Federal health agencies say they are ending their recommended pause on use of Johnson & Johnson's Janssen, following the vote of a panel of advisers to the Centers for Disease Control and Prevention on resuming the single-shot vaccine.
The Food and Drug Administration said they have revised their emergency use authorization for the vaccine to include a new warning about the "plausible" risk of rare but serious blood clots in adult women under 50.
A panel of advisers to the Centers for Disease Control and Prevention voted earlier Friday to recommend resuming use of the Johnson & Johnson vaccine. The shots are expected to be accompanied by a new warning about an increased risk of rare but serious blood clots for adult women under 50.
A federal health official told the panel Friday that vaccinations could resume once the CDC director approves its recommendations and the Food and Drug Administration publishes an update to its emergency use authorization for the vaccine.
A total of three women have died from the clotting disorder after receiving the Janssen vaccine, out of 16 cases like it in total among women in the U.S, the CDC told its panel of advisers on Friday. Seven remain hospitalized and five have been released. Most were under the age of 50.
One man was also diagnosed with the same symptoms after receiving the shot in Johnson & Johnson's clinical trials.
The cases make up a tiny fraction of the more than 8 million doses that have been given, according to CDC figures released Friday. During the recommended pause, at least 170,338 Johnson & Johnson shots were given and another 9.6 million doses that had been delivered to jurisdictions have gone unused.
Resuming the Janssen vaccine for all adults could prevent 600 to 1,400 deaths from COVID-19, the CDC estimated but could also lead to 26 to 45 of the blood clotting cases. The agency predicted that vaccinating all willing Americans could be delayed up to two weeks if the shots are not resumed for all adults.
"The benefits do clearly outweigh the risks from a population perspective and an individual perspective, and I think it's reassuring to me anyway that while we don't have all the information, I think we do have enough information to move forward," said Dr. Beth Bell, a member of the panel and a former top CDC official.
The panel's vote comes more than a week afterfollowing the initial reports of the blood clots in eight people under the age of 50.
A CDC official told the panel that the agency planned to mount a "public education" effort to raise awareness around the risks. Johnson & Johnson said it had agreed with the Food and Drug Administration on specific language for a warning to accompany the shot for healthcare professionals.
The agency said it had observed a handful of clotting events among recipients of the Moderna and Pfizer shots as well, but none had the unusual and dangerous combination of low blood platelets seen in the 16 people following the Janssen vaccine.
"At the same time I think that there is a real risk. It's admittedly an extremely small risk, and smaller than many other risks that we choose to take every day. But nonetheless, there are alternatives at least for us in the United States," remarked Dr. Bell.
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