Federal health officials urged vaccination centers across the country on Tuesday to pause their use of the Johnson & Johnson COVID-19 vaccine after six women — one of whom died and another who is in critical condition — developed blood clots within two weeks of vaccination.
Members of the U.S. Food and Drug Administration and Centers for Disease Control and Prevention have said the condition, called cerebral venous sinus thrombosis (CVST), is “extremely rare” after getting the Johnson & Johnson shot.
The pause, which is expected to last for a couple of days, stemmed from an abundance of caution, giving officials time to understand what’s causing the severe type of clotting and prepare health care systems to recognize and treat patients appropriately if more cases appear.
The events are similar to those reported in Europe following the administration of the AstraZeneca COVID-19 vaccine, which has not been authorized for emergency use in the U.S.
The Tuesday announcement is a recommendation — not a mandate — officials said. So, vaccination sites can continue to vaccinate adults with the Johnson & Johnson vaccine, but people should discuss their risks with their health care providers before receiving their shot.
Some states have already announced they will be following the federal guidance on pausing the shot’s use, including New Jersey, Connecticut, Massachusetts, Maryland, Nebraska, Georgia, Indiana, Texas and Virginia, according to the New York Times.
The announcement will not have a significant impact on the country’s vaccination plan, according to a White House statement. The Johnson & Johnson vaccine makes up less than 5% of the recorded shots in arms in the United States to date. As of April 12, more than 6.8 million Americans have received the single-dose shot.
The CDC said its Advisory Committee on Immunization Practices is meeting Wednesday to “review these cases and assess their potential significance.”
What’s the risk of this happening to you?
Cerebral venous sinus thrombosis or CVST typically occurs anywhere between 2-14 people per one million people, Dr. Peter Marks, director of the Center for Biologics Evaluation and Research at the FDA, said during a news conference Tuesday morning, meaning the condition is very rare.
However, what’s “notable” is that the six cases of the condition were coupled with low blood platelet counts, which together “make a pattern” that’s even more rare, Marks said. It’s so rare that there is no annual rate of occurrence that health care professionals are aware of.
“We have to take the time to make sure we understand this complication and we address it properly,” Marks said.
There also does not seem to be a link between birth control use and the six cases reported in the U.S., all of which occurred in women between ages 18 and 48, Marks added. Some types of the contraceptive pill are associated with clotting problems.
Dr. Carlos del Rio, the executive associate dean at Emory University School of Medicine, told CNN on Tuesday that people who received the Johnson & Johnson vaccine should not “freak out,” because they have “a much higher chance of getting run over by a car” than developing blood clots after the shot.
“I think the first takeaway is that it’s a very rare event. I mean, you’re talking about one per million. And when you give millions of doses of vaccines, you will see events like this that you won’t see in the clinical trials just because you didn’t have millions of people involved,” del Rio told the outlet.
Still, he said, the CDC and FDA did the right thing by calling for a pause.
“Vaccine safety has always been a priority, and I think this is exactly the right move until we understand what’s going on and what’s the way forward,” he said.
What are the symptoms of cerebral venous sinus thrombosis?
Physical symptoms associated with CVST include severe headache, blurred vision, fainting, abdominal pain, leg pain or shortness of breath. They can vary depending on where the blood clot forms.
The condition occurs when a blood clot forms in the brain, preventing blood from draining out of it, causing blood cells to break and leak into brain tissues, according to Johns Hopkins Medicine. It’s essentially a rare form of stroke that affects about 5 people in 1 million each year.
The six cases reported in the U.S. after Johnson & Johnson vaccination occurred six to 13 days after getting the shot.
When to call a doctor
People who received their Johnson & Johnson COVID-19 vaccine more than a month ago face “very low” risks at this time, Dr. Anne Schuchat, CDC’s principal deputy director, said during the news conference.
Those who got their shot in the last couple weeks should be on the lookout for symptoms, however, such as severe headache, leg pain, abdominal pain or shortness of breath. Schuchat noted these symptoms are different from the flu-like symptoms that may be felt in the days after COVID-19 vaccination.
If these symptoms are present following Johnson & Johnson vaccination, then people should contact their health care providers and seek appropriate medical treatment.
