What to Know About the J&J COVID Vaccine Pause
April 13, 2021 – After receiving reports of a rare blood clot in people receiving the Johnson & Johnson COVID-19 vaccine, the FDA and CDC have recommended a pause in vaccine use, pending investigation further.
Here’s what you need to know:
Why was the break suggested?
After reviewing the data, the agencies found six reports of people who experienced rare blood clots associated with low platelets, which are the smallest cells in the blood and involved in clotting. The six reports were found on over 6.8 million doses administered. The FDA and CDC initiated the break “out of caution.”
What else do we know?
According to a joint statement released by the CDC and the FDA, the six cases involved women between the ages of 18 and 48. Symptoms appeared 6 to 13 days after vaccination. The type of clot is medically known as cerebral venous sinus thrombosis (CVST) and has been seen in association with low levels of blood platelets. Click here to learn more about these types of blood clots.
Of the six cases, one woman died; another was in critical condition.
The treatment for this type of clot is different from that for other types, according to the CDC and the FDA. Usually, an anticoagulant drug, heparin, is used. But for this type of clot, alternative treatment may be needed.
Why is this happening?
“We don’t have a definitive answer yet, but it appears to involve an immune response related to the J&J vaccine that negatively affects platelet function, preventing the normal clotting process from occurring,” says Robert Glatter, MD , emergency physician at Lenox Hill Hospital in New York.
He says the explanation “may ultimately be linked to the adenovirus vector [used in the vaccine] himself. “
Why does it seem to affect women more than men?
This is not yet known, says William Schaffner, MD, professor of preventive medicine and infectious disease specialist at Vanderbilt University Medical Center in Nashville. “This was true for the AstraZeneca [vaccine] as well as their blood clot problems, “he says. If it’s an immune problem, women tend to have more of these problems than men in general, he says.
What should people who have received the J&J vaccine know and do?
Keep in mind that reports of blood clots were rare, suggests Schaffner. The odds are about 1 in a million, based on six reports of 6.8 million doses administered. “It’s actually a testament to the sensitivity of our vaccine safety system,” he says, that these few reports would be detected over millions of doses.
People who have received the vaccine should be vigilant for symptoms, say the FDA and CDC. If you have received the Johnson & Johnson vaccine and develop severe headache, abdominal pain, leg pain, or shortness of breath within 3 weeks of vaccination, contact your healthcare provider.
How long will the break last?
This is not yet known either. The CDC’s Advisory Committee on Immunization Practices (ACIP) will meet on Wednesday to further review the cases and “assess their potential importance.” The FDA is also examining the data further.
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