Johnson & Johnson vaccine probe will likely take ‘a matter of days,’ FDA says

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US hitting pause on J&J COVID vax after 6 women — out of 7M shots — develop blood clots

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The Food and Drug Administration will likely require only a “matter of days” to look into reports of patients who received the Johnson & Johnson vaccine experiencing dangerous blood clots, officials said Tuesday.

“This timeframe will depend obviously on what we learn in the next few days, however, we expect it to be a matter of days for this cause,” Acting FDA Commissioner Janet Woodcock told reporters.

The FDA and the Centers for Disease Control and Prevention called for use of the shot to be paused Tuesday as they investigate rare blood clots in six women after the vaccination.

One woman died and a second was hospitalized in critical condition.

The women, whose ages range from 18 to 48, had experienced low platelet counts along with the clots in veins that draw blood from the brain, officials said.

The cases occurred an average of nine days after they received the one-dose vaccine, the agency said.

CDC principal deputy director Dr. Anne Schuchat said not all of the women had predisposing conditions.

“The review of six [cases] is difficult to make generalizations from. We’re going to have our expert committee take a careful look,” Schuchat told reporters.

Regulators said they wanted to alert patients and health care professionals about the condition since — when treated with the blood thinner heparin — it could be potentially “dangerous.”

It’s unclear whether Johnson & Johnson will stop any of its vaccine trials currently underway.

In New York, people scheduled to have the Johnson & Johnson shot will either get the Pfizer vaccine or have their appointment rescheduled, officials said.

The pause comes after regulators in other countries raised concerns about a similar issue with another vaccine, developed by AstraZeneca and Oxford University researchers, which is not in use in the US.

“That pattern is very, very similar to what was seen in Europe with another vaccine, so I think we have to take the time to make sure we understand this complication and we address it properly,” Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, told the press conference.

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