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Photo: Michael Ciaglo/Getty Images

The U.S. FDA on Tuesday recommended an immediate halt of the use of Johnson & Johnson's COVID-19 vaccine, citing cases of a rare blood clot disorder that six women developed within two weeks of receiving the shot.

The latest: Acting FDA Commissioner Janet Woodcock said at a briefing that she expects the pause to only last "a matter of days," as health officials investigate the data surrounding the "extremely rare" blood clots.

Driving the news: The FDA's recommendation was issued "out of an abundance of caution" and to prepare health providers to recognize and treat patients appropriately, since these types of blood clots require a different kind of treatment.

  • The White House said in a statement Tuesday that the pause "will not have a significant impact" on the administration's vaccination plans, noting that it has secured enough Moderna and Pfizer doses for 300 million Americans.
  • Nonetheless, some White House officials are concerned that the FDA's decision could increase vaccine hesitancy.

The big picture: Nearly 7 million Johnson & Johnson doses have been administered in the U.S., and another 9 million have been shipped out to the states.

  • The six women who developed the blood clots were between the ages of 18 and 48, according to the FDA.
  • While people who have received a J&J shot more than a month ago have a relatively low risk of developing any complications, the FDA recommends people vaccinated in the last three weeks contact their health care provider if they are experiencing severe headache, abdominal pain, leg pain or shortness of breath.
  • The FDA authorized the vaccine for emergency use on Feb. 27. The U.S. will stop administering the vaccine at federal sites and recommends that states do the same.

What they're saying: "Right now, these adverse events appear to be extremely rare," the FDA and the CDC wrote in a statement.

  • "Treatment of this specific type of blood clot is different from the treatment that might typically be administered."
  • The agencies noted that the vaccine pause is important "to ensure that the health care provider community is aware of the potential for these adverse events and can plan for proper recognition and management due to the unique treatment required with this type of blood clot."

Between the lines: The CDC said there are too few cases to determine whether there are any subpopulations particularly at risk. The health agencies are not ready to single out any subgroups at this time.

What to watch: A CDC expert committee will convene on Wednesday to "review these cases and assess their potential significance."

Go deeper

Apr 13, 2021 - Health

New York to replace today's J&J vaccine appointments with Pfizer

A box of Johnson & Johnson's Janssen COVID-19 vaccine doses at Grubb's Pharmacy on Capitol Hill on April 12. Photo: Tom Williams/CQ-Roll Call, Inc via Getty Images

New York will replace Johnson & Johnson's COVID-19 vaccines with the Pfizer vaccine for appointments scheduled for Tuesday, New York's health commissioner Howard Zucker said in a statement.

Why it matters: The FDA, out of "an abundance of caution," recommended on Tuesday an immediate pause of the use of Johnson & Johnson's COVID-19 vaccine, citing cases of a rare blood clot disorder that six women developed within two weeks after receiving the shot.

Apr 13, 2021 - Health

Moderna says its COVID-19 vaccine has not led to blood clots following J&J reports

Photo: Steve Parsons/Pool/AFP via Getty Images

Moderna released a statement Tuesday reassuring people of the safety of its coronavirus vaccine hours after the FDA recommended pausing the administration Johnson & Johnson (J&J) vaccines due to reported cases of "extremely rare" blood clots.

What they're saying: After over 64.5 million doses administered globally, a comprehensive assessment using data through March 22 "does not suggest an association with" blood clots in the brain or veins, Moderna said.

Apr 13, 2021 - Health

White House says J&J pause will not have "significant impact" on vaccination plan

Biden at the White Houe on April 6. Photo: Oliver Contreras/Sipa/Bloomberg via Getty Images

The White House said Tuesday that the FDA's recommendation that the U.S. pause use of Johnson & Johnson's COVID-19 vaccine "will not have a significant impact" on the administration's vaccination plans.

Why it matters: The Biden administration says it has secured enough Moderna and Pfizer doses for 300 million Americans. The U.S. will be able to continue administering 3 million vaccine doses a day even without the Johnson & Johnson shot, according to the White House.