DORAL, FL – The Johnson & Johnson vaccine against the coronavirus could be paused across the United States after six reported cases of blood clot led the US Centers for Disease Control and Prevention and the FDA to issue the recommendation.
“CDC will convene a meeting of the Advisory Committee on Immunization Practices (ACIP) on Wednesday to further review these cases and assess their potential significance,” reads a statement on Tuesday from Dr. Anne Schuchat, principal deputy director of the CDC and Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research.
According to the joint statement released on Tuesday, the FDA will also study the cases of the six women between the ages of 18 and 48 who presented a “rare and severe” type of blood clot 6 to 13 days after getting the Johnson and Johnson vaccine.
“Until that process – the investigation- is complete, we are recommending a pause in the use of this vaccine out of an abundance of caution,” continues the statement.
The decision aims at giving time to the health care provider community to “plan for proper recognition and management due to the unique treatment required with this type of blood clot.”
Nevertheless, the statement provides a sense of calm by stating these cases are not within the normality ranges. In fact, they are “extremely rare”.
“It’s a very rare event. You’re talking about 1 per million, and when you give millions of doses of vaccines, you will see these events like this that you couldn’t see in the clinical trials just because you didn’t have millions of people enrolled,” Dr. Carlos del Rio, executive associate dean of the Emory University School of Medicine at Grady Health System, told CNN.
But regardless of this, the pause of the Johnson & Johnson vaccine in the U.S. has to do with the fact that this type of blood clot wasn’t listed among the potential adverse side effects the vaccine could cause.
Meanwhile, it will be up to every state to decide whether or not to stop distributing the vaccine since each has a separate allocation of doses, although all federal health sites will immediately pause for the time being.
If you received the J&J shot and developed symptoms such as severe headache, abdominal pain, leg pain or shortness of breath within three weeks after vaccination, it is recommended to contact your health care provider.