COVID-19 Research, Drug trials and Pathophysiology

$13 per dose? Cheap as ****. Sign me up lol(I'd have to travel to Russia and learn Russian though).

And yeah, maybe it might not be "as good" as other vaccines, but given everything that Centerfield has taught us. A bad vaccine= Ten, if not fifty times better than getting the virus.

 

Actually Sputnik V is the only vaccine that does not have any serious side affects - so I don't know what you mean that it's a bad vaccine?. The others have all been failing miserably and might never be ready.

What I can't understand is that Russia admitted that it doesn't have the facilities like Germany and the US to mass produce the vaccine, and they are willing to outsource it. So the question is, will we all suffer because they don't want the Russian vaccine since it won't be as profitable as their own vaccines - that is if they are ever able produce one without serious side affects?

 

Ahhhh the Kremlin has spoken

 

You're right, the Kremlin has spoken and this is what Putin said according to a Greek site:

The Russian president said, Russia is ready to sell the vaccine production rights to foreign companies, but not at the expense of vaccination in Russia itself.
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Basically they don't have the facilities to mass produce. Vladimir Putin also said that a second vaccine has also proven affective, and a third one is almost ready.

 

The Russians have nothing at the present, beside record breaking cases

 

It's like a direct link to Pravda.

 

Well if that's what you're told. As for me, it shocks me that pressure is being applied to nations not to buy the Russian vaccine for political and economic reasons at the cost of human lives. Here are some translated excerpts from the Greekpronews:

Staff at eight of Moscow's 25 hospitals that are conducting clinical trials of the vaccine told Reuters that the vaccination of new volunteers participating in phase III of the clinical trials of the vaccine has been temporarily suspended as demand is huge.​

Hundreds of thousands of Russians have already been vaccinated, resulting in the exhaustion of the first batches of pre-production and to stop until the production of new ones!

The first ones were given to the Russian police, the armed forces and the health officials (nurses, doctors, etc.) who are in the front line of danger. Unofficial sources say vaccinations will resume around November 10.

Athens did not dare discuss the vaccine with Lavrov, and seems to prefer the solution of the general lockdown and the economic disaster, so as not to "displease" specific interests.

According to information from Moscow, the Russian government would have no problem granting Greece permission for up to 20 million doses for just $ 35 per installment, compared to the $ 65 to $ 80 cost of the AstraZeneca vaccine, which no one knows when it will be ready for the general population with some predictions saying in the spring 21!
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Nothing more than sales propaganda. Russia has no vaccine, but exploding cases and death.

Since Greece is in the EU it will be hardly able to use a vaccine which has not gone through the EU certification.

 

Oh, so Russia is selling something it doesn't have? Interesting! As for EU certification, what certification can the EU possibly require for a vaccine that is non existent - or at least according to you?

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To reason or not to reason
that is the question?

How can'st one reason
where knowledge is not,
when reasoning itself
requires a lot - Jeannette
​

 

https://www.bbc.com/news/world-54334496


https://www.statista.com/chart/21170/coronavirus-death-rate-worldwide/

 

That does not change the fact, that Russia is reporting everyday new infection numbers that brake its own records, record breaking numbers.
Were is their vaccine ?
Sputnik is on some orbit, lost in Space.

 

The WHO Solidarity remdesivir trial was very disappointing. And then, pooling it together with three other RCTs, for a total of 7,000 patients, suggested that remdesivir doesn't really prevent deaths or serious disease. The WHO has now issued a statement disavowing remdesivir. It remains approved by the FDA and by the European Union equivalent agency, for Covid-19.

 

Reportedly the Russians are having trouble with keeping their vaccine stable, and also have had little success in scaling up their production capacity. I do believe that the optimism around the Sputinik-V is state propaganda. But on the other hand, they did release preliminary phase 3 trials regarding 16,000 subjects, and the numbers allegedly indicate 92% efficacy. The problem is, I don't know if I can trust their numbers. Anyway, in another thread (my State of the Vaccines thread, pinned to the top of the subforum Coronavirus Discussions) I ranked the Sputinik-V dead last in my preference, if I were to pick one vaccine for me, and had ample choice of all 6 main candidates.

Here is my ranking:

By order:

1. Moderna/NIH. Better odds that their cold chain won't break down. Excellent efficacy. No serious reactions.

2. Pfizer/BioNTech. Excellent efficacy, no serious reactions in a larger phase 3 trial than Moderna's but bigger risk of deep cold chain breakdown which is why I place it behind the Moderna one. If I could be 100% reassured that the dose being injected into me never got above the required temperature, then I would prefer the Pfizer product due to the larger trial and the efficacy for older people unless the final results of the Moderna are also good among older volunteers. Which is weird because as far as I know, their phase 3 only had volunteers aged 18-60 so I don't know how they say that it didn't lose efficacy in older people.

3. Sinofarm/Butantan CoronaVac. Efficacy data not in yet, but immunogenicity looks great and safety data benefits from the 52,000 company employees who were given it, with no serious reactions. True and tried method (inactivated virus).

4. Novavax. Still far behind but looking great in all phases already completed. Good platform (protein subunit).

5. Oxford/AstraZeneca. Unknown efficacy. Did result in two serious reactions although later, they were cleared, but while I have no problem with clearing the MS case, I'm more suspicious of the TM case. But I don't have access to the TM case information, and the Brits and the FDA ultimately cleared them to resume phase 3, so I guess it's all good.

6. Gamaleya Sputinik-V. If you believe in their information, it looks good but phase 3 is still half-way and I simply don't trust the Russians with their information. I'd have said the same of the Chinese but they do have the Brazilians vouching for them and I do trust the Brazilians (Butantan is a high quality and ethical institute; I personally know many of their scientists) so I don't even question the Chinese data, but I still do question the Russian data.

 

then whose info to be trusted ?

 

I trust the NIH, the Institut Pasteur, the Instituto Butantan, etc. - that is, the places were ethical and idealistic career scientists work and are not 100% profit-oriented, and belong to governments that are less prone to blatant lying as a propaganda tool (oh well, ours has now moved into this category but I still trust the NIH; they have resisted contamination better than the CDC and the FDA). I also tend to trust high quality academic institutions such as Oxford University.

 

Interesting stuff, huh? I remember all the drama surrounding this drug back in March and April.
https://www.statnews.com/pharmalot/2020/03/25/gilead-covid19-coronavirus-orphan-drug/

I‘m not sure who to trust on this one anymore.

 

that is all about reputation, and reputations are mendacious.

it is through systems of repute the world got into the mess it is now.

and it was those 'respectable' that have brought us a crisis after a crisis.

with so much funds spent on these institutions only to get a medieval plague...

talk about lies and propaganda now academics prove to be no better than shamen.

yes of course, high tech gear and white robes might look impressive, but that's about it.

 

That may be about it for you. Not for me. I know personally many people in the organizations I've mentioned and I've worked professionally with them in multiple occasions and over decades. I have reasons to trust them.

 

trust in people does not mean trust in the organisation they work for.

 

I wouldn't put it as "who to trust." It's not a question of lying. As you know, science evolves and as we learn more about something, we revise recommendations, we adjust theories, we come up with new theories...

Remdesivir had two favorable RCTs (modest effect but measurable). So it got approved. Apparently now there are 4 more and those are negative. (I actually didn't read the four studies. I just reported the above based on a notification I received in my mailbox from a trade newsletter.

Recommendations can only be based on currently existing evidence, not on future one that hasn't been published yet. So, if you have 2 RCTs and they look good, and that's all you have at the time and the pandemic is raging, you may recommend something; then subsequently you get 4 more and they look bad; the evidence then switches against recommending it.

This is not unique in Medicine at all. Recommendations are revised and changed all the time, when new evidence surfaces. For example, statins were recommended at higher doses in the past, with lower cholesterol targets. Later we realized that the higher doses were causing too much rhabdomyolysis and also determined that cholesterol didn't need to be that low, for decent cardiovascular protection. So the recommendation changed, to use smaller doses of statins.

Medications are sometimes approved and marketed, and later more evidence (post-marketing experience) surfaces and they can be yanked out of the market. For example, nefazodone was widely used as an antidepressant but later, new evidence of severe liver toxicity in some cases was described, and these days its use is discouraged, in favor of better alternatives.

So there is nothing extraordinary in the fact that the verdict on remdesivir seems to be fluctuating, now.

You might say, "but there were positive RCTs before; how come?" How can RCTs fail? Well, they aren't 100% fail-proof. There is always the possibility of a fluke or an intervening factor that remained unknown and not suspected. You know that all good scientific studies have a section for self-criticism and list of limitations. So what does a low p number give us? It gives us a statistically significant likelihood that the result is not a fluke. But it doesn't guarantee 100% that result is not a fluke. Likelihood is not the same as irrefutable, absolute proof.

We do the best we can. We try to control all variables we can. We try to design a clinical trial as best as we can. But sometimes, especially when the effect size is small, or the number of subjects is small, we can reach provisional conclusions that are latter contested by larger/subsequent studies.

To answer your implied question, "who to trust?" I'd say, trust the current best evidence. It may change in the future but we can't predict the future. We have to practice in the present.

 

It does, when those people ARE the organization. So if a specific faculty group leads and mans a department at Oxford University for example, and you know them, and you witness their high level of expertise, ethics, and seriousness over the years, then when you see that they have diffused a new conclusion on the current evidence linked to a scientific matter, you tend to think "chances are that they are right or at least saying what they currently genuinely believe to be right."

 

Excellent analysis and I agree. I’m just suspicious because of the shenanigans back in the spring I guess.

 

I also don't trust Sputnik V. My top 3 would be:

1. Moderna
2. Pfizer/BioNTech
3. Oxford/AstraZeneca

 

Weird. Fluvoxamine, an antidepressant, had strikingly good results in this small trial for mild symptomatic Covid-19. As the authors highlight, this is to be considered as a hypothesis-generating study rather than proof of efficacy; larger studies are needed.

https://jamanetwork.com/journals/jama/fullarticle/2773108