The US Food and Drug Administration (FDA) has recommended that the use of Johnson & Johnson’s vaccine be suspended as a “precaution” pending confirmation of the results of a study that the vaccine may cause blood clots. The U.S. Health Authority said six cases of blood clots have been counted so far in patients who received the vaccine. 6.8 million people in the United States received a dose of the Johnson & Johnson vaccine to the limit of Monday. Johnson & Johnson also announced the postponement of the vaccine launch in Europe after the US decision.
U.S. health authorities have recommended that the use of Johnson & Johnson’s covid-19 vaccine be frozen out of “due diligence” pending confirmation of a possible link between the vaccine and a blood clot, a regulator said Tuesday. “We recommend freezing until this process is completed,”the U.S. Food and Drug Administration reported the window.
In parallel with the announcement by U.S. health authorities, Johnson & Johnson announced Tuesday that it will postpone the launch of its covid-19 vaccine in Europe due to health concerns.
The U.S. Food and Drug Administration said via Twitter that it and the Centers for Disease Control and Prevention are assessing the “potential significance” of six recorded cases of rare blood clots in patients who received the vaccine.
The Administration reported that more than 6,8 million doses of Johnson & Johnson’s vaccine had been administered in the United States as of Monday. The European Medicines Agency had reported days ago that it was looking into possible cases of blood clots in people who had received the Johnson & Johnson vaccine.
The U.S. Food and Drug Administration reported via Twitter that it and the Centers for Disease Control are “reviewing data on six cases recorded in the United States of a rare and severe type of blood clot in individuals after receiving the vaccine. Currently, these negative events seem extremely rare.”
She stressed that she is calling for its use to be stopped to allow health workers to plan “the unique treatment that this type of blood clot will need.”
A CDC advisory committee will meet Wednesday to “further review these cases and assess their potential relevance,” the tweets said. The FDA will review this analysis while also investigating these cases.”