After all, you can’t report what you’ve been careful not to study (just as with vaccine safety).
From “COVID-19 Vaccine Side Effects: Is the System Working?” in MedPage Today:
Marshall: Now when it comes to the COVID vaccines, we’re seeing all three of those [data collection systems] being employed, correct?
Kesselheim: Well, so far with the COVID vaccine, you know —
Marshall: You hesitated there. So I’m assuming that’s probably a no?
Kesselheim: Well, I mean, I think that there are a lot of ways that the post-market surveillance of the COVID vaccine could be going better. I think that we are seeing a lot of spontaneous reporting. And we are seeing a lot of local institutions keeping track of people who receive vaccines and sort of mini registries in a sense. So far in the U.S. we’ve only had vaccines available through Emergency Use Authorizations.
We haven’t yet had those kinds of formal post-approval studies that have been developed and designed for these trials. So we haven’t really seen that yet.
And the other major issue is, right now a lot of vaccines are being given outside of healthcare systems, through public, state government supported vaccine delivery websites and the goal here being to get as many vaccines as quickly as possible into people as quickly as possible.
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