DALLAS — Reports of six cases of blood clots associated with the Johnson & Johnson COVID-19 vaccine prompted U.S. health authorities to pause its administration.
Soon after the CDC and the FDA recommended that healthcare providers and vaccination centers pause the Johnson & Johnson vaccine, word began to spread on social media that the vaccine had been “recalled.”
THE QUESTION
Did the FDA recall the Johnson & Johnson COVID-19 vaccine?
THE SOURCES
Dr. Amesh Adalja, Senior Scholar at the Johns Hopkins Center for Health Security
THE ANSWER
According to the data from the CDC, FDA and Dr. Amesh Adalja, the vaccine has not been recalled. The FDA and CDC have jointly recommended a pause on giving out doses while this vaccine undergoes a review.
WHAT WE FOUND
The FDA and the CDC released a joint statement that explains the decision of recommending a pause on the administration of the Johnson & Johnson vaccine while they evaluate a specific type of blood clot found in six women after vaccination. In total, more than 6.8 million doses of the Johnson & Johnson vaccine have been administered.
“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,” the statement reads.
Both authorities will further review these cases starting Wednesday. The vaccine will be paused in the United States while this analysis is underway.
Dr. Amesh Adalja explained this pause is temporary and doesn’t mean the vaccine is less effective or will lose its Emergency Use Authorization.
“Think about your DVD remote when you hit pause, that means you're going to come back and hit the unpause button,” Dr. Adalja said. “So this usually is a temporary stoppage in order to take a look at the data, the lay of the land, the risk communication messaging, and then move forward.”
The FDA website defines a recall as “a voluntary action taken by a company to remove a defective drug product from the market.”
And that’s not the definition of the current recommended pause on this vaccine.
The FDA and the CDC have not yet confirmed that the vaccine caused these blood clots, as they will continue to work together to look at any possible links before moving forward. Dr. Adalja believes this is only temporary and people shouldn’t worry about the vaccine efficacy either.
"When you're pausing, the intention is that this will resume and I do suspect the Johnson and Johnson vaccine will resume."
In a statement, Johnson & Johnson said in part, "We have been working closely with medical experts and health authorities, and we strongly support the open communication of this information to healthcare professionals and the public."
VERIFY's Mauricio Chamberlin contributed to this report.