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Safety concerns as Russia pushes to roll out world's first coronavirus vaccine

Old 08-07-20, 08:52 PM
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CycleryNorth81
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Safety concerns as Russia pushes to roll out world's first coronavirus vaccine

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Old 08-07-20, 09:48 PM
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The question that isn't being asked here - is this untested vaccine more dangerous than being a front-line COVID health care worker (probably one of the more dangerous occupations out there) without any vaccine?

Flip side of the argument - how many will die before a properly FDA approved vaccine appears that could have been saved by this rushed one.

I'm not saying this should go out on the market now. But I think we (citizens of the US) should be glad that Russia is doing this and we get to see sooner if this vaccine might work and save lives. This take me to thinking of wartime. For example, we built B-17s in a huge rush to bomb Germany in WW2, We built them so fast the Germans didn't have planes, anti-aircraft, pilots or bullets to shoot them down fast enough. Those B-17s would have flunked pre-flight inspections. For the most part, the glitches were known and the mechanics in England fixed them but some slipped through. One defect was the machine gun lubricant; oil with traces of water in it. Those guns worked fine on the ground but at 40,000' froze up solid. One brand new bomber flew its first sortie with 11 of 13 guns out of commission, (We know because the German pilot who could have shot the plane down decided to have mercy on a sitting duck; knew the plane was already shot up to be trash and decided not to kill the remaining crew.. Even escorted the plane over the German AA batteries.)

Despite the big gaps in quality control that cost real US lives, flooding the skies over Europe with lots of planes worked. Throwing enough vaccines soon against this virus could save a lot of lives, even if they take some in the process. (Had we thrown enough testing and tracing against the virus back in February, the proper "safe and sound" approach would have looked a lot more "safe and sound". Now it is a guarantee of a lot of deaths.)

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Old 08-08-20, 12:40 AM
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It's risky but as long as folks take informed decisions it'll probably turn out okay for most folks.

I got the usual zillion vaccines in boot camp and had a reaction to only one -- the plague. Made most of us feel stoned. We were over it the next day.

But the one that got me was gamma globulin. I needed it after being exposed to hepatitis -- I was in hemodialysis nursing at the time, high risk. Had a rare but documented adverse reaction. Screwed up my immune system for life, ended up with Hashimoto's which finally resulted in thyroid cancer a couple of years ago.

I still support vaccines. I get my flu and pneumonia shots as advised by my doctors. I knew the risk and took it.
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Old 08-08-20, 02:25 AM
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Originally Posted by 79pmooney View Post
The question that isn't being asked here - is this untested vaccine more dangerous than being a front-line COVID health care worker (probably one of the more dangerous occupations out there) without any vaccine?

Flip side of the argument - how many will die before a properly FDA approved vaccine appears that could have been saved by this rushed one.

I'm not saying this should go out on the market now. But I think we (citizens of the US) should be glad that Russia is doing this and we get to see sooner if this vaccine might work and save lives. This take me to thinking of wartime. For example, we built B-17s in a huge rush to bomb Germany in WW2, We built them so fast the Germans didn't have planes, anti-aircraft, pilots or bullets to shoot them down fast enough. Those B-17s would have flunked pre-flight inspections. For the most part, the glitches were known and the mechanics in England fixed them but some slipped through. One defect was the machine gun lubricant; oil with traces of water in it. Those guns worked fine on the ground but at 40,000' froze up solid. One brand new bomber flew its first sortie with 11 of 13 guns out of commission, (We know because the German pilot who could have shot the plane down decided to have mercy on a sitting duck; knew the plane was already shot up to be trash and decided not to kill the remaining crew.. Even escorted the plane over the German AA batteries.)

Despite the big gaps in quality control that cost real US lives, flooding the skies over Europe with lots of planes worked. Throwing enough vaccines soon against this virus could save a lot of lives, even if they take some in the process. (Had we thrown enough testing and tracing against the virus back in February, the proper "safe and sound" approach would have looked a lot more "safe and sound". Now it is a guarantee of a lot of deaths.)

Ben
The German fighter pilot eventually met the B-17 pilot many years after the war. They became friends and it was a tear jerker. Makes some stuff seem pointless.
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Old 08-08-20, 11:34 AM
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The phase 1 tests should help determine how robust the immune response seems to be. Also how long lasting the immune response is.

Are the health care workers continuing to get the disease at a higher rate than the general population despite PPE and precautions?

I'd do a blinded randomized placebo trial with health care workers without changing their work protocols. Say one has a group with 10x the potential exposure of the general population, then the efficacy of the vaccine should be far more apparent. One wouldn't necessarily have to do a 50/50 split on the placebo... perhaps 1/3 placebo, 2/3 vaccine.

The video talks about risk to health care workers if they become lax with PPE precautions.

On the other hand, there is a high risk of nosocomial infections. Health care workers that are either infected and spread the disease, or spread the disease from room to room due to lax procedures.

So there would be significant benefits of vaccinating the health care workers first, while still using procedures to protect workers and patients.
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Old 08-08-20, 11:42 AM
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One thing that needs to be discussed is revaccination. Time frame for the revaccination? Also vaccinating individuals who have had a prior infection.

One of the early phase 1 trials apparently gave the patient a second dose of the vaccine which created an extremely robust immune response, and made the patient very ill, requiring medical care.

So, what if the first vaccine out only has, say a 30% efficacy.

Then it is followed by a vaccine with a 60% efficacy.

And, followed by a vaccine with a 90% efficacy.

What will be the impact of getting all 3 vaccines one after the other?

Could it cause a severe reaction? Mess with the efficacy?

Or, perhaps we should mix vaccines.
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Old 08-08-20, 11:49 AM
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^ Messy set of questions, to be sure.

Makes one appreciate a fairly rigorous, "approved" process for development, trials, evaluation.
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Old 08-08-20, 12:27 PM
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Originally Posted by canklecat View Post
It's risky but as long as folks take informed decisions it'll probably turn out okay for most folks.

I got the usual zillion vaccines in boot camp and had a reaction to only one -- the plague. Made most of us feel stoned. ....
> USMC > they gave us all chloroquine > SEMPER WHY
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... and so it goes
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Old 08-08-20, 01:17 PM
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Cholorquine was state of the art Malaria preventive treatment in about 1974. When I was sent to west africa in Ď74 I was given a bottle of once a week pills. I took one every Sunday (easy to keep track of).

For anyone now to think that is somehow an appropriate medicine to take now for Covid-19 is just total stupidity. So many morons from top to bottom.
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Old 08-08-20, 01:51 PM
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Originally Posted by Joe Bikerider View Post
Cholorquine was state of the art Malaria preventive treatment in about 1974. When I was sent to west africa in Ď74 I was given a bottle of once a week pills. I took one every Sunday (easy to keep track of).

For anyone now to think that is somehow an appropriate medicine to take now for Covid-19 is just total stupidity. So many morons from top to bottom.
Because a medicine is old doesn't mean it is ineffective.

Aspirin is still around, and is even being used differently than originally intended, such as a prophylactic blood thinner. While injectable penicillin has fallen by the wayside, spinoffs like amoxicillin are still in use. Trimethoprim/sulfamethoxazole dates back to the 70's in its current formulation, and sulfamethoxazole as a separate component dates back to the 60's, and is still in widespread use, especially as a UTI treatment (concentrated in the kidneys).

The problem with the hydroxychloroquine fiasco is that the theory as a immune mediator is good. But, like any medicine, it needed clinical trials, dosing, etc. Yet, or president decided to push approval with no clinical trials.

Anecdotes may help guide studies, but are no substitute for clinical trials.

It also had a prophylactic dose for malaria (your weekly dose), and a treatment dose which is much higher, with no guidelines for COVID.
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Old 08-08-20, 02:13 PM
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Originally Posted by Hondo Gravel View Post
The German fighter pilot eventually met the B-17 pilot many years after the war. They became friends and it was a tear jerker. Makes some stuff seem pointless.
The book "A Highter Call". I found it fascinating that the US pilot wouldn't do an interview with the author until the author sat down with the Geman pilot and got the whole story. Also to read about Germany in WW2 from the view of a military man who was not a Nazi.
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Old 08-08-20, 05:24 PM
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Originally Posted by CliffordK View Post
...Are the health care workers continuing to get the disease at a higher rate than the general population despite PPE and precautions?
As a former, and longtime, health care worker, I'm concerned about a couple of the risks being ignored that have nothing to do with exposure to pathogens. And it's the same risks that are being largely ignored by the media and government.

In underfunded, understaffed and overworked health care jobs, nurses, aides, paramedics, EMTs, etc., tend to neglect their own health. They eat crappy diets, often too high in sugar and carbs. They don't get enough rest including breaks during shifts. They're exhausted. They get fat, end up with high blood pressure, at risk for diabetes, cardiovascular disease, circulatory problems from being in the same position too long -- on their feet or sitting. The stress is enormous. I'm seeing it among friends who work in health care. They're too young to be in such poor physical and mental health. And I've seen it since the 1970s when I got into health care.

I suspect that's the main risk to health care workers. Not merely exposure to the coronavirus or other pathogens.

As with federal regulations for interstate truckers, there should be standards to ensure health care workers get adequate nutrition and rest. Otherwise we'll lose them to illness, death and burnout.

And if it were up to me I'd scour social media for The Karens and The Bretts, the denialists, anti-vaxxers and anti-maskers, and draft them into compulsory duty in the front line health care battle. Nothing is more persuasive than harsh reality.
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Old 08-08-20, 05:36 PM
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Sign me up for some of that untested Russian medicine!

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Old 08-08-20, 05:41 PM
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Originally Posted by 79pmooney View Post
The question that isn't being asked here - is this untested vaccine more dangerous than being a front-line COVID health care worker (probably one of the more dangerous occupations out there) without any vaccine?

Flip side of the argument - how many will die before a properly FDA approved vaccine appears that could have been saved by this rushed one.

....
Until it's well tested, we won't know if it's a net positive or a net negative.
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Old 08-08-20, 11:55 PM
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Originally Posted by canklecat View Post
In underfunded, understaffed and overworked health care jobs, nurses, aides, paramedics, EMTs, etc., tend to neglect their own health. They eat crappy diets, often too high in sugar and carbs. They don't get enough rest including breaks during shifts. They're exhausted. They get fat, end up with high blood pressure, at risk for diabetes, cardiovascular disease, circulatory problems from being in the same position too long -- on their feet or sitting. The stress is enormous. I'm seeing it among friends who work in health care. They're too young to be in such poor physical and mental health. And I've seen it since the 1970s when I got into health care.


My observation is that many doctors are more health conscious than others in the health profession, including many who ride bikes regularly.

One of the issues in particular are interns and residents who get ABUSED with long hours and sleep deprivation. But, much of that may change later in life, at least if they choose to do so.

The medical system does seem to artificially restrict the number of physicians in the USA for one reason or another, leaving a perpetual shortage of physicians in some fields like surgeons, and often months of waiting for appointments. And lots of discussion about a shortage of doctors in rural areas.

Are we not letting American Citizens practice medicine, but allowing foreign doctors come to practice medicine?

Our current crisis, of course, has hammered many medical institutions, while others are largely unaffected. It looks like we now have 2 COVID patients admitted in our local hospital.

Nursing may be different.

Apparently about 2% of physicians smoke, but about 25% of LPNs smoke.
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Old 08-09-20, 12:25 AM
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Originally Posted by tyrion View Post
Until it's well tested, we won't know if it's a net positive or a net negative.
Phase 1 testing should give one general safety information about the vaccine. So, if they tested, say 1000 patients, we should know at least in the short term how many patients have had a life threatening reaction.

If ZERO phase 1 patients died, or developed the disease, that would mean something, and may put the mortality rate < 0.1%, far lower than COVID.

Phase 2/3 will continue to study adverse effects, but is more about efficacy. Does it really help?

I'm not finding a lot of information about the dangers of vaccines. There has been a slight risk auto immune disease with the vaccines currently in use. However, some of those are still better than if the person had contracted the disease.

We have had several drugs that have passed all the clinical trials, and yet have been rejected after widespread use. And, I fear if one of the COVID vaccines fails for adverse effects, it could fail as side-effects become apparent only after widespread distribution.

Of course, there is also the risk of giving people a false hope, leading to a risky change in behavior.
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Old 08-09-20, 07:46 PM
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There will be no vaccine. COVID 19 is one of many viruses turned loose on the world over the past 60 years, some of which have killed more people per capita than COVID 19. We have never developed a vaccine for any of them. They are still working on a vaccine for the swine flu of 2009, and SARS from 2003, and after years of work, and billions spent, they still haven’t found one. Many more billions are being spent on COVID 19, and the usual people are getting richer than they already were, but there will be no vaccine.
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Old 08-09-20, 07:54 PM
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Old 08-09-20, 08:49 PM
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Originally Posted by 50PlusCycling View Post
There will be no vaccine. COVID 19 is one of many viruses turned loose on the world over the past 60 years, some of which have killed more people per capita than COVID 19. We have never developed a vaccine for any of them. They are still working on a vaccine for the swine flu of 2009, and SARS from 2003, and after years of work, and billions spent, they still havenít found one. Many more billions are being spent on COVID 19, and the usual people are getting richer than they already were, but there will be no vaccine.
Who's working on vaccines for SARS? Why would any corporation spend a dime working on a vaccine for something that isn't an issue? On the other hand there is an enormous application of resources currently being applied to a vaccine for Covid. No guarantee they'll get one but it's an apples to oranges comparison to SARs.
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Old 08-10-20, 05:59 AM
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Originally Posted by gregf83 View Post
Who's working on vaccines for SARS? Why would any corporation spend a dime working on a vaccine for something that isn't an issue? On the other hand there is an enormous application of resources currently being applied to a vaccine for Covid. No guarantee they'll get one but it's an apples to oranges comparison to SARs.
Yeah. A couple of SARS vaccines were developed and tested on a limited basis, but when the virus did not re-emerge the money dried up.
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Old 08-10-20, 07:14 AM
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Originally Posted by 50PlusCycling View Post
There will be no vaccine. COVID 19 is one of many viruses turned loose on the world over the past 60 years, some of which have killed more people per capita than COVID 19. We have never developed a vaccine for any of them. They are still working on a vaccine for the swine flu of 2009, and SARS from 2003, and after years of work, and billions spent, they still havenít found one. Many more billions are being spent on COVID 19, and the usual people are getting richer than they already were, but there will be no vaccine.
As was pointed out before there was a swine flu vaccine developed within months after the 2009 swine flu pandemic.

https://en.wikipedia.org/wiki/2009_s...ndemic_vaccine
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Old 08-11-20, 10:04 AM
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Global scientists pour scorn on Putin's 'reckless, foolish and unethical' claim that Russia has won Covid-19 vaccine race with 'Sputnik V' jab already given to his daughter which he claims offers 'two years' immunity' but has not been fully tested

https://www.dailymail.co.uk/news/art...-given-it.html
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Old 08-11-20, 10:45 AM
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Originally Posted by CycleryNorth81 View Post

Global scientists pour scorn on Putin's 'reckless, foolish and unethical' claim that Russia has won Covid-19 vaccine race with 'Sputnik V' jab already given to his daughter which he claims offers 'two years' immunity' but has not been fully tested

https://www.dailymail.co.uk/news/art...-given-it.html
But unlike the first Sputnik, our quack-in-chief beat Putin to the punch with the "cure" he promoted (and took himself). So if this vaccine doesn't work out, Putin can do no better than Quack No 2, If it does work, he gets to wear the crown of duck feathers with pride.

I hope this vaccine works. I hope also that it (or whatever the first working vaccine is) will be shared internationally and peacefully and dispensed properly and efficiently so it does the most good. That happens and Putin can wear that crown as long as he wants.

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Old 08-11-20, 09:43 PM
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Some commentary on the Russian vaccine:

Many will have heard Russiaís announcement that they have approved a coronavirus vaccine. Iíve already had several people ask me what I think of it, so let me be clear: I think itís a ridiculous publicity stunt. If itís supposed to make Russia look like some sort of biotechnology powerhouse, then as far as Iím concerned it does the opposite. It makes them look desperate, like the nation-state equivalent of a bunch of penny-stock promoters. The new airliner design prototype just got off the ground Ė time to sell tickets and load it full of passengers, right?
In the Pipeline
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Old 08-12-20, 09:54 AM
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Vladimir Putin's coronavirus vaccine 'was approved after tests on only 38 people' and 'causes side-effects including fever, pain and swelling', official Russian documents reveal

https://www.dailymail.co.uk/news/art...38-people.html
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