CDC advisory committee wants more data before making recommendation on J&J vaccine

WASHINGTON — An advisory committee for the Centers for Disease Control and Prevention said Wednesday it may not be ready to vote on whether to revise its recommendations on who should be receiving the Johnson & Johnson COVID-19 vaccine. Committee members said they wanted more data about rare blood clots before recommending whether to continue or halt a pause on the J&J vaccine.

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The CDC and the Food and Drug Administration said the pause was recommended so officials could further review the cases. The CDC’s Advisory Committee on Immunization Practices heard presentations on the safety data from the company and CDC safety experts during Wednesday’s emergency meeting, The Washington Post reported. The presentations included details about the cases of six women, who were between the ages of 18 and 48.

Committee members said they did not have enough information to recommend changes in their recommendations, CNN reported.

“I do not want to vote on this issue today. I do not want to vote not to recommend the vaccine -- I think that is not really something I necessarily believe,” Dr. Beth Bell, a clinical professor at the University of Washington in Seattle, said during the meeting. ”I just don’t feel there’s enough information to make an evidence-based decision. We won’t have all the information, but I think there are some things that we can gather relatively quickly, which all have to do with the benefit/risk balance.

“We do need to better understand the risk, which we know is going to be very rare, very low, but we really don’t know exactly how low and how to correctly characterize it,” Bell said. “I think we need to not vote and gather the necessary information so we can make an evidence-based decision.”

A Virginia woman who received the vaccine died in March, the Post reported. Another recipient is in critical condition, the newspaper reported.

Two patients have been discharged, and three remain in the hospital, a CDC official said.

As of Tuesday, more than 7 million people in the United States have received the J&J shot, and another 10 million doses have been shipped out, The New York Times reported, citing CDC data.

Dr. Aran Maree, chief medical officer for pharmaceuticals at Johnson & Johnson’s Janssen vaccine arm, detailed the known cases of blood clots during the emergency meeting.

“I’d like to reiterate that based on the current data, Janssen believes the overall benefit-risk profile for our vaccine is positive across the population for which it’s authorized,” Maree said. “We strongly support ensuring awareness of the signs and symptoms of this very rare event, as well as recommendations to ensure the correct diagnosis, treatment, and reporting by healthcare professionals.”

Two of six patients have been discharged, and three remain in the hospital, a CDC official said.

The advisory committee’s staff members said they would seek a time to meet again quickly.

“We will find a time to reconvene,” ACIP executive secretary Dr. Amanda Cohn told members. “We will try to identify what that date is by Friday of this week so that people have a little bit more time to get it on the calendars.”

Cox Media Group