Source: The Wall Street Journal (free link).
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.
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Personally, I will be first in line for the new vaccine formulation.
But, I expect many of the same people who damn FDA for going too slow will be among those damning for going too fast.
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The basic mRNA vaccine is the same. The virus evolved in such a way that the antibodies produced no longer fit the spike protein of the current form of the virus on the physiochemical level.
The updated vaccine simply changes that coding for the receptor end of the antibody to fit.
Think of it as someone changing the lock on a door, and the locksmith cutting a new key to fit. We don’t expect the locksmith to reinvent and patent the lock all over again each time he cuts a new key.
I will get one of the updated vaccines(haven’t decided on Moderna or Pfizer yet) as soon as they are available as being old, the virus is a much higher risk for me than the vaccine. . A younger person with less risk might well choose to wait and see if I sprout broccoli out of my ears.
For young children, there is no measurable benefit as the risk of the disease is close to equal to the risk of the vaccine, and there is nothing to be gained by stimulating Antigenic Original Sin in them and decrease their ability to fight the next mutation.
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