After an 11-day review, U.S. federal health officials lifted the suspension of Johnson & Johnson’s New Crown vaccine on Friday (April 23), after authorities announced the suspension citing the product for triggering a blood clot reaction in six women.
“We have concluded that the known and potential benefits of the Johnson & Johnson vaccine outweigh its risks to individuals 18 years of age and older,” said Janet Woodcock, acting director of the U.S. Food and Drug Administration (FDA), in a statement. “We are confident that this vaccine will continue to meet our standards for safety, efficacy and quality.”
The move is in line with expectations. Since recent days, a growing number of state officials have warned that the suspension of Johnson & Johnson vaccines has led more people to take a wait-and-see approach to vaccines. West Virginia CDC specialist Clay Marsh previously noted that suspending Johnson & Johnson would make people who doubt the safety of vaccines “more hesitant and nervous.”
In late April, vaccination sites across the U.S. said their supply of vaccines was outstripping demand and that many vaccines were going unused, leading them to request smaller quantities of vaccines.
The Johnson & Johnson vaccine will be recommended for people 18 years and older in the U.S. population, according to an emergency use authorization issued by the FDA, which is preparing to update the vaccine’s labeling to state that women under age 50 should be aware of the risk of a rare coagulation syndrome associated with the vaccine.
Earlier, Johnson & Johnson officials said they had agreed to update the label, acknowledging that the vaccine may trigger the risk of blood clots in the thrombocytopenia syndrome, or TTS, category.
On Friday, the Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) voted to reinstate Johnson & Johnson vaccines or not, with 10 votes in favor, four against and one abstention.
Non-voting ACIP member Jason Goldman, a physician in private practice in Coral Springs, Florida, told CNN that he believes the product still helps prevent severe coronavirus disease and “needs to be aware of that fact.
Prior to that, the Johnson & Johnson vaccine had been administered 7 million times across the U.S. The product also caused abnormal blood clotting symptoms in six women. More than 9 million Johnson & Johnson vaccines will be in use in the U.S. after the call for termination.
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