Randy
Well-known member
Brietbart upset the apple cart yesterday.
https://www.breitbart.com/tech/2020...ess-conference/amp/?__twitter_impression=true
https://www.breitbart.com/tech/2020...ess-conference/amp/?__twitter_impression=true
I find it crazy that this virus has become so partisan. Once again I feel glad I am not in the vulnerable group- because this isn't going away. Got to make sure we protect the vulnerable as best as possible as a society.
That's confidence for your!The virus isn't partisan, it's just that there is a a large proportion of the population with immunity (or resistance) and a small portion without.
It's great news that Sars Cov 2 specific T cells were found in 50% of healthy, uninfected individuals in a recent singapore study. There is also now evidence that Sars Cov 1 immunity is effective with Sars Cov 2, which might help to explain why certain far eastern countries that had Sars Cov 1 badly, have done very well with Sars Cov 2.
Anyway, the fact that T cell immunity appears to be 1, widespread and 2, long lasting is great news. It means that this should become a relatively insignificant disease in time.
https://www.sciencedaily.com/releases/2020/07/200716101536.htm
NoI seem to remember someone putting up a timeline on here or Facebook for a vaccine a few years ago the was 11 months between development and usage.
I'm not sure where this idea of vaccines having long-term side effects comes from. There's no evidence to support it, as far as I can tell.It's just the length of time a phase 3 trial will take. It's not just efficacy they need to prove, it's things like side effects. These can take a lot longer to manifest themselves.
I can find no scientific basis for that statement. Can you provide one?It's simply not possible to have completed safe trials by then.
One Phase III goal is to assess vaccine safety in a large group of people. Certain rare side effects might not surface in the smaller groups of subjects tested in earlier phases. For example, suppose that an adverse event related to a candidate vaccine might occur in 1 of every 10,000 people. To detect a significant difference for a low-frequency event, the trial would have to include 60,000 subjects, half of them in the control, or no vaccine, group (Plotkin SA et al. Vaccines, 5th ed. Philadelphia: Saunders, 2008).
Years working in the Pharma industry including working for quite a few biotech firms and one charity that staged trials has taught me that.I can find no scientific basis for that statement. Can you provide one?
As I've mentioned before, there is no requirement stated by any regulatory body that phase 3 trials must last any specific length of time, nor any absolute scientific necessity for it as far as I'm aware. Yes, it's typical for phase 3 trials to last longer but I can't find anything saying they have to or giving a scientific reason why they must, so long as safety and efficacy can be reliably established.
Here's an extract from an article linked to from the US CDC website, talking about the different phases of vaccine development:
Based on what that says, the concern about rare side effects is more to do with the number of people tested than the length of the phase.
Afraid not. That's why I said I worked in biopharma.Maybe vaccine development is a bit different? As mentioned above.
Afraid not. That's why I said I worked in biopharma.
The have to follow the same Good Clinical Practice Rules. Vaccines are no different to any other drug in that regard
To be honest, taking a year IS reducing the timeframe. I think the longest clinical trial I've seen has been just over 7 years. A year is JUST ABOUT` enough time to get a good spread of trials with a good cross section of the population. I would be very cautious about any vaccine released before that. I mentioned earlier though, we have studied other coronavirus' and will have been trying to develop vaccines for them, so the only chance is shortcutting some of the trial by saying we already know how x or y works in the human body.But as mentioned, since you don't have the same 'cumulative effects' with vaccines that you might have with other therapeutic drugs, maybe it's possible to reduce the timescale of Phase 3 more safely? - I don't know.... just asking.
Pinnochio!Years working in the Pharma industry including working for quite a few biotech firms and one charity that staged trials has taught me that.
Moreover I’ve given you the scientific basis, that you need long term trials to test the efficacy over a general population and ensure there are no long term side effects
Are you having a test?Chef at work was chosen for one of the random antibody finger pick tests that were sent out recently.
Came back positive for antibodies. Some may remember I said I was adamant I'd had the virus in January and it had spread round the kitchen at work.
Seems we were right.
Not sure. £50 aren't they? Where would I purchase one from?Are you having a test?