The U.S. Food and Drug Administration and the U.S. Centers for Disease Control and Prevention rescinded their pause on the use of Johnson & Johnson’s COVID-19 vaccine Friday, clearing the way for states to resume immunizations with the single-dose shot.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 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.
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.”
In Los Angeles County, health officials said they expect to resume distribution within a day or two.
“We are prepared to resume very quickly,” said Dr. Paul Simon, chief science officer for the L.A. County Department of Public Health. “We are in the process of developing or finalizing education materials for clients and also providers so we can move forward in the safest way.”
Still unknown is whether members of the public will have cooled to the Johnson & Johnson vaccine despite the CDC panel’s insistence that it’s safe for shots to resume.
“It’s still not entirely clear how much of a setback this has been,” Simon said. “We don’t want to see vaccine shopping. We really want to see people get the first vaccine available to them.”
The pause does not appear to have limited vaccine access in L.A. County, since supplies of the Pfizer-BioNTech and Moderna vaccines remained high and demand for the shots has slowed, he added.