The FDA Just Added This Warning for the Johnson & Johnson Vaccine

The FDA and CDC lifted the pause on the vaccine, but added this warning for recipients.

If you were among the estimated 8 million people in the U.S. who received the one-dose Johnson & Johnson COVID vaccine before it was paused by the U.S. Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC), you can relax now, or at least try to. The pause, which was implemented on Apr. 13 "out of an abundance of caution" due to six instances of blood clots, has been lifted after 11 days. While the vaccine is back and able to be administered to those 18 and older, it's now coming with a warning from the FDA. Read on to find out what you should know about the rare adverse events, and for more on blood clots from the Johnson & Johnson vaccine, check out Dr. Fauci Says This Medication Could Make Blood Clots Worse.

The FDA and CDC lifted the pause on the Johnson & Johnson vaccine after confirming the benefits outweigh the risks.

johnson & johnson vaccine logo, hands, blue gloves
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At a meeting of the CDC's Advisory Committee on Immunization Practices (ACIP) on Apr. 23, the committee voted 10 to 4—with one abstention—to resume use of the vaccine among all adults in the U.S. The decision was made after a "thorough safety review," the FDA said in a statement. However, they did recommend that a warning be added to the Johnson & Johnson label to include the possibility that the vaccine may increase the risk of blood clots.

FDA Commissioner Janet Woodcock, MD, said in a statement that the pause was lifted based on "the FDA and CDC's review of all available data and in consultation with medical experts and based on recommendations from the CDC's Advisory Committee on Immunization Practices." She further explained: "We have concluded that the known and potential benefits of the Janssen COVID-19 vaccine outweigh its known and potential risks in individuals 18 years of age and older. We are confident that this vaccine continues to meet our standards for safety, effectiveness and quality."

During the ACIP meeting, according to Live Science, CDC scientist Sara Oliver, MD, presented modeling research that showed that continuing to administer the Johnson & Johnson vaccine for everyone ages 18 and older may cause 26 to 45 cases of blood clots, but would prevent 600 to 1,400 deaths and 800 to 3,500 ICU admissions.

If they recommended the Johnson & Johnson vaccine just for people 50 and older, it would likely lead to two or three blood clot events and prevent 300 to 1,000 ICU admissions and 40 to 250 deaths.

And for more on vaccine reactions you'll likely see with another shot, check out Moderna Caused This Reaction in 82 Percent of People, New Study Says.

The FDA's new warning with the Johnson & Johnson vaccine is specifically directed at women under 50.

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On Friday, the FDA added a new warning to its Johnson & Johnson vaccine fact sheet for recipients and caregivers. The agency warns "blood clots involving blood vessels in the brain, abdomen, and legs along with low levels of platelets (blood cells that help your body stop bleeding), have occurred in some people who have received the Janssen COVID-19 Vaccine."

The FDA says women under the age of 50 should particularly be aware of the rare blood clotting condition, known as thrombosis-thrombocytopenia syndrome (TTS). Women who had blood clots and low levels of platelets started seeing symptoms one to two weeks after getting vaccinated.

The warning comes after Tom Shimabukuro, MD, the agency's Immunization Safety Office Deputy Director, advised at the ACIP meeting that the blood clotting disorder is "rare, but clinically serious" and seems to largely affect women of a particular age. Of the 8 million Johnson & Johnson vaccines administered, there were 15 instances of TTS. Thirteen out of the 15 cases were women between the ages of 18 and 49 and the two other cases were among women between the ages of 50 and 64. For women 18 to 49, the risk of developing blood clots appears to be 7 per million, while the risk for women 50 and older appears to be 0.9 per million, as Live Science points out.

There wasn't a clear trend in risk factors among those who developed TTS other than being women under a certain age—seven were obese; two had hypothyroidism; two were using birth control; and two had high blood pressure.

The ACIP says there are another 10 cases currently under review, which may include men.

And for another vaccine's most common side effects, Pfizer Caused This Reaction in Half of Recipients, New Study Says.

Thus far, the blood clots linked to the Johnson & Johnson vaccine have resulted in three deaths.

a doctor administers the COVID vaccine
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At the CDC's ACIP meeting, it was revealed that of the total 15 women who experienced blood clots, three died, seven remain hospitalized (four of whom are in the ICU), and five were discharged home.

In 12 of the 15 cases, the women specifically experienced cerebral venous sinus thrombosis (CVST), a blood clot formed in the brain's venous sinuses.

"Symptom onset appears to occur at least several days after vaccination, typically around one to two weeks after vaccination," Shimabukuro explained, according to CNN. "The clinical features of TTS following the Janssen COVID-19 vaccine appear similar to what is being observed following the AstraZeneca COVID-19 vaccine in Europe. It is important to recognize TTS early and initiate appropriate treatment."

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The FDA and CDC urge you to get immediate medical attention if you have specific symptoms after the Johnson & Johnson shot.

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For anyone planning to get the revived Johnson & Johnson vaccine, the CDC and FDA urge you to seek immediate medical attention if you notice a handful of specific symptoms after getting the jab. Initial symptoms included headache, chills, fever, nausea, vomiting, and tiredness, according to the CDC. Later on, women who had TTS also experienced severe headache with neck pain, speech difficulty, loss of consciousness, unilateral weakness, and seizure.

And for another factor to be aware of, Make Sure to Do This the Day After Your COVID Vaccine, Experts Say.

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