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FDA says Dec 17 meeting to discuss. This contradicts some earlier opinions that the reason the FDA was taking so long to review Pfizer (Dec 10 scheduled date) w

FDA says Dec 17 meeting to discuss. This contradicts some earlier opinions that the reason the FDA was taking so long to review Pfizer (Dec 10 scheduled date) was that they were planning to review 2-3 candidates together. For context, scheduling the meeting to review the candidates is running at 5-10% of the development time for these vaccines. 20M vaccines represent about 1/3 the elderly population in the US, there are about 1,300 deaths a day right now, and most deaths are in the high risk category. So you can estimate the cost of the delay to be quite high (depending on your assumptions, but hard not to estimate the cost to be >1000 lives). I'm unsure of any vaccine side effect or release that could be considered worse. Pendemrix caused 1 in 18,000 narcolepsy, which for the 20M at risk who could get the vaccine seems like a good trade-off (if this was as bad as that). Moderna entered phase 1 trials in March. Vaccines entering phase 1 trials have a 33% success rate overall, 85% successful for efficacy. So this is not a case of hindsight bias, this was always reasonably likely to work. And these numbers include issues like enrollment issues, or the diesease dying out (ebola). So lets make some assumptions to see what it would look like to "just approve things for the high risk in a pandemic": For example, let's say that a vaccine maker instead of pushing something 85% likely to be efective pushed through pushed through something 40% likely to work. And for safety, let's just assume it's going to be 2x worse than the worst vaccine ever, so maybe 1 in 10,000 get narcolepsy. But they still push it through. This implies taking the untested vaccine has a 40% chance of protecting you and 0.1% chance of serious side effect. For the elderly, who at the beginning of the pandemic has a conservative IFR of >10% and let's assume a 10% chance of getting it. Not taking the vaccine has something like a 1% chance of death. For the elderly, taking the untested vaccine would in this example would reduce your chance of death by 0.6% but increase the chance of serious disease by 0.1%. For most people, this should be an obvious decision to vaccinate, even using the most pessimistic adaptions possible. It almost sounds like a conspiracy theory, but in the real world Moderna had a working vaccine in March, and it was always statistically likely to work with low relative downside (for some population), and it has been banned the entire time until now. The next pandemic could be completely prevented if we focus our efforts on how to approve vaccine candidates in days not months. Note: I think the bar for requiring a vaccination can/should definitely be higher than the bar to lift a total ban on a vaccine.

ghaff 6y ago
>Note: I think the bar for requiring a vaccination can/should definitely be higher than the bar to lift a total ban on a vaccine. It's unlikely in the US that the federal government could require vaccination. States maybe could but only because of very old case law that might well not stand up today. Of course, private workplaces, schools, government offices, airlines, etc. could to the degree that it might be quite difficult at some point to refuse. To your broader point, if a roll the dice strategy backfired, you could not only have had dead people but you'd basically make vaccine development untenable both for this and probably other diseases.
- throwawaysea 6y ago
  > States maybe could but only because of very old case law that might well not stand up today. Of course, private workplaces, schools, government offices, airlines, etc. could to the degree that it might be quite difficult at some point to refuse. States probably can compel people to take it, considering some already require it for use of public services like schools. I’m guessing private companies can do whatever they want as long as they avoid running into disability law. I think this is a problem though - as a matter of principle, bodily autonomy is sacrosanct. Citizens who are forced to give up bodily autonomy to use basic services they can’t reasonably avoid (roads, public transportation, schools, etc) simply don’t have basic freedoms in my view.
  - ghaff 6y ago
    IANAL, but the Supreme Court case I'm aware of upheld a Massachusetts law requiring smallpox vaccinations (in 1905). That said, the Supreme Court also upheld forced sterilization of the mentally defective in the early 20th Century so I'm not at all sure 100-year old court cases would be expected to be upheld today. I don't really disagree with you in general. SWAT teams won't be holding people down and injecting people by force. But the practical effect isn't that different from a jurisdiction effectively requiring proof of vaccination to leave your house.
  - ogre_codes 6y ago
    > States probably can compel people to take it, considering some already require it for use of public services like schools. Public schools likely could not exist in the densities they currently exist if people didn't vaccinate. Likewise, dense urban housing, and many public venues would cease to be viable. Measles spread far faster than COVID; even with something like 95% of the population vaccinated we still have outbreaks in high anti-vaxxer communities. If we didn't require measles vaccines where we do, it would be absolutely everywhere. Likewise similarly conquered diseases like smallpox and polio. > Citizens who are forced to give up bodily autonomy to use basic services they can’t reasonably avoid (roads, public transportation, schools, etc) simply don’t have basic freedoms in my view. To date, no state requires vaccinations to use roads/ public transportation and I find it unlikely that they ever will. But I would support requiring proof of vaccination at the state/ national borders during an outbreak to prevent spreaders. Likewise, large gatherings (including schools) absolutely must require vaccinations. This isn't a matter of freedom/ versus not freedom. If they didn't require vaccination, they could not safely exist. If you choose to opt out of large events, then I support that right. But schools/ colleges/ concerts/ etc, cannot exist in a vaccine optional world.

ghaff 6y ago

>Note: I think the bar for requiring a vaccination can/should definitely be higher than the bar to lift a total ban on a vaccine. It's unlikely in the US that the federal government could require vaccination. States maybe could but only because of very old case law that might well not stand up today. Of course, private workplaces, schools, government offices, airlines, etc. could to the degree that it might be quite difficult at some point to refuse. To your broader point, if a roll the dice strategy backfired, you could not only have had dead people but you'd basically make vaccine development untenable both for this and probably other diseases.

throwawaysea 6y ago
> States maybe could but only because of very old case law that might well not stand up today. Of course, private workplaces, schools, government offices, airlines, etc. could to the degree that it might be quite difficult at some point to refuse. States probably can compel people to take it, considering some already require it for use of public services like schools. I’m guessing private companies can do whatever they want as long as they avoid running into disability law. I think this is a problem though - as a matter of principle, bodily autonomy is sacrosanct. Citizens who are forced to give up bodily autonomy to use basic services they can’t reasonably avoid (roads, public transportation, schools, etc) simply don’t have basic freedoms in my view.
- ghaff 6y ago
  IANAL, but the Supreme Court case I'm aware of upheld a Massachusetts law requiring smallpox vaccinations (in 1905). That said, the Supreme Court also upheld forced sterilization of the mentally defective in the early 20th Century so I'm not at all sure 100-year old court cases would be expected to be upheld today. I don't really disagree with you in general. SWAT teams won't be holding people down and injecting people by force. But the practical effect isn't that different from a jurisdiction effectively requiring proof of vaccination to leave your house.
- ogre_codes 6y ago
  > States probably can compel people to take it, considering some already require it for use of public services like schools. Public schools likely could not exist in the densities they currently exist if people didn't vaccinate. Likewise, dense urban housing, and many public venues would cease to be viable. Measles spread far faster than COVID; even with something like 95% of the population vaccinated we still have outbreaks in high anti-vaxxer communities. If we didn't require measles vaccines where we do, it would be absolutely everywhere. Likewise similarly conquered diseases like smallpox and polio. > Citizens who are forced to give up bodily autonomy to use basic services they can’t reasonably avoid (roads, public transportation, schools, etc) simply don’t have basic freedoms in my view. To date, no state requires vaccinations to use roads/ public transportation and I find it unlikely that they ever will. But I would support requiring proof of vaccination at the state/ national borders during an outbreak to prevent spreaders. Likewise, large gatherings (including schools) absolutely must require vaccinations. This isn't a matter of freedom/ versus not freedom. If they didn't require vaccination, they could not safely exist. If you choose to opt out of large events, then I support that right. But schools/ colleges/ concerts/ etc, cannot exist in a vaccine optional world.