Analysis: An FDA adviser said we need to give kids vaccines to fully understand their safety. Here’s the crucial context.

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Wed, 2021-10-27 18:29 — mike kraft

Analysis | An FDA adviser said we need to give kids vaccines to fully understand their safety. Here’s the crucial context. Vaccine skeptics are highlighting comments in which a Food and Drug Administration advisory committee member said the decision was tough and “we’re never going to learn about how safe this vaccine is unless we start giving it.” Here's some important context. Aaron Blake Washington Post

The Food and Drug Administration’s advisory committee Tuesday provided a pretty resounding endorsement for giving a coronavirus vaccine to children ages 5 to 11. It voted 17 to 0 in favor of what is known as emergency-use authorization, with one member abstaining.

This paves the way for the agency to make the Pfizer-BioNTech vaccine available to that age group for the first time, possibly as soon as next week.

But even as that news landed, some are pointing to a few less-than-resounding comments from one of the advisory committee members. While voting for the authorization, Eric Rubin acknowledged that it was “a much tougher one, I think, than we had expected coming into it.” He also said that “we’re never going to learn about how safe this vaccine is unless we start giving it.”

Those latter comments, in particular, have begun circulating widely in conservative media and among vaccine skeptics. Some have likened them to House Speaker Nancy Pelosi’s (D-Calif.) statement that Congress had “to pass [Obamacare] so that you can find out what’s in it.” Others have suggested the authorization would be akin to turning children into guinea pigs.

But the comments — and the situation — deserve some context.

First, here’s a look at the fuller comments from Rubin, who is a professor at Harvard University and also editor in chief of the New England Journal of Medicine (with key parts bolded):

This is a much tougher one, I think, than we had expected coming into it. The data show that this vaccine works and it’s pretty safe … And yet, we’re worried about a side effect that we can’t measure yet, but it’s probably real. And we see a benefit that isn’t that same as it is in older patients. …

It’s a very, sort of, personal choice. If I had a child who was a transplant recipient, I would really want to be able to use a vaccine. And there are certain kids who probably should be vaccinated. The question of how broadly to use I think is a substantial one. And I know it’s not question, and I know we’re kind of punting that to ACIP.

But I do think that it’s a relatively close call. As Dr. [Ofer] Levy just said, and Dr. [Hayley] Gans said, it really is going to be a question of what the prevailing conditions are. But we’re never going to learn about how safe this vaccine is unless we start giving it. That’s just the way it goes. That’s how we found out about rare complications of other vaccines like coronavirus vaccine. And I do think we should vote to approve it....

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