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This is how the FDA's refusal to balance up-side risk is going to damage all of us. They're only interested in minimizing the risk from a treatment itself, and

This is how the FDA's refusal to balance up-side risk is going to damage all of us. They're only interested in minimizing the risk from a treatment itself, and pay little to no attention to the risk from not having any treatment. It's been a full year since the first vaccines were formulated, and it took the FDA 11 months to give the OK. That was a large streamlining of their normal processes, but not a meaningful balancing of risk, the standards remained the same. In the meantime, the virus has had millions of opportunities to mutate like this. If we'd accepted a bit more risk, we could have significantly decreased its opportunities to mutate. At least in this case, the virus can't mutate faster than our ability to formulate a new vaccine. Whether we can retool vaccine manufacturing I don't know. But so long as the FDA won't allow us to react quickly, the hole we're in keeps getting deeper.

nicpottier 6y ago
This is an interesting take for sure that I hadn't heard before. Do you have more information on how they could have accelerated things? If feels like the risk of shipping a vaccine that later is found to have adverse side effects would be so dangerous to the trust of the FDA that it would be really dangerous. Think of the shattered trust on both the FDA side and on vaccines in general, feels like maybe that would be too big a risk to take.
kube-system 6y ago
The FDA is slow? Compared to what? They approved the first vaccine 3 days after the NHS. If your window of success vs. failure is very small, you simply have to test before you push to prod. Especially when using a technique with a long history of failed attempts.
valarauko 6y ago
On the flip side, you have a sizable portion of the population that feels even the Emergency Use Authorization (EUA) by the FDA was rushed (To be clear, I'm playing the Devil's Advocate here - I personally don't disagree with the FDA's decisions, and got my own shot weeks ago) Genuine Q: which steps of the process do you see as superfluous? Pfizer announced the end of the phase 3 trials on November 18th, they submitted an application to the FDA for EUA on the 20th of November (or sometime shortly after), and the EUA was granted on the 11th of December. It didn't take 11 months for the FDA to give the OK. It took 11 months to design a vaccine from scratch, conduct phase I safety trials, phase 2 human safety and dosage trials, and a phase 3 trial to determine efficacy. This includes actual production of the mRNA & its vector in quantities sufficient for the trial, subject recruitment, shipping logistics worldwide to participants, administration of the test doses, data collection, analyses, and compiling results. Honestly, 11 months from start to finish seems like an amazingly short time to achieve so much.
- CWuestefeld 6y ago
  It didn't take 11 months for the FDA to give the OK. It took 11 months to design a vaccine from scratch, conduct phase I safety trials, phase 2 human safety and dosage trials, and a phase 3 trial to determine efficacy. The standards for the phase 1-3 trials are largely set by the FDA. Further, the whole idea that I can't weigh my own risks, and sign a paper saying "I acknowledge that this treatment is not fully tested, and choose to take my chances" is driven by the FDA. So yes, the time span before the public had access was driven by the FDA.
  - valarauko 6y ago
    Sure, the timeline is driven by established protocols of safety & efficacy testing. So what should be done differently here? Are you advocating for mass availability to the general public on a caveat emptor basis, after say, animal safety trials? From the FDA side, I suppose the issue is that in the absence of preliminary phase trial data, we don't know what we don't know. So it's less about not trusting the public to understand their individual risks, but that the drugs/vaccine offer risks that are unbounded. So perhaps the vaccine lipid nanoparticles are contaminated with toxic precursors that were not fully purified in the supply chain, or the lipids trigger an immune response to implants (something that did happen with cosmetic fillers), or they cross react with prescription statins in dangerous ways, or the encapsulated mRNAs trigger ANA antibodies, and so on. You may understand your own risk, but we were extremely ill equipped to understand the risks associated with the vaccines themselves till very recently.
rflrob 6y ago
Given that most of the vaccines were produced "at risk" (i.e. before the trials showed that they were effective), I doubt that if the FDA had approved these vaccines on the day they were designed, we would have significantly more doses in people's arms today.
randcraw 6y ago
You seem to be arguing that if FDA had begun widespread inoculation earlier with the current vaccines, variant COVID strains would not have arisen. But that's wrong on several levels. Even if we had started producing vaccine en-masse in March, it would still take many more months (several years) to inoculate everyone on the planet. These novel strains would still have arisen within that time frame. We would also have introduced additional problems that undertested therapies often suffer from and that the Chinese vaccine appears to have -- low efficacy. If quickly approved vaccines were no more than 50% efficacious on large fraction of the planet's peoples, herd immunity would take longer to accumulate and novel strains would still emerge. Of course, toxicity is another likelier outcome from undertesting a new vaccine. Others can assess that risk better than I. In short, when it comes to combating pestilence, there's no free lunch.
- CWuestefeld 6y ago
  You seem to be arguing that if FDA had begun widespread inoculation earlier with the current vaccines, variant COVID strains would not have arisen. My statement isn't quite that strong. It MAY NOT have arisen; it's all probabilities. Every time the virus is passed to another person, there's another opportunity for a mutation. If we could have driven the infection rate down sooner via vaccine, then there's some chance that it wouldn't have happened. Assuming ad arguendo that the new S. African strain is able to skirt the vaccines that are being distributed in America, what do we do? Wait another 11 months for a new formulation to be approved, and potentially for yet another slippery variant to arise? How do we get off that treadmill?
  - randcraw 6y ago
    I sympathize. But vaccines are only one way to diminish the infection rate. Other options have not been employed to their maximum effect in the US, like distributing (and requiring) better masks, requiring mask wearing at all times when not at home, mandatory quarantine of infected people in encampments (as China and Singapore have done), and legal punishment of those who do not comply. Employing medical procedures which are probably unsafe is not the only solution left to us.

nicpottier 6y ago

This is an interesting take for sure that I hadn't heard before. Do you have more information on how they could have accelerated things? If feels like the risk of shipping a vaccine that later is found to have adverse side effects would be so dangerous to the trust of the FDA that it would be really dangerous. Think of the shattered trust on both the FDA side and on vaccines in general, feels like maybe that would be too big a risk to take.

kube-system 6y ago

The FDA is slow? Compared to what? They approved the first vaccine 3 days after the NHS. If your window of success vs. failure is very small, you simply have to test before you push to prod. Especially when using a technique with a long history of failed attempts.

valarauko 6y ago

On the flip side, you have a sizable portion of the population that feels even the Emergency Use Authorization (EUA) by the FDA was rushed (To be clear, I'm playing the Devil's Advocate here - I personally don't disagree with the FDA's decisions, and got my own shot weeks ago) Genuine Q: which steps of the process do you see as superfluous? Pfizer announced the end of the phase 3 trials on November 18th, they submitted an application to the FDA for EUA on the 20th of November (or sometime shortly after), and the EUA was granted on the 11th of December. It didn't take 11 months for the FDA to give the OK. It took 11 months to design a vaccine from scratch, conduct phase I safety trials, phase 2 human safety and dosage trials, and a phase 3 trial to determine efficacy. This includes actual production of the mRNA & its vector in quantities sufficient for the trial, subject recruitment, shipping logistics worldwide to participants, administration of the test doses, data collection, analyses, and compiling results. Honestly, 11 months from start to finish seems like an amazingly short time to achieve so much.

CWuestefeld 6y ago
It didn't take 11 months for the FDA to give the OK. It took 11 months to design a vaccine from scratch, conduct phase I safety trials, phase 2 human safety and dosage trials, and a phase 3 trial to determine efficacy. The standards for the phase 1-3 trials are largely set by the FDA. Further, the whole idea that I can't weigh my own risks, and sign a paper saying "I acknowledge that this treatment is not fully tested, and choose to take my chances" is driven by the FDA. So yes, the time span before the public had access was driven by the FDA.
- valarauko 6y ago
  Sure, the timeline is driven by established protocols of safety & efficacy testing. So what should be done differently here? Are you advocating for mass availability to the general public on a caveat emptor basis, after say, animal safety trials? From the FDA side, I suppose the issue is that in the absence of preliminary phase trial data, we don't know what we don't know. So it's less about not trusting the public to understand their individual risks, but that the drugs/vaccine offer risks that are unbounded. So perhaps the vaccine lipid nanoparticles are contaminated with toxic precursors that were not fully purified in the supply chain, or the lipids trigger an immune response to implants (something that did happen with cosmetic fillers), or they cross react with prescription statins in dangerous ways, or the encapsulated mRNAs trigger ANA antibodies, and so on. You may understand your own risk, but we were extremely ill equipped to understand the risks associated with the vaccines themselves till very recently.

rflrob 6y ago

Given that most of the vaccines were produced "at risk" (i.e. before the trials showed that they were effective), I doubt that if the FDA had approved these vaccines on the day they were designed, we would have significantly more doses in people's arms today.

randcraw 6y ago

You seem to be arguing that if FDA had begun widespread inoculation earlier with the current vaccines, variant COVID strains would not have arisen. But that's wrong on several levels. Even if we had started producing vaccine en-masse in March, it would still take many more months (several years) to inoculate everyone on the planet. These novel strains would still have arisen within that time frame. We would also have introduced additional problems that undertested therapies often suffer from and that the Chinese vaccine appears to have -- low efficacy. If quickly approved vaccines were no more than 50% efficacious on large fraction of the planet's peoples, herd immunity would take longer to accumulate and novel strains would still emerge. Of course, toxicity is another likelier outcome from undertesting a new vaccine. Others can assess that risk better than I. In short, when it comes to combating pestilence, there's no free lunch.

CWuestefeld 6y ago
You seem to be arguing that if FDA had begun widespread inoculation earlier with the current vaccines, variant COVID strains would not have arisen. My statement isn't quite that strong. It MAY NOT have arisen; it's all probabilities. Every time the virus is passed to another person, there's another opportunity for a mutation. If we could have driven the infection rate down sooner via vaccine, then there's some chance that it wouldn't have happened. Assuming ad arguendo that the new S. African strain is able to skirt the vaccines that are being distributed in America, what do we do? Wait another 11 months for a new formulation to be approved, and potentially for yet another slippery variant to arise? How do we get off that treadmill?
- randcraw 6y ago
  I sympathize. But vaccines are only one way to diminish the infection rate. Other options have not been employed to their maximum effect in the US, like distributing (and requiring) better masks, requiring mask wearing at all times when not at home, mandatory quarantine of infected people in encampments (as China and Singapore have done), and legal punishment of those who do not comply. Employing medical procedures which are probably unsafe is not the only solution left to us.