Bad news about live theater public performance

[Posaunus]

It may not be safe to conduct public live theater performances for quite some time, if you believe Dr Anthony Fauci:

https://bestlifeonline.com/fauci-theate ... 44540.html

" Given the potential timeline for the rollout and distribution of a COVID vaccine, even if one were developed by the end of this year (2020), it would be unlikely that the majority of the population could be vaccinated before fall 2021, Fauci noted. That means it would be at least a year from now before we might be able to ... 'sit in a theater and watch our favorite performers up on stage again.' "

[DougHulme]

There are at least 3 perfectly viable and fully developed vaccines in existance right now (and I dont count Putins, short cut, amongst that). They are as we read this being injected into dozens if not hundreds of people in various trials to make sure there are no side effects. Now that said that doesent alter the truth of what Posaunus just said because there is a world of difference between having the vaccione and using the vaccine. The biggest problem of course is that we have left the province of the scientist and entered that of the politician. This means anything could happen or nothing could happen! How quickly any production plant could manufacture millions of doeses is debatable. Posaunus may be right on his projected timetable but it could be a lot quicker if things are organised properly.

By the way, as an aside and just for anyones interest, I have connections with Finland - there they are holding live concerts. They had one last night The Kymi Sinfonietta Orchestra in Kotka did a Mozart performance. The concert was just an hour long, no interval and they did it twice once at 5pm then again at 8pm both with an audience of 100 or so well spaced apart (in a hall that would normally seat about 300 I would guess).

Doug

[Burgerbob]

The problem is even if we get a good, effective vaccine, there's no way to inoculate enough people for effective herd immunity in a span of less than many months. They're hard to make, hard to distribute, and it's hard enough to get people to take the shots. It's going to be a long haul.

[Dennis]

There are at least 3 perfectly viable and fully developed vaccines in existance right now (and I dont count Putins, short cut, amongst that). They are as we read this being injected into dozens if not hundreds of people in various trials to make sure there are no side effects.

There are 8 candidate vaccines in Phase III trials in Europe and the US and another dozen or so in Phase I or II trials in various places in the world. The three on trial in the US take three distinct approaches to immunization. The Moderna vaccine is the longest shot: it is an mRNA vaccine. No mRNA vaccine has ever been approved for use. Astra-Zeneca has a modified (non-replicating) adenovirus that carries the SARS-CoV-2 genes for the spike protein and if memory serves one other capsid protein. Johnson & Johnson's single-dose vaccine uses an unspecified non-replicating viral vector. This is the same technology used in developing Janssen's Ebola vaccine. The Phase III trials are all slated for 30- 60 thousand subjects. The AZ trial is randomizing 2:1 Vaccine:Placebo. I'm not sure how Moderna and Johnson & Johnson are randomizing, but 2:1 would be usual.

I work in clinical trials research. It seems likely to me that at least one of these will be found to be safe and 'effective'. Because of the urgency of the situation, the FDA will accept a 50% reduction in serious COVID cases as meeting the effectiveness criterion. (That is very low.) These vaccines are not 'fully developed': if they were, they would be deployed. We do clinical trials for a reason.

Do not expect a vaccine to be deployed before February 2021. The Data Safety Monitoring Boards won't be meeting for an interim look until there are something on the order of 150 hospitalized COVID cases in each study. Regardless of what Trump says, that is not happening next month. The trials just haven't been going on long enough. If a vaccine is released next month look hard at political interference in the FDA. It's an awful world where we have to rely on the manufacturers to not submit a NDA before it's ready but that's where we are.

When a vaccine is released, it will initially go to medical workers and first responders. Individuals at elevated risk will be next. Widespread deployment before this time in 2021 will mean we have done very well.

[harrisonreed]

There are at least 3 perfectly viable and fully developed vaccines in existance right now (and I dont count Putins, short cut, amongst that). They are as we read this being injected into dozens if not hundreds of people in various trials to make sure there are no side effects.

[Posaunus]

These [clinical trial] vaccines are not 'fully developed': if they were, they would be deployed. We do clinical trials for a reason.

Do not expect a vaccine to be deployed before February 2021. ... Regardless of what Trump says, that is not happening next month. The trials just haven't been going on long enough. If a vaccine is released next month look hard at political interference in the FDA. It's an awful world where we have to rely on the manufacturers to not submit a NDA before it's ready but that's where we are.

When a vaccine is released, it will initially go to medical workers and first responders. Individuals at elevated risk will be next. Widespread deployment before [fall] 2021 will mean we have done very well.

Thanks, Dennis, for the factual information from an "insider." We in the U.S are fed too much nonsense.

When a vaccine (or vaccines) are released, we will stand in line to receive our doses (probably multiple) after those in greatest need. Probably a year from now.

[BGuttman]

There are at least 3 perfectly viable and fully developed vaccines in existance right now (and I dont count Putins, short cut, amongst that). They are as we read this being injected into dozens if not hundreds of people in various trials to make sure there are no side effects.

Dozens to hundreds is a Phase I (safe) or Phase II (possible effectiveness) trial. Phase III is the large scale test to look for side effects and more detailed response characteristics and requies a very large population sample.

[harrisonreed]

Sounds like it's neither fully viable or developed yet. I'm all about vaccines, but only if they aren't rushed through.

[Vegasbound]

A second vaccine here in the UK has been moved on to stage 3 trials, perhaps others can explain better, but it involves vaccinating the volunteers then infecting them with covid, from the news reports the volunteer groups include people from all ages

[FOSSIL]

Yes, it looks like the best we can hope for at the moment is the ability to record work for broadcast and that may well be an uphill struggle .

Chris

[timothy42b]

I work in clinical trials research. It seems likely to me that at least one of these will be found to be safe and 'effective'. Because of the urgency of the situation, the FDA will accept a 50% reduction in serious COVID cases as meeting the effectiveness criterion. (That is very low.) These vaccines are not 'fully developed': if they were, they would be deployed. We do clinical trials for a reason.

Ah ha! Someone knowledgeable to point me in the right direction on a question that's been bugging me.

We've been hearing on the news that catching the virus doesn't necessarily confer future immunity.

If that is the case for this particular virus, won't the same problem affect a vaccine?

[olivegreenink]

Not trying to step into anything here - I know is this is a subject everyone is implicitly passionate about.

Thank you Doug so much for your explanation.

I spent a healthy chunk of my career working for a company that designed and built manufacturing lines and labs in the pharmaceutical and biologics space. Even with that level of familiarity I gained by working on proposals for every major and most minor players in the industry, I still walked away with a relatively limited understanding compared to folks like Doug and his colleagues.

That said, if there was one thing I learned from our clients was that sometimes there is no substitute for time. Every one of them was incentivized to recoup their R&D investments as quickly as possible (and ramp up demand as quickly as possible so they could bring in max revenue before it opened up to generics). Our company had be very in sync with all the pharma/bio firms and their product development life cycles and pipeline because there was no need for us to build a facility until there was something to manufacture.

Research and trials, etc. simply must require some minimum amount of time for measurement and observation. Just like practicing trombone or anything else, time is a required ingredient. Think about eating a bad piece of shrimp - there is a minimum amount of time required for your body to react and reject it. Same goes for analyzing interactions and effects of anything that is administered to our body.

Based on my limited understanding, I would not have confidence in anything that came out any time soon. Again, that’s just my opinion shaped by my own personal experiences. But certainly hoping for one ASAP-and-safe

Cheers

[Dennis]

Ah ha! Someone knowledgeable to point me in the right direction on a question that's been bugging me.

We've been hearing on the news that catching the virus doesn't necessarily confer future immunity.

If that is the case for this particular virus, won't the same problem affect a vaccine?

Right now, there is a lot more we don't know about SARS-CoV-2 than we do know. It appears that it may be possible (is that weasel-worded sufficiently?) that we can be infected by different variants of the virus. This is a positive-sense RNA virus and prone to rapid mutation. The virus uses a surface protein (called the spike protein) as a key to infect cells. SARS-CoV-2 has a spike protein that is well-adapted to human receptors.

Evolutionary theory suggests that despite the mutation rate the spike protein should be strongly conserved, because changing its shape is more likely to make it less infectious than more infectious. All the vaccines that I am aware of are targeting the spike protein.

There is also evidence that previous infection with other coronaviruses has some protective effect against SARS-CoV-2. Human coronaviruses typically cause around 15% of colds (upper respiratory infections). Coronaviruses cause gut infections in other animals: it appears that SARS-CoV-2 crossed over from bats or pangolins to humans, and from causing diarrhea to lower respiratory infections.

Disclaimer: what follows is speculation on my part.

I suspect that we are going to end up getting an annual COVID vaccine, like we get the flu vaccine. Flu is probably a tougher target than SARS-CoV-2, because influenza viruses are basically a genetic Lego kit. Whenever two of them infect the same host cell they get busy swapping proteins and genetic material. Making a flu vaccine requires monitoring of the currently circulating serotypes and making your best guess about what the major players will be in the next flu season. SARS-CoV-2 doesn't appear to behave that way. We may end up with a vaccine that has several spike protein forms, and we will have to monitor changes in the virus, but the changes shouldn't be as rapid as influenza.

[Dennis]

A second vaccine here in the UK has been moved on to stage 3 trials, perhaps others can explain better, but it involves vaccinating the volunteers then infecting them with covid, from the news reports the volunteer groups include people from all ages

I'm amazed. This is called a challenge trial, and I am stunned that an ethics review board would approve a challenge trial for a potentially lethal disease. IRB/ERBs are supposed to be about protection of trial participants: I'm not convinced that truly informed consent can be given in this situation.

This is the fast path to proving efficacy. It doesn't demonstrate safety, but it will prove (or disprove) efficacy of the vaccine.

[BGuttman]

I would doubt that this is a challenge trial. They are probably just going to do statistics on infection rates of the vaccinated versus the control. We see many areas with infection rates of 5000 per 100000 population so a large enough trial in one of those areas could show statistical significance.

[DougHulme]

Olivegreenink said Research and trials, etc. simply must require some minimum amount of time for measurement and observation.

... and then we had the explainations of various trials definitions then Dennis talked about the ethics of it. All of which is absolutely true of course but there is an interesting trial going on in the world without ethical revue or full safety checks. It is of course the vaccine endorsed by President Putin.

There is a suggestion that the Russians may have somehow got hold of the Oxford research (though I cant see how). The reason for this suggestion is there is apparently a great similarity between the two. If we could only get accurate information out of Russia maybe it would have saved Oxford some trials!!!! (I jest). It is interesting though. I assume they are injecting people as fast as they can make the vaccine now that Putin has said its safe (though as Burgerbob points out the logistics of manufacturing and administering wil lbe a nightmare and the Russians are not great at these things generally speaking). I should think all American citizens might for once be grateful to Putin, if he hadnt got there first with a premature and untested vaccine I fancy Trump might have been tempted to do the same, especially with an election coming up? Forgive an Englishman intruding into anothers politics.

It would be interesting to know whats happening in Russia though... Doug

[BGuttman]

Back to the original thread, the New York Metropolitan Opera has cancelled the remainder of the 2020-2021 season. My wife has season tickets and she was just notified.

[Dennis]

I would doubt that this is a challenge trial. They are probably just going to do statistics on infection rates of the vaccinated versus the control.

I have my doubts about it being a challenge trial: I don't think I would have missed an ERB/IRB approval of a COVID challenge trial. But the description given (inoculate individuals with vaccine and intentionally try to infect them with SARS-CoV-2) is a challenge trial.

As to what Putin is doing, it's been reported that the FSB (successor to the KGB) and the Chinese intel agencies have been hacking into University, Commercial, and regulatory computer systems hunting for SARS-CoV-2 research. (This is an interesting approach itself, because most of that knowledge and essentially all the academic stuff is getting published PDQ. Now, how you go from the book knowledge of HOW it's done to actually producing a vaccine is an interesting question. Suffice it to say that Putin's vaccine isn't getting anywhere near my arm or the arms of those I care for.

[Doug Elliott]

The Right to bare arms?

[BGuttman]

The Right to bare arms?

Right to arm bears