FDA panelist on vaccinating 5-year-olds: "We're never going to learn about how safe the vaccine is until we start giving it" 😬

Oct 27th

My guess is that Harvard Prof. Eric Rubin is going to be getting a very stern call from the FDA after this particular gaffe:

For reference, here are Dr. Rubin's full remarks in context:

This is a much tougher (question), I think, then we had expected coming into it. The data show that the vaccine works, and is pretty safe, at least by immuno-bridging, and even by some clinical data…and yet, we're worried about a side-effect that we can't measure yet. But it's probably real. And we are going to see a benefit that isn't the same as it is in older age groups.

So, for me, I think it's going to revolve around two questions: First off, whether there is going to be a use for this vaccine in this age group, and then how the decision gets made to use it within this age group.

And I think what sways me here is that, 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 like this. And there are certain kids who probably should be vaccinated.

The question of how broadly to use it, though, I think is a substantial one. And I know it's not our question, and I know we're kind of punting that to [the Advisory Committee on Immunization Practices]. But I do think that it's a relatively close call…it really is going to be a question of what the prevailing conditions are. But we're never going to learn about how safe the 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 the rotavirus vaccine. I do think we should vote to approve it.

Just to be clear: the panel did indeed vote to recommend that 5-11-year-olds get the shot.

I guess we'll probably find out "how safe it is" very soon!


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