Some doctors are OK, some not, with authorization of Covid-19 booster shots without data from human trials.
The article raises a couple of interesting questions:
- If a new drug is similar but not identical to an old drug that is known to be safe and effective, does that mean the new drug is safe and effective?
- To what extent do non-human trials reliably predict human results?
It may seem obvious that no new drug can be deemed safe and effective in humans until it is tested in humans, but the issue at hand is more complex than just one technicality. The FDA must choose between the risks associated with not authorizing the new boosters ahead of Covid-19’s peak season and the risks associated with authorizing them in the absence of human trials.
There are good arguments for either decision.