This is what the White House says about Johnson & Johnson vaccine pause 1:50
(CNN) -
Have you received the Johnson & Johnson single-shot covid-19 vaccine in the past month?
If you experience a severe headache that does not go away, significant abdominal or leg pain that does not subside, or increasing shortness of breath, health officials want you to call your doctor immediately.
These could be signs of a serious and extremely rare type of clot that may be related to the Johnson & Johnson vaccine;
so rare that only six cases have been reported in the United States of the approximately 7 million doses applied by Johnson & Johnson to date.
However, if you received the J&J vaccine more than a month ago, the risk is "very low," said Dr. Anne Schuchat, senior deputy director of the US Centers for Disease Control and Prevention (CDC). , during a virtual briefing on Tuesday.
The CDC announced that six women between the ages of 18 and 48 had developed cerebral venous sinus thrombosis (CVST), a clot in the area of the brain that collects and drains blood without oxygen.
When this happens, "blood cells can rupture and leak blood into brain tissues, forming a hemorrhage," according to Johns Hopkins Medicine.
All of the women developed symptoms of this "rare and severe type of blood clot" between six and 13 days after their J&J vaccination, the CDC said.
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One of the women died 12 days after receiving the vaccine and entering the hospital with "retching, sudden worsening of the headache and weakness on the left side," according to a registry of the Vaccine Adverse Event Reporting System of the Department of Health. from the US Another woman is in critical condition.
The cases prompted the CDC and the US Food and Drug Administration (FDA) to recommend that the J&J covid-19 vaccine be paused to allow further investigation.
What does a pause mean?
It really allows both the FDA and the CDC to do more research on these cases to try to understand some of the mechanisms of what they are, some more details about the history of the people involved, ”said Dr. Anthony Fauci, director of the National Institute of Allergies and Infectious Diseases, during a briefing at the White House on Tuesday.
In response, Johnson & Johnson decided to pause vaccines in all of its clinical trials while the company updates the "guide for researchers and participants," according to a press release published Tuesday afternoon.
CDC's Advisory Committee on Immunization Practices will meet Wednesday and share its subsequent analysis with the FDA to take action, the agency said.
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What does this mean if I have had the J&J vaccine?
"Without panicking, I would get on with my life, but I would be very aware of my body," Dr. Carlos del Rio, executive associate dean of the Emory University School of Medicine, told CNN's Poppy Harlow on Tuesday. .
"If I have trouble breathing, if my leg hurts, if my head hurts, and I'm within two to three weeks of getting the Johnson & Johnson vaccine, I would immediately notify my healthcare provider," Del continued. River.
The key here is unrelenting pain, said Dr. Mark Crowther, a fellow of the American Society of Hematology, an expert on CVST.
“A lot of people have headaches, a lot of people have abdominal pain but (CVST) it is sustained, it is very severe and it gets worse.
It's not the pain that gets better on its own, ”said Crowther, who chairs the department of medicine at McMaster University in Ontario, Canada.
While CVST is not a stroke, people can experience stroke-like difficulties speaking or moving an arm or leg, he added.
“If patients have something like that, they should seek medical attention immediately.
It's not the kind of thing you wait until your doctor's office opens on Monday before dealing with that, ”Crowther said.
The CDC is working on an "aggressive" approach to physicians so they are aware of possible risks and how to identify symptoms, Schuchat said at the briefing.
"Doctors wouldn't see many of these in their career, so they may not recognize them as quickly," Crowther said.
"We have some highly effective treatments for this, so the problem is getting doctors to recognize this extraordinarily rare problem and treat it appropriately."
In some cases, doctors may not realize that the common anticoagulant drug heparin should not be used to treat CVST, said Dr. Peter Marks, director of the FDA's Center for Biological Evaluation and Research, during a briefing. virtual Tuesday.
"With cerebral venous sinus thrombosis, heparin can be dangerous and alternative treatments need to be given, preferably under the guidance of physicians experienced in treating blood clots," said Marks.
The need to communicate proper treatment to physicians was part of the reason the FDA and CDC acted so quickly to stop the J&J deployment this week, health officials said.
This development should not deter Americans or anyone else from continuing to be vaccinated with the Pfizer / BioNTech and Moderna two-shot vaccines, or even the J&J vaccine once the government gives the green light, Crowther stressed.
"Covid is associated with a risk of blood clots that is thousands of times greater" than blood clots caused by any vaccine, he said.
"It's important that people don't forget that," Crowther added.
"Get vaccinated!"
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How do low platelets influence?
Cerebral venous sinus thrombosis affects about five people in 1 million each year, according to Johns Hopkins Medicine, and occurs primarily in young adults and children.
"CVST has been around for decades, and there are many conditions in which CVST can be seen," said Crowther.
'Meningitis, which is the bacterial infection around the brain, causes CVST.
In babies, one cause of CVST is actually severe dehydration.
CVST clots in six people in the U.S. occurred in combination with thrombocytopenia, a condition in which people have a low blood count of platelets, the sticky, colorless blood cells that help blood clot, according to the statement. by J&J.
A rare immune response that caused blood clots and low platelets also occurred in 16 European patients who received AstraZeneca's covid-19 vaccine, according to two articles published last week in
The New England Journal of Medicine.
In those articles, doctors describe clots in the brain and abdomen of patients that could indicate an abnormal immune response in 11 patients in Germany and Austria and five patients in Norway.
There appear to be similarities between the rare blood clotting events possibly associated with Johnson & Johnson's coronavirus vaccine and AstraZeneca's coronavirus vaccine, Marks said Tuesday from the FDA, noting "an immune response that occurs very, very rarely. after some people get the vaccine. '
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: AstraZeneca covid-19 vaccine: How common are blood clots and should I be concerned?
One possibility, Crowther said, is that the vaccines trigger an exaggerated immune response that attacks blood platelets.
Platelets become activated and, as a result, cause blood to clot, even when their number decreases.
But that doesn't mean that vaccines always cause this phenomenon, Crowther emphasized.
Many people have lower platelet counts and don't realize it, he said, so when they get any vaccine and then are diagnosed with thrombocytopenia, it can be attributed to the vaccine "even though (they) may have had it for 10 years and only never they knew it ».
CNN's Elizabeth Cohen, Jacqueline Howard, Michael Nedelman, and Deidre McPhillips contributed to this report.
Johnson and Johnsonvaccine against covid-19
