The FDA and CDC recommend pausing the use of Johnson & Johnson’s COVID vaccine. What you should know

Federal drug safety regulators recommend the U.S. pause use of the Johnson & Johnson COVID-19 vaccine after “extremely rare” reports of blood clots in people who get the vaccine.

The Food and Drug Administration and the Centers for Disease Control and Prevention are investigating six cases involving vaccinated women who developed blood clots, called cerebral venous sinus thrombosis (CVST), in combination with low levels of blood platelets.

The women were between the ages of 18 and 48 and experienced symptoms six to 13 days after vaccination. One woman died, and another remains in critical condition, federal health officials said.

What is cerebral venous sinus thrombosis?

Cerebral venous sinus thrombosis (CVST) is a rare and severe type of blood clot that forms in the brain’s venous sinuses and prevents blood from draining out of the brain, according to Cedars Sinai Medical Center in Los Angeles.

It can occur in two to 14 people out of 1 million with normal blood platelet counts each year, said Peter Marks, director of the Food and Drug Administration’s Center for Biologics Evaluation and Research.

What’s notable in the Johnson & Johnson cases is that the six patients had both cerebral venous sinus thrombosis and extremely low platelet counts, a condition known as thrombocytopenia.

“It’s their occurrence together that makes a pattern, ” Marks said. “And that pattern is very, very similar to what was seen in Europe with other vaccines,” referring to the AstraZeneca vaccine.

Although an anticoagulant drug heparin is commonly used to treat blood clots, health officials say using this drug could be dangerous and recommend medical providers use alternative treatments.

What do I do if I’ve gotten the J&J shot?

It depends on when you received the vaccine. For those who received the J&J vaccine a month ago or longer, the risk of developing these rare blood clots is very low, said Anne Schuchat, the CDC’s principal deputy director.

Others, who received the vaccine over the past couple of weeks, should monitor for symptoms such as severe headaches, abdominal pain, leg pain or shortness or breath. Individuals who develop such symptoms should contact a health care provider and seek medical treatment.

“Now these symptoms are different than the mild flu-like symptoms, fever and so forth, that many people have experienced in the couple of days after they have received the vaccine,” Schuchat said.

People who have appointments for the Pfizer-BioNTech or Moderna vaccines during the coming days or weeks should keep them. There have been no reports of such blood clots from those who received those authorized vaccines. Health officials are working to reschedule people who have J&J vaccine appointments in the coming days.

“This may be a bit bumpy,” Schuchat said. “We want to make sure we’re getting the word out to the public and to our providers.”

How will the J&J pause impact the US COVID-19 vaccination effort?

The J&J vaccine is one of three COVID vaccines to receive FDA emergency use authorization and the only single-dose vaccine. The other two vaccines made by Moderna and Pfizer-BioNTech require two shots to be administered.

White House COVID-19 Response Coordinator Jeff Zients said pausing the J&J vaccine “will not have a significant impact” on the Biden administration’s vaccination plan.

The Johnson & Johnson vaccine was the third vaccine authorized, and represents less than 5% of COVID-19 vaccines administered in the United States so far. Zients said the nation has enough Pfizer and Moderna doses for 300 million Americans, enough supply to administer 3 million shots per day.

What prompted the pause of the J&J vaccine?

Federal health officials wanted to notify the public and medical community to monitor for these rare cases.

While heparin is commonly used for blood clots, such a standard treatment might cause “tremendous harm, or the outcome can become fatal,” when used on people in these cases, Marks said

Doctors who treat patient with blood clots and low blood platelets should ask the patients about recent vaccinations. This will allow doctors to diagnose and tailor any potential treatments.

The J&J vaccination pause is meant to give doctors time to learn about diagnosing, treating and reporting these rare cases. “The decision was based on the events that might occur between when we made that realization and when we got the word out,” Schuchat said.

How do I reschedule my shot?

That will vary depending on where you are getting vaccinated. Because this news just came out Tuesday morning, vaccination sites will be scrambling to contact patients scheduled for the next few days first. They will then be waiting for recommendations from FDA and CDC about how to move forward.

The FDA and CDC haven’t said the Johnson & Johnson vaccine should no longer be given. They called for a pause to give researchers time to examine the cases of blood clotting they’ve seen to determine whether or not it should be stopped. That answer should come quickly.

Contributing: Elizabeth Weise

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