PITTSBURGH (KDKA) — The CDC and the FDA have paused immunization with the Johnson & Johnson coronavirus vaccine because of six cases of a rare clotting syndrome in women ages 18 to 48 within two weeks of their shot.
“Only six cases out of 6.8 million doses. On the other hand, if you’re one of the unfortunate patients who have symptoms after receiving this vaccine, I can understand why they might be concerned,” said Dr. Marc Itskowitz, a primary care internist at the Allegheny Health Network.
“Of the clots seen in the United States, one was fatal and one patient is in critical condition,” said Dr. Peter Marks, director of biologics at the Food and Drug Administration.
The clots can happen in the brain, the abdomen, the leg — thought to be related to an overactive immune response to the Johnson & Johnson vaccine. The unusual feature here is that the level of certain blood cells, called platelets, is low.
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“It appears to be occurring primarily in younger women, in which the immune system we know is typically more robust, more aggressive in causing these autoantibodies,” said Dr. Itskowitz.
“For people who got the vaccine more than a month ago, the risk is very low at this time,” said Dr. Anne Scheuchet, principal deputy director of the CDC.
If you got the J&J vaccine in the last couple of weeks, watch for symptoms.
“Severe headache, abdominal pain, leg pain or shortness of breath,” Dr. Scheuchet said. “You should contact your health care provider and seek medical treatment.”
Treating with a standard anticoagulant called heparin makes it worse, so doctors must use alternatives.
“This is evidence that the monitoring system is working,” said Dr. Itskowitz. “The fact that the CDC and the FDA were able to determine this rare side effect was occurring, I think is a credit to the system.”
He has been busy reassuring concerned patients.
“Just because they received the J&J vaccine is not a cause for concern. What we’ve been telling them is let us know if they’re developing any unusual symptoms, especially within 13 days, 14 days of having received the vaccine,” Dr. Itskowitz said.
“As long as we can provide enough supply of the other two vaccines, it really makes sense to encourage those vaccines at this time,” he added.
“We have not detected this type of syndrome with the low platelets among the other vaccines,” said Dr. Scheuchet.
“But it will cause concern among patients who have received the vaccine,” Dr. Itskowitz said. “It will also, unfortunately, fuel more hesitancy.”
The CDC’s vaccine advisory panel is meeting on Wednesday to discuss whether to restrict the Johnson & Johnson vaccine to certain groups, such as men over 50, or whether to halt the use in favor of Pfizer and Moderna.