Both the U.S. Food and Drug Administration and the Centers for Disease Control and Prevention have called a halt to the use of the Johnson & Johnson COVID-19 vaccine, following reports of blood clotting in a rare number of cases.
The April 13 decision to halt the Johnson & Johnson vaccine comes after “six recipients in the United States developed a rare disorder involving blood clots within about two weeks of vaccination,” according to the New York Times. The report noted they were all women, between the ages of 18-48, with one fatality and another recipient currently hospitalized in critical condition.
“We are recommending a pause in the use of this vaccine out of an abundance of caution,” Dr. Peter Marks, a Food and Drug Administration official, and Dr. Anne Schuchat, principal deputy director of the C.D.C., said in a joint statement. “Right now, these adverse events appear to be extremely rare.”
Nearly 7 million doses of the vaccine have already been given to people throughout the U.S., with about 9 million doses distributed. The single-dose vaccine was approved in late February for use in the U.S., and it has been part of the nation’s vaccine arsenal since early March.
The agencies warned that those who have received the Johnson & Johnson vaccine and “have developed severe headache, abdominal pain, leg pain, or shortness of breath within three weeks after vaccination should contact their health care provider,” though those symptoms were determined to be “extremely rare.”
“It’s a very rare event,” Dr. Carlos del Rio, executive associate dean of the Emory University School of Medicine, told CNN regarding the blood clotting. “You’re talking about 1 per million, and when you give millions of doses of vaccines, you will see events like this that you couldn’t see in the clinical trial just because you didn’t have millions of people enrolled.”
“But I want to congratulate the CDC and the FDA for very quickly jumping on it, halting the vaccinations until we know more and really trying to understand what’s going on,” he added. “I think vaccine safety has always been a priority—and I think this is exactly the right move until we understand what’s going on and what’s the way forward.”
Del Rio also noted that the blood clotting may have to do with the Johnson & Johnson vaccine being an adenovirus vector vaccine. The AstraZeneca coronavirus vaccine, not currently in use in the U.S. but garnering scrutiny for similar cases in Europe, is also an adenovirus vector vaccine.
As CNN reported, “The European Medicines Agency recently concluded that unusual blood clots with low blood platelets should be listed as ‘very rare side effects’ of the AstraZeneca vaccine. While advising the public to look out for the signs of clots, the regulators said the benefits of the shot were still worth the risk.”
MarketWatch reported April 12 that the Australian government has decided against buying the Johnson & Johnson vaccine to supplement its vaccination efforts, with a shift toward a two-dose mRNA vaccine in the works.
That article noted, “Australia had planned to rely on Australian-manufactured AstraZeneca, with the goal of delivering at least one dose of vaccine to all eligible adults among a population of 26 million by October. But the government announced last week that the Pfizer vaccine is now the preferred option for people under 50 because of a potential health risk from AstraZeneca.”
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