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It is of vital importance that the majority of people feel safe taking the vaccine, because you need herd immunity. If people have doubts that it has been corre

It is of vital importance that the majority of people feel safe taking the vaccine, because you need herd immunity. If people have doubts that it has been correctly vetted they will be reluctant to get vaccinated which makes the whole investment in the vaccines pointless.

garmaine 6y ago
Safety tests were already completed and approved by regulators months ago. The Phase 3 trials are efficacy trials to show that the vaccine gives immunity. Certainly we learned more about the safety of the vaccines from Phase 3 data, but we already knew that adverse immediate reactions would be very rare. What's ridiculous about this situation is that the regulatory authorities are not willing to weigh against the benefit which would come from an early emergency-use authorization (which could have happened as early as August). It's like CPU branch prediction: approve the vaccine for early distribution as fast as it can be made--which would only have been a few hundred million doses globally so far--while the phase 3 studies are going on. The early distribution would be watched as observational studies, of course. If it fails Phase 3, stop distribution and move on to the next vaccine. If the vaccine works, this strategy would have directly saved tens or hundreds of thousands of lives, and potentially millions from getting sick and whatever long-term complications come from COVID-19. Indirectly, early vaccination of essential workers would work to decrease R0 and therefore cause fewer people to get sick through normal means. If the vaccine doesn't work, there isn't much money wasted since the manufacturing is already being done pre-approval anyway. In the worst case if the vaccine primes and adverse immune reaction, that is bad and an argument against early approval. However you have to weigh the added risk (that early vaccinated people have a higher CFR) vs the probability of that happening, which is low. High likelihood of highly beneficial outcome if it works. Lower possibility of a relatively moderate bad outcome to a smaller population if it doesn't. Certainty of many added deaths if you wait. I don't have the data the regulators have that is necessary to quantify this and make the call. But for dumb political reasons, this option is off the table. Only Russia and China went ahead with early vaccination; all the other national agencies decided not to even think about early distribution. It was not even an option on the table.
- djsumdog 6y ago
  The 1970s swing flu vaccine was ineffective but harmless for millions and left a few thousand with permanent neurological symptoms. This disease has over a 98% survival rate, and even higher if you're under 40. Many of the "long COVID" studies I've read have been in high risk or elderly people, they were limited case studies and I think a case can be made that most "long COVID" could be nocebo or mass hysteria at this point (or the fact that it could just take the body months to heal from a bad infection). We've never approved a drug, much less a vaccine, at this speed before. Unless you go back to the days of Jenner where he just stabbed people with Horsepox and there was no real regulation or long term data collection.
- fuoqi 6y ago
  >Only Russia and China went ahead with early vaccination I don't know about China, but mass vaccination have not started in Russia yet. It will begin only from the next week starting with medical personnel and teachers. Effectively the Russian vaccine has only finished phase 3 trials (based on 40k volunteers) relatively recently.
  - garmaine 6y ago
    Which is what I've described: early vaccination, not mass vaccination.
rootusrootus 6y ago
It'll be interesting to see what happens if there is a significant amount of antivax attitude towards the COVID vaccines. I wonder if we'll see a lot of employers mandating it.
stjohnswarts 6y ago
Especially when you have so many antiscience/luddites/antivaxxers in the USA. We will probably need at least 70% of the population to get the vaccine if it's really 95% successful before we can start going back to normal. That's going to be a hard thing to do before the end of 2021.

garmaine 6y ago

Safety tests were already completed and approved by regulators months ago. The Phase 3 trials are efficacy trials to show that the vaccine gives immunity. Certainly we learned more about the safety of the vaccines from Phase 3 data, but we already knew that adverse immediate reactions would be very rare. What's ridiculous about this situation is that the regulatory authorities are not willing to weigh against the benefit which would come from an early emergency-use authorization (which could have happened as early as August). It's like CPU branch prediction: approve the vaccine for early distribution as fast as it can be made--which would only have been a few hundred million doses globally so far--while the phase 3 studies are going on. The early distribution would be watched as observational studies, of course. If it fails Phase 3, stop distribution and move on to the next vaccine. If the vaccine works, this strategy would have directly saved tens or hundreds of thousands of lives, and potentially millions from getting sick and whatever long-term complications come from COVID-19. Indirectly, early vaccination of essential workers would work to decrease R0 and therefore cause fewer people to get sick through normal means. If the vaccine doesn't work, there isn't much money wasted since the manufacturing is already being done pre-approval anyway. In the worst case if the vaccine primes and adverse immune reaction, that is bad and an argument against early approval. However you have to weigh the added risk (that early vaccinated people have a higher CFR) vs the probability of that happening, which is low. High likelihood of highly beneficial outcome if it works. Lower possibility of a relatively moderate bad outcome to a smaller population if it doesn't. Certainty of many added deaths if you wait. I don't have the data the regulators have that is necessary to quantify this and make the call. But for dumb political reasons, this option is off the table. Only Russia and China went ahead with early vaccination; all the other national agencies decided not to even think about early distribution. It was not even an option on the table.

djsumdog 6y ago
The 1970s swing flu vaccine was ineffective but harmless for millions and left a few thousand with permanent neurological symptoms. This disease has over a 98% survival rate, and even higher if you're under 40. Many of the "long COVID" studies I've read have been in high risk or elderly people, they were limited case studies and I think a case can be made that most "long COVID" could be nocebo or mass hysteria at this point (or the fact that it could just take the body months to heal from a bad infection). We've never approved a drug, much less a vaccine, at this speed before. Unless you go back to the days of Jenner where he just stabbed people with Horsepox and there was no real regulation or long term data collection.
fuoqi 6y ago
>Only Russia and China went ahead with early vaccination I don't know about China, but mass vaccination have not started in Russia yet. It will begin only from the next week starting with medical personnel and teachers. Effectively the Russian vaccine has only finished phase 3 trials (based on 40k volunteers) relatively recently.
- garmaine 6y ago
  Which is what I've described: early vaccination, not mass vaccination.

rootusrootus 6y ago

It'll be interesting to see what happens if there is a significant amount of antivax attitude towards the COVID vaccines. I wonder if we'll see a lot of employers mandating it.

stjohnswarts 6y ago

Especially when you have so many antiscience/luddites/antivaxxers in the USA. We will probably need at least 70% of the population to get the vaccine if it's really 95% successful before we can start going back to normal. That's going to be a hard thing to do before the end of 2021.