FDA Freezes Johnson & Johnson Coronavirus Vaccine Rollout After Six Blood-Clot Cases

Jamie Ross
·2 min read
Reuters/Lucy Nicholson
Reuters/Lucy Nicholson

Federal health agencies have called for a pause in the rollout of Johnson & Johnson’s coronavirus vaccine in the United States after six blood-clot cases were reported in people who have been given the shot.

According to The New York Times, the federal government will immediately stop using the vaccine at all federally run vaccination sites across the nation. State health officials will have been advised to follow suit and not use the J&J shots they have in storage.

In a Tuesday statement, the Food and Drug Administration confirmed that it has recommended a freeze in the vaccine’s use. The agency said it made its decision after six reported cases of what it called “rare and severe type of blood clot in individuals after receiving the vaccine,” but it stressed: “Right now, these adverse events appear to be extremely rare.”

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Some seven million Americans have received Johnson & Johnson shots to date, and around nine million more have been shipped out, according to data from the Centers for Disease Control and Prevention. The shots make up a key part of the Biden administration’s vaccine rollout because they only require a single dose and are easier to store than others.

Health officials told the Times that the six U.S. recipients developed a rare disorder involving blood clots within about two weeks of their shots. All of them were women between the ages of 18 and 48. One is reported to have died and another remains in serious condition in a hospital.

The FDA and CDC is now expected to examine any possible link between the vaccine and the disorder, and decide whether to continue the Johnson & Johnson rollout or restrict its use to certain age groups.

“Until that process is complete, we are recommending this pause,” the FDA wrote. “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.

Johnson & Johnson said in a statement that there’s no evidence to confirm its vaccine caused the very rare blood-clot cases. “We are aware that thromboembolic events including those with thrombocytopenia have been reported with COVID-19 vaccines,” the company reportedly said. “At present, no clear causal relationship has been established between these rare events and the Janssen COVID-19 vaccine.”

The announcement follows a similar setback in Europe, where the AstraZeneca vaccine was paused to investigate its possible link to blood-clot events. After studying 86 European cases, the European Medicines Agency decided that the benefits of the vaccine outweighed the risk, even with the possibility that blood clots are an extremely rare side-effect.

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