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  1. Naked Science Forum
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  3. That CAN'T be true!
  4. How long should a Vaccine Trial take?
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How long should a Vaccine Trial take?

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Offline Jolly2 (OP)

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How long should a Vaccine Trial take?
« 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.

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Offline Bored chemist

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Re: How long should a Vaccine Trial take?
« Reply #1 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".

Quote from: Jolly2 on 21/01/2021 13:32:28
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.
« Last Edit: 21/01/2021 13:52:42 by Bored chemist »
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Offline alancalverd

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Re: How long should a Vaccine Trial take?
« Reply #2 on: 21/01/2021 15:44:08 »
Quote from: Jolly2 on 21/01/2021 13:32:28
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).
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Offline Jolly2 (OP)

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Re: How long should a Vaccine Trial take?
« Reply #3 on: 21/01/2021 16:50:41 »
Quote from: alancalverd on 21/01/2021 15:44:08
Quote from: Jolly2 on 21/01/2021 13:32:28
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?


Quote from: alancalverd on 21/01/2021 15:44:08
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?
« Last Edit: 21/01/2021 16:53:47 by Jolly2 »
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Offline Bored chemist

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Re: How long should a Vaccine Trial take?
« Reply #4 on: 21/01/2021 17:12:40 »
Quote from: Jolly2 on 21/01/2021 16:50:41
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.


Quote from: Jolly2 on 21/01/2021 16:50:41
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?

Quote from: Jolly2 on 21/01/2021 16:50:41
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.
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Offline alancalverd

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Re: How long should a Vaccine Trial take?
« Reply #5 on: 21/01/2021 19:16:00 »
Quote from: Jolly2 on 21/01/2021 16:50:41
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.
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Re: How long should a Vaccine Trial take?
« Reply #6 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?
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Offline Bored chemist

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Re: How long should a Vaccine Trial take?
« Reply #7 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.
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Offline Jolly2 (OP)

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Re: How long should a Vaccine Trial take?
« Reply #8 on: 21/01/2021 20:47:09 »
Quote from: alancalverd on 21/01/2021 19:16:00
Quote from: Jolly2 on 21/01/2021 16:50:41
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.

Quote from: alancalverd on 21/01/2021 19:16:00
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.

Quote from: alancalverd on 21/01/2021 19:16:00
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.

Quote from: alancalverd on 21/01/2021 19:16:00
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
« Last Edit: 21/01/2021 20:53:23 by Jolly2 »
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Offline Jolly2 (OP)

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Re: How long should a Vaccine Trial take?
« Reply #9 on: 21/01/2021 20:51:50 »
Quote from: 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?

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
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Re: How long should a Vaccine Trial take?
« Reply #10 on: 21/01/2021 20:57:51 »
Quote from: Jolly2 on 21/01/2021 20:51:50
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.
« Last Edit: 21/01/2021 21:16:06 by Kryptid »
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Online evan_au

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Re: How long should a Vaccine Trial take?
« Reply #11 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)
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Offline Bored chemist

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Re: How long should a Vaccine Trial take?
« Reply #12 on: 21/01/2021 21:44:30 »
Quote from: Jolly2 on 21/01/2021 20:47:09
Clinton is actively seeking war with Russia.
That's remarkably off topic, but it does speak volumes about your understanding of evidence.
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Offline Jolly2 (OP)

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Re: How long should a Vaccine Trial take?
« Reply #13 on: 21/01/2021 21:51:41 »
Quote from: 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).

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. 


Quote from: evan_au on 21/01/2021 21:34:31
- 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.

Quote from: evan_au on 21/01/2021 21:34:31
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?
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Offline Kryptid

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Re: How long should a Vaccine Trial take?
« Reply #14 on: 21/01/2021 22:00:21 »
Quote from: Jolly2 on 21/01/2021 21:51:41
I again find inactivated virus vaccine far more beneficial they are not synthetic

Why it is being synthetic a problem?
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Re: How long should a Vaccine Trial take?
« Reply #15 on: 22/01/2021 08:45:25 »
Quote from: Jolly2 on 21/01/2021 21:51:41
they are the virus.
No, that would be silly.
They are what's left after you inactivate the virus.
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Re: How long should a Vaccine Trial take?
« Reply #16 on: 22/01/2021 16:39:37 »
Quote from: Kryptid on 21/01/2021 22:00:21
Quote from: Jolly2 on 21/01/2021 21:51:41
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.

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Offline Bored chemist

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Re: How long should a Vaccine Trial take?
« Reply #17 on: 22/01/2021 17:19:32 »
Quote from: Jolly2 on 22/01/2021 16:39:37
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.
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Re: How long should a Vaccine Trial take?
« Reply #18 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
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Re: How long should a Vaccine Trial take?
« Reply #19 on: 31/01/2021 14:15:00 »
Quote from: 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.

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.


Quote from: evan_au on 23/01/2021 06:38:59
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
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