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We Had the Vaccine the Whole Time

 
Old 12-07-20, 03:13 PM
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CliffordK
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We Had the Vaccine the Whole Time

Interesting article by NY Magazine.

We Had the Vaccine the Whole Time



You may be surprised to learn that of the trio of long-awaited coronavirus vaccines, the most promising, Moderna’s mRNA-1273, which reported a 94.5 percent efficacy rate on November 16, had been designed by January 13. This was just two days after the genetic sequence had been made public in an act of scientific and humanitarian generosity that resulted in China’s Yong-Zhen Zhang’s being temporarily forced out of his lab. In Massachusetts, the Moderna vaccine design took all of one weekend. It was completed before China had even acknowledged that the disease could be transmitted from human to human, more than a week before the first confirmed coronavirus case in the United States. By the time the first American death was announced a month later, the vaccine had already been manufactured and shipped to the National Institutes of Health for the beginning of its Phase I clinical trial.
The article goes onto look at developments throughout the course of the year, and testing, and "warp speed", and etc, and is worth reading.

In the end, though, this is early December, and in the USA we have 15 million documented cases of the virus, and 283,000 dead. Likely closer to 30 million in the USA have been exposed to the virus.

Globally 70 million cases and 1.5 million dead, and again, likely an underestimate.

We've pounded the US, European, and Global economies. Parts of the tourism, transportation, hospitality, and restaurant sectors have been absolutely devastated.

Beyond the simple mortality numbers, there is a much harder to quantify morbidity. Days lost from work, pain and suffering, days in the hospital, or stuck at home in bed, etc.

We've had vaccines for viral infections for eons. However, mostly inactivated viruses, live attenuated viruses, or in some cases similar ancestral or zoonotic viruses.

mRNA viruses are somewhat new. And, perhaps that is part of the delay.

January 2018, mRNA vaccines — a new era in vaccinology


.

RNA vaccines: an introduction



Antibodies and Convalescent Plasma had been in use for certain treatments for some time, yet it wasn't until late summer when it was beginning to be used for COVID (of course noting the risk of blood borne illnesses).

Could we have shut down the virus outbreak in the USA and Europe last spring? What if 100,000 individuals had severe reactions to the vaccine, while eventually saving over a million people from dying from the disease? Of course one never knows how bad the disease outbreak will be until hindsight. Although the writing was on the wall mighty early as the cases in China jumped from a handful to a few hundred to a few thousand to over 80,000 cases in a few weeks. And the disease was rapidly discovered in countries around the world.

Now, the new genetic medicine research is very different from previous drugs.

The body uses RNA/DNA. Metabolizes it, and recycles it. Almost everything we eat has RNA, DNA, and various proteins in it.

Most of our classic medicines (Aspirin, Tylenol, Penicillin, etc), will use a chemical agent to target specific receptors either on our body, or perhaps disrupt pathogen replication. We've certainly had our share of mistakes. And, even with old "GRAS" medications, there are still some things that are not fully understood like liver damage from Tylenol, or Aspirin and Reye's syndrome. And, we've had our share of drugs pulled from the market due to unintended consequences not fully realized even during the clinical trials.

But, perhaps we could develop a different approval process for active biologicals (proteins, mRNA, etc) than active chemicals.
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Old 12-07-20, 03:46 PM
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Here is a vaccine I will not take.

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Old 12-07-20, 06:10 PM
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Sounds like a conspiracy theory, but I guess that ok, since it's coming from the NYT.
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Old 12-07-20, 06:57 PM
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Originally Posted by work4bike View Post
Sounds like a conspiracy theory, but I guess that ok, since it's coming from the NYT.
Did you read the article?

The question is whether Moderna and Pfizer each made 100 different vaccine candidates, and then eventually narrowed it down to one. The article reads like they chose to put all their eggs in a single basket very quickly.

To a large extent, the theory should have been strong enough to push the vaccine through quicker.

But, I think we are about a decade too early in the technology development for rapid rollout. However, as the spike protein evolves, we might get newer updated vaccines and vaccine cocktails quicker.

The Russian Sputnik V is also based on the spike protein, but uses that Adenovirus as a delivery mechanism. Something they've apparently been working with for some time.

I think other companies are using an inactivated virus vaccine with somewhat lower efficacy, but easier for handling and storage (which could impact real-world efficacy.
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Old 12-07-20, 07:26 PM
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I disagree with the premise of calling an untested candidate a vaccine. It is not a vaccine until is has proven to be effective and at minimum safer across the targeted population than the disease itself.

Now if there are reasons to know if is safe ahead of current testing requirements then I agree that there should be a closer look development and testing methodology to ensure both effectiveness and safety under a shorter timeline.
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Old 12-07-20, 08:37 PM
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My understanding is that what Moderna had in January was a design for a molecule - a theory that they could not be certain was correct and not even so much as a method for synthesizing it directly, much less mass producing it. There's a huge difference between having a design and a plan and realizing an actual medicine.
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Old 12-07-20, 08:59 PM
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Originally Posted by MinnMan View Post
My understanding is that what Moderna had in January was a design for a molecule - a theory that they could not be certain was correct and not even so much as a method for synthesizing it directly, much less mass producing it. There's a huge difference between having a design and a plan and realizing an actual medicine.
Yes. It took them another month to make the actual vaccine.

By the time the first American death was announced a month later, the vaccine had already been manufactured and shipped to the National Institutes of Health for the beginning of its Phase I clinical trial.
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Old 12-07-20, 09:02 PM
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Originally Posted by skookum View Post
Yes. It took them another month to make the actual vaccine.
uh huh, but not one that they had any clinical data on. No info on efficacy, no info on side effects, and so on. First tests with animals, and then to humans, plans for production, etc etc. Yes, it was all miraculously fast, but that's far different from the impression some have that we all could have been vaccinated in February or May, etc.
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Old 12-08-20, 12:39 AM
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What is a vaccine? Crazy 3 of them all at the same time.
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Old 12-08-20, 06:21 AM
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Originally Posted by CliffordK View Post
Did you read the article?

The question is whether Moderna and Pfizer each made 100 different vaccine candidates, and then eventually narrowed it down to one. The article reads like they chose to put all their eggs in a single basket very quickly.

To a large extent, the theory should have been strong enough to push the vaccine through quicker.

But, I think we are about a decade too early in the technology development for rapid rollout. However, as the spike protein evolves, we might get newer updated vaccines and vaccine cocktails quicker.

The Russian Sputnik V is also based on the spike protein, but uses that Adenovirus as a delivery mechanism. Something they've apparently been working with for some time.

I think other companies are using an inactivated virus vaccine with somewhat lower efficacy, but easier for handling and storage (which could impact real-world efficacy.
No, I have not read the article, I wasn't sufficiently enticed by the OP. Simply because the opening line titled, We Had the Vaccine the Whole Time.

It just sounds like conspiracy. Yes, I know we had the mRNA, which gives these companies a huge head start in developing a vaccine, but this is relatively new technology that I think it's dangerous to just jump in feet first and say we have a vaccine, even considering that this method of creating vaccines have been researched for decades. When they explain this new technology using mRNA, you gotta remember that they're simplifying it for all us non-scientists. I'm sure it's a little more complicated.

If you think as you stated above, "To a large extent, the theory should have been strong enough to push the vaccine through quicker.". Then maybe we should ask people like Dr Fauci (I'm not sure if he's in the article or not) why they didn't push for a faster release of the "vaccine".


As for getting vaccines earlier in the future, I absolutely agree with that, it's called progress and we humans are pretty good at that nowadays. Maybe as this thread goes on, I'll be sufficiently enticed to open your link and read it....




.
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Old 12-08-20, 06:30 AM
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Originally Posted by CliffordK View Post
...The Russian Sputnik V is also based on the spike protein, but uses that Adenovirus as a delivery mechanism...
BTW, this thing about the Russian vaccine is interesting. Putin reported back in August that they had a vaccine and even his daughter got a shot, showing how much confidence they had in this vaccine. https://www.bbc.com/news/world-europe-53735718

But now they're still suffering from surges and it seems like many are very skeptical of the Russian "vaccine". It'll be interesting to watch Russia as time goes on...

https://www.themoscowtimes.com/2020/...n-board-a72265

While compulsory vaccination of frontline health, education and social workers is already underway, many of the medical professionals with priority access to Sputnik V are deeply sceptical of it.

The Moscow Times interviewed 12 medics based in the capital, most of whom expressed reluctance — or outright refusal — to take a vaccine that has not yet passed sufficient trials for international clinical approval and was greenlighted based on results from much smaller groups of volunteers than its Western counterparts.
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Old 12-08-20, 07:58 AM
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According to Sputnik, they have a 92.5% efficacy with a single dose, and a 95% efficacy with two doses (sightly different vector for second dose). With "no unexpected adverse events during the trials."

https://sputnikvaccine.com/newsroom/...-vaccine-on-d/


Russia is showing a spike of infections. But to put it into perspective, they have just under half the population of the USA.

USA has 15 million cases
Russia has 2.5 million cases
USA has 284,000 deaths
Russia has 44,000 deaths.
USA has about 200,000 new cases a day, and about 2,500 deaths a day.
Russia has about 28,000 new cases a day and about 500 deaths a day.

What Russia seems to have done was a partial rollout of the vaccine while still doing trials. And, perhaps push the front line workers to participate in the study.

Ethics?

I think Russia pushed front line workers to participate in the trials (some probably got a placebo).
The USA told "volunteers" to resume normal activities without social distancing, likely putting the placebo group into a greater risk.

Now, I realize there is no substitute for a blinded placebo controlled study, but not if it puts the participants at greater risk.
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Old 12-08-20, 08:54 AM
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I question everything Russia reports. Time will tell....
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Old 12-08-20, 02:46 PM
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Originally Posted by work4bike View Post
Sounds like a conspiracy theory, but I guess that ok, since it's coming from the NYT.
What is the conspiracy??

Edit to add: nevermind, you said further on that you have no idea what you're talking about.

Last edited by Seattle Forrest; 12-08-20 at 02:50 PM.
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Old 12-08-20, 03:50 PM
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I applaud Russia for getting their vaccine out fast. Yes, there will almost certainly be issues from this untested vaccine. Perhaps more than a few deaths and long term issues. By contrast, we are going to do it right. And the lives lost due to the time for protocols to be met is just the cost of doing things right. We get to write off the recent 100,000 or so deaths as in the interests of good science.
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