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> fast-tracked vaccines It would be accurate to say that these vaccines have been developed in the optimal time, and vaccines are usually 'slow-tracked'. Not

> fast-tracked vaccines It would be accurate to say that these vaccines have been developed in the optimal time, and vaccines are usually 'slow-tracked'. Nothing has been rushed here in the sense of cutting clinical corners. The development of these vaccines has gone through the same phases of testing that every other vaccine has. Things that slow down all vaccine development: funding, finding volunteers for testing groups, committee approval for the development of vaccines, submission and resubmission of proposals to name but a few. All of these barriers were removed by governments throwing cash at the various companies, and the companies and universities themselves removing barriers.

Izkata 6y ago
> Nothing has been rushed here in the sense of cutting clinical corners. The development of these vaccines has gone through the same phases of testing that every other vaccine has. They were approved for emergency use, which means skipping tests for long-term side-effects, because those usually take around two years. Every other vaccine has been around for a while and gone through this.
- SV_BubbleTime 6y ago
  Not to mention this is these are the very first mRNA vaccines deployed in this scale. We’re going to be honest about long-term risks, and possibilities, we can’t just hand waive this away. It’ll be fine. But pretending that long term risk isn’t there because we don’t want it to be isn’t very sciencey. It’s wrong to equate these to previous vaccines in multiple ways.
  - lofi_lory 6y ago
    In the past "long term" side effects meant within weeks after the fact. This includes things like autoimmune disease. However, the statistical signal may only appear years later. The mRNA vaccines also don't "infect" the whole body, but only the injection site, and they are metabolized quickly. There really is no reason to assume any late effects say 5 years later. If they were frequent late side effects, we would totally know by now. By the way, they are a brilliantly less complex system, much easier to reason about, than traditional vaccines.
- DrBazza 6y ago
  > because those usually take around two years As I said in my parent comment, COVID vaccines appear 'fast tracked' because all the bureaucracy was removed to expedite them. Every phase of clinical trials have been followed otherwise the MHRA (and the EMA) would not have approved them. https://www.nhs.uk/conditions/clinical-trials/ https://www.nhs.uk/conditions/clinical-trials/ All vaccines have been through phases 1-3. > skipping tests for long-term side-effect That would be the standard phase 4 being "The safety, side effects and effectiveness of the medicine continue to be studied while it's being used in practice." "Only carried out on medicines that have passed all the previous stages and have been given marketing licences – a licence means the medicine is available on prescription."
  - Izkata 6y ago
    Phase 3 under normal circumstances from that link: > Trials often last a year or more and involve several thousand patients. Also this seems to be a US/UK difference, as over here phase 3 includes long-term safety before it's approved for use, with emergency use authorization to skip that being the exception: https://coronavirus.jhu.edu/vaccines/timeline https://coronavirus.jhu.edu/vaccines/timeline
    - DrBazza 6y ago
      > Trials often last a year or more and involve several thousand patients. Agreed. Though not all last a year, and the COVID trials had large numbers of volunteers. I defer to someone that works in the industry to say whether vaccine trials last longer than regular medicine (e.g. Parkinsons or Alzheimers drugs). But I suspect that vaccines need less time for trials because vaccines are made using standardised processes that are tweaked to produce the expected responses, vs. novel drugs that have never been synthesized before. This one [0] in the UK famously went wrong: "The German company that developed the drug hoped it would revolutionise treatment of leukaemia and rheumatoid arthritis. But within minutes of having the drug administered, all of the test subjects began feeling unwell." 0. https://www.bbc.co.uk/news/magazine-35766627#:~:text=When%20Rob%20Oldfield%20signed%20up,men%20fighting%20for%20their%20lives https://www.bbc.co.uk/news/magazine-35766627#:~:text=When%20....
    - 6y ago

Izkata 6y ago

> Nothing has been rushed here in the sense of cutting clinical corners. The development of these vaccines has gone through the same phases of testing that every other vaccine has. They were approved for emergency use, which means skipping tests for long-term side-effects, because those usually take around two years. Every other vaccine has been around for a while and gone through this.

SV_BubbleTime 6y ago
Not to mention this is these are the very first mRNA vaccines deployed in this scale. We’re going to be honest about long-term risks, and possibilities, we can’t just hand waive this away. It’ll be fine. But pretending that long term risk isn’t there because we don’t want it to be isn’t very sciencey. It’s wrong to equate these to previous vaccines in multiple ways.
- lofi_lory 6y ago
  In the past "long term" side effects meant within weeks after the fact. This includes things like autoimmune disease. However, the statistical signal may only appear years later. The mRNA vaccines also don't "infect" the whole body, but only the injection site, and they are metabolized quickly. There really is no reason to assume any late effects say 5 years later. If they were frequent late side effects, we would totally know by now. By the way, they are a brilliantly less complex system, much easier to reason about, than traditional vaccines.
DrBazza 6y ago
> because those usually take around two years As I said in my parent comment, COVID vaccines appear 'fast tracked' because all the bureaucracy was removed to expedite them. Every phase of clinical trials have been followed otherwise the MHRA (and the EMA) would not have approved them. https://www.nhs.uk/conditions/clinical-trials/ https://www.nhs.uk/conditions/clinical-trials/ All vaccines have been through phases 1-3. > skipping tests for long-term side-effect That would be the standard phase 4 being "The safety, side effects and effectiveness of the medicine continue to be studied while it's being used in practice." "Only carried out on medicines that have passed all the previous stages and have been given marketing licences – a licence means the medicine is available on prescription."
- Izkata 6y ago
  Phase 3 under normal circumstances from that link: > Trials often last a year or more and involve several thousand patients. Also this seems to be a US/UK difference, as over here phase 3 includes long-term safety before it's approved for use, with emergency use authorization to skip that being the exception: https://coronavirus.jhu.edu/vaccines/timeline https://coronavirus.jhu.edu/vaccines/timeline
  - DrBazza 6y ago
    > Trials often last a year or more and involve several thousand patients. Agreed. Though not all last a year, and the COVID trials had large numbers of volunteers. I defer to someone that works in the industry to say whether vaccine trials last longer than regular medicine (e.g. Parkinsons or Alzheimers drugs). But I suspect that vaccines need less time for trials because vaccines are made using standardised processes that are tweaked to produce the expected responses, vs. novel drugs that have never been synthesized before. This one [0] in the UK famously went wrong: "The German company that developed the drug hoped it would revolutionise treatment of leukaemia and rheumatoid arthritis. But within minutes of having the drug administered, all of the test subjects began feeling unwell." 0. https://www.bbc.co.uk/news/magazine-35766627#:~:text=When%20Rob%20Oldfield%20signed%20up,men%20fighting%20for%20their%20lives https://www.bbc.co.uk/news/magazine-35766627#:~:text=When%20....
  - 6y ago