Did the FDA/CDC Make the Right Call?

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April 13, 2021 10:06 a.m.

There is a huge amount of criticism of the CDC and FDA bubbling up on social media about the decision to pause administration of the J&J Janssen vaccine. As I noted earlier, based on these preliminary and unconfirmed rates of risk it is virtually certain that discontinuing use of this vaccine would lead to many more deaths from COVID than any saved from the rare clotting disorder. But before you think the regulators are idiots who are down a rabbit hole of untethered risk aversion, a few points are worth mentioning.

If you look at the statement from CDC and FDA the pause seems less like a preliminary step on the way to discontinuing usage as much as a pause to analyze the demographic profile of who is affected and prepare guidance for surveillance and treatment. The standard treatment for blood clots can be harmful with this condition.

One key source of public mistrust of regulators, state authority, health guidance is the belief that the real information is being hidden. There are many sources of vaccine hesitancy. But this is certainly one of them. So once you find a potential safety signal there’s no way around making it public and going through a process of analysis.

I’m seeing lots of people saying that this halt will only increase hesitancy. I share that concern. Perhaps a better approach would have been to issue this announcement but wait on issuing a call for a pause. I’m really not sure. Lots of people die every year from side effects and secondary effects of antibiotics. Birth control pills cause a small but non-trivial number of blood clots every year. My point is that trust is a key factor in vaccine hesitancy. Trust requires a system of transparency and disclosure.

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