response triggered by the vaccine was the cause. (The New York Times)
Side effect reports for the @jnjnews vaccine that look a lot like the problems the @AstraZeneca vaccine causes are piling up in VAERS.
— Alex Berenson (@AlexBerenson) April 9, 2021
The cases are striking because the US had given only about 4 million doses of the JNJ shot as of last week - far fewer than the mRNA vaccines. pic.twitter.com/DKPR4q7stN
The FDA will hold a press conference at 10 a.m.
Please join us via YouTube for an audio press conference at 10 a.m. EDT. We will keep the public updated as we learn more. https://t.co/fWguuQzhMR
— U.S. FDA (@US_FDA) April 13, 2021