Use of Johnson & Johnson's COVID-19 vaccine should be resumed in the United States, advisers to U.S. health regulators said on Friday, after weighing evidence of the shot's link to extremely rare but potentially deadly blood clots.
Lisa Bernhard produced this report.
The use of Johnson & Johnson's COVID-19 vaccine should be resumed in the U.S. despite evidence that it is linked to extremely rare but potentially deadly blood clots, advisers to the U.S. Centers for Disease Control and Prevention recommended on Friday.
UNIDENTIFIED SPEAKER FROM ADVISORY PANEL SESSION: "So the vote is 10 in favor, four opposed and one abstention.
The motion carries.
The Janssen COVID vaccine is recommended for persons 18 years of age and older in the U.S. population under the FDA's Emergency Use Authorization." The recommendation paves the way for J&J's shot to begin going into arms again in the U.S. once they are confirmed by regulators.
CDC director Dr. Rochelle Walensky, speaking earlier in the day, was among the top health officials hoping for a quick return to the vaccine's use.
“I think the FDA and I both feel strongly and the CDC feel strongly that we need to act swiftly after that analysis but I do think that there's plenty of people who are interested in the J&J vaccine if just for convenience as well as for single dose option.” The FDA will update the emergency use authorization for the vaccine to include information about the risk and how to recognize and treat the condition, J&J executives told the panel.
Dr. Beth Bell, a member of the advisory panel and a clinical professor at the University of Washington in Seattle, said (quote), "The benefits do clearly outweigh the risk from a population and individual perspective,” adding (quote), “It's admittedly an extremely small risk and smaller than many other risks that we choose to take every day." Late on Friday, the New York Times reported the FDA officially ended its recommended pause on the J&J vaccine.