7 ms·

> Public health officials say it will take a year to 18 months to fully validate any potential vaccine. Why?

asdfasgasdgasdg 7y ago
I'm not a professional vaccine researcher, but I can only imagine you want to validate 1. that the vaccine is effective and 2. that the vaccine doesn't cause everyone who takes it to get an aneurysm six months later. These things have to be pipelined. You don't want to inject 10k people with something you've only tested on 45. You don't want to inject 45 with something you haven't tested on animals. You don't want to stop the 10k person trial too early in case if there is a longer term side effect you missed. You don't want to start manufacturing billions of doses until your 10k trial is done. Etc.
- refurb 7y ago
  As someone who works in the industry, you pretty much covered it. If you dose people with a new vaccine, you’ll need to monitor them 6 months at a minimum. 12 months would be better. It takes 3 months to nail down the protocol and for all the sites to be ready. Then you start recruiting and for a vaccine, you’d want a large population (reflects usage). So assume 6 months to recruit 1000 people. They don’t all start at the same time, so if you’re tracking for 6 months, it will probably take 9 monthsfor the last person to finish the trial. Then you need to analyze all the data you collected, so another 3 months. Then the FDA takes 3 months to review and approve. There is a TON of work that goes into running a clinical trial.
  - WalterBright 7y ago
    But it does sound like if there's priority and fear, much time could be saved. For example, "6 months to recruit 1000 people". I suspect in this case, a week can work. > Then you need to analyze all the data you collected, so another 3 months. Help me understand this. You vaccinate 1000 people. In 6 months, the number of them that get sick is 10% of the rate of the unvaccinated. 0.1% have a bad reaction. How much more analysis do you need? > the FDA takes 3 months to review and approve How much time if that is moved to the front of the queue and all hands work on it? Given how enormously disruptive the coronavirus is, we cannot afford to not have all hands working on it.
    - thisiszilff 7y ago
      Not who you're replying to, but I imagine bad, immediate reactions will be easy to spot, but more subtle, chronic problems would be found only after analysis. A part of this work would be figuring out what is attributable to the vaccine and what is not.
    - refurb 7y ago
      Let's tackle recruitment. I've seen trials recruit really fast and that took a month. It's not like someone says "hey I'd like to take part in this trial" and you give them a shot of drug. You need to screen everyone who comes in. Basic labs, then make sure they don't have some other disease that will mess up the results. That's just one part of it. Then in terms of the trial, 6 months would be nice, but it wouldn't be ethical to actually expose them to the virus. You'd simply need to recruit a very large number of patients and see if the treatment groups has less disease than the non-treated group. With infection rates pretty low across the entire population, you'd need to recruit thousands, just to capture the handful that actually get exposed. Then when it comes to analysis, you need to clean the data (yes, there will be errors), then you need to do a statistical analysis of not only efficacy but every possible side effect. You're probably measuring things like viral shedding, so that's another entire dataset. Oh, then you'll have missing data. Do you toss that patient's data out entirely? Or keep them? What impact does that have on your conclusion? I could go on and on, but suffice to say it's a ton of work. And yes, you can speed up some parts, but other parts you just have to let them run their course.
      - dantillberg 7y ago
        If tens or hundreds of thousands of people were dying every day from the virus, might we find many volunteers willing to be intentionally exposed to the virus in order to rapidly test the efficacy of a vaccine? I imagine so. I believe the magnitude of this pandemic will in time push us (rather violently) to think outside the box.
        majewsky 7y ago
        Even if volunteers take the vaccine, this will not significantly change the timeline. Do you really want to cut short the observation time to e.g. 1 month, then greenlight the vaccine and administer it to millions or billions of people, only to find out that after 6 months it causes an aneurysm or whatever in 10% of them?
  - acchow 7y ago
    Any chance review and approval can take 3 days instead of 3 months? For example with the review process happening concurrently while monitoring the whole trial?
    - refurb 7y ago
      Sure, you could probably accelerate review from 3 months to a few weeks. The FDA is familiar with rolling submissions where you send data to them as it becomes available. 3 days? That's really aggressive.
  - mancerayder 7y ago
    The OP and this response are both very useful for us to read. This is speculative but what process would you expect them to follow for these next steps of expanding the scope of testing volunteers? Would they prioritize higher-risk people like medical? Older people? Healthy people? Some random combo? Volunteers? There are going to be a lot of volunteers.
deleted 7y ago
[deleted]
dguest 7y ago
If you rush a vaccine that causes 5% of patients develop a fatal complication in 1 year you've just killed twice as many people as COVID-19 would have. Personally I'd rather take my chances with COVID-19 than risk injecting myself with an untested vaccine.
mads 7y ago
The Dengvaxia controversy, Dengvaxia issue, or Dengvaxia mess is an ongoing controversy about the use of anti-dengue vaccine Dengvaxia in the Philippines. In late November 2017, the Department of Health suspended a school-based vaccination program utilizing French drug-based vaccine maker Sanofi Pasteur's Dengvaxia vaccine because reports circulated that several children died from various complications allegedly attributed to the dengue vaccine. https://en.wikipedia.org/wiki/Dengvaxia_controversy https://en.wikipedia.org/wiki/Dengvaxia_controversy

I'm not a professional vaccine researcher, but I can only imagine you want to validate 1. that the vaccine is effective and 2. that the vaccine doesn't cause everyone who takes it to get an aneurysm six months later. These things have to be pipelined. You don't want to inject 10k people with something you've only tested on 45. You don't want to inject 45 with something you haven't tested on animals. You don't want to stop the 10k person trial too early in case if there is a longer term side effect you missed. You don't want to start manufacturing billions of doses until your 10k trial is done. Etc.

refurb 7y ago
As someone who works in the industry, you pretty much covered it. If you dose people with a new vaccine, you’ll need to monitor them 6 months at a minimum. 12 months would be better. It takes 3 months to nail down the protocol and for all the sites to be ready. Then you start recruiting and for a vaccine, you’d want a large population (reflects usage). So assume 6 months to recruit 1000 people. They don’t all start at the same time, so if you’re tracking for 6 months, it will probably take 9 monthsfor the last person to finish the trial. Then you need to analyze all the data you collected, so another 3 months. Then the FDA takes 3 months to review and approve. There is a TON of work that goes into running a clinical trial.
- WalterBright 7y ago
  But it does sound like if there's priority and fear, much time could be saved. For example, "6 months to recruit 1000 people". I suspect in this case, a week can work. > Then you need to analyze all the data you collected, so another 3 months. Help me understand this. You vaccinate 1000 people. In 6 months, the number of them that get sick is 10% of the rate of the unvaccinated. 0.1% have a bad reaction. How much more analysis do you need? > the FDA takes 3 months to review and approve How much time if that is moved to the front of the queue and all hands work on it? Given how enormously disruptive the coronavirus is, we cannot afford to not have all hands working on it.
  - thisiszilff 7y ago
    Not who you're replying to, but I imagine bad, immediate reactions will be easy to spot, but more subtle, chronic problems would be found only after analysis. A part of this work would be figuring out what is attributable to the vaccine and what is not.
  - refurb 7y ago
    Let's tackle recruitment. I've seen trials recruit really fast and that took a month. It's not like someone says "hey I'd like to take part in this trial" and you give them a shot of drug. You need to screen everyone who comes in. Basic labs, then make sure they don't have some other disease that will mess up the results. That's just one part of it. Then in terms of the trial, 6 months would be nice, but it wouldn't be ethical to actually expose them to the virus. You'd simply need to recruit a very large number of patients and see if the treatment groups has less disease than the non-treated group. With infection rates pretty low across the entire population, you'd need to recruit thousands, just to capture the handful that actually get exposed. Then when it comes to analysis, you need to clean the data (yes, there will be errors), then you need to do a statistical analysis of not only efficacy but every possible side effect. You're probably measuring things like viral shedding, so that's another entire dataset. Oh, then you'll have missing data. Do you toss that patient's data out entirely? Or keep them? What impact does that have on your conclusion? I could go on and on, but suffice to say it's a ton of work. And yes, you can speed up some parts, but other parts you just have to let them run their course.
    - dantillberg 7y ago
      If tens or hundreds of thousands of people were dying every day from the virus, might we find many volunteers willing to be intentionally exposed to the virus in order to rapidly test the efficacy of a vaccine? I imagine so. I believe the magnitude of this pandemic will in time push us (rather violently) to think outside the box.
      - majewsky 7y ago
        Even if volunteers take the vaccine, this will not significantly change the timeline. Do you really want to cut short the observation time to e.g. 1 month, then greenlight the vaccine and administer it to millions or billions of people, only to find out that after 6 months it causes an aneurysm or whatever in 10% of them?
- acchow 7y ago
  Any chance review and approval can take 3 days instead of 3 months? For example with the review process happening concurrently while monitoring the whole trial?
  - refurb 7y ago
    Sure, you could probably accelerate review from 3 months to a few weeks. The FDA is familiar with rolling submissions where you send data to them as it becomes available. 3 days? That's really aggressive.
- mancerayder 7y ago
  The OP and this response are both very useful for us to read. This is speculative but what process would you expect them to follow for these next steps of expanding the scope of testing volunteers? Would they prioritize higher-risk people like medical? Older people? Healthy people? Some random combo? Volunteers? There are going to be a lot of volunteers.

deleted 7y ago

[deleted]

dguest 7y ago

If you rush a vaccine that causes 5% of patients develop a fatal complication in 1 year you've just killed twice as many people as COVID-19 would have. Personally I'd rather take my chances with COVID-19 than risk injecting myself with an untested vaccine.

mads 7y ago

The Dengvaxia controversy, Dengvaxia issue, or Dengvaxia mess is an ongoing controversy about the use of anti-dengue vaccine Dengvaxia in the Philippines. In late November 2017, the Department of Health suspended a school-based vaccination program utilizing French drug-based vaccine maker Sanofi Pasteur's Dengvaxia vaccine because reports circulated that several children died from various complications allegedly attributed to the dengue vaccine. https://en.wikipedia.org/wiki/Dengvaxia_controversy https://en.wikipedia.org/wiki/Dengvaxia_controversy