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On Vaccine Development and Testing

Giordano said:
I suspect it is pretty easy to quickly ramp up fertile egg production. And relatively cheap. There already are in place huge commercial chicken breeding and egg production facilities.
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Yes, but they are reserved for Trump's Easter celebration!
 
Roboramma said:
Perhaps relevant to this thread:

https://www.mercatus.org/publicatio...ors-could-allow-early-use-covid-19-vaccine-or
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I think this is unhelpful because the author conflates vaccines, preventative treatment given to well persons who have not been infected, with treatment given to ill people who have been infected. most of the former have little gain and much to lose. Most people will not come to any significant harm from covid. At best the vaccine offers most people two weeks less cough and a week less feeling miserable. It might do them harm. A few probably <1% might have their lives saved. In the latter group treatment for those in hospital and unwell may offer all benefit and save 25%? of their lives. Any effective treatment in this group will be easy to detect on a relatively small study, though harms might require a larger study. Given a high mortality of those admitted to hospital with covid 19 studies should be easy and quick.

However preventative studies will need to be much larger if they are to detect saving lives, because only a few of the people vaccinated will die. equally it is more important to detect harms because most people are well when vaccinated.
 
blutoski said:
The complication is that the people putting pressure on the government to expedite testing are usually the patients at risk themselves.

Again, reaching back to my experience, the strongest lobbyists for Fast Tracking HIV drugs were AIDS patients who were running out of time. For them, the tradeoff seemed worth it.

The analogy with COVID19 is probably closer to research involving a treatment rather than a vaccine. In the above list, antisense, antibody, antiviral protein binders, those sorts of things, they're potential treatments post-infection. Sort of like snake venom antidote.

For patients who are infected and have poor prospects, they're being rational if they want to explore something that has credible hope.

This is the thing about science is that especially with medical sciences, a lot of definitions are influenced by culture. Is pregnancy a medical condition? Is chickenpox a disease? Is giving an informed patient a choice of being untreated and probably dying versus participating in a trial for a promising treatment that may save them or kill them faster 'exploitation'? Or is it 'patient autonomy'?

Medical Ethics is a rich field of study, and this is an old discussion that reasonable people hold differing opinions about.
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Indeed.
All rather moot (on COVID-19) I guess as it appears that researchers are testing on healthy (mostly) young subjects so as not to endanger anyone.
And I guess - fewer complicating health factors needet to account for in their analyses.
 
The new mRNA vaccines look very promising.
Instead of containing viral proteins they contain viral mRNA and rely on your cells to produce the viral proteins. This bypasses the difficult and time consuming process of having to produce pure viral proteins in large quantities.

Coronavirus: A new type of vaccine using RNA could help defeat COVID-19

mRNA-1273 is ready for clinical trials in humans, it encodes for a stable form of the SARS-CoV-2 spike protein.
 
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It is reported that SARS-CoV-2 is mutating relatively slowly, which is good news for vaccination efficacy and production.

Our initial data show that this is a very stable RNA virus, with only five novel variants,” Professor Stefano Menzo, head of Virology at Ancona University Hospital, said in a statement. "Had we investigated other viruses we might have expected up to dozens of new mutations after so many infectious cycles in patients."

Menzo also explained how this could impact a potential vaccine. “A virus with a stable genome is good news for vaccine development because it indicates that the effectiveness of vaccines could be more consistent, possibly over many years.”​
Informed speculation is that a SARS-CoV-2 may quite possibly be a single vaccine, rather than an new vaccine each year, as is needed for flu.

They do caution, “[that]findings are not “over interpreted,” as sample sizes are still small and we are still early in the outbreak” and also that there is a possible second (older) strain circulating in humans .
 
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Cheetah said:
The new mRNA vaccines look very promising.
Instead of containing viral proteins they contain viral mRNA and rely on your cells to produce the viral proteins. This bypasses the difficult and time consuming process of having to produce pure viral proteins in large quantities.

Coronavirus: A new type of vaccine using RNA could help defeat COVID-19

mRNA-1273 is ready for clinical trials in humans, it encodes for a stable form of the SARS-CoV-2 spike protein.
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And also is not grown in eggs.


Sent from my iPhone using Tapatalk
 
EHocking said:
It is reported that SARS-CoV-2 is mutating relatively slowly, which is good news for vaccination efficacy and production.

Our initial data show that this is a very stable RNA virus, with only five novel variants,” Professor Stefano Menzo, head of Virology at Ancona University Hospital, said in a statement. "Had we investigated other viruses we might have expected up to dozens of new mutations after so many infectious cycles in patients."

Menzo also explained how this could impact a potential vaccine. “A virus with a stable genome is good news for vaccine development because it indicates that the effectiveness of vaccines could be more consistent, possibly over many years.”​
Informed speculation is that a SARS-CoV-2 may quite possibly be a single vaccine, rather than an new vaccine each year, as is needed for flu.

They do caution, “[that]findings are not “over interpreted,” as sample sizes are still small and we are still early in the outbreak” and also that there is a possible second (older) strain circulating in humans .
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My understanding is that can cut both ways. Makes it easier to vaccinate. But, that may not be easy, especially with some minor mutations.

As I understand it, Spanish flu hit large. Then it mutated and hit harder, but not as large. Then it mutated again, and went out. So it hit twice. But it was really the last mutation that drove it to essential extinction.

I don't know.
 
DevilsAdvocate said:
My understanding is that can cut both ways. Makes it easier to vaccinate. But, that may not be easy, especially with some minor mutations.

As I understand it, Spanish flu hit large. Then it mutated and hit harder, but not as large. Then it mutated again, and went out. So it hit twice. But it was really the last mutation that drove it to essential extinction.

I don't know.
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Influenza is far more mutagenic than CoronaVirus.
 
This is similar to what I was talking about this the OP:

https://www.sciencemag.org/news/202...rately-infecting-volunteers-not-so-fast-some#
Stanley Plotkin of the University of Pennsylvania, inventor of the current rubella vaccine and a leader in the vaccine field, says a carefully designed “human challenge” trial could offer clear proof of a vaccine’s worth at blinding speed. “We’re talking 2, 3 months,” says Plotkin, who has co-authored a commentary, now being submitted for publication, that describes how this might be ethically done. “People who are faced with a terrifying problem like this one will opt for measures that are unusual. And we have to constantly rethink our biases.” A similar proposal for coronavirus challenge studies was published online today in the Journal of Infectious Diseases.
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Myron Levine, a vaccine researcher at the University of Maryland School of Medicine who has conducted challenge experiments for more than 40 years, doubts traditional clinical trials for COVID-19 vaccine candidates will be as slow as some fear. “I think we’re going to move very, very fast,” he says. Because of the high levels of new infections occurring in many places, conventional trials will reveal a vaccine’s worth on the same timeline as a human challenge. “I cannot imagine that it would be ethical and would really speed up what we have to do.”
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Another interesting article on vaccine development:

https://blogs.sciencemag.org/pipeline/archives/2020/04/15/coronavirus-vaccine-prospects
Time for another look at the coronavirus vaccine front, since we have several recent news items. Word has come from GSK and Sanofi that they are going to collaborate on vaccine development, which brings together two of the more experienced large organizations in the field. It looks like Sanofi is bringing the spike protein and GSK is bringing the adjuvant (more on what that means below). Their press release says that they plan to go into human patients late this year and to have everything ready for regulatory filing in the second half of 2021. For its part, Pfizer has announced that they’re pushing up their schedule with BioNTech and possibly starting human trials in August, which probably puts them on a similar timeline for eventual filing.

“But that’s next year!” will be the reaction of many who are hoping for a vaccine ASAP, and I can understand why. The thing is, that would be absolutely unprecedented speed, way past the current record set by the Ebola vaccine, which took about five years. More typical development times are ten years or more. But hold that thought while you peruse another news item today from J&J. They have an even more aggressive timeline proposed for their own vaccine work: they have already announced that they have a candidate, and they say that they plan first-in-human trials in September. Data will be available from those in December, and in January 2021 they say that they will have the first batches of vaccine ready for an FDA Emergency Use Authorization. Now that is shooting for the world record on both the scientific and regulatory fronts.
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That's just the first two paragraphs, the article goes in to considerable detail on vaccine development, worth a read for those interested.
 
Darat said:
Don’t know if this was in an earlier post: https://www.reuters.com/article/us-...-covid-19-vaccines-before-proof-idUSKBN21Z25M

I know someone earlier mentioned about producing vaccine before its safety and effectiveness was established, that is what is happening with at least one candidate.
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Rather than waiting for the results of phase 2 testing (safety testing in humans) vaccines that look successful in terms of provoking the intended immune response will go straight into manufacturing, with the first use being the phase 3 proof of clinical effectiveness study, so that if phase 3 studies are effective there will already be millions of doses available without delay. This does not mean the vaccine will be used without completing testing, but normally full manufacturing would only be done following testing so there is often many months between drugs or vaccines being found effective in trials and them becoming widely available, this delay will be cut out.
 
Why not ask for volunteers to be given candidate vaccines and then deliberately infected under controlled conditions?

Yes this would be dangerous for the volunteers. Some would die. We would call them heroes and build statues of them for their sacrifice.

This would significantly speed up the development of a usable vaccine. It would save a lot of lives in the long run and might save our economic system from total collapse.

The stakes are high - if people volunteer knowing the risks - I don't think there should be ethical concerns.

I suspect there would not be a shortage of volunteers. Just like in WW2 where we asked people to risk their lives for a cause and they volunteered in huge numbers.

I think in 6 months time when the economic situation is much worse we will do this anyway to speed up the development of a vaccine - because people will have woken up to the fact our whole civilisation is in a fight for survival. We should save time and do it now.

- Drelda
 
drelda said:
Why not ask for volunteers to be given candidate vaccines and then deliberately infected under controlled conditions?

Yes this would be dangerous for the volunteers. Some would die. We would call them heroes and build statues of them for their sacrifice.

This would significantly speed up the development of a usable vaccine. It would save a lot of lives in the long run and might save our economic system from total collapse.

The stakes are high - if people volunteer knowing the risks - I don't think there should be ethical concerns.

I suspect there would not be a shortage of volunteers. Just like in WW2 where we asked people to risk their lives for a cause and they volunteered in huge numbers.

I think in 6 months time when the economic situation is much worse we will do this anyway to speed up the development of a vaccine - because people will have woken up to the fact our whole civilisation is in a fight for survival. We should save time and do it now.

- Drelda
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I agree, and I think it can be done relatively safely (certainly there would still be risk), by as you say doing it under controlled conditions with medical staff monitoring their conditions, and choosing volunteers who are in the groups least likely to suffer serious symptoms of the disease. Young, healthy people, well monitored and cared for during the process.
 
Roboramma said:
I agree, and I think it can be done relatively safely (certainly there would still be risk), by as you say doing it under controlled conditions with medical staff monitoring their conditions, and choosing volunteers who are in the groups least likely to suffer serious symptoms of the disease. Young, healthy people, well monitored and cared for during the process.
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Yes the first tests could be done with young, healthy people, so if the vaccine is totally ineffective they have a good chance. However once the candidate vaccines have been tested to show which work at all, they will then need to test on older or more at risk people to make sure it also works for them and doesn't have side effects for them. This could also be done using volunteers.

Again I doubt there would be any shortage of volunteers, even amongst older or at risk people. If the vaccine has already been shown to be effective on younger people then the likely outcome would be they are the first to get an effective vaccine. If the test shows the vaccine has some side effects for them and some of them die - then we will remember them and build monuments to them - and carry on working on a better vaccine much faster than with traditional vaccine testing.

They should stop wussing around over 'ethical concerns'. Asking people to volunteer to do something heroic for the greater good is ethically fine. Just make sure they really understand what that are getting into - and look after the families of anyone that dies.

- Drelda
 
One way to test vaccines ethically is if the virus gets into a nursing home they give the vaccine to half the people there. The other half get a fake vaccine as a control. Then compare the two results. Of course blood tests would need to be taken before and after. For example the test will be no good if most of the people have already had the virus.
 
rjh01 said:
One way to test vaccines ethically is if the virus gets into a nursing home they give the vaccine to half the people there. The other half get a fake vaccine as a control. Then compare the two results. Of course blood tests would need to be taken before and after. For example the test will be no good if most of the people have already had the virus.
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How is that ethical?

In one vial you have something you know to be a potentially life-saving drug.

In the other vial you have something you know to be completely useless.

How can you ethically withhold the first vial from half the residents in a nursing home where the disease is already spreading?
 
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