The US Food and Drug Administration (FDA) will add a warning to the Johnson and Johnson one-dose COVID vaccine and lift its recommended pause on the shots.
The agency acted quickly to get the vaccine back into distribution after a Centers for Disease Control and Prevention (CDC) advisory panel met on Friday and voted to continue to recommend its use in adults ages 18 and up.
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 ages 18 to 59 within a few weeks of getting their vaccines. Three of the women died. Seven have been treated in intensive care units.
“What we are seeing is the overall rate of events was 1.9 cases per million people. In women 18 to 29 years there was an approximate 7 cases per million. The risk is even lower in women over the age of 50, at .9 cases per million,” said CDC Director Rochelle Walensky, MD, in a press briefing Friday night.
In the end, the potential benefits of the vaccine far outweighed its risks.
“In terms of benefits, we found that for every 1 million doses of this vaccine, the [Johnson and Johnson] vaccine could prevent over 650 hospitalizations and 12 deaths among women ages 18-49,” Walensky said.
The potential benefits to women over 50 were even greater: It could prevent 4700 hospitalizations and 650 deaths.
“In the end, this vaccine was shown to be safe and effective for the vast majority of people,” Walensky said.
She pointed out that over the past few days, as regulators have reviewed the rare events, newly identified patients had been treated appropriately, without the use of heparin, which is not advised with TTS.
As a result, regulators felt like their messages had gotten out to doctors who now knew how to take special precautions when treating patients with the disorder.
Walensky said the Johnson and Johnson vaccine remained an important option because it was convenient to give and easier to store than the other vaccines currently authorized in the United States.
Peter Marks, MD, PhD, director of FDA’s Center for Biologics Evaluation and Research, said the agency had already added information describing the risk for the rare clotting disorder to its fact sheets for patients and doctors.
Janet Woodcock, acting commissioner of the FDA, said vaccination centers could resume giving the “one and done” shots as early as Saturday morning.