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by roenxi 2034 days ago
On the one hand I tend to agree, and all my expectations for this vaccine are positive. The medical industry tends to be paranoid to a level that exceeds rationality and even if they dropped their standards for this that should only get them down to "conservative and rather safe" levels of caution.

On the other, a cursory search says the current record for fastest developed vaccine was mumps at 4 years. So this is a vaccine setting new milestones, and there is a risk that not all of them will be positive. I'd rather be a little late to be vaccinated than a little early, especially being in a lower risk demographic.

1 comments

I'm not an expert by any means, but I do know that a lot of the speed comes from moving along the CHEAP-FAST side of the CHEAP-FAST-SAFE triangle, without necessarily changing anything on the FAST-SAFE axis. In particular, governments paid for the companies to start producing enough vaccines for phase 3 trials before phase 1 was complete, while normally drug companies would wait for phase 1 to be completed before preparing for phase 2 for economic reasons.
BiondVax recently finished their phase 3 trial of a universal flu vaccine. It was 15 years in the making. Science was (still is solid). Phase 3 took two years to account for ADE and other safety issues.

At the 1-year mark, everything looked perfect. At the towo years mark (original endpoint) the conclusion was that while it was safe, it offered statistically insignificant protection.

Properly designed tests need those 2 years, at the very least. The “SAFE” confidence axis was compromised. Whether or nit it is justified is what we’re discussing here.