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Federal health agencies say they are ending their recommended break on the use of Johnson & Johnson’s Janssen vaccine, following a group of Centers for Disease Control and Prevention advisers vote on resuming the vaccine single injection.
The Food and Drug Administration says it revised its authorization for emergency use of the vaccine to include a new warning about the “plausible” risk of rare but serious blood clots in adult women under the age of 50.
A group of advisers from the Centers for Disease Control and Prevention voted earlier Friday to recommend resuming use of the Johnson & Johnson vaccine. The injections should be accompanied by a new warning about an increased risk of rare but serious blood clots in adult women under the age of 50.
A federal health official told the committee on Friday that vaccinations could resume once the CDC director approves his recommendations and the Food and Drug Administration releases an update to its emergency use authorization for the vaccine.
A total of three women have died of the bleeding disorder after receiving the Janssen vaccine, out of a total of 16 similar cases in women in the United States, the CDC told its panel of advisers on Friday. Seven remain hospitalized and five have been released. Most were under 50.
A man was also diagnosed with the same symptoms after receiving the vaccine in clinical trials from Johnson & Johnson.
The cases represent a tiny fraction of the more than 8 million doses that have been administered, according to CDC figures released on Friday. During the recommended break, at least 170,338 injections of Johnson & Johnson were administered and 9.6 million additional doses that had been administered to the courts went 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 cases of blood clotting. The agency predicted that vaccination for all consenting Americans could be delayed for up to two weeks if vaccines are not resumed for all adults.
“The benefits clearly outweigh the risks from a population perspective and an individual perspective, and I think he reassures me anyway that even though we don’t have all the information, I think we have enough information to move forward, ”said panel member and former CDC official Dr Beth Bell.
The panel’s vote comes more than a week after the vaccine distribution was suspended following the first reports of blood clots in eight people under the age of 50.
A CDC official told the panel that the agency plans to mount a “public education” effort to raise awareness of the risks. Johnson & Johnson said it had agreed with the Food and Drug Administration on specific language for a warning accompanying the shooting for medical professionals.
The agency said it had also observed a handful of clotting events in recipients of the Moderna and Pfizer injections, but none exhibited the unusual and dangerous combination of low blood platelets seen in the 16 people following the vaccine. Janssen.
“At the same time, I think there is a real risk. It is admittedly an extremely low risk, and smaller than many other risks that we choose to take every day. But nevertheless, there are alternatives at least. for us in the United States, ”noted Dr Bell.
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