The Food and Drug Administration (FDA) and Centers for Disease Control & Prevention (CDC) announced early Tuesday that they recommended pausing use of the Johnson & Johnson (Janssen) single-dose coronavirus vaccine (which has been given to more than 6.8 million people in the United States as of April 12) out of an abundance of caution due to six women between the ages of 18 and 48 developing a rare type of blood clot, according to a joint statement from the agencies. Per The New York Times, one woman died due to a blood clot and another was hospitalized.
Though the FDA did note on twitter that these instances were “extremely rare,” the agencies decided on the pause out of an abundance of caution until they are able to fully look into the cases of blood clots and determine if there is any connection to the vaccine (particularly as these mirror concerns with the AstraZeneca vaccine in Europe) and to better prepare medical providers to react to and treat these clots if they occur.
The news early Tuesday immediately launched worries for what this might mean for overall vaccine rollout and vaccine hesitancy in the United States, so it’s important to emphasize exactly how rare these blood clots are and that there is, so far, no proven causal relationship established between the clots and the vaccine, which Johnson & Johnson noted in their statement. So far, the agencies are citing six cases out of 6.8 million doses — meaning there is a less than one in a million chance of getting a blood clot post-dose (though, again there is no proven connection between the two yet).
For context, these numbers have been stacked against other known risk and side effects of common medications — including birth control. As The National Blood Clot Alliance notes “for the average woman taking birth control pills, the absolute risk of a blood clot is very small: Only [one in 1,000] women per year who are taking birth control pills will develop such a clot.”
The CDC and FDA wrote that the agencies will meet on Wednesday to review the cases of clots and what it means for their overall understanding of the data they have: “Until that process is complete, we are recommending a pause in the use of this vaccine out of an abundance of caution,” per the statement. “This is important, in part, to ensure that the health care provider community is aware of the potential for these adverse events and can plan for proper recognition and management due to the unique treatment required with this type of blood clot.”
What we know about these blood clot cases
Per the CDC and FDA, “In these cases, a type of blood clot called cerebral venous sinus thrombosis (CVST) was seen in combination with low levels of blood platelets (thrombocytopenia). All six cases occurred among women between the ages of 18 and 48, and symptoms occurred six to 13 days after vaccination.”
They write that while it is unknown exactly how many people in the United States experience this particular type of blood clot, “approximately 5 to 8% of the U.S. population has one of several genetic risk factors, also known as inherited thrombophilias in which a genetic defect can be identified that increases the risk for thrombosis.”
They note that treatment for this type of clot is a bit different than the typical treatment as the traditional anticoagulant drug (heparin) “may be dangerous, and alternative treatments need to be given.”
What does this mean for the people getting vaccinated?
The pause comes after the recent news that the company had to discard nearly 15 million doses of the Johnson & Johnson vaccine after a facility error in Baltimore, so there has already been an anticipated decrease in supply of the vaccine. For individuals who were scheduled to receive the J&J vaccine, you should contact your local vaccination facility for direction on how and when to reschedule your appointment or if you’ll be switched to one of the other vaccines available. It’s still overwhelmingly recommended that you get a COVID-19 vaccine when it’s available to you (both to protect you and vulnerable members of your community).
However, the pause of the Johnson & Johnson shot shouldn’t concern people scheduled to receive one of the other shots — as it is a different design than the other approved two-part shots from Moderna and Pfizer. While the latter use mRNA technology to send fat-covered pieces of genetic materials to the body’s cells, the Johnson & Johnson vaccine uses a “shell” of an adenovirus (which normally causes colds) to teach the immune system to identify and fight the virus.
“Inside the adenovirus is the DNA that your body will use to make into RNA and then into the spike protein of the coronavirus,” UC San Francisco infectious disease expert Monica Gandhi, MD, MPH told University of San Francisco in March. “…the spike protein doesn’t look like anything in our human body. So, you raise an immune response with T cells and antibodies to that spike protein, and that allows you to fight the virus if you ever see it in the future.”
If you or someone in your circle have already been vaccinated with the Johnson & Johnson vaccine, don’t panic! You’re encouraged to contact a healthcare provider if you “develop severe headache, abdominal pain, leg pain, or shortness of breath within three weeks after vaccination.”
What does this all mean for the Johnson & Johnson shot?
The company announced in a statement that they were working with agencies in the U.S. and abroad to prioritize vaccine safety and make sure that these rare cases are fully understood by researchers.
“We are aware of an extremely rare disorder involving people with blood clots in combination with low platelets in a small number of individuals who have received our COVID-19 vaccine,” Johnson & Johnson wrote in a statement Tuesday morning. “…Right now, these adverse events appear to be extremely rare. COVID-19 vaccine safety is a top priority for the federal government, and we take all reports of health problems following COVID-19 vaccination very seriously.”
Johnson & Johnson say they will also be reviewing the cases with European health officials and will be proactively delaying their European vaccine rollout.
Need to stock up on kid-friendly face masks for spring? This kids face mask gallery is a good place to start shopping!
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