No shipments of J&J's Covid-19 vaccine have gone out from the government in weeks, official says - CNN

Vaccine advisers to the US Food and Drug Administration on Thursday debated what kind of detailed information the agency would need to consider authorizing the use of coronavirus vaccines in children under age 12.

While a few advisers said it’s far too soon to consider using vaccines in children because kids are at such low risk from the virus, most argued that it’s important to have authorizations on hand should there be a resurgence of the virus in the fall and winter.

The members of the Vaccines and Related Biological Products Advisory Committee were not asked to provide specific advice or a vote. The FDA will now advise companies on what kinds of clinical trials and data it would like to see to consider extending use of authorized vaccines to children.

Dr. Cody Meissner, director of pediatric infectious diseases at Tufts University School of Medicine, said children are at low risk of severe disease from the virus and more study is needed about safety in younger age groups.  “Before we start vaccinating millions of adolescents and children, it’s important to find out what the consequences are,” Meissner said, noting a low hospitalization rate among children.

“As more people are immunized and become immune from infection, I think it’s likely that we are going to get this pandemic under pretty good control,” he said.

But other members of the committee sharply disagreed.

“I think we need these vaccines sooner rather than later in children,” said Dr. Mark Sawyer, a pediatrics professor at the University of California San Diego School of Medicine.

Dr. Eric Rubin, editor in chief of The New England Journal of Medicine and an adjunct professor at the Harvard T.H. Chan School of Public Health, noted the situation doesn’t look bad at present, but that could change.

“There’s not much disease right now,” he said.

“We don’t know what’s going to happen. I think that’s precisely the reason why we want to have these in our arsenal. Because we give an EUA to the vaccine doesn’t mean we have to use it and I think we’d have to think hard how to use it, given all the concerns that’s been raised,” Rubin added.

And the FDA’s Marion Gruber expressed some frustration. 

“We are hearing that we need the vaccines soon and we need them soon in children because we do not know what the virus will doing in fall and kids are back in school and indoors,” she said. 

“If we wait too long and do these clinical trials with large numbers of pediatric subjects, we may not be ready to have these tools available when we need them.”

“Achieving consensus, as people can see, may be a little bit challenging,” noted Dr. Peter Marks, who heads the FDA’s division that evaluates vaccines.

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No shipments of J&J's Covid-19 vaccine have gone out from the government in weeks, official says - CNN
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