The U.S. Food and Drug Administration and the U.S. Centers for Disease Control and Prevention rescinded their pause on the use of Johnson & Johnson’s COVID-19 vaccine Friday, clearing the way for states to resume immunizations with the single-dose shot.
The decision came just hours after a federal advisory panel recommended that immunizations with the J&J vaccine be resumed despite a tiny risk of blood clots.
On a 10-4 vote, the CDC’s Advisory Committee on Immunization Practices reaffirmed its earlier guidance that the vaccine be used for people ages 18 and up.
Safety concerns about the shot arose from six cases of a rare and perplexing clotting disorder seen among recipients of the single-shot vaccine. All six of those cases involved women between the ages of 18 and 48.
The blood clots were unusual because they were accompanied by a dangerously low level of platelets, the building blocks of blood clots.
The initial six cases rose to 15 when safety experts went back and reviewed records of adverse reactions to the J&J vaccine. All of those cases involved women, and all but one of was under 50.
Even so, the advisory panel said the risk was still tiny — in effect 1.9 cases per million people in the general population, or 7 cases per million women under 50.
Scientific and medical teams at the FDA and CDC agreed, having determined that the “known and potential benefits” of the vaccine outweigh its “known and potential risks.”
“The FDA and CDC have confidence that this vaccine is safe and effective in preventing COVID-19,” the agencies said in a joint statement, adding that they “will remain vigilant in continuing to investigate this risk.”
The CDC advisory panel rejected a plan that would have explicitly called on women between the ages of 18 and 50 to “be aware” of the risk of the clotting disorder and make clear that they “may choose” another COVID-19 vaccine.
Panel members cautioned that such language might be seen as requiring these women to give explicit consent to taking the Johnson & Johnson shot, or that it might oblige vaccine clinics to carry alternative vaccines, thereby imposing logistical and other constraints that could hamper vaccination.
The FDA granted emergency use authorization for the J&J vaccine in February.
On Saturday, New York State Health Commissioner Dr. Howard Zucker said, “Yesterday evening, following a thorough safety review, the CDC and FDA lifted the recommended pause on the COVID-19 Johnson & Johnson vaccine and said that the United States can resume the use of the vaccine for adults, 18 years of age and older. Following discussions with New York State’s Clinical Advisory Task Force and Governor Cuomo, I recommend that New York State accept the federal recommendations and resume Johnson & Johnson vaccinations effective immediately.
“The data has shown the vaccine’s known benefits far outweigh the potential and extremely rare risks, but we urge anyone with questions about the COVID-19 vaccines to speak with their healthcare provider. We will continue to communicate regular updates and guidance from the federal government to providers and the general public about the Johnson & Johnson vaccine and all vaccines on the market.
“We encourage all New Yorker’s to get whichever vaccine is available to them, as quickly as possible, so we can finally defeat this virus and continue our path towards fully reopening our communities and economy.”
Vaccine experts said Friday’s moves also would have broad — albeit unofficial — implications across the globe, since other countries look to the world’s most stringent regulators to set the standard for safety.
When the FDA and CDC first called for the pause, public health leaders worried it might wind up costing more lives than it saved, especially in poorer countries where skepticism about the vaccines runs high and other immunization options are limited.
“This is going to assist in restoring confidence in the vaccine. There isn’t any doubt about that,” said Dr. William Schaffner, an infectious disease expert at Vanderbilt University.
Around the world, he said, “ministries of health are going to take notice of this action.”