4 ms·

> 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 e

> 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....
- lofi_lory 6y ago
  Normally you won't have an incidence rate this high, therefore you need to run the trails for longer to get enough people in the control group sick. Massive amounts of volunteers and a high prevalence made sound statistics possible in a relatively short amount of time. "Long term" side effects mean weeks or few month later, not years as many people assume. In the past things like rare autoimmune disease associated with vaccination appeared within weeks after the dose, but it may take years to pick up the statistical signal, which may explain this belief. There is literally no reason to assume the mRNA vaccines will cause side effects 5 years later or something.

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....
lofi_lory 6y ago
Normally you won't have an incidence rate this high, therefore you need to run the trails for longer to get enough people in the control group sick. Massive amounts of volunteers and a high prevalence made sound statistics possible in a relatively short amount of time. "Long term" side effects mean weeks or few month later, not years as many people assume. In the past things like rare autoimmune disease associated with vaccination appeared within weeks after the dose, but it may take years to pick up the statistical signal, which may explain this belief. There is literally no reason to assume the mRNA vaccines will cause side effects 5 years later or something.