The Center for Disease Control and Prevention and the Food and Drug Administration are recommending pausing the use of Johnson & Johnson’s coronavirus vaccine.
Why? They are citing six reported U.S. cases where people who received the vaccine experienced a “rare and severe” blood clot which demands a different treatment. Those six cases were among the over 6.8 million doses of the Johnson & Johnson vaccine administered in the U.S. They all occurred in women between the ages of 18 and 48, who exhibited symptoms 6 to 13 days after getting inoculated, according to a joint statement from Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, and Dr. Anne Schuchat, principal deputy director of the CDC.
One of the women died and another one was hospitalized.
What’s next? Scientists with the agencies will conduct a joint review to determine whether there is a link between the blood clots and the vaccine. They will also determine whether the FDA should continue to authorize the Johnson & Johnson vaccine for emergency use and whether it should impose some limits. CDC’s outside advisory committee will hold an emergency meeting on Wednesday.
“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,” Marks and Schuchat said in a statement. “FDA will review that analysis as it also investigates these cases. Until that process is complete, we are recommending a pause in the use of this vaccine out of an abundance of caution. 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.”
Johnson & Johnson issued a statement on Tuesday, saying that the “safety and well-being of the people who use our products is our number one priority.”
“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,” the company said, adding that it decided to “proactively delay the rollout” of its vaccine in Europe.
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