The nationwide pause on the use of Johnson & Johnson's coronavirus vaccine should be lifted, a Centers for Disease Control and Prevention (CDC) vaccine advisory committee recommended Friday.
The CDC Advisory Committee on Immunization Practices voted 10-4 with one abstention, that the vaccine's benefits outweigh the risks, and that it will save lives.
The panel did not specifically ask for a warning label, but recommended the Food and Drug Administration (FDA) add a label intended to make providers aware of the risk of a rare complication involving blood clots in women under the age of 50.
Women in that age group should get the vaccine if they feel comfortable and are aware of the risks, but should also know there are other options available if they are not comfortable, the panel decided.
Adding a label is similar to the move taken by the European Union's top regulator, which said the vaccine needed a warning label but did not recommend any restrictions, because its overall benefits outweigh the risks.
Johnson & Johnson has already negotiated the label language with FDA, a company official said.
"We absolutely agree with the FDA on the implementation of a warning within our label and patient and physician fact sheets describing this very rare event, including how it can be identified early and diagnosed and treated,” the company's chief medical officer Joanne Waldstreicher said.
The warning label states, in part, that the relationship between the vaccine and the blood clotting syndrome, called thrombosis with thrombocytopenia, is "plausible." The label notes an increased clotting risk in women aged 18-49, with some fatal cases.
The condition is rare because it combines blood clots with a low level of platelets, which help promote clotting.
The outcome is good news for state and local health officials waiting to resume using the one-dose vaccine, which could be key in vaccinating hard-to-reach and vulnerable communities, like homeless people, homebound people and college students.
The recommendation will need to be approved by CDC Director Rochelle WalenskyRochelle WalenskyThousands descend on DC for anti-vaccine mandate rally New CDC studies show boosters provide strong protection from omicron variant The Hill's Morning Report - Presented by Facebook - Biden talks, Senate balks MORE, who would then suggest resumption of the shots within a matter of hours or days.
"I think the FDA and I both feel strongly —and the CDC feels 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 a single-dose option," Walensky said during a White House briefing Friday.
Use of the vaccine has been paused since early last week to allow health officials to investigate the rare blood clots.
There are about 9.5 million doses of the vaccine sitting on shelves across the country that could be deployed immediately.
So far, 15 cases of clotting syndrome have been confirmed, each of them occurring in women. There were 13 cases in women between age 18 and 49, and the median age of those affected was 37.
Women between 30 and 39 appear to be at greatest risk, with 11.8 cases per million doses given, CDC said. Additional potential cases, including some in men, are being reviewed.
There are three known deaths among nearly 8 million Americans who have received the shot. Seven more people are hospitalized — including four in intensive care — and five have been discharged home, the CDC said.
A risk-benefit analysis presented by CDC staff found if the vaccines resume in all adults over age 18, about 26 cases of clotting could occur out of a projected 9.8 million doses administered over the course of six months.
Over the same period, about 2,200 deaths and 1,400 ICU admissions would be prevented if the vaccine were resumed for use in all adults.
Michael Streiff, a hematologist at Johns Hopkins University, told the panel that people who have received the Johnson & Johnson vaccine and develop severe headaches, abdominal pain, leg pain or shortness of breath within three weeks after vaccination should contact their medical provider, though most patients have started showing symptoms after one to two weeks.
Physicians are also advised to avoid using heparin, which is a common treatment for blood clots, because it can exacerbate the clotting condition.
The CDC panel met Friday for the second time in less than two weeks to discuss the next steps regarding the use of Johnson & Johnson vaccine.
The independent committee initially met April 14 to discuss the decision to pause the inoculation, but did not make a recommendation because they felt there was not enough evidence yet.
The Biden administration has ordered enough vaccines from Pfizer-BioNTech and Moderna to cover all American adults without the help of J&J. Still, public health experts have grown increasingly concerned about the impact of the pause, especially on vaccine hesitancy.