CDC vaccine experts punt on Johnson & Johnson COVID-19 vaccine guidance, extending the pause

COVID-19 vaccine
Six Johnson & Johnson COVID vaccine recipients have reported rare blood clot events out of 7.2 million doses that have been administered. There have been no such events among the 182.6 million doses administered of the Pfizer and Moderna vaccine. (Fierce Healthcare)(Getty/Meyer & Meyer)

U.S. vaccine experts have identified three potential options for Johnson & Johnson's COVID-19 vaccine in the U.S. going forward. But while they wait for more data, the shot's nationwide pause will continue.

Moving forward, the United States could continue the vaccine's use with a safety warning, or it could put age and gender restrictions on the product. Officials could also discontinue use of the shot entirely, experts at the CDC's Advisory Committee on Immunization Practices said during a Wednesday meeting. 

For now, though, the group has decided to punt on any decisions and collect more data. The group plans to meet in about a week for a new session.

This signals that the shot's pause will extend longer than indicated by the FDA on Tuesday, when acting commissioner Janet Woodcock said she expected it to last a “matter of days.”

With Pfizer and Moderna supplying a combined 14 million vaccine doses weekly to the U.S., there is less urgency to solve the safety issue of J&J shot, Sara Oliver of the CDC said on Wednesday.

The Wednesday meeting came after U.S. officials on Tuesday recommended a pause to the shot's rollout after rare but serious blood clots in six people after vaccination. One died and one was in critical condition, officials said Tuesday. About 7 million people had been vaccinated before the pause. 

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Of the six CVST cases in the U.S., all have been white women between the ages of 18 and 48. The clots have occurred between 6 and 13 days after vaccinations. More cases could surface because around half of the J&J doses administered were in the last two weeks, officials said.

With the data the experts currently have, it’s impossible to come to conclusions about the shot’s safety, Oliver said.

Meanwhile, there have been no CVST cases reported among the 97.9 million doses of the Pfizer vaccine and 84.7 million doses of the Moderna vaccine administered so far, the CDC said.

As the group prepares for its next meeting, a number of factors could inform its ultimate decision. Those include the positive risk-benefit profile of the Pfizer and Moderna mRNA vaccines, plus available supply of those shots, and the available J&J doses on deck. The FDA, which issued an emergency use authorization for the product, could also weigh in.

In the end, the experts may not make their decision based on the risk of J&J's vaccine versus COVID, Oliver said. It could also depend on the risk-benefit profiles of the mRNA and J&J shots.