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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 pla

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.

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.