J&J COVID-19 vaccine in limbo in US

Johnson & Johnson’s COVID-19 vaccine remains in limbo in the United States as a health panel calls for more data before making a decision on how and whether to resume use of the one-dose shot.

The US Centers for Disease Control and Prevention (CDC) advisory panel on Wednesday delayed a vote on how best to use the J&J shot even after a US Food and Drug Administration scientist told advisers he believed warnings could mitigate the risk of extremely rare but serious blood clots.

The panel is reviewing six reported cases of rare brain blood clots in women who received the J&J vaccine, a day after the FDA and CDC jointly recommended pausing its use to assess the issue.

Dr. Lynn Batha, an epidemiologist at the Minnesota health department, and several others spoke in favour of extending the pause to gather more safety information.

“By having more robust information, I think we can be more confident about how we talk about the safety of this vaccine,” she told other members of the advisory panel.

Earlier, the FDA’s deputy director for vaccine development, Doran Fink, told the panel that his current thinking was that warning statements and communications from the federal agency would allow doctors to weigh risks and benefits of the vaccine.

Other panel members and advisers, however, expressed concern that extending the pause could worsen issues related to equitable access to the vaccine, which is seen as important for serving hard-to-reach communities because it can be stored at normal refrigerator temperatures and given as one dose instead of two.

Several panel members wanted to vote to extend the pause by as much as a month, but Dr. Beth Bell, a global health expert at the University of Washington, argued that would send a signal globally of a major issue with the vaccine.

“I don’t want to send the message that there is something fundamentally wrong with this vaccine, which I don’t agree with,” she said.

“It’s a very rare event,” Bell said of the cases of blood clots in the brain, known as cerebral venous sinus thrombosis (CVST), along with low blood platelets.

“Nothing is risk-free.”

The six cases, all in women under age 50, were reported out of 7.2 million doses of the J&J vaccine administered in the US – a risk federal health officials and immunology experts said was extremely low, especially when weighed against the potential ravages of COVID-19.

One of the six women died and three remain hospitalised. 

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