3 ms·

I think it is clear the regulatory framework wasn't ideal. The last stage of the trial (which took three months) was not about if they were safe - but simply i

I think it is clear the regulatory framework wasn't ideal. The last stage of the trial (which took three months) was not about if they were safe - but simply if they worked. Meaning, they were cleared to have minimal side effects, just unclear if it worked. If you had approved people to choose to take the vaccine in August we could have had 50M people with shots already. A lot of people have my skepticism that the main reason that the FDA didn't want to do that since it might be a bit of a media heartache for them, but so what. Even if you thought it would only work 20% of the time that 20% of the time it saves 100,000+ lives.

vvillena 6y ago
50M doses isn't something that gets suddenly summoned. It's a big logistics problem. Your assumption is valid only if the pharmas have capacity to make a extremely big amount of vaccine doses. That costs money and (I guess) materials, and both of those things could go towards a vaccine that is proven to be effective.
- handmodel 6y ago
  They had the vaccines in storage in October. Not as many as they had in December but they were just awaiting approval. The rollout would have been slower then with less to go around - but a headstart on the vulnerable population or potential spreaders would have been significant.
hcknwscommenter 6y ago
I think you misunderstand the clinical trial approval process. Yes, phase 2 is primarily about safety, but these are much smaller trials than phase 3, which in turn is much smaller than the post-marketing patient population (cohort). Safety issues routinely arise in phase 3, or even after, due to the much larger cohort sizes. Good phase 2 results are not proof of safety, rather an indication of safety. It is bordering on genocidal levels of reckless endangerment to release a vaccine for general use after Phase 2 in the hopes that it might be effective and is probably safe.
- handmodel 6y ago
  Whether or not it would have been a full three months I stand by my belief the current system was not designed for the cost-benefit of a raging pandemic. The three month time of phase III had nothing to do with safety. That long period was only used because it took that long time for enough people to catch Covid naturally for them to prove statistical effectiveness. In the current system, if Covid had been raging at an extreme rate they would have had enough positives in the control group after a month and ended the trial then. If it had been under control, it actually would have taken many more months to declare effectiveness even though the extra wait time would have shown no more data on safety. Whether or not phase II was sufficient on its own they could have declared the vaccine probably safe a month after phase III began instead of after three months. This would have still saved 50,000 lives in the US at minimum.

vvillena 6y ago

50M doses isn't something that gets suddenly summoned. It's a big logistics problem. Your assumption is valid only if the pharmas have capacity to make a extremely big amount of vaccine doses. That costs money and (I guess) materials, and both of those things could go towards a vaccine that is proven to be effective.

handmodel 6y ago
They had the vaccines in storage in October. Not as many as they had in December but they were just awaiting approval. The rollout would have been slower then with less to go around - but a headstart on the vulnerable population or potential spreaders would have been significant.

hcknwscommenter 6y ago

I think you misunderstand the clinical trial approval process. Yes, phase 2 is primarily about safety, but these are much smaller trials than phase 3, which in turn is much smaller than the post-marketing patient population (cohort). Safety issues routinely arise in phase 3, or even after, due to the much larger cohort sizes. Good phase 2 results are not proof of safety, rather an indication of safety. It is bordering on genocidal levels of reckless endangerment to release a vaccine for general use after Phase 2 in the hopes that it might be effective and is probably safe.

handmodel 6y ago
Whether or not it would have been a full three months I stand by my belief the current system was not designed for the cost-benefit of a raging pandemic. The three month time of phase III had nothing to do with safety. That long period was only used because it took that long time for enough people to catch Covid naturally for them to prove statistical effectiveness. In the current system, if Covid had been raging at an extreme rate they would have had enough positives in the control group after a month and ended the trial then. If it had been under control, it actually would have taken many more months to declare effectiveness even though the extra wait time would have shown no more data on safety. Whether or not phase II was sufficient on its own they could have declared the vaccine probably safe a month after phase III began instead of after three months. This would have still saved 50,000 lives in the US at minimum.