The U.S. Food and Drug Administration along with the Centers for Disease Control and Prevention have recommended a pause in the administration of the Johnson & Johnson COVID-19 vaccine after six women were reported to have suffered a rare type of blood clot after getting the vaccination.
The women were all between the ages of 18 and 48, and all developed the blood clot within about two weeks of vaccination. One death was reported among the women.
According to the CDC, more than 6.8 million Americans have received the Johnson & Johnson COVID-19 vaccine, and nearly 9 million doses have been shipped out to the states, according to the CDC.
“We are recommending a pause in the use of this vaccine out of an abundance of caution,” Dr. Peter Marks, director of the Food and Drug Administration’s Center for Biologics Evaluation and Research; and Dr. Anne Schuchat, principal deputy director of the CDC said in a joint statement. “Right now, these adverse events appear to be extremely rare.”
“For people who recently got the vaccine within the last couple of weeks, they should be aware to look for any symptoms. If you receive the vaccine and develop severe headaches, abdominal pain, leg pain or shortness of breath, you should contact your health care provider and seek medical treatment,” she said.
According to a news conference on Tuesday, FDA and CDC researchers will be examining the possible links between the vaccine and the disorder, called cerebral venous sinus thrombosis. FDA officials will decide if its authorization of the use of the vaccine should be re-examined.
According to the FDA, cerebral venous sinus thrombosis is being seen in combination with low levels of blood platelets, or cells that cause blood to clot.
What is cerebral venous sinus thrombosis?
What is cerebral venous sinus thrombosis? Here is what we know about the rare clotting issue.
Cerebral venous sinus thrombosis (CVST) is a blood clot that forms in a portion of the brain called the venous sinuses. The venous sinuses help to drain blood from the brain as blood circulates through the body.
The thrombosis, or clot, prevents blood from draining out of the brain. Because blood is prevented from leaving the brain in this usual way, it can leak into brain tissue and cause a hemorrhage, or bleeding in the brain.
The clot and bleeding cause a stroke.
How common is CVST?
CVST is very rare. Generally, it affects about five people in 1 million each year. It can strike at any age, including in newborns.
What are the symptoms of cerebral venous sinus thrombosis?
According to Johns Hopkins Medicine, these are the symptoms of CVST: (symptoms may vary depending on where the blood clot is located).
- Blurred vision
- Fainting or loss of consciousness
- Loss of control over movement in part of the body
What should you do if you have had a Johnson & Johnson vaccination?
If you have had the Johnson & Johnson vaccine and you develop severe headache, abdominal pain, leg pain, or shortness of breath within three weeks after the inoculation, the FDA recommends that you contact your health care provider.
If you are past the three-week period, health officials say the chance of developing CVST is very remote.
What happens next?
An emergency meeting of the CDC’s vaccine advisory committee has been scheduled for Wednesday.
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