Naked Science Forum

On the Lighter Side => That CAN'T be true! => Topic started by: Jolly2 on 21/01/2021 13:32:28

Title: How long should a Vaccine Trial take?
Post by: Jolly2 on 21/01/2021 13:32:28
Quote

Since infection is an exponential function, we can measure time linearly as log(COVID deaths). How many years would have been acceptable in your view?

The trail phases for vaccines are fairly well established science.  If there was no pandemic as an excuse no scientist would or should accept the current program of 3 months for phase one and a combined 8 months for phases 2 and 3.

Reducing years of study down to a matter on months I consider reckless.

Interestingly  the Lancet published yesterday:-

Quote
The ability of SARS-CoV-2 vaccines to prevent infection or ongoing transmission remains unclear.

https://www.thelancet.com/journals/lanres/article/PIIS2213-2600(21)00045-X/fulltext

As such I have trouble understanding why the current covid vaccine has been authorised at all, according to the Lancet article it has not clearly shown the ability to prevent infection or transmission.

Title: Re: How long should a Vaccine Trial take?
Post by: Bored chemist on 21/01/2021 13:48:18
"How long should a Vaccine Trial take?"

Until you are sure (at some level of statistical certainty) that the risk from the disease is bigger than the risk from the vaccine.

Nobody gets vaccinated against smallpox anymore.
It's not that the vaccine became more dangerous; it's just that the risk of the disease is now vanishingly small.
On the other hand, it's not so long ago (Mid 1980s I think), that after centuries of using salicylates as fever remedies, the medical establishment recognised that here was a small, but unnecessary. risk of Reye's syndrome associated with the use of aspirin in children.
And (for most things) aspirin is no longer given to those under 12.

It's not as if there isn't an ongoing process of monitoring, even for drugs with a hundred year safety record.
So the real answer to the question might be "forever".

Reducing years of study down to a matter on months I consider reckless.
The rest of us think that letting people die from covid is reckless.

Yes, they say "The ability of SARS-CoV-2 vaccines to prevent infection or ongoing transmission remains unclear." and goes on to explain that the virus is changing.
Well, if you are aiming at a moving target, you have to move faster than it does.
Which is part of the reason why the trials are kept short.
Title: Re: How long should a Vaccine Trial take?
Post by: alancalverd on 21/01/2021 15:44:08
If there was no pandemic
But there was.

Beware of "ignoring the weight of the elephant...." (a phrase my father swore he saw in an Indian exam paper).
Title: Re: How long should a Vaccine Trial take?
Post by: Jolly2 on 21/01/2021 16:50:41
If there was no pandemic
But there was.

IS.
Exactly the issue, lower standards.

Do you have any concerns this might set a president where all future vaccines will also have a lower trial phase?


Beware of "ignoring the weight of the elephant...." (a phrase my father swore he saw in an Indian exam paper).

Umm is the elephant a vaccine producing big pharma company?
Title: Re: How long should a Vaccine Trial take?
Post by: Bored chemist on 21/01/2021 17:12:40
Exactly the issue, lower standards.
No.
Exactly the same standard.
The vaccine has to be better than not having the vaccine.
That was why I mentioned the smallpox vaccine. Nobody gets it any more.
The vaccine is exactly the same "standard" as it was before.


Do you have any concerns this might set a president where all future vaccines will also have a lower trial phase?
No, because it's the same standard.
The standard is "good enough in the circumstances".

Do you understand that it was granted an emergency license?
Do you not realise that most things are not an emergency?

Umm is the elephant a vaccine producing big pharma company?
No, it's world leading death rate due to a pandemic that's killing more people in the UK than everything else put together.
Title: Re: How long should a Vaccine Trial take?
Post by: alancalverd on 21/01/2021 19:16:00
Do you have any concerns this might set a president where all future vaccines will also have a lower trial phase?
I would be very concerned if anything set a president in the UK. The last one turned the USA from a prosperous democracy into the Turd Reich in a matter of weeks.

In the civilised world there is no end to the trial phase of any medicine or medical device. Postmarket surveillance and adverse event reporting is mandatory for the commercial life of the product and beyond.

Time to release depends on demonstration of an Acceptable Quality Level, and AQL depends on circumstances. The Mark 24 Spitfire was much faster and better armed than  the Mark 1, but did not fly until 6 years after the Battle of Britain. Thank God Air Marshal Jolly wasn't in charge.
Title: Re: How long should a Vaccine Trial take?
Post by: Kryptid on 21/01/2021 20:44:14
This appears to be an attempt to circumvent the locking of the other thread. The exact same back-and-forth is going on in here. Should this be locked as well?
Title: Re: How long should a Vaccine Trial take?
Post by: Bored chemist on 21/01/2021 20:46:25
Probably best to lock it before I get into trouble for using a perfectly accurate  word to describe someone who will not recognise that few dead people is better than many dead people.
Title: Re: How long should a Vaccine Trial take?
Post by: Jolly2 on 21/01/2021 20:47:09
Do you have any concerns this might set a president where all future vaccines will also have a lower trial phase?
I would be very concerned if anything set a president in the UK. The last one turned the USA from a prosperous democracy into the Turd Reich in a matter of weeks.
Dont hold your breath. Clinton is actively seeking war with Russia.
The turd Reich  as you call it atleast didnt go to war.

In the civilised world there is no end to the trial phase of any medicine or medical device. Postmarket surveillance and adverse event reporting is mandatory for the commercial life of the product and beyond.

Sure but this vaccine they seek to vacinate everyone with inside a year.... all good and well reporting issues after everyone already has it.

Time to release depends on demonstration of an Acceptable Quality Level, and AQL depends on circumstances. The Mark 24 Spitfire was much faster and better armed than  the Mark 1,

Spitfire was mark 1 built in 1940. They should have used the hurricane far cheaper to build.

but did not fly until 6 years after the Battle of Britain. Thank God Air Marshal Jolly wasn't in charge.

As understand from a previous posting you are literally one of the people  responsible for this vaccine... hence I find you slightly defensive.

Still we have one group of scientists expressing concern about potential damage to placenta on one side and on the other a group of scientists saying "Dont know, let's suck it and see". I find the latter rather rediculas
Title: Re: How long should a Vaccine Trial take?
Post by: Jolly2 on 21/01/2021 20:51:50
This appears to be an attempt to circumvent the locking of the other thread. The exact same back-and-forth is going on in here. Should this be locked as well?

Like your notions of scientific majority rule, your desire to close down discussion in a discussion forum is very unscientific.

Sorry you feel so threathen. You dont have to engage in the discussion
Title: Re: How long should a Vaccine Trial take?
Post by: Kryptid on 21/01/2021 20:57:51
Like your notions of scientific majority rule

You misunderstand my position. It's not that the majority is always right. They aren't. Rather, it's that scientific experts in their given field will have access to the relevant education and evidence that ultimately leads to the well-informed majority position on a subject. It isn't like they took a vote on what they wanted to be true. They formed a conclusion based on the evidence. Can they be wrong? Yes, but the evidence would have to point to them being wrong. Misinformation and conspiracy theories spread on the Internet, however, is not evidence that they are wrong.

I would also like to point out that I wasn't the one who locked the old thread. I proposed locking this thread as a matter of principle. Opening another thread about the exact same thing as a locked thread is basically the same as invalidating a moderator's decision. It's not that we are trying to shut down a discussion: we are trying to shut down fruitless discussions.
Title: Re: How long should a Vaccine Trial take?
Post by: evan_au on 21/01/2021 21:34:31
Quote from: Jolly2
Do you have any concerns this might set a president where all future vaccines will also have a lower trial phase?
If the virus continues with the current slow rate of point mutations, and we have millions of people vaccinated with the current vaccines, then later vaccines will not be for "emergency approval" (at least in Western countries).
- Characteristics like "single dose", "temperature-stable", "low cost" and "cheap enough for a cat or a mink" become more important concerns
- However, "Two-Thirds World" countries that can't afford or transport the RNA vaccines will be looking at these later vaccines as an emergency use authorization.

I do have a concern that the virus might mutate, rendering the current tested & approved vaccines ineffective.
- More likely, it will just render them less effective, since the immune system will generate antibodies to several parts of the spike protein (and different people will generate different sets of antibodies). It is unlikely that the spike protein will become totally unrecognizable, in the short term.

But if there is a major mutation (to which presidents and other politicians contributed by letting it breed uncontrollably and evolve rapidly), then  then it will become an emergency again, and we will need a new vaccine.
- The beauty of the RNA vaccines is that they are generated from an RNA sequence.
- So if the virus mutates (new RNA sequence), these vaccines can pivot rapidly (6-12 weeks)
- And because the production infrastructure & processes don't change, and the cold chain is in place, and the injection method doesn't change, these will be able to (safely) have an even shorter approval cycle (more like the seasonal flu vaccine, which is basically the same product as the previous year's vaccine)
Title: Re: How long should a Vaccine Trial take?
Post by: Bored chemist on 21/01/2021 21:44:30
Clinton is actively seeking war with Russia.
That's remarkably off topic, but it does speak volumes about your understanding of evidence.
Title: Re: How long should a Vaccine Trial take?
Post by: Jolly2 on 21/01/2021 21:51:41
Quote from: Jolly2
Do you have any concerns this might set a president where all future vaccines will also have a lower trial phase?
If the virus continues with the current slow rate of point mutations, and we have millions of people vaccinated with the current vaccines, then later vaccines will not be for "emergency approval" (at least in Western countries).

My concern was more towards the idea that pharmaceutical companies might use this as an excuse to rush all future vaccines.

But i see that mutations are also a possibility for covid requiring potentially another vaccine.

Ofcousre with an inactivated virus vaccine you simply deactivate the mutant strain, theoretically the procedure for deactivation of covid should apply to the mutations. 


- Characteristics like "single dose", "temperature-stable", "low cost" and "cheap enough for a cat or a mink" become more important concerns
- However, "Two-Thirds World" countries that can't afford or transport the RNA vaccines will be looking at these later vaccines as an emergency use authorization.

I do have a concern that the virus might mutate, rendering the current tested & approved vaccines ineffective.
- More likely, it will just render them less effective, since the immune system will generate antibodies to several parts of the spike protein (and different people will generate different sets of antibodies). It is unlikely that the spike protein will become totally unrecognizable, in the short term.

The mRNA vaccine induces a synthetic spike protein, it mimics the spike protein of covid. A new strain therefore needs a new synthetic.

I again find inactivated virus vaccine far more beneficial they are not synthetic, they are the virus.

But if there is a major mutation (to which presidents and other politicians contributed by letting it breed uncontrollably and evolve rapidly), then  then it will become an emergency again, and we will need a new vaccine.
- The beauty of the RNA vaccines is that they are generated from an RNA sequence.
- So if the virus mutates (new RNA sequence), these vaccines can pivot rapidly (6-12 weeks)
- And because the production infrastructure & processes don't change, and the cold chain is in place, and the injection method doesn't change, these will be able to (safely) have an even shorter approval cycle (more like the seasonal flu vaccine, which is basically the same product as the previous year's vaccine)

The flu vaccine is an inactivated virus vaccine correct?
Title: Re: How long should a Vaccine Trial take?
Post by: Kryptid on 21/01/2021 22:00:21
I again find inactivated virus vaccine far more beneficial they are not synthetic

Why it is being synthetic a problem?
Title: Re: How long should a Vaccine Trial take?
Post by: Bored chemist on 22/01/2021 08:45:25
they are the virus.
No, that would be silly.
They are what's left after you inactivate the virus.
Title: Re: How long should a Vaccine Trial take?
Post by: Jolly2 on 22/01/2021 16:39:37
I again find inactivated virus vaccine far more beneficial they are not synthetic

Why it is being synthetic a problem?

If they dont match well, add increased functions to the immune responses or diminished functions. Surely. At least with the inactivated virus you are sure the body see it clearly.

Title: Re: How long should a Vaccine Trial take?
Post by: Bored chemist on 22/01/2021 17:19:32
If they dont match well, add increased functions to the immune responses or diminished functions. Surely. At least with the inactivated virus you are sure the body see it clearly.
That did not, in any way, address the question of why you think it matters that it is synthetic.
Title: Re: How long should a Vaccine Trial take?
Post by: evan_au on 23/01/2021 06:38:59
Quote from: Jolly2
with the inactivated virus you are sure the body see it clearly
With an inactivated virus, the body will probably ignore it.
- Your immune system reacts to threats. An inactivated virus is not a threat.

With vaccines made from inactivated virus, manufacturers often mix it with an adjuvant, which does cause some localized tissue irritation, and grabs the attention of the immune system.
- The immune system responds to the site of injection, looks around for something that looks out of place
- The thing that seems most out of place is the (inactive) virus particles, so the immune system generates antibodies to the virus.

See: https://en.wikipedia.org/wiki/Adjuvant
Title: Re: How long should a Vaccine Trial take?
Post by: Jolly2 on 31/01/2021 14:15:00
Quote from: Jolly2
with the inactivated virus you are sure the body see it clearly
With an inactivated virus, the body will probably ignore it.
- Your immune system reacts to threats. An inactivated virus is not a threat.

its foreign. If your statement was true then a mRNA vaccine would be utterly useless the spike proteins are themselves not threats. So therefore the mRNA "treatments" Wouldnt work


They both work because the protein or the virus are seen as foreign.


With vaccines made from inactivated virus, manufacturers often mix it with an adjuvant, which does cause some localized tissue irritation, and grabs the attention of the immune system.
- The immune system responds to the site of injection, looks around for something that looks out of place
- The thing that seems most out of place is the (inactive) virus particles, so the immune system generates antibodies to the virus.

See: https://en.wikipedia.org/wiki/Adjuvant

Nasal spray is by far a better solution, for SARS cov2
Title: Re: How long should a Vaccine Trial take?
Post by: alancalverd on 31/01/2021 15:12:13
Nasal spray is by far a better solution, for SARS cov2
Please provide a reference to your clinical trial.
Title: Re: How long should a Vaccine Trial take?
Post by: Jolly2 on 31/01/2021 15:55:18
Nasal spray is by far a better solution, for SARS cov2
Please provide a reference to your clinical trial.

Ref:

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
Title: Re: How long should a Vaccine Trial take?
Post by: 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

Title: Re: How long should a Vaccine Trial take?
Post by: Bored chemist on 31/01/2021 17:41:10
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
Title: Re: How long should a Vaccine Trial take?
Post by: alancalverd on 31/01/2021 17:55:44
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.
Title: Re: How long should a Vaccine Trial take?
Post by: Jolly2 on 31/01/2021 20:59:11
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
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.
Title: Re: How long should a Vaccine Trial take?
Post by: 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.

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.   
Title: Re: How long should a Vaccine Trial take?
Post by: Bored chemist on 01/02/2021 12:19:29
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?
Title: Re: How long should a Vaccine Trial take?
Post by: Jolly2 on 01/02/2021 14:04:46
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.

Title: Re: How long should a Vaccine Trial take?
Post by: Jolly2 on 01/02/2021 14:11:37
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.
Title: Re: How long should a Vaccine Trial take?
Post by: Bored chemist 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.
If it is that vaccine then clearly it hasn't been subject to reliable testing.
Why are you advocating it?
Title: Re: How long should a Vaccine Trial take?
Post by: alancalverd on 01/02/2021 14:46:06
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.
Title: Re: How long should a Vaccine Trial take?
Post by: Jolly2 on 01/02/2021 18:29:47
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.
Title: Re: How long should a Vaccine Trial take?
Post by: Bored chemist on 01/02/2021 19:56:22
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.
Title: Re: How long should a Vaccine Trial take?
Post by: 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.

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.
Title: Re: How long should a Vaccine Trial take?
Post by: Jolly2 on 01/02/2021 21:39:19
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.

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.
Title: Re: How long should a Vaccine Trial take?
Post by: 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.

Title: Re: How long should a Vaccine Trial take?
Post by: Jolly2 on 01/02/2021 23:44:12
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.
Title: Re: How long should a Vaccine Trial take?
Post by: evan_au 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
Title: Re: How long should a Vaccine Trial take?
Post by: Bored chemist on 07/02/2021 10:32:08
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.

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
Title: Re: How long should a Vaccine Trial take?
Post by: alancalverd on 07/02/2021 18:39:58
Yet the trial period isnt simply an examination of the efficacy it is also a consideration of side effects and other dangers.
Phase 1 trials involve tens  of volunteers, determine essential safety and tolerability, and also reveal "common" side effects  - i.e. those occurring in 5 - 10 % of cases.
Phase 2 trials with hundreds to thousands of patients and controls look at effectiveness and thus reveal "occasional" side effects  down to 0.1% occurrence
Phase 3 trials have commercial and longterm significance: does the vaccine or whatever perform better or have fewer ("rare") or milder side effects than the existing standard treatment when tens to hundreds of thousands of actual  patients are treated?

Pretty obviously you can't ethically conduct a competitive Phase 3 trial of the first and only vaccine for a newly emerging and rapidly spreading disease but the licence for emergency use will require adequate "postmarket surveillance" for rare and late complications including single instances correlated with but not proven caused by the medication.

If anyone actually read the caution leaflet, nobody would take aspirin.
Title: Re: How long should a Vaccine Trial take?
Post by: Jolly2 on 08/02/2021 14:55:49
Yet the trial period isnt simply an examination of the efficacy it is also a consideration of side effects and other dangers.
Phase 1 trials involve tens  of volunteers, determine essential safety and tolerability, and also reveal "common" side effects  - i.e. those occurring in 5 - 10 % of cases.

Normally lasts around 2 years. For these experimental mRNA treatments they took 3 months.

Phase 2 trials with hundreds to thousands of patients and controls look at effectiveness and thus reveal "occasional" side effects  down to 0.1% occurrence
Phase 3 trials have commercial and longterm significance: does the vaccine or whatever perform better or have fewer ("rare") or milder side effects than the existing standard treatment when tens to hundreds of thousands of actual  patients are treated?

Normally takes between 3 to 5 years.

Pretty obviously you can't ethically conduct a competitive Phase 3 trial of the first and only vaccine for a newly emerging and rapidly spreading disease but the licence for emergency use will require adequate "postmarket surveillance" for rare and late complications including single instances correlated with but not proven caused by the medication.

Again phrase 3 trails normally take 4 years.

So what should have been a trail of arround 7 years for phase 2 and 3 have been combined into an 8 month trail.

In all its 11 months of trials for all 3 trail phases. That's less time then a normal phase 1 trail takes.

We have learnt from experience we need time to assess the dangers, involved with a new vaccine. To add an experimental treatment into the mix just adds to potential problems.

If anyone actually read the caution leaflet, nobody would take aspirin.

Disagree Aspirin is naturally occurring in willow bark, people have taken it for years as a herbal remedy. Willow bark however contains other toxins that are removed with general aspirin.
Title: Re: How long should a Vaccine Trial take?
Post by: Jolly2 on 08/02/2021 14:58:13
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.

Shows you have no understanding of the issue, the only way that shows up in a trail is if people catch the wild virus, or one of its mutations. The virus tested against isnt wild.
Title: Re: How long should a Vaccine Trial take?
Post by: Jolly2 on 02/03/2021 18:21:08
Whistle blower claims 25% of old peoples home residents died after taking the Pfizer vaccine in Germany.

https://childrenshealthdefense.org/defender/german-nursing-home-residents-died-pfizer-vaccine/
Title: Re: How long should a Vaccine Trial take?
Post by: Jolly2 on 02/03/2021 18:29:59
https://childrenshealthdefense.org/defender/health-officials-push-pregnant-women-covid-vaccine/

"Nearly a third (31%) of the women had miscarriages or preterm births, which occurred within as little as one day of injection — the majority after a single dose of vaccine."

Looks like the doctors original concerns when approaching European health authorities with regards to fertility and the vaccine may have been correct.


Title: Re: How long should a Vaccine Trial take?
Post by: Bored chemist on 02/03/2021 19:29:32
Whistle blower claims 25% of old peoples home residents died after taking the Pfizer vaccine in Germany.

https://childrenshealthdefense.org/defender/german-nursing-home-residents-died-pfizer-vaccine/
They also died after Boris was elected.
https://en.wikipedia.org/wiki/Post_hoc_ergo_propter_hoc



"Nearly a third (31%) of the women had miscarriages or preterm births, which occurred within as little as one day of injection — the majority after a single dose of vaccine."
If that was widespread I would have heard about it on the news not from a link to a sensationalist web page.
Title: Re: How long should a Vaccine Trial take?
Post by: Jolly2 on 02/03/2021 22:20:08
Whistle blower claims 25% of old peoples home residents died after taking the Pfizer vaccine in Germany.

https://childrenshealthdefense.org/defender/german-nursing-home-residents-died-pfizer-vaccine/
They also died after Boris was elected.
https://en.wikipedia.org/wiki/Post_hoc_ergo_propter_hoc



"Nearly a third (31%) of the women had miscarriages or preterm births, which occurred within as little as one day of injection — the majority after a single dose of vaccine."
If that was widespread I would have heard about it on the news not from a link to a sensationalist web page.

Why would corporate media tell the truth? They generally don't
Title: Re: How long should a Vaccine Trial take?
Post by: alancalverd on 02/03/2021 22:33:46
The average length of stay in old folks' nursing homes is 13 weeks. 100% die eventually, so if only 25% die after receiving COVID vaccine, we seem to have found the elixir of life.

About 30% of human pregnancies abort spontaneously.

So: very few people understand statistics, but bad journalists can still make a living.

 
Title: Re: How long should a Vaccine Trial take?
Post by: Bored chemist on 02/03/2021 22:44:13
Why would corporate media tell the truth? They generally don't
How could you know?
Title: Re: How long should a Vaccine Trial take?
Post by: Jolly2 on 03/03/2021 01:06:11
Why would corporate media tell the truth? They generally don't
How could you know?

Past experience. Combined with censorship of truthful information the establishment wants suppressed.

I've caught CNN lying so many times, it's almost a given today it's all they do. And we see the Truth censored on Twitter and Facebook repeatedly.
Title: Re: How long should a Vaccine Trial take?
Post by: Kryptid on 03/03/2021 05:23:08
Why would corporate media tell the truth? They generally don't

And yet you trust some unidentified whistle-blower?

My grandmother, who is 80 years old, got her second COVID shot on February 3rd. She is doing just fine. Ditto for my 72-year old uncle, who got his first shot a week or so ago.
Title: Re: How long should a Vaccine Trial take?
Post by: Bored chemist on 03/03/2021 08:50:08
My grandmother, who is 80 years old
Yeah, but I bet she's not pregnant...
Title: Re: How long should a Vaccine Trial take?
Post by: alancalverd on 03/03/2021 13:43:52
And why not? Jolly has already told us (reply # 43) that the vaccine prevents death, so perhaps it restores youth too?
Title: Re: How long should a Vaccine Trial take?
Post by: Kryptid on 04/03/2021 00:31:43
Yeah, but I bet she's not pregnant...

True, but my post was in response to this in particular:

Whistle blower claims 25% of old peoples home residents died after taking the Pfizer vaccine in Germany.

https://childrenshealthdefense.org/defender/german-nursing-home-residents-died-pfizer-vaccine/
Title: Re: How long should a Vaccine Trial take?
Post by: Jolly2 on 04/03/2021 00:58:01
Why would corporate media tell the truth? They generally don't

And yet you trust some unidentified whistle-blower?

My grandmother, who is 80 years old, got her second COVID shot on February 3rd. She is doing just fine. Ditto for my 72-year old uncle, who got his first shot a week or so ago.

Statistics are slightly more important than anecdotes.

Sadly the companies producing the vaccines have an interest in suppressing negative information, and influence over the both government and media narratives, it's a sad time for actual science and truth, we have Facebook and Twitter picking sides when experts disagree about issues, they and the media have no qualification to do so, legitimate concerns about the rushed nature of the vaccines, there experimental nature and the potential side effects are all being suppressed by an imposed consensus which is utterly unscientific.

The majority of the data we have is coming from trial ran and controlled by the very companies that produced them and they are not even sharing all their data, this entire situation is a travesty.
Title: Re: How long should a Vaccine Trial take?
Post by: Kryptid on 04/03/2021 01:00:03
Statistics are slightly more important than anecdotes.

Says the person sharing an anecdote from an unidentified whistle-blower.
Title: Re: How long should a Vaccine Trial take?
Post by: Bored chemist on 04/03/2021 08:58:06
Given that this thread is based on a false premise- that the trials actually stop- has it run its course now?
they and the media have no qualification to do so
Nor have you- as demonstrated at length in this thread and others.
Title: Re: How long should a Vaccine Trial take?
Post by: alancalverd on 04/03/2021 12:21:33
Statistics are slightly more important than anecdotes.
Which is why every trial has an independent data monitoring committee and reports intermediate and final results to another independent research ethics committee. A product is not licensed for general release until the entire trial to date has been scrutinised by the MHRA and a program is in place for continuous postmarket surveillance and monitoring.

It is true that the stuff that gets published in peer-reviewed journals rarely includes products that failed to work, and probably less than 10% of stuff that reaches a Phase 2 trial makes it to market. "Suppression" is a rather harsh word for scrapping a project.
Title: Re: How long should a Vaccine Trial take?
Post by: Jolly2 on 04/03/2021 18:03:29
Statistics are slightly more important than anecdotes.
Which is why every trial has an independent data monitoring committee and reports intermediate and final results to another independent research ethics committee. A product is not licensed for general release until the entire trial to date has been scrutinised by the MHRA and a program is in place for continuous postmarket surveillance and monitoring.

It is true that the stuff that gets published in peer-reviewed journals rarely includes products that failed to work, and probably less than 10% of stuff that reaches a Phase 2 trial makes it to market. "Suppression" is a rather harsh word for scrapping a project.

As I have been trying to point out for a while the system is broken, business and the suggestion that the market is better then government to control society has allowed regulators to be captured by the very market forces they are meant to be monitoring.  We need a new system.
Title: Re: How long should a Vaccine Trial take?
Post by: Jolly2 on 04/03/2021 18:08:28
Statistics are slightly more important than anecdotes.

Says the person sharing an anecdote from an unidentified whistle-blower.

Funny that for the last 4 years and even before anonymous sources about Russia gate weapons of mass destruction in Iraq and all manner of other lies have been propagated by the media, when it's a anonymous whistle blower, which Assange at Wikileaks used often, and Wikileaks has never had to retract a story because they were false. Suddenly it's a problem,  what a joke, anonymous whistle blowers are fine if they help the corporate system and its agendas and bad if they don't, sorry if I find the double standard rediculas.

Monumental scandal
Title: Re: How long should a Vaccine Trial take?
Post by: Kryptid on 04/03/2021 21:08:35
anonymous whistle blowers are fine if they help the corporate system and its agendas and bad if they don't, sorry if I find the double standard rediculas.

Well, I don't hold that double standard.

All anonymous whistle-blowers should be viewed with suspicion.
Title: Re: How long should a Vaccine Trial take?
Post by: Jolly2 on 04/03/2021 23:04:55
anonymous whistle blowers are fine if they help the corporate system and its agendas and bad if they don't, sorry if I find the double standard rediculas.

Well, I don't hold that double standard.

All anonymous whistle-blowers should be viewed with suspicion.

While I'm inclined to agree, whistle blowers used to be offered protection under the law, sadly today, we see whistle blowers like, Seth Rich shot in the back in cold blood, and other whistle blowers like Chelsea Manning in prison being tortured,  or as with Edward Snowden in Russia incapable of being able to return to America for the same reasons, there can be no expectation of a fair trial for Snowden and the clear possibility that he might not even survive long enough on returning to America to see a trail.

Seems clear the only option for whistle blowers today is to do so in secret, or risk being murdered or tortured by states like Britan and America that claim a moral high ground over countries that do exactly the same thing.

Whole of the west is ran by complete and total hypocrisy. Ruled by thugs.

I ponder what you suggest a whistle blower is to do? Allowing the criminality they seek to expose to continue out of fear,  is exactly the response those that are currently torturing whistle blowers seek.

We should we do just except that criminal thugs control our counties? Those same criminal thugs use anonymous sourses all the time to further their agendas.
Title: Re: How long should a Vaccine Trial take?
Post by: Bored chemist on 04/03/2021 23:16:01
We need a new system.
To the extent that what you say is true (and that's not a zero extent but...) what we need is the old system back again.

A system where we don't hand power to billionaires just because they claim that running a country is the same as running a business (where they don't mind going bankrupt from time to time).
Title: Re: How long should a Vaccine Trial take?
Post by: Bored chemist on 04/03/2021 23:17:32
I ponder what you suggest a whistle blower is to do?
Join forces with other whistle blowers (and whatever you want to call the people who have noticed that the system has gone to Hell in a hand cart.
Title: Re: How long should a Vaccine Trial take?
Post by: alancalverd on 04/03/2021 23:58:28
the suggestion that the market is better then government to control society has allowed regulators to be captured by the very market forces they are meant to be monitoring. 
Whilst I have always found  European Union Directives to be fundamentally biassed in favor of the market, everyone I have worked with in ethics committees and national regulatory agencies (apart from the Health and Safety Executive) has been scrupulously honest and for the most part competent.
Title: Re: How long should a Vaccine Trial take?
Post by: Kryptid on 05/03/2021 00:03:31
I ponder what you suggest a whistle blower is to do?

Get a hold of objective evidence.
Title: Re: How long should a Vaccine Trial take?
Post by: Jolly2 on 06/03/2021 18:46:02
I ponder what you suggest a whistle blower is to do?

Get a hold of objective evidence.

Which is basically saying nothing, whistle blowers generally release objective evidence, that proves the government or security services were acting criminally. The objective evidence isnt the issue, when providing that evidence lands a person in prison being tortured by the very criminals they sort to expose.
Title: Re: How long should a Vaccine Trial take?
Post by: Jolly2 on 06/03/2021 21:57:35
the suggestion that the market is better then government to control society has allowed regulators to be captured by the very market forces they are meant to be monitoring.
Whilst I have always found  European Union Directives to be fundamentally biassed in favor of the market, everyone I have worked with in ethics committees and national regulatory agencies (apart from the Health and Safety Executive) has been scrupulously honest and for the most part competent.

Not sure that is relevant,  if the system has been designed intentionally to benefit the designers, honesty for participants in a system that is achieving its objectives, doesn't change the corruption the system was built to allow and protect.
Title: Re: How long should a Vaccine Trial take?
Post by: Kryptid on 06/03/2021 22:59:13
So what objective evidence was given by that anonymous nursing home worker in Germany to support their claims?
Title: Re: How long should a Vaccine Trial take?
Post by: Jolly2 on 07/03/2021 03:40:10
So what objective evidence was given by that anonymous nursing home worker in Germany to support their claims?

It was as part of an interview the whistle blowers voice is changed to help hide their identity.

https://players.brightcove.net/6223967412001/default_default/index.html?videoId=6235744314001
Title: Re: How long should a Vaccine Trial take?
Post by: Kryptid on 07/03/2021 04:06:51
It was as part of an interview the whistle blowers voice is changed to help hide their identity.

https://players.brightcove.net/6223967412001/default_default/index.html?videoId=6235744314001

Before I spend time watching a 39-minute video, tell me whether any objective evidence that Pfizer vaccinations actually caused deaths are presented or if the only thing we are given is the word of this anonymous caregiver.
Title: Re: How long should a Vaccine Trial take?
Post by: Jolly2 on 07/03/2021 04:25:23
It was as part of an interview the whistle blowers voice is changed to help hide their identity.

https://players.brightcove.net/6223967412001/default_default/index.html?videoId=6235744314001

Before I spend time watching a 39-minute video, tell me whether any objective evidence that Pfizer vaccinations actually caused deaths are presented or if the only thing we are given is the word of this anonymous caregiver.

You'll just have to watch it make up your own mind,  he describes his experience,  discusses how the 8 people died,  the changes in behaviour of the 11 other that suffered side effects, overall changes in the behaviour of all the people vaccinated. Their shock seeing army soldiers inside the care home protecting the Vaccine. It's the care givers perspective, that 7 died after the 1st vaccination isnt really in dispute.
Title: Re: How long should a Vaccine Trial take?
Post by: Kryptid on 07/03/2021 04:28:25
You'll just have to watch it make up your own mind,  he describes his experience.

So an anecdote then.

that 7 died after the 1st vaccination isnt really in dispute.

Where has it been confirmed? How do we know that the vaccine was responsible?
Title: Re: How long should a Vaccine Trial take?
Post by: evan_au on 07/03/2021 06:50:44
Quote from: OP
Re: How long should a Vaccine Trial take?
The field trial of a new 3rd generation vaccine could take a lot longer, if:
- It comes on the market in (say) 1 year,
- after herd immunity is achieved in some country
- and there is little virus circulating in that country

Solutions might be to:
- Test the new vaccine in a country which has a high level of circulating virus
- or high levels of a new strain of the virus
- Or, assuming the basic design/manfacturing process of the vaccine is already proven, to test the effectivenes of the vaccine in generating antibodies against the new (and old) strains
- This is how the lead-time for producing the seasonal flu is kept under 12 months - they don't actually do a double-blind placebo-controlled trial (the latter "gold-standard" clinical trial was done for the COVID-19 vaccines that were approved in countries with an independent approval body)
Title: Re: How long should a Vaccine Trial take?
Post by: Jolly2 on 08/03/2021 22:49:04
You'll just have to watch it make up your own mind,  he describes his experience.

So an anecdote then.

Asking you to think for yourself is hardly anecdotal.

that 7 died after the 1st vaccination isnt really in dispute.

Where has it been confirmed? How do we know that the vaccine was responsible?

Sadly the media and social media are suppressing any negative reporting on the vaccines. I honestly don't know how people like yourself are going to find any truth, with regard to the vaccines.
Title: Re: How long should a Vaccine Trial take?
Post by: Bored chemist on 08/03/2021 23:04:13
Asking you to think for yourself is hardly anecdotal.
True. Asking us to think wouldn't be anecdotal.
But that's not what you did is it.
What you were doing was asking us to let some anonymous guy on the internet who claims to be a care worker make up our minds for us.

And that's why we don't think you understand how science works.
Sadly the media and social media are suppressing any negative reporting on the vaccines.
Then how do you know about it?

If you know about it, then it's plain that it hasn't been suppressed, has it?
Title: Re: How long should a Vaccine Trial take?
Post by: Bored chemist on 08/03/2021 23:04:44
Asking you to think for yourself is hardly anecdotal.
True. Asking us to think for ourselves wouldn't be anecdotal.
But that's not what you did is it?
What you were doing was asking us to let some anonymous guy on the internet who claims to be a care worker make up our minds for us.

And that's why we don't think you understand how science works.
Sadly the media and social media are suppressing any negative reporting on the vaccines.
Then how do you know about it?

If you know about it, then it's plain that it hasn't been suppressed, has it?

Title: Re: How long should a Vaccine Trial take?
Post by: Kryptid on 08/03/2021 23:54:39
Asking you to think for yourself is hardly anecdotal.

No, I'm saying that the evidence presented in the video is anecdotal.

Sadly the media and social media are suppressing any negative reporting on the vaccines. I honestly don't know how people like yourself are going to find any truth, with regard to the vaccines.

So is that an admission that the claims of this anonymous caregiver cannot be confirmed?

Let me pose some questions to you: do you require that any claims presented in the media have to be back-checked as true before you accept them as truth? Likewise, do you require that any claims presented by an anonymous source on the Internet be back-checked as true before accepting them as true? If you have different standards for one than the other, please explain why.
Title: Re: How long should a Vaccine Trial take?
Post by: Jolly2 on 14/03/2021 12:10:03
Asking you to think for yourself is hardly anecdotal.

No, I'm saying that the evidence presented in the video is anecdotal.

Sadly the media and social media are suppressing any negative reporting on the vaccines. I honestly don't know how people like yourself are going to find any truth, with regard to the vaccines.

So is that an admission that the claims of this anonymous caregiver cannot be confirmed?

Currently, but I do not see why that would be a reason to dismiss them out of hand. Rather surely such an interview should spark an investigation into finding the truth.

As I said before there seems to be an agenda to suppress all negative information about the current vaccines. Supressing data isn't scientific, are you not concerned that health care workers feel the only way to tell the truth is by doing so in secret, in the same way someone fleeing the mafia would. The current climate imposed by the media corporations have a lot to answer for in that regard
 

Let me pose some questions to you: do you require that any claims presented in the media have to be back-checked as true before you accept them as truth?
Likewise, do you require that any claims presented by an anonymous source on the Internet be back-checked as true before accepting them as true? If you have different standards for one than the other, please explain why.

I don't think I suggested that they were True 100% unquestionably,  An anonymous source is an anonymous source with all that goes with that. We cant say if it's TRUE or not, hence there should be a wider investigation.

Geert vanden Bossche
Is calling for a halt

https://straightlinelogic.com/2021/03/13/halt-all-covid-19-mass-vaccination-immediately-open-letter-to-the-who-by-geert-vanden-bossche-phd-dvm/

Halt All Covid-19 Mass Vaccination Immediately (Open Letter to the WHO) , by Geert Vanden Bossche, PhD, DvM

Geert Vanden Bossche, PhD, DVM, is a vaccine research expert. He has a long list of companies and organizations he’s worked with on vaccine discovery and preclinical research, including GSK, Novartis, Solvay Biologicals, and Bill & Melinda Gates Foundation. Dr Vanden Bossche also coordinated the Ebola vaccine program at GAVI (Global Alliance for Vaccines and Immunization).

He is board-certified in Virology and Microbiology, the author of over 30 publications, and inventor of a patent application for universal vaccines. He currently works as an independent vaccine research consultant.....

He believes that:

Ongoing mass vaccination deployments are “highly-likely to further enhance ‘adaptive’ immune escape as none of the current vaccines will prevent replication/transmission of viral variants”
As such, “The more we use these vaccines for immunizing people in the midst of a pandemic, the more infectious the virus will become”.
And “With increasing infectiousness comes an increased likelihood of viral resistance to the vaccines”.
Title: Re: How long should a Vaccine Trial take?
Post by: Bored chemist on 14/03/2021 12:33:26
Rather surely such an interview should spark an investigation into finding the truth.
There will have been one.
But the local police looking into it and finding that there's no actual story won't get reported in the news, will it?
So the lasting message that the people get from this non issue is "vaccines are bad".
That was entirely predictable.
So, the remaining question is why do you spread these  fairy tales?

Speaking of entirely predictable.
Man wants current vaccinations stopped because....
"Geert Vanden Bossche, PhD, DVM, is a vaccine research expert....

He is ... inventor of a patent application for universal vaccines. He currently works as an independent vaccine research consultant...."

Do you remember the damage caused by Andrew Wakefield when he did much the same thing with the MMR vaccine.
Wakefield also worked for a competitor to the vaccine he lied about.




Title: Re: How long should a Vaccine Trial take?
Post by: alancalverd on 14/03/2021 13:59:00
Doctor of Veterinary Medicine, eh? Does he torture animals for Big Pharma, or develop vaccines for bovine mastitis?

So he says we should do nothing to prevent people becoming infected with COVID. How long did they put up with him  telling them to let ebola rip rather that vaccinate people against it?

Had all governments responded as quickly and thoroughly to COVID as they did to Ebola, and in particular tightly quarantined the Wuhan area rather than pretend there wasn't a problem, the problem would have been contained within Vanden Bossche's range of experience. Fortunately it seems that African governments have the wit to tell the rest of the world that they have a problem and want help, unlike the idiots who run China, Europe and the USA, whose only concern is electoral popularity.

So we now have a very different problem, to which mass vaccination seems to be the only response. It worked for polio and smallpox - why not COVID?
Title: Re: How long should a Vaccine Trial take?
Post by: Kryptid on 14/03/2021 14:18:37
Currently, but I do not see why that would be a reason to dismiss them out of hand. Rather surely such an interview should spark an investigation into finding the truth.

Sure, investigations are fine. But until such a thing is done, we should take the claims of an anonymous person as just that: claims by an anonymous person. There is little weight behind it.

As I said before there seems to be an agenda to suppress all negative information about the current vaccines. Supressing data isn't scientific

Evidence?

are you not concerned that health care workers feel the only way to tell the truth is by doing so in secret, in the same way someone fleeing the mafia would.

Since when was it established that this anonymous source was telling the truth?

Ongoing mass vaccination deployments are “highly-likely to further enhance ‘adaptive’ immune escape as none of the current vaccines will prevent replication/transmission of viral variants”

The vaccines do work against the mutant variants, just at a reduced efficacy.
Title: Re: How long should a Vaccine Trial take?
Post by: evan_au on 14/03/2021 22:00:43
Quote from: Jolly2
Ongoing mass vaccination deployments are “highly-likely to further enhance ‘adaptive’ immune escape as none of the current vaccines will prevent replication/transmission of viral variants”
Allowing the virus to spread with minimal controls (eg in USA, UK and Brazil, last year) is certain to produce many variants of the virus.
- Some of these variants will be worse matches for the vaccine,
- and also worse matches for those who have achieved immunity by recovering from infection.

 So it is important to both:
- reduce community infection numbers to reduce the generation of new variants (eg quarantine, social distancing masks, lockdowns, contact tracing)
- and rollout the vaccine to reduce the number of people who will get infected in future

And we need to monitor people with compromised immune systems, as they may not be able to control the virus (even after vaccination), and some of them will continue to throw off new variants.
- These individuals may need a higher dose of vaccine than usual.
Title: Re: How long should a Vaccine Trial take?
Post by: Jolly2 on 15/03/2021 17:27:25
Currently, but I do not see why that would be a reason to dismiss them out of hand. Rather surely such an interview should spark an investigation into finding the truth.

Sure, investigations are fine. But until such a thing is done, we should take the claims of an anonymous person as just that: claims by an anonymous person. There is little weight behind it.

As I said before there seems to be an agenda to suppress all negative information about the current vaccines. Supressing data isn't scientific

Evidence?

Ok what reality are you living in there are plenty of examples today of qualified professionals being banned on Facebook and Twitter for expressing concerns, or sharing information those controlling the current narrative do not like.


are you not concerned that health care workers feel the only way to tell the truth is by doing so in secret, in the same way someone fleeing the mafia would.

Since when was it established that this anonymous source was telling the truth?

Not the point, we currently are living in a situation where health workers only seem to get air time,  if they do so secretly. Which is rediculas.

Ongoing mass vaccination deployments are “highly-likely to further enhance ‘adaptive’ immune escape as none of the current vaccines will prevent replication/transmission of viral variants”

The vaccines do work against the mutant variants, just at a reduced efficacy.

That's not the point of concern, the point of concern being raised is that the vaccines are doing nothing to prevent transmission. And as they are not going to halt transmission as Fauci himself said they wouldn't, vaccinated people can still spread the virus and increase the number of mutations and also there are possible implications to mutations from vaccinated people.

We should be looking at treatments not vaccines. Which I have been talking about since the beginning, treatments end transmission.
Title: Re: How long should a Vaccine Trial take?
Post by: Kryptid on 15/03/2021 17:55:07
Ok what reality are you living in there are plenty of examples today of qualified professionals being banned on Facebook and Twitter for expressing concerns, or sharing information those controlling the current narrative do not like.

If there are plenty of examples, then please show me some.

Not the point

So it's not the point whether or not someone who is anonymous is telling the truth? Right...

we currently are living in a situation where health workers only seem to get air time,  if they do so secretly.

Do you have evidence for that?

he point of concern being raised is that the vaccines are doing nothing to prevent transmission.

Yes, they do: https://www.charlotteobserver.com/news/coronavirus/article249950469.html

We should be looking at treatments not vaccines.

Ideally, we would want both.
Title: Re: How long should a Vaccine Trial take?
Post by: Bored chemist on 15/03/2021 19:32:20
We should be looking at treatments not vaccines.
That's... a less common point of view than...
https://en.wiktionary.org/wiki/prevention_is_better_than_cure

Can you explain why history has always got this wrong?
(Preferably without making false assumptions)
Title: Re: How long should a Vaccine Trial take?
Post by: evan_au on 16/03/2021 08:13:27
Quote from: Jolly2
We should be looking at treatments not vaccines.
The current vaccines will reduce severe disease by more than 90% (for current variants).
- These vaccines have undergone extensive safety & efficacy trials
- So the priority is to deploy the vaccines we have approved
 
Meanwhile, the search for safe and effective treatments can continue
- There was a clinical trial of Hydroxychloroquine. It is not very safe, and completely ineffective. Scratch the Trump candidate.
- There have been trials of monoclonal antibodies. They have been shown to be pretty safe, and somewhat effective.
- There is a clinical trial of Ivermectin underway. This is known to be quite safe, but we don't yet know if it is effective. It could be rapidly deployed if (and only if) it is proved effective.
- Meanwhile, the 6-9 month process of clinical trials and approvals can continue for any other candidate treatments that labs around the world can identify (plus the 3-6 month process of setting up a factory, if it is a new product)

Bear in mind that viruses can evade treatments, too, especially if:
- They aren't 100% effective at prevention
- they are used by the general population as a preventative (prophylactic).
- They aren't used rigorously at an effective dose
Title: Re: How long should a Vaccine Trial take?
Post by: Bored chemist on 16/03/2021 08:46:57
There is a clinical trial of Ivermectin underway. This is known to be quite safe, but we don't yet know if it is effective. It could be rapidly deployed if (and only if) it is proved effective.
Just a quick note of caution.
https://en.wikipedia.org/wiki/COVID-19_misinformation#Ivermectin
Title: Re: How long should a Vaccine Trial take?
Post by: alancalverd on 16/03/2021 08:57:38
vaccines are doing nothing to prevent transmission
Transmission requires an infectious transmitter to be in contact with an unprotected receiver. Vaccines reduce the numbers of both, and thus reduce transmission throughout the community.

The only action that completely prevents transmission is total quarantine.
Title: Re: How long should a Vaccine Trial take?
Post by: Jolly2 on 07/05/2021 01:34:32
Quote from: Jolly2
We should be looking at treatments not vaccines.
The current vaccines will reduce severe disease by more than 90% (for current variants).
- These vaccines have undergone extensive safety & efficacy trials
- So the priority is to deploy the vaccines we have approved
 
Meanwhile, the search for safe and effective treatments can continue
- There was a clinical trial of Hydroxychloroquine. It is not very safe,

On what basis are you claiming that Hydroxychloroquin isnt safe?.
It's a malaria medication licenced for decades and used by millions.

and completely ineffective.

Bad studies, the original study that said HCQ didn't work and started all this,  was retracted because it was based on bad science. All studies since have failed to combine HCQ with Zink and vitamin C and also failed to start the treatments early once the patients show symptoms.

Mainly the studies have been giving HCQ to people at the end of the Virus' activity after the damage is done then claiming its ineffective. Just bad science.

The Association American Frountline doctors, which is made up of doctors working in the A and E departments across America have been saying that they have seen good results using HCQ and are protesting the media behaviour in discrediting the treatment. Seems to be linked to Trump suggesting it was effective and the media determined to rubbish it simply to make Trump look bad.

Some have claimed this is simply about money as HCQ is a cheep option and big pharma want it out of the picture.
Title: Re: How long should a Vaccine Trial take?
Post by: Kryptid on 07/05/2021 19:58:46
All studies since have failed to combine HCQ with Zink and vitamin C and also failed to start the treatments early once the patients show symptoms.

So you are saying that the conditions of the initial study have not been replicated in subsequent studies? If so, then that means that findings of the initial study have not been verified. Without successful replication, you can't say whether the treatment really works or not. Feel free to say that we should be trying replicate the initially study more faithfully, but please do not say that we should be using it because we know it is effective. If the findings haven't been verified via replication, then we don't know that it's effective.

The Association American Frountline doctors

Should not be trusted as a reliable source of information: https://www.medpagetoday.com/infectiousdisease/covid19/90536, https://www.mcgill.ca/oss/article/covid-19-critical-thinking-pseudoscience/back-away-americas-frontline-doctors, https://en.wikipedia.org/wiki/America%27s_Frontline_Doctors

Your prior post makes it look like you are trying to inject conspiracy theory thinking into the COVID-19 pandemic again. If I'm not mistaken, that's what got you suspended last time. You might want to tread lightly.
Title: Re: How long should a Vaccine Trial take?
Post by: Bored chemist on 08/05/2021 00:30:04
The Association American Frountline doctors, which is...
Noted for telling lies...
"America's Frontline Doctors is an American right-wing political organization. Founded by Simone Gold and promoted by the Tea Party Patriots, "
from
https://en.wikipedia.org/wiki/America%27s_Frontline_Doctors

Title: Re: How long should a Vaccine Trial take?
Post by: evan_au on 08/05/2021 06:57:50
Quote from: OP
How long should a Vaccine Trial take?
Answer: As short as possible, but not shorter...
- If you make the trial longer than necessary, more people will die before the medication is approved.
- If you make the trial shorter than necessary, you will not know whether the treatment works or not, or whether it has significant side-effects

From what I have heard, the size of a Phase 3 trial should be big enough (sufficient treated & monitored patients) and long enough (in duration) to capture around 150-200 adverse events.
- Where, for a COVID vaccine, "adverse event" might be "ending up in hospital", "ending up in ICU" or "Death", due to COVID-19.
- And, to know if the vaccine is effective or not, it must be a double-blinded study with a placebo. The adverse events are counted across both the placebo and treatment arms of the trial.

Clearly, you will reach this number of adverse events quicker if there is more virus around, and more people dying of it, so a useful trial will be shorter.
- Fortunately (for a rapid trial), we have had several governments around the world who said "Don't worry, it's just like the flu", "go about your normal business", "don't do shutdowns..." etc.
- Unfortunately (for the population of those countries), this led to uncontrolled outbreaks, overloaded hospitals and excess deaths.
 
Title: Re: How long should a Vaccine Trial take?
Post by: Jolly2 on 08/05/2021 22:27:44
All studies since have failed to combine HCQ with Zink and vitamin C and also failed to start the treatments early once the patients show symptoms.

So you are saying that the conditions of the initial study have not been replicated in subsequent studies?

No, if the initial study was retracted because of the bad science involved repeating it is rather rediculas.

If so, then that means that findings of the initial study have not been verified. Without successful replication, you can't say whether the treatment really works or not.

Exactly, yet some how every newspaper and media organisations is claiming it doesnt based on bad studies.

It was a French Doctor that first claimed he had very good results treating patients with HCQ, Trump was repeating what that French doctor had claimed, then there was this now retracted study claiming it didnt work and the media ran with it.

Feel free to say that we should be trying replicate the initially study more faithfully, but please do not say that we should be using it because we know it is effective. If the findings haven't been verified via replication, then we don't know that it's effective.

As I stated before, HCQ has to be given earily, almost all the studies are giving HCQ to patients at the end of the virus' activity, after the damage is already done,  HCQ needs to be administered earily, as earily as possible as it should interfere with Covids ability to infect cells. But HCQ need to combined with Zink to allow that process to function. Vitamin C also.

So doing a study late in the infection, and not combining with Zink and vitamin C is a waste of time in my opinion.

The Association American Frountline doctors

Should not be trusted as a reliable source of information: https://www.medpagetoday.com/infectiousdisease/covid19/90536, https://www.mcgill.ca/oss/article/covid-19-critical-thinking-pseudoscience/back-away-americas-frontline-doctors, https://en.wikipedia.org/wiki/America%27s_Frontline_Doctors



Wikipedia is a false information site,  there are countless examples today of fake information on there especially about individuals and groups who have all tried to get this bad information removed or changed and failed to do so. Wikipedia is an untrustworthy site.


Your prior post makes it look like you are trying to inject conspiracy theory thinking into the COVID-19 pandemic again. If I'm not mistaken, that's what got you suspended last time. You might want to tread lightly.

No I was suspended last time for a joke. Without explination, and without warning. I just found my account suspended with no explanation at all. But it clear on the joke thread, the mod that did this wrote after reading the joke, you need a break from the site, ofcourse I couldn't read it while suspended.
Title: Re: How long should a Vaccine Trial take?
Post by: Bored chemist on 08/05/2021 22:43:20
there are countless examples today of fake information on there
Please  provide a link to a few.
Title: Re: How long should a Vaccine Trial take?
Post by: Kryptid on 09/05/2021 03:01:36
No, if the initial study was retracted because of the bad science involved repeating it is rather rediculas.

So then why would you trust that it works if you claim that it's bad science?

As I stated before, HCQ has to be given earily

How do you know? Where is the replicated study that showed such to be the requirement?

But HCQ need to combined with Zink to allow that process to function. Vitamin C also.

Based on what follow-up study? Aren't you the one claiming that no one successfully replicated that study (and as such, no one verified whether this was true or not)?

Wikipedia is a false information site,  there are countless examples today of fake information on there especially about individuals and groups who have all tried to get this bad information removed or changed and failed to do so. Wikipedia is an untrustworthy site.

Given that we are discussing the Wikipedia issue elsewhere, then please address the other links I supplied.

No I was suspended last time for a joke.

That was simply the straw that broke the camel's back. I see what goes on behind the scenes. Your conspiracy theory posts about COVID absolutely contributed strongly to your suspension.
Title: Re: How long should a Vaccine Trial take?
Post by: Jolly2 on 09/05/2021 10:28:28
No, if the initial study was retracted because of the bad science involved repeating it is rather rediculas.

So then why would you trust that it works if you claim that it's bad science?

As I stated before, HCQ has to be given earily

How do you know? Where is the replicated study that showed such to be the requirement?

But HCQ need to combined with Zink to allow that process to function. Vitamin C also.

Based on what follow-up study? Aren't you the one claiming that no one successfully replicated that study (and as such, no one verified whether this was true or not)?

No I was claiming all the current studies have been bad, not just the initial study that was retracted but also the studies that followed, sadly who pays the study somehow has a huge impact on the results, if you could find a study that gave HCQ early in the infection and combined it with zinc and high dose Vitamin C please share it, sadly you'll find none of them do.


Wikipedia is a false information site,  there are countless examples today of fake information on there especially about individuals and groups who have all tried to get this bad information removed or changed and failed to do so. Wikipedia is an untrustworthy site.

Given that we are discussing the Wikipedia issue elsewhere, then please address the other links I supplied.

Really cute you know I'm not allowed to share links currently.


No I was suspended last time for a joke.

That was simply the straw that broke the camel's back. I see what goes on behind the scenes. Your conspiracy theory posts about COVID absolutely contributed strongly to your suspension.

What conspiracy theory post?

That covid came.from a laboratory isnt a conspiracy theory, it's one possibie hypothesis amoung others, a hypothesis that many scientists subscribe to today. Concerns about the mRNA vaccine also are comming from the scientific community, they are concerns not conspiracies. And to label legitimate concerns conspiracies, is just being dismissive with no legitimacy to do so. We need more discussion not less by throwing around the conspiracy theory label wildly Nilly you are making the situation worse not better.
If someone has a concern that's incorrect you can correct them and not simply label them a conspiracy theorist, much more helpful.
Title: Re: How long should a Vaccine Trial take?
Post by: jeffreyH on 09/05/2021 11:01:52
Really cute you know I'm not allowed to share links currently.

You were asked to address them, not post them. You stop being cute!
Title: Re: How long should a Vaccine Trial take?
Post by: jeffreyH on 09/05/2021 11:09:02
The group right-wing talking point in the USA is China bad! This is to distract from the total lack of policy proposals to help ordinary citizens. The idea that the virus came out of the lab in Wuhan fits their narrative perfectly. How do you debunk it when every right wing psycho politician is parroting it repeatedly?
Title: Re: How long should a Vaccine Trial take?
Post by: Bored chemist on 09/05/2021 11:10:02
That covid came.from a laboratory isnt a conspiracy theory, it's one possibie hypothesis amoung others,
If it had happened then some people would know about it.
And they are not admitting to it.
That group of people getting together and agreeing not to admit wat happened is a conspiracy.
So it is a conspiracy theory.

Stop trying to pretend otherwise, it just makes you look sillier.
Title: Re: How long should a Vaccine Trial take?
Post by: evan_au on 09/05/2021 12:01:52
Quote from: Jolly2
you know I'm not allowed to share links currently.
As I understand it, for (untrusted) newbies, there is a precaution that their links are not clickable (the displayed text says "Nofollow" or similar)
- This is to prevent forum users from accidentally clicking on potentially dangerous links from new forum members on probation
- But the links are still displayed
- And if people want to risk it, they can view this website by copying the URL and pasting it into another window

Are you saying the forum software won't let you post links? (If so, what error message does it give you?)
- Or are you saying you can't post links because people will see that they are all pointing to highly politicized conspiracy-theory websites?
Title: Re: How long should a Vaccine Trial take?
Post by: Kryptid on 09/05/2021 15:21:23
Again, if the studies about hydrochloroquine combined with zinc and vitamin C are based on bad science, then what reason do we have to believe that it works?

I didn't ask you to post any links. I asked you to address the links that I posted.

If COVID came from a lab leak, then it's obviously being covered up. That makes it a conspiracy theory. It isn't just that, though. It's the general spreading of misinformation that lead to your suspension.