The U.S. Centers for Disease Control and Prevention formally lifted its pause on the Johnson & Johnson vaccine after a panel on Friday recommended resuming the use of Johnson & Johnson’s COVID-19 vaccine, despite a very rare risk of blood clots.
Out of nearly 8 million people vaccinated before the U.S. suspended J&J’s shot, health officials uncovered 15 cases of a highly unusual kind of blood clot, three of them fatal. All were women, and most younger than 50.
Advisers to the CDC voted 10-4 to resume the shot’s emergency use authorization in the U.S. for everyone 18 and older. The panel said Friday that the vaccine’s benefits outweigh that serious but small risk — especially against a virus that’s still infecting tens of thousands of Americans every day.
"Above all else, health and safety are at the forefront of our decisions," CDC Director Dr. Rochelle Walensky said in a statement. "Our vaccine safety systems are working. We identified exceptionally rare events – out of millions of doses" of the J&J shot and will continue to monitor them.
Johnson & Johnson's chief scientific officer weighed in after the decision to resume use of its vaccines. "We are grateful to the Advisory Committee and its medical experts for the rigorous evaluation of our COVID-19 vaccine," Dr. Paul Stoffels said. "The Committee’s recommendation is an essential step toward continuing urgently needed vaccinations in a safe way for millions of people in the U.S."
"As the global pandemic continues to devastate communities around the world, we believe a single-shot, easily transportable COVID-19 vaccine with demonstrated protection against multiple variants can help protect the health and safety of people everywhere. We will continue to collaborate with the CDC, FDA and health authorities around the world, including the European Medicines Agency and the World Health Organization, to ensure this very rare event can be identified early and treated effectively. We remain committed to the health and safety of people worldwide," Stoffels said.
The three FDA-authorized vaccines were brought to market in record time, leading to skepticism about how thoroughly the vaccines were tested and their safety. Critics had stressed that pausing the use of the vaccine would be detrimental to the fight against vaccine hesitancy.
A syringe lies on a bottle of fluid in front of Johnson & Johnson's logo due to J&J's new vaccine against coronavirus on March 02, 2021, in Dortmund, Germany. (Photo by Alex Gottschalk/DeFodi Images via Getty Images)
Unlike vaccines from Pfizer and Moderna, the J&J vaccine is a single-dose shot and doesn’t have to be stored at extremely cold temperatures. It’s a crucial instrument in fighting the pandemic in rural areas that often lack the storage facilities needed by other vaccines.
Even so, the pause had support from experts like Dr. Vivek Murthy, the U.S. Surgeon General, who told FOX News that the pause reflects how seriously officials are taking public safety.
"This is your safety system working for you, what you are seeing right now," Murthy said. "A signal came up, the FDA and CDC jumped on it and decided to investigate thoroughly and that’s what’s happening. That if anything, I believe, should increase people’s confidence that they are being told what’s going on and that any signals are being investigated."
European regulators earlier this week allowed the rollout of J&J's shot after also concluding those benefits outweigh what appears to be an exceedingly rare risk.
This story was reported from Atlanta. The Associated Press contributed.