Federal health agencies have ended their recommended pause on the use of Johnson & Johnson’s Janssen coronavirus vaccine.
This comes after a panel of Centers for Disease Control and Prevention advisors voted to resume the one-dose vaccine.
Emergency use authorization, from The Food and Drug Administration for this vaccine now includes a new warning about the “plausible” risk of rare but serious blood clots in adult women under 50.
The vote to recommend resuming use of the Johnson & Johnson vaccine was held Friday, April 23, 2021, by a panel of advisers to the Centers for Disease Control and Prevention The shots are expected to be accompanied by a new warning concerning 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 vaccine. 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 case numbers are small when compared to 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 municipalities have gone unused.
A resumption of the vaccine for all adults could prevent 600 to 1,400 deaths from COVID-19, the CDC estimated.
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 vote took place more than a week after the vaccine’s distribution was paused following 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” response to awareness around the risks. Johnson & Johnson stated they agreed with the Food and Drug Administration on specific language for a warning to accompany the shot for healthcare professionals’ information.
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 Johnson and Johnson 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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