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  4. How long should a Vaccine Trial take?
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How long should a Vaccine Trial take?

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Offline alancalverd

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Re: How long should a Vaccine Trial take?
« Reply #20 on: 31/01/2021 15:12:13 »
Quote from: Jolly2 on 31/01/2021 14:15:00
Nasal spray is by far a better solution, for SARS cov2
Please provide a reference to your clinical trial.
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Offline Jolly2 (OP)

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Re: How long should a Vaccine Trial take?
« Reply #21 on: 31/01/2021 15:55:18 »
Quote from: alancalverd on 31/01/2021 15:12:13
Quote from: Jolly2 on 31/01/2021 14:15:00
Nasal spray is by far a better solution, for SARS cov2
Please provide a reference to your clinical trial.

Ref:

Quote from: set fair on 23/01/2021 00:36:48
Yes there are recognised advantages to using a nasal spray for vacination against respiratory diseases. But I imagine not for all types of vaccine. If you want to hear a very brief reference to this I can give you two youtube links - I'm not sure which of the two it's in - 90 minutes each and maybe 30 seconds of relevance to your question.

I believe they are developping one in India and Lancaster U has done a trial.

Lancaster U
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Offline Jolly2 (OP)

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Re: How long should a Vaccine Trial take?
« Reply #22 on: 31/01/2021 15:59:14 »
24 million people outside China have taken their inactivated virus vaccine and appear to show less side effects compared to ALL the other vaccine types, and not just for covid

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Offline Bored chemist

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Re: How long should a Vaccine Trial take?
« Reply #23 on: 31/01/2021 17:41:10 »
Quote from: Jolly2 on 31/01/2021 15:59:14
24 million people outside China have taken their inactivated virus vaccine and appear to show less side effects compared to ALL the other vaccine types, and not just for covid

Have they improved the effectiveness yet?
Because if it still has an efficiency of about 50% it won't actually help much
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Offline alancalverd

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Re: How long should a Vaccine Trial take?
« Reply #24 on: 31/01/2021 17:55:44 »
Quote from: Jolly2 on 31/01/2021 15:55:18
Lancaster U
Do let us know the outcome. And don't forget to tell Lancaster U how long their trial must continue in order tobe valid. You can't trust scientists, statisticians and ethics committees these days - they are all part of a global conspiracy to which you hold the key.

Quote
appear to show less side effects compared to ALL the other vaccine types, and not just for covid
In other words, it probably doesn't trigger the immune system at all. How very honest of them to admit it.
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Offline Jolly2 (OP)

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Re: How long should a Vaccine Trial take?
« Reply #25 on: 31/01/2021 20:59:11 »
Quote from: alancalverd on 31/01/2021 17:55:44
Quote from: Jolly2 on 31/01/2021 15:55:18
Lancaster U
Do let us know the outcome. And don't forget to tell Lancaster U how long their trial must continue in order tobe valid. You can't trust scientists, statisticians and ethics committees these days - they are all part of a global conspiracy to which you hold the key.

The issue is more relative to vaccines mimicking the normal transmission method being more effective.


Quote from: alancalverd on 31/01/2021 17:55:44
Quote
appear to show less side effects compared to ALL the other vaccine types, and not just for covid
In other words, it probably doesn't trigger the immune system at all. How very honest of them to admit it.

70% effective with first shoot, 90% with second.
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Offline alancalverd

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Re: How long should a Vaccine Trial take?
« Reply #26 on: 01/02/2021 11:33:16 »
We discussed inhaled vaccines in another thread somewhere.

In principle they are of course ideal - self-administered and following the normal entry route of infection.

In practice they are less than ideal. The received dose depends on correct procedure and the condition of the nasal passages on induction. Since the nasal system has evolved to trap anything that isn't air, and can envelop particulates in snot that gets blown or spat out or swallowed, the pharmacokinetics of nasal administration is very variable. You need to get the virus or substitute into the lungs and this is usually more effective with oral inhalation which involves less filtration. From there on, the immune system response depends on the active ingredient reaching the bloodstream, so it depends on the condition of the alveolar mucosa and the patient's breathing regimen.

Intramuscular injection is very consistent. But if you could mix an attenuated virus with cocaine, I'm sure you could vaccinate a huge proportion of the public in a day and make a profit.   
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Offline Bored chemist

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Re: How long should a Vaccine Trial take?
« Reply #27 on: 01/02/2021 12:19:29 »
Quote from: Jolly2 on 31/01/2021 20:59:11
70% effective with first shoot, 90% with second.
Are we talking about the Sinovac vaccine where the actual trial (in Brazil) gave a effectiveness of 50.4%?
If not then you need to tell us what you are on about.
If it is that vaccine then clearly it hasn't been subject to reliable testing.
Why are you advocating it?
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Offline Jolly2 (OP)

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Re: How long should a Vaccine Trial take?
« Reply #28 on: 01/02/2021 14:04:46 »
Quote from: alancalverd on 01/02/2021 11:33:16
We discussed inhaled vaccines in another thread somewhere.

In principle they are of course ideal - self-administered and following the normal entry route of infection.

In practice they are less than ideal. The received dose depends on correct procedure and the condition of the nasal passages on induction. Since the nasal system has evolved to trap anything that isn't air, and can envelop particulates in snot that gets blown or spat out or swallowed, the pharmacokinetics of nasal administration is very variable. You need to get the virus or substitute into the lungs and this is usually more effective with oral inhalation which involves less filtration. From there on, the immune system response depends on the active ingredient reaching the bloodstream, so it depends on the condition of the alveolar mucosa and the patient's breathing regimen.

Which is just a question about administration of the vaccine. A nasal spray can  be administered more then once also.

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Offline Jolly2 (OP)

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Re: How long should a Vaccine Trial take?
« Reply #29 on: 01/02/2021 14:11:37 »
Quote from: Bored chemist on 01/02/2021 12:19:29
Quote from: Jolly2 on 31/01/2021 20:59:11
70% effective with first shoot, 90% with second.
Are we talking about the Sinovac vaccine where the actual trial (in Brazil) gave a effectiveness of 50.4%?
If not then you need to tell us what you are on about.
If it is that vaccine then clearly it hasn't been subject to reliable testing.
Why are you advocating it?

As always you troll.


Over 50% effective is the mark by which all vaccines are excepted.

As the article showed with over 24 million people vaccinated the results show a protection of between 60 to 70% with the first shoot around 90% with the secound.

With the added advantage that the side effects are less then all the other vaccines.

Clearly you could care less about the potential and actual damage these experimental mRNA vaccines are doing.

As usual you just ignore the reality and keep trolling. I'm done conversing with you. You are in now way interested in actual science or genuine discussion.
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Re: How long should a Vaccine Trial take?
« Reply #30 on: 01/02/2021 14:18:35 »
You were so busy lying about me being a troll that you forgot to answer the question.

50% is the minimum cut-off for acceptability.
But a 50% effectiveness will not stop the pandemic.
Quote from: Bored chemist on 01/02/2021 12:19:29
If it is that vaccine then clearly it hasn't been subject to reliable testing.
Why are you advocating it?
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Offline alancalverd

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Re: How long should a Vaccine Trial take?
« Reply #31 on: 01/02/2021 14:46:06 »
Quote from: Jolly2 on 01/02/2021 14:04:46
Which is just a question about administration of the vaccine. A nasal spray can  be administered more then once also.
OK, how many doses are required for effectiveness in all cases? What is the maximum safe dose in all cases? How do you know when you have received the right amount in the right place?

Of course it's about administration. Most vaccines are administered by injection or orally, and you are advocating nasal administration. I've pointed out why other routes are generally more reliable and controllable.
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Re: How long should a Vaccine Trial take?
« Reply #32 on: 01/02/2021 18:29:47 »
Quote from: alancalverd on 01/02/2021 14:46:06
Quote from: Jolly2 on 01/02/2021 14:04:46
Which is just a question about administration of the vaccine. A nasal spray can  be administered more then once also.
OK, how many doses are required for effectiveness in all cases? What is the maximum safe dose in all cases? How do you know when you have received the right amount in the right place?

Of course it's about administration. Most vaccines are administered by injection or orally, and you are advocating nasal administration. I've pointed out why other routes are generally more reliable and controllable.

They are all questions for the trails.
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Offline Bored chemist

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Re: How long should a Vaccine Trial take?
« Reply #33 on: 01/02/2021 19:56:22 »
Quote from: Jolly2 on 01/02/2021 18:29:47
They are all questions for the trails.
No.
They are questions you need to answer in order to know if the trial is safe and worthwhile.
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Offline evan_au

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Re: How long should a Vaccine Trial take?
« Reply #34 on: 01/02/2021 21:07:38 »
Quote from: Jolly2
How long should a Vaccine Trial take?
From what I have heard, it takes somewhere around 196 infections to complete the efficacy trial of a vaccine.
- If there are practically no cases of the disease in the population, the trial can take forever
- If the disease is running riot (as in Brazil), the trial doesn't need to take nearly as long.

If you have a blinded, randomized, placebo-controlled trial (the gold standard), half of the participants will be randomly selected to get the vaccine, and the other half will only think they got the vaccine.
- By the time 196 people catch the disease, you can compare how many of these had received the vaccine, and how many received the placebo.
- If 90% of the infections are in the placebo arm, then you can say the vaccine has very high efficacy.

Now, I am sure there is some reason why they picked a number like 196 infections.
- Probably to do with the minimum number of infections to provide a 95% confidence in the efficacy results

How long the trials should last for safety is determined by entirely different measures - you are looking for rare side-effects, and this typically means enrolling around 30,000 people in the trial, half of whom will receive the vaccine.
- You compare the extent of side-effects in the people vaccinated vs non-vaccinated
- Salt water does not make a good placebo, as it has almost no side-effects (apart from a sore arm)
- One of the vaccine trials gave the placebo subjects a vaccine for a different virus, which better simulates the side-effects of activating your immune system, and possible allergic reactions.
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Re: How long should a Vaccine Trial take?
« Reply #35 on: 01/02/2021 21:39:19 »
Quote from: evan_au on 01/02/2021 21:07:38
Quote from: Jolly2
How long should a Vaccine Trial take?
From what I have heard, it takes somewhere around 196 infections to complete the efficacy trial of a vaccine.
- If there are practically no cases of the disease in the population, the trial can take forever
- If the disease is running riot (as in Brazil), the trial doesn't need to take nearly as long.

Yet the trial period isnt simply an examination of the efficacy it is also a consideration of side effects and other dangers.

Quote from: evan_au on 01/02/2021 21:07:38
If you have a blinded, randomized, placebo-controlled trial (the gold standard), half of the participants will be randomly selected to get the vaccine, and the other half will only think they got the vaccine.
- By the time 196 people catch the disease, you can compare how many of these had received the vaccine, and how many received the placebo.
- If 90% of the infections are in the placebo arm, then you can say the vaccine has very high efficacy.

Now, I am sure there is some reason why they picked a number like 196 infections.
- Probably to do with the minimum number of infections to provide a 95% confidence in the efficacy results

How long the trials should last for safety is determined by entirely different measures - you are looking for rare side-effects, and this typically means enrolling around 30,000 people in the trial, half of whom will receive the vaccine.
- You compare the extent of side-effects in the people vaccinated vs non-vaccinated
- Salt water does not make a good placebo, as it has almost no side-effects (apart from a sore arm)
- One of the vaccine trials gave the placebo subjects a vaccine for a different virus, which better simulates the side-effects of activating your immune system, and possible allergic reactions.

I believe there should also be a concern with antibodies dependent enhancement. ADE.

We know there was an issue with cats and ferrets with the original SARS Cov1 vaccine.

While the process isn't totally clear and needs research,  it appears on secondary infections macrophages could be used by the viruses to propagate thus turning the immune response against the host.
The dengue vaccine has had study's related as the vaccine was shown to trigger ADE with infections,  it is  now recomended to only vaccinate children that have already had dengue to prevent it.
« Last Edit: 01/02/2021 21:42:08 by Jolly2 »
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Offline charles1948

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Re: How long should a Vaccine Trial take?
« Reply #36 on: 01/02/2021 22:12:10 »
Let's just wait and see what happens to the people who've been injected with the "vaccine"

Perhaps they'll be OK.  I hope so.

But I'd rather be cautious.

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Re: How long should a Vaccine Trial take?
« Reply #37 on: 01/02/2021 23:44:12 »
Quote from: charles1948 on 01/02/2021 22:12:10
Let's just wait and see what happens to the people who've been injected with the "vaccine"

Perhaps they'll be OK.  I hope so.

But I'd rather be cautious.

Again "lets suck it and see" is not a scientific approach.

The inactivated virus vaccines have far more historic data related to them. The entire scientific community has a relative good understanding of how they work and the issues that can arise. That is not the case with these new mRNA vaccines.

The chiense inactivated vaccine has now been shown to have less side effects even then the flu vaccine, and an efficacy of upto 90% with the second shot

My greater concern however relates to the process by which the mRNA vaccines work, they cause the production of the spike protein, those proteins attach to cells which then are identified as infected or foreign that process causes the action of macrophages. Therefore if macrophages are responsible for ADE its potentially far more likley to occur with a mRNA vaccine then with an inactivated vaccine which would inspire a response more from another side of the immune system.

We need more time to check this, but the intention is to vacinate everyone inside a year.

If there is a serious risk that people when they come into contact with the wild virus or a mutation of covid after being given the vaccine, that ADE could occur, we should be atleast certian that won't happen before we rush ahead. A One year vaccination program has potentially devastating risks.
« Last Edit: 01/02/2021 23:58:19 by Jolly2 »
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Offline evan_au

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Re: How long should a Vaccine Trial take?
« Reply #38 on: 07/02/2021 03:54:31 »
Quote from: Jolly2
The inactivated virus vaccines have far more historic data related to them.
The chiense inactivated virus vaccine and appear to show less side effects compared to ALL the other vaccine types
I agree that an inactivated virus (when paired with an adjuvant) can trigger the immune system to make antibodies against the virus.
- But antibody production drops off if there are no new challenges from that virus
- And antibodies are flushed out of the blood by the kidneys, with a half-life of about 2 weeks

However, there is another arm of the immune system called "killer T cells", which can destroy infected human cells before they bud off more virus particles that go on to infect other human cells.
- I understand that these killer T cells are activated when they detect human cells producing an alien protein (in this case, the SARS-COV2 spike protein)
- Because an inactivated virus is inactive (Duh!), human cells don't start budding off SARS-COV2 proteins, and so this killer T-Cells are not primed to be ready for an attack of the virus. This may be why the Sinovac inactivated virus vaccine has such low efficacy - it doesn't fully engage the immune system.
- The RNA vaccines cause human cells to produce spike protein from their ribosomes, and activate both parts of the immune system
- The Oxford-Zeneca vaccine infects human cells with a monkey virus (once-only - it can't multiply in humans), and this causes the human cells to produce spike protein, and should activate both parts of the immune system (provided the immune system doesn't react to the monkey virus first...)

Conclusion: inactivated virus vaccines can be effective (when combined with an adjuvant). But they are not necessarily more effective than an RNA vaccine (and with clinical trial results released so far, the Sinovac inactivated virus vaccine is considerably less effective than the RNA vaccines).

See: https://en.wikipedia.org/wiki/Cytotoxic_T_cell
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Re: How long should a Vaccine Trial take?
« Reply #39 on: 07/02/2021 10:32:08 »
Quote from: Jolly2 on 01/02/2021 21:39:19
I believe there should also be a concern with antibodies dependent enhancement. ADE.
It would show up in any trial.
It didn't, so it is, if it's a problem at all, less of a problem than the virus.

Quote from: Jolly2 on 01/02/2021 21:39:19
While the process isn't totally clear and needs research, 
They have done (and published) research.
https://www.nature.com/articles/s41564-020-00789-5
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