U.S. lifts pause on J&J vaccinations, clearing the way for shots to resume

The U.S. Food and Drug Administration and the U.S. Centers for Disease Control and Prevention rescinded their pause on the use of Johnson & Johnson’s COVID-19 vaccine Friday, clearing the way for states to resume immunizations with the single-dose shot.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, severe and perplexing clotting disorder seen among recipients of the 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. That makes the clots tricky to treat.

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.”

Federal teams have reached out to doctors around the country to make sure they know how to recognize and treat the rare clotting disorder, which the agencies called thrombosis-thrombocytopenia syndrome, or TTS.

It is similar to a condition known as autoimmune thrombocytopenia, which occurs when the immune system misfires and generates antibodies to the patient’s own blood platelets.

A similar reaction to another COVID-19 vaccine made by AstraZeneca prompted the European Union to temporarily halt its use. Regulators there turned up 44 reports of vaccine-induced immune thrombocytopenia, or VITT, among 20.2 million doses administered. (That vaccine has not been authorized for use in the U.S.)

The AstraZeneca and Johnson & Johnson vaccines both use an adenovirus — a common cold germ stripped of its ability to sicken — to deliver to the immune system the prompt it needs to recognize and attack the SARS-CoV-2 virus. The J&J vaccine employs a human adenovirus; the one in the AstraZeneca vaccine is derived from chimpanzees.

At Friday’s meeting, 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, and just over 8 million doses have been administered nationwide, federal figures show.

The vaccine is seen as a valuable part of the nation’s immunization arsenal because it’s easier to store and transport than other COVID-19 vaccines. In addition, its single-dose design is well-suited for vaccinating hard-to-reach populations.

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 of the J&J vaccine 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.”

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.

Still unknown is whether members are 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.”

Corey Matthews, the chief operating officer of Community Coalition, a South Los Angeles organization that helped set up and run vaccine sites, said some of the people his group served had lingering hesitation about the Johnson & Johnson vaccine even before the pause. They had viewed it as a second-class shot because it didn’t seem to perform as well in clinical trials as the Pfizer and Moderna vaccines — and publicity about the rare blood clotting disorder didn’t help.

“We certainly suffered a little bit of a blow to the momentum we had of getting people vaccinated quickly, especially people who weren’t originally comfortable with it,” Matthews said.

But the J&J vaccine did have its admirers, especially those who appreciated the simplicity of its single dose.

“Some folks just don’t like needles,” he said. “I’m thankful we quickly got it reinstated.”

Times staff writers Colleen Shalby, Emily Baumgaertner and Deborah Netburn contributed to this report.