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The U.S. Food and Drug Administration (FDA) will add a warning to the one-dose Johnson and Johnson COVID vaccine and lift the recommended pause in shots.
The agency acted quickly to redistribute the vaccine after the advisory group of the Centers for Disease Control and Prevention (CDC) met on Friday and voted to continue recommend its use in adults over 18 years of age.
The vote came after the CDC and the FDA conducted a safety review of 15 cases of thrombosis-thrombocytopenia syndrome (TTS) that occurred in women 18 to 59 years of age within a few weeks of receiving the vaccines. Three of the women died. Seven have been treated in intensive care units.
“What we are seeing is that the overall rate of events was 1.9 cases per million people. In women aged 18 to 29 there were approximately 7 cases per million. The risk is even lower in older women. 50 – year – olds, with 0.9 cases per million, “CDC director Rochelle Walensky, MD, told a news conference Friday night.
In the end, the potential benefits of the vaccine far outweighed its risks.
“In terms of benefits, we found that for every million doses of this vaccine, the [Johnson and Johnson] the vaccine could prevent more than 650 hospitalizations and 12 deaths among women aged 18 to 49, ”Walensky said.
The potential benefits for women over 50 were even greater: it could prevent 4,700 hospitalizations and 650 deaths.
“In the end, this vaccine was shown to be safe and effective for the vast majority of people,” Walensky said.
He noted that in recent days, as regulators have reviewed infrequent events, newly identified patients had been treated appropriately, without the use of heparin, which is not recommended with TTS.
As a result, regulators felt that their messages had reached doctors who now knew how to take special precautions when treating patients with this disorder.
Walensky said the Johnson and Johnson vaccine remained an important option because it was convenient to administer and was easier to store than other vaccines currently authorized in the United States.
Peter Marks, MD, PhD, director of the FDA’s Center for Biological Product Assessment and Research, said the agency had already added to its patient and physician fact sheets information describing the risk of this disorder. of coagulation.
Janet Woodcock, the FDA’s acting commissioner, said vaccination centers could resume vaccinations on Saturday morning.