Russian Medical Development: News

The mere fact that the NATzO fake stream media accused Russia of being "reckless" with its "unsafe" vaccine after two safety trials
proves that NATzO is not "asking" questions but engaged in full bore smear propaganda.

Even if the vaccine wasn't 100% safe and 2% of people who took it got headaches and raised temperatures for a bit it is still better than more deaths in six months that the US lost in Vietnam in 10 years of war... by a factor of about three...

They did skip stage 3 testing...that is the sheer amount of biased ignorance on this forum. You point out a simple fact and propagandists like you have to run to the rescue.

They have not skipped anything.

Moronic remark, each disease is unique ad working on another doesn't give you much insight at all into the other on what the side effects could be, what could happen. That was just a cheap excuse giving by the russians.

...and the British are too busy wasting time fabricating bull shit about Novichok to get real work done...

Facts are

1. Russia did not complete stage 3 mass tests before mass-producing the vaccine

2. They have no data to show how safe or effective it is on a mass scale.

These are the facts and if you and those two other biased people can't handle these facts being said that's not my problem.

Facts don't become facts when you make them up yourself...

Btw I checked into it and they still haven't ran the stage three tests DESPITE saying so. Lets recap Tass the media mouthpiece that is funded and ran by the Russian government. Has also stated the two facts I did....I suppose I gave you to much credit expecting you to have critical thinking skills.

So hang on... they said they ran stage three tests and then you say they said they didn't... very selective about which you believe to be true and which you assume is a lie... what makes you think you got it the right way around?

You do know the article you posted said stage three trials will begin in 7 to 10 days time... and the article is dated 16 August?

So 10 days time would be the 26th August... which is what... 2 weeks ago?

The information they released to the British medical journal was on September 4th who published the results of trials one and two... I doubt trial three was fully completed yet, but unless it was delayed it was probably in process.

How about all the answers you want, or should I say clearly don't want to hear...

BTW it mentions that despite the Russian second trial of 76 people compared with over 1,000 in the British trial was mentioned by the western media the British trial actually only included 10 people getting two injections that were actually needed for the test so Russian trial 76 people and British trial 10 people... you work out which is a better test?

Also in the below article is this:

The post-registration studies involving more than 40,000 people started in Russia on August 26...

And since I am quoting from this article:

Question 5: Why has the Sputnik V vaccine already become eligible for emergency use registration?

Because of the very positive results of the Phase 1-2 trials and because the human adenoviral vector-based delivery platform has been proven the safest vaccine delivery platform over decades including through 75 international scientific publications and in more than 250 clinical trials.

But here is the full article...

Sputnik V questions ANSWERED: Head of team financing world’s first Covid-19 vaccine explains formula to critics

Kirill Dmitriev is the CEO of the Russian Direct Investment Fund - one of the world's leading sovereign funds with a reserve capital of $10 billion under its management.
Since the launch of the Sputnik V vaccine, developed by scientists from Moscow's Gamaleya Center, Russia has seen immense interest and expressions of hope from many countries and has received requests for 1 billion doses.

However, it has also faced criticism and questions from some Western countries and companies, especially those developing their own vaccines—often based on technologies yet to be proven for safety and efficacy, such as mRNA or monkey adenoviral vector-based platforms. Following the publication of the results of the Phase 1 and Phase 2 clinical trials of Sputnik V in The Lancet, last week, we would like to address some issues that have been raised and ask a few questions of our own.
Question 1: Did you steal your vaccine?

No, we did not steal it. The vaccine uses a unique two-vector human adenovirus technology which no-one else in the world currently has for COVID-19. Vectors are engineered viruses, unable to reproduce, which carry genetic material from the spike of coronavirus. Our technology employs two different human adenoviral vectors, Ad5 and Ad26, for a first and a second injection. This technology helps to overcome pre-existing immunity to adenoviruses. Russia has benefitted from modifying for COVID-19 an existing two-vector vaccine platform developed in 2015 for Ebola fever, which went through all phases of clinical trials and was used to help defeat the Ebola epidemic in Africa in 2017.

Admittedly, after some initial hype this question was dropped even by Russia’s most strident critics, because it had no grounds. But it is still important to highlight it since we saw attempts to paint the Russian vaccine in a negative light even before it was registered.
Question 2: When will the Phase 1 and 2 clinical trials results be published?

They were published on September 4 in The Lancet, one of the oldest and most respected medical publications in the world, after going through a thorough peer review process. This is just the beginning of a series of publications. The key points of The Lancet article are:

Phase 1-2 clinical trials of Sputnik V showed no serious adverse events (SAE, Grade 3) under any of the criteria, while the incidence of serious adverse events for other candidate vaccines ranged from 1 to 25 percent.

All participants in the clinical trials for Sputnik V generated a stable humoral and cellular immune response. The level of virus-neutralizing antibodies of volunteers vaccinated with Sputnik V was 1.5 times higher than the level of antibodies of severe COVID-19 patients who had recovered from COVID-19. In contrast, British pharmaceutical company AstraZeneca demonstrated the level of antibodies of its volunteers under its clinical trial at a level virtually equal to the level of antibodies of those who had recovered from coronavirus. T-cell immunity with both types of CD4+ and CD8+ special cells was formed in all volunteers participating in clinical trials of the Sputnik V vaccine. These special cells recognize and disrupt the cells infected by SARS-CoV-2 and form the basis for long-term immunity.

Specialists from the Gamaleya Center managed to prove the effectiveness of the human adenoviral vectors platform, despite concerns that vaccinated people could have pre-existing immunity to human adenoviruses. The optimal safe dosage has been determined, which allowed an effective immune response to be achieved in 100 percent of those vaccinated in trials, even in those who have recently had an adenovirus infection. Concern about the pre-existing immunity for adenoviral infections was the main reason for the emergence of alternative methods such as monkey adenoviral vector or mRNA platforms that have not been studied and tested over
many years. The proven efficacy of Sputnik V reduces the need for hasty development of such platforms at the expense of safety.

Through the use of two different vectors - based on human adenovirus serotypes Ad5 and Ad26 - in two separate shots, it is possible to achieve a more effective immune response. Whereas in the case of using the same vector for two shots, the immune system launches defense mechanisms and begins to reject the drug in the second injection. Thus, the use of two different vectors in the Sputnik V vaccine avoids a possible neutralizing effect and provides for a stronger and more durable immune reaction.

Question 3: Were there too few participants in Phase 1-2 trials of Sputnik V?

On the surface the Sputnik V trial with 76 participants seems smaller in size compared to 1,077 people that, for example, AstraZeneca had in its Phase 1-2 studies. However, the design of the Sputnik V trial was much more efficient and based on better assumptions. AstraZeneca ran its trial from the beginning with a one-shot model but that was a false assumption since only a two-shot model can provide a long lasting immunity as AstraZeneca conceded following the trials. As a result of wrong initial assumptions, AstraZeneca tested the two-shot model only on 10 people out of 1,077. Overall, the number of people who received two injections in the Sputnik V trial exceeded the similar number in AstraZeneca trial by 4 times. Most media missed this point.
Question 4: Will there be clinical trials on more people?

The post-registration studies involving more than 40,000 people started in Russia on August 26, before AstraZeneca has started its Phase 3 trial in the U.S. with 30,000 participants. Clinical trials in Saudi Arabia, United Arab Emirates (UAE), the Philippines, India and Brazil will begin this month. The preliminary results of the Phase 3 trial will be published in October-November 2020.
Question 5: Why has the Sputnik V vaccine already become eligible for emergency use registration?

Because of the very positive results of the Phase 1-2 trials and because the human adenoviral vector-based delivery platform has been proven the safest vaccine delivery platform over decades including through 75 international scientific publications and in more than 250 clinical trials.

The scientists provided convincing data on safety of use of human adenoviral vaccines and medicines worldwide based on studies since 1953. According to records, more than 10 mln U.S. military personnel have received human adenoviral vaccines since 1971. A cancer treatment, Gendicine, based on human adenoviral vectors has been administered to more than 30,000 people in China in the course of 15 years. Clinical trials of vaccines based on human adenoviral vector technology using the same vectors as Sputnik V, have already involved more than 25,000 people worldwide. Since 2015 more than 3,000 people were administered human adenoviral vector-based vaccines against Ebola fever and Middle East Respiratory Syndrome (MERS) created in the Gamaleya Center.

So Russia registered the vaccine because it had a, previously approved, safe and efficient human adenovirus delivery platform for other illnesses. Since the registration of Sputnik V in Russia, other countries also announced plans to follow the Russian approach for emergency use registration of their vaccines. Sinovac Biotech’s vaccine received a similar approval in China. The government of the United Kingdom and the head of the US Food and Drug Administration (FDA) Stephen Hahn have signaled the potential for fast-track registration for British and American vaccine makers, respectively, despite their earlier reservations.

Question 6: Does anyone else use similar technology for their vaccines?

Some other companies are using human adenoviral vector-based platforms for their COVID-19 vaccines. For example, Johnson & Johnson uses only an Ad26 vector and China’s CanSino only Ad5 while Sputnik V uses both of these vectors. The work of Johnson & Johnson and CanSino not only validates the Russian approach but also shows Sputnik V’s advantage as studies have demonstrated that two different vectors produce better results than one.
Our Questions

With all this in mind, Russia, as a clear established leader in vaccine research and having developed the safest and the most effective COVID-19 vaccine, has some questions of its own for Western vaccine makers who use mRNA and monkey adenovirus vector-based technologies. We can now ask the critics: “Why do you look at the speck of sawdust in your brother’s eye and pay no attention to the plank in your own eye?”

Question 1: Are there any long-term studies of mRNA and monkey adenovirus vector-based technologies for carcinogenic effects and impact on fertility? (Hint: there are none)

Question 2: Could their absence be the reason why some of the leading pharmaceutical firms making COVID-19 vaccines based on these technologies pushed the countries buying their vaccines for full indemnification from lawsuits if something goes wrong?

Question 3: Why is Western media not reporting on the lack of long term studies for mRNA and monkey adenoviral vector-based vaccines?
Human vaccine or monkey vaccine

The monkey adenovirus and mRNA vaccines have never been used and approved before and their research is lagging the proven human adenoviral vector-based platform by at least 20 years. However, their developers have already secured supply contracts worth billions of dollars from Western governments and may potentially apply for fast-track registration—while receiving full indemnity at the same time. There are many advantages in mRNA technology, which can play an important role in the future, but long-term safety checks are not yet among these advantages. The fatal flaw of monkey adenoviral vector-based and mRNA vaccines is that even Phase 3 trials do not answer questions on long term risks of these vaccines while such questions on human adenoviral vector-based vaccines have been successfully answered.

At least some executives are open about that. AstraZeneca’s senior executive Ruud Dobber called it “a unique situation where we as a company simply cannot take the risk if in … four years the vaccine is showing side effects. In the contracts we have in place, we are asking for indemnification.”

We believe it is important to make people aware of the risks involved in approval of novel, untested solutions such as mRNA or monkey adenovirus vector-based platforms. We appreciate the planned “pledge of safety” by pharmaceutical companies to be announced shortly but hope that it pledges not only to ensure short term results but also pledges commitment to ensure that there are no increased long term risks of cancer and infertility due to their vaccines. This information will help to safeguard people’s health and demonstrate long term thinking.
Not all vaccine platforms are created equal

To conclude: not all vaccine platforms are created equal. While post-registration trials are yet to be completed, Sputnik V is built on the safest and proven available platform and has received its emergency use registration in full compliance with Russian law and procedures. Several actors in the West are also considering early emergency use registration, but for vaccines built on unproven novel approaches.

We hope that our questions on long term risks will be answered as well as other questions that unproven vaccine platforms may raise in the future. The worst pandemic in a century has all of us urgently searching for solutions. But we would hope our critics hold themselves to the same standards of rigor, safety and transparency as they have held for the Russian vaccine. After all, we need to address the pandemic jointly, with full transparency and without biases.

Source: https://www.rt.com/russia/500087-worlds-first-covid-19-vaccine-questions/

They did Skip stage three testing BEFORE they started mass producing the vaccine.

The vaccine requires two injections to work and they are doing the third stage testing on 40,000 people... that is 80,000 injections... when should they have started mass production... next year?

Those quotes you posted are about did Russia steal any data (I never committed on this) and stage 1 and 2 testings (we all know they did stage 1 and 2).

And it also says they started stage three tests on August 26th... two weeks ago.

You are again DEFLECTING quite poorly, SHOW me and I mean show me HARD PROOF.

What hard proof do you need?

The Lancet published the information about the first and second trials... it is a peer reviewed publication so they cannot have just had the results arrive... skim over them and then just republish them on the 4th of September. Experts need to examine the results and discuss with other experts and decide if it is valid and if there are any problems in procedure.

They did or are in the process of stage three testing, You show me that, and fine I am wrong.

Did you even read the article I quoted above?

"While post-registration trials are yet to be completed,  Sputnik V is built on the safest and proven available platform".

"So hang on... they said they ran stage three tests and then you say they said they didn't"

OK... you talk about us talking out our ass.... they said they started third stage trials on August 26th and that the two injection vaccine is for 40,000 people... and now you are complaining that it is not finished yet and the results are not out yet?

I read the article again, there is no mention of stage three being completed in the title it even says "may begin in 7-10 days" KEY WORD "MAY". If you are going to start blatantly lying, why would I waste time on you.

That article was dated the 16th of August. The article I posted was after the Lancet published their review of the first two trials... they posted that on September the 4th.

And you can quibble with the word May.... I am sure with such an important vaccine that has shown no problems to date they might just decide not to bother because it is not that important right?

I would think the uncertainty was about whether it would be 7 days or 10 days before the 3rd trial.... not whether the trial would be done at all.

And that article is from the 16th of August so it is just as well they said 7 or 10 days... if they had been strict and said 7 days then you would have been jumping up and down about how it took ten days and why is it in mass production when the haven't done the third stage trials yet... those 80,000 doses must be hand made...

Well, looky here.   Apparently it is OK to conduct Phase I and II trials on non-human primates when it comes to western "high tech".

Dude... you are in Canada and I am in New Zealand.... it seems we are going to get the monkey serum based drugs, while the Russians and her real partners will get the good stuff...  

Waiving safety rules so they can use vaccines that might have serious side effects... this might be the vaccine that makes all western people infertile.... I am sure there is a movie in that somewhere... except we are doing it to ourselves out of pride instead of asking for the good stuff...

For the record with your first post, you are right in the respect. The proper testing wasn't done to see how safe that vaccine was and your right it wasn't, I agree with that point. So yes they did not do the proper testing and there might be unseen medical problems has a result, the proper testing wasn't done. But this is where your a moron comes in, you are assuming I think it's okay if others do it. No, I do not.

If you read the article I posted the type of vaccine the Russians have developed has been used since the 1950s and has a clear history of safe use. The western alternative vaccine by the British amongst others is based on monkey DNA and has no history so before they will sell it to western countries those countries need to accept a waver promising not to sue the British company if anything goes wrong in five or ten years time... I bet the people who sold asbestos insulation and thalidomide wished there was a global pandemic where they could get countries to sign wavers over future civil law suits when they were in business....

Both excellent products... did exactly what they were supposed to do... but the cost for some far outweighed the benefits...

You are a liar if you can read you will notice the document clearly says they conducted limited stage 1 testing with the Canadian vaccine and the results look promising enough to move forward with stage 2 and then stage 3.

"Early vaccine trials During the multicentre phase 1 trials, researchers demonstrated the vaccine's safety and its ability to provoke an immune response (immunogenicity). The next trials will determine the expanded safety, protective immune response, and efficacy of the vaccine with at-risk populations in Africa".

I suggest you read your articles before you post them you literally made yourself look like an idiot.

So you read the article he posted... why didn't you read mine... or was it not the hymn you are used to reading?

Garry did not debunk jack, I have yet to be shown or given factual proof stage three tests were conducted by the Russians with their vaccine. Until that proof shows up and the proof is labeled before they started to mass-produce it, you, Garry, and Mike are full of it. So keep lashing out because I of valid criticism of the Russians, it just makes you look like a child and personally I find it funny.

You are clearly in defence mode. To run stage three trials they need 80,000 injections worth of the vaccine that comes in two parts to allow them to vaccinate 40,000 people. They started on the 26th of August with many of the tests done in Moscow where a lot of the infected people are.

It will take quite some time to inject that many people and then monitor the results... and then come up with the final results to publish for peer review again like they did with the first two trials.

They had finished the stage one and two tests by the time that article you posted from August the 16th, and the Lancet published their peer review of those first two tests on September the 4th.

It is September the 9th and you want the results of the third test now?

Are you being unreasonable?

I can't believe you are actually this stupid, so I assume you are being willfully stupid... which is fine...

Pre registration means before registration... they registered their drug before the third trial... two trials were complete and went without problems.... which is unusal, so they registered the drug Sputnik-V

How about:

The post-registration studies involving more than 40,000 people started in Russia on August 26,

in English because that is clearly a problem for you... the studies after the Sputnik-V drug was registered involves 40,000 people and started in Russia on August the 26th.... which is ten days after August the 16th which you posted that said stage three trials will start in 7 to ten days...

It goes on to say:

...before AstraZeneca has started its Phase 3 trial in the U.S. with 30,000 participants.

So it is comparing the post registration studies in Russia with the Phase three trial in the US with 30,000 participants... could that be because they are both stage three trials maybe?

Clinical trials in Saudi Arabia, United Arab Emirates (UAE), the Philippines, India and Brazil will begin this month. The preliminary results of the Phase 3 trial will be published in October-November 2020.

Clinical trials started on 26th August in Russia but a lot of the 40,000 people being tested are in Saudi Arabia and UAE and the Philippines and India and Brazil which will start this month.... you know... September... I say again 40,000 people is a lot of tests and can't be done in a week... the first results of the Phase 3 trials will be published in october-november... I typed that out again because of your reading problems...

But, I hear you saying... if the US and Russian drugs are going through stage three trials now why is it that the Russian vaccine is already registered...

well I am glad you asked....

Because of the very positive results of the Phase 1-2 trials and because the human adenoviral vector-based delivery platform has been proven the safest vaccine delivery platform over decades including through 75 international scientific publications and in more than 250 clinical trials.

The scientists provided convincing data on safety of use of human adenoviral vaccines and medicines worldwide based on studies since 1953. According to records, more than 10 mln U.S. military personnel have received human adenoviral vaccines since 1971. A cancer treatment, Gendicine, based on human adenoviral vectors has been administered to more than 30,000 people in China in the course of 15 years. Clinical trials of vaccines based on human adenoviral vector technology using the same vectors as Sputnik V, have already involved more than 25,000 people worldwide. Since 2015 more than 3,000 people were administered human adenoviral vector-based vaccines against Ebola fever and Middle East Respiratory Syndrome (MERS) created in the Gamaleya Center.

Astra has not started any phase trail trials in the US. S

Honestly I couldn't give a fuck about Astra... I don't care if they never to trials.

Trails are planned in the US and Japan but haven't started.

So they are way behind with their monkey juice... no surprise... it is probably taking them this long to work out how much of a markup they can get away with charging in each country...

Is 1000% too much? Probably not.

This is related to stage 2.... ALSO.

The Lancet journal did a review of Phase I and Phase II... why would they do that if Phase II is not complete?

Let's ASSUME that was stage three testing, Russia approved the vaccine for mass production and whatnot on the 11th of August a full 15 days before this date, you realize even if I am wrong you still didn't prove me wrong in fact you only proved me right. Soooo thanks?.

Bullshit.

You said there was no stage three testing and why are they mass producing it if it hasn't completed stage three testing.

The response is that stage three testing involves 40,000 subjects across the entire planet with two injections each for the vaccine to work properly, they have to put it into production to have enough to use for the testing.

De Nile is a lovely river in Egypt but you can get lost in yourself if you stay there too long... and drink the kool aide from the waters flowing by... (Denial for those that didn't get it).

Since the vaccine was fully approved and has been shipped to other countries before the August 26th date...You will remember I asked for proof they conducted stage three testing before they rubber-stamped it.

It has been shipped to the other countries for stage three testing, but as a registered drug they can use it if they want without doing any further testing... it has been approved... and published and peer reviewed in an international medical journal they don't control politically... a British one... so you know it wasn't rubber stamped like the British one will be despite monkey bits being used...

So congrats Garry you truly just let me know you are full of it and we are done here..

Yeah, we've been done so many times I am beginning to think you don't know what that means either...

Lol now your just making shit up, Phase three trails are a thing everywhere. Its a standard amount vaccine creation for a reason.

Now you are an expert.

It said in the article I posted that the technique they used for their two stage vaccine had a history going back to the 1950s, and has so far proven safe and effective. The actual test results show people given the vaccine have 50% more anti bodies than people with severe reactions who go the disease and survived, which suggests it is very very effective.

I look forward to when western sources start their testing with their brand new experimental monkey drugs... three phase tests would not be enough would they?

How can you determine long term effects with a brand new treatment... the simple answer is that you can't... so as that article I posted says the companies who make those vaccines will demand wavers from the countries that use them to ensure that 10 years down the line if serious side effects start to appear they can't be sued...

In comparison this vaccination from the Russians has been used since the mid 1950s and has proven effective and safe...

kvs, do you consider Phase 3 trials to be unnecessary? It is my impression that in the field of life saving drugs (i.e. cancer treatments) they just prolong the time for a drug to enter the market by 5 years.

It is a catch 22 situation... there are lots of drugs that are developed that seem safe and effective. Thalidomide was a very good drug that did exactly what it was supposed to do... the problem was that it was used to treat depression and did some terrible things to the unborn children of women if they were pregnant when they took that drug. This was a problem because not every woman knows whether they are pregnant when they start taking that drug.

If you made a rule that thalidomide could only be prescribed for men it would be fine.

The reverse is true too however where drugs that could save many lives are held up because they need to be thoroughly tested to make sure they work and have no dangerous side effects and lots of people can die because the companies are afraid of being sued and are just covering their asses.

I would think the best solution is emergency use... someone who is going to die if they don't get the drug tested or not should be allowed to join the testing and see if it can save them... sign a waver so they can't sue if it makes them infertile or gay or something... I think if I were dying I would be happy to try it and sign anything you like.

The Sputnik V vaccine showed very good early results and has been peer reviewed and made from solid reliable methods that have worked well in the past so after two trials they registered it as an option for those who want to take the risk can try it.

In this case with a world wide pandemic providing enough samples becomes the problem so access is the real issue here.

But I am sure politics will be involved as well...