On April 13, the Centers for Disease Control and Prevention (CDC) and the U.S. Food and Drug Administration (FDA) recommended pausing use of the Johnson&Johnson vaccine after six reports of rare blood clots. Since then, the number of reported blood clots grew to 15, all of which were investigated by the agencies. On April 23, the FDA and CDC recommended lifting the pause on the Johnson&Johnson vaccine, determining "the known and potential benefits … outweigh its known and potential risks."
The Johnson&Johnson vaccine now comes with a warning, specifically for a certain group. That's because all of the 15 people who experienced these rare blood clots following the Johnson&Johnson jab had one significant thing in common: They were all women under 60. Now, a new case of clotting in a man has been reported, the first of its kind in the U.S. Read on to find out the details of the latest patient, and what it could mean for you. And for more on blood clots, beware that If You Take This Medication, You're More Likely to Get a Blood Clot.
This is the first reported male recipient of the Johnson&Johnson vaccine to develop a blood clot since it was authorized for emergency use.
Two days after the Johnson&Johnson pause was lifted, on April 25, the University of California San Francisco (UCSF) reported the first known case of a man in the U.S. who developed a blood clot after receiving the Johnson&Johnson vaccine since the FDA authorized it for general use, according to the San Francisco Chronicle. The man is in his early 30s and was hospitalized with a clot in his leg.
The 15 cases that came before this one had all been in women, most of whom were under 50. As the CDC advised in new guidance posted on April 25, "Nearly all reports of this serious condition, which involves blood clots with low platelets, have been in adult women younger than 50 years old. … Women younger than 50 years old should be aware of the rare but increased risk of this adverse event."
Depending upon how this case turns out, that warning could change.
And for more commonalities with COVID, The CDC Says People Who Get COVID After Vaccination Have This in Common.
The man's symptoms developed more than a week after he was vaccinated.
The man in the Bay Area received the Johnson&Johnson jab on April 8 and began to experience increasing pain in his lower back and leg on April 16, the San Francisco Chronicle reported. Similarly, the women who developed blood clots all started to show symptoms 6 to 13 days after their Johnson&Johnson vaccination.
Andrew Leavitt, MD, a hematologist who oversaw the man's care at UCSF, told the San Francisco Chronicle that he expects the patient to be able to leave the hospital in the next couple of days. "I saw him today, and he was doing beautifully," Leavitt said on April 25. "When I saw him, he was in good spirits chatting with his dad."
The doctor said he plans to share the facts of his patient's case with peer-reviewed journals to help researchers try to understand why these rare adverse events occur. To see if you're more prone to blood clots, know that If You Have This Blood Type, You're More Likely to Get Blood Clots.
There was one case of a man in the Johnson&Johnson clinical trials who had a blood clot.
While this is the first instance of a man in the real world experiencing a blood clot after the Johnson&Johnson vaccine, a man during the clinical trials for the vaccine also experienced a blood clot, The New York Times reports.
But because his case was before the vaccine was authorized for emergency use by the FDA, it was not included in the CDC and FDA's analysis, ScienceNews points out.
The CDC's risk-benefit analysis predicted that for every million Johnson&Johnson doses administered, only two men under 50 will develop blood clots, while 5,513 hospitalizations, 1,485 ICU admissions, and 708 of deaths among men under 50 would be prevented. No cases of blood clots are expected in older men, according to the CDC's modeling.
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The doctor treating the new male patient says the CDC and FDA were right to lift the pause.
Although Leavitt saw the effects of a Johnson&Johnson-related blood clot firsthand, he still feels the CDC and FDA made the right decision in lifting the pause. "The CDC did a great job with the pause," said Leavitt. "Absolutely, this should not preclude people from getting vaccinated."
White House COVID adviser Anthony Fauci, MD, felt similarly. During an appearance on ABC's This Week on April 25, Fauci said the pause made the case that "we take safety really very seriously." He said now that the agencies confirmed the vaccine is safe, it's time to carry on with vaccinations. "We've looked at it; now let's get back and get people vaccinated. And that's what we're going to be doing, get as many people vaccinated as we possibly can, as quickly as we can, because we have a very, very effective vaccine for the people here and throughout the world," said Fauci. And for more vaccine news, find out why This Vaccine Side Effect Could Mean You Already Had COVID, New Study Says.