Johnson & Johnson Vaccine Should be Paused in U.S. After ‘Extremely Rare’ Blood Clots, FDA and CDC Say

Federal health agencies on Tuesday recommended pausing the use of the Johnson & Johnson vaccine after a small number of people experienced “a rare and severe type of blood clot” after receiving the shot.

The Food and Drug Administration and the Centers for Disease Control and Prevention issued a statement saying they were “recommending a pause in the use of this vaccine out of an abundance of caution.”

Some 6.8 million people have received the single-shot vaccine in the United States. Of these, six have experienced the clot, the agencies said, adding: “Right now, these adverse events appear to be extremely rare.”

“The CDC and the FDA are taking these concerns about blood clots and the J&J vaccine seriously and are diligently assembling data,” the official said.

An expert outside the government who is familiar with the situation agreed that health officials are taking the matter seriously.

“The CDC is very concerned and they’re very working hard on this and monitoring this closely,” said the expert, who spoke on the condition of anonymity due to the sensitive nature of the issue.

There have been “four serious cases of unusual blood clots” reported after people received the Johnson & Johnson vaccine, according to European health authorities. Like their US counterparts, the European authorities say they’re still investigating these cases and that “it is currently not clear” whether there’s a causal association between the vaccine and the clots.

The concern in the United States isn’t just about the Johnson & Johnson shot per se. At a time when US health officials are encouraging Americans to get vaccinated as soon as they can, there’s a worry that news coverage about clots being studied in relation to Johnson & Johnson’s vaccine might make some Americans more hesitant to get any Covid-19 vaccine.

Vaccine hesitancy is already an issue in the US, and officials at the US Centers for Disease Control and Prevention and the US Food and Drug Administration are “thinking through how to communicate about the issue without creating the impression that something might be wrong with the [Johnson & Johnson] vaccine,” the federal health official said.

Another expert familiar with the situation said that was the right approach, stressing the importance of communicating without scaring people.

“I would hope that HHS is having a confab about this right now,” the expert said, referring to the US Department of Health and Human Services.

In a statement, Johnson & Johnson said its tracking of side effects revealed “a small number of very rare events following vaccination. At present, no clear causal relationship has been established between these rare events and the [Johnson & Johson] COVID-19 vaccine.”

The FDA released a statement last week that it was aware of reports of “serious thromboembolic events” in the US that occurred “in a few individuals following receipt of the [Johnson & Johnson] COVID-19 vaccine” and that “at this time we have not found a causal relationship with vaccination.”