Russia’s Sputnik V vaccine not yet approved in Thailand due to lack of data

[jacko45k]

34 minutes ago, friendofthai said:

Do you think that ordinary folks know what "Phase 3 trial" is ? Just ask your friends in the US - what is "Phase 3 trial"? You will be surprised to see that nobody knows what it is.

Russians would likely be tripped up by the word 'trial'.....

[Comrade]

23 hours ago, friendofthai said:

"Russians don't want Sputnik" Is it true? Yes. But the following is also true: "65% of Russians are anti-vaxers and don't want ANY vaccine"

I'm sure 65% is bs. We take many vaccines throughout our lives. i don't know any person who was anti-vaxer, but of course they exist ???? 

Just look at this https://www.ipsos.com/en/what-worries-world-march-2021 Only 18% Russians were worried about covid (the last place with Argentina), they are not really scared. 

[friendofthai]

19 minutes ago, Comrade said:

I'm sure 65% is bs. We take many vaccines throughout our lives. i don't know any person who was anti-vaxer, but of course they exist

If you ask anyone - are you an anti-vaxxer? Most people will say NO! After that you should ask - Why haven't you got your jab? And you will hear one of the standard stories from the anti-vaxxer websites. The Gold medal will be given to "The tale of deadly adjuvants" :

People will say that they are not against vaccines but the producers of the vaccines MUST provide them with 10000000000 proofs that they are not using deadly adjuvants.
The Silver medal will go to "The Tale of deadly chipization". People will tell you that they are not against the vaccines actually. They just want 10000000000 more certificates that there will be no micro-chips in their jab.
The Bronze medal will go to "The Tale of corruption in medicine". You will probably see a person that "are not against vaccines actually", he just need  10000000000 more proof that he will not be a laboratory mice for medical trials of dangerous medications from the US or Europe.
I am so tired of all these tales and the phrase "I am not against vaccines actually"...

[placeholder]

6 hours ago, friendofthai said:

Do you think that ordinary folks know what "Phase 3 trial" is ? Just ask your friends in the US - what is "Phase 3 trial"? You will be surprised to see that nobody knows what it is.

That's an unproveable claimi. And it certainly doesn't justify Russia's skipping the Phase 2 trial and widely vaccinating people with it.

[friendofthai]

18 minutes ago, placeholder said:

That's an unproveable claimi. And it certainly doesn't justify Russia's skipping the Phase 2 trial and widely vaccinating people with it.

"Phase 2" or "Phase 3" usually suggests that a big set of complex measurements should be performed. But in order to start using the vaccine it is enough to be sure that it is safe. Russian government started to use the vaccine immediately after it became completely sure that the vaccine is safe. Putin was so confident in the safety of the vaccine that he gave it to his daughter.
Now Sputnik V has become the presidential vaccine. Respected world leaders such as Maduro, Putin, Assad, Fernández - they are all vaccinated with Sputnik V.

[Nojohndoe]

17 minutes ago, placeholder said:

That's an unproveable claimi. And it certainly doesn't justify Russia's skipping the Phase 2 trial and widely vaccinating people with it.

Your post has brought back a thought to me about this whole question about the "trials" of new vaccines or whatever but in particular the vaccines produced  for this "pandemic" and the "ethics" of it.

First stage trials are laboratory events which are an attempt to demonstrate a desired result on intended recipient cells with no apparent expectation of contradictory damage.

Once that is established Stage two trials on a small number of living individuals are for the confirmation of the expectations of the efficacy primarily.

Stage three trials as the next step involve a larger sample of individuals which can further confirm efficacy and identify possible side effects that the small number in stage two may not have revealed PLUS establish an advantage in that efficacy or lessening of side effects over prior treatments.

An obvious  problem with the ethical application of trial conventions re' vaccines for Covid-19 is that it is  a "novel" virus for which there are no previous comparative "treatments" and a global pandemic has been declared requiring urgent attention.

If a person or  many persons are seen to be at severe risk of drowning and they are thrown a freshly painted life preserver that later later results in an allergic rash from the wet  paint but are alive to complain about it what answer should they be given?

 

 

[Zikomat]

43 minutes ago, friendofthai said:

Respected world leaders such as Maduro, Putin, Assad, Fernández 

Are you serious?

[placeholder]

1 hour ago, friendofthai said:

"Phase 2" or "Phase 3" usually suggests that a big set of complex measurements should be performed. But in order to start using the vaccine it is enough to be sure that it is safe. Russian government started to use the vaccine immediately after it became completely sure that the vaccine is safe. Putin was so confident in the safety of the vaccine that he gave it to his daughter.
Now Sputnik V has become the presidential vaccine. Respected world leaders such as Maduro, Putin, Assad, Fernández - they are all vaccinated with Sputnik V.

So you're claiming that one of the major reasons for phase 3 trials isn't to to test whether a medication is safe? 

Utter nonsense. As for Putin giving it to his daughter. That's what he claimed. 

I think Russia's gamble with innocent people's lives paid off. It looks like it is safe. But that's no excuse for violating scientific safety protocols.

[placeholder]

1 hour ago, Nojohndoe said:

Your post has brought back a thought to me about this whole question about the "trials" of new vaccines or whatever but in particular the vaccines produced  for this "pandemic" and the "ethics" of it.

First stage trials are laboratory events which are an attempt to demonstrate a desired result on intended recipient cells with no apparent expectation of contradictory damage.

Once that is established Stage two trials on a small number of living individuals are for the confirmation of the expectations of the efficacy primarily.

Stage three trials as the next step involve a larger sample of individuals which can further confirm efficacy and identify possible side effects that the small number in stage two may not have revealed PLUS establish an advantage in that efficacy or lessening of side effects over prior treatments.

An obvious  problem with the ethical application of trial conventions re' vaccines for Covid-19 is that it is  a "novel" virus for which there are no previous comparative "treatments" and a global pandemic has been declared requiring urgent attention.

If a person or  many persons are seen to be at severe risk of drowning and they are thrown a freshly painted life preserver that later later results in an allergic rash from the wet  paint but are alive to complain about it what answer should they be given?

But if that lead preserver turns out to made of lead and drags them down. Most of those people floating around in that water weren't going to drown, were they?

[mommysboy]

I'm sure it's good, but if there is a basic lack of safety data then of course it can't be approved.  All currently approved western vaccines have been through at least one major trial in the USA, or UK.  Sinovac, presumably, was able to provide real world data from its extensive use.

[Soikhaonoiken]

So why order a vaccine, which has no data on its success....... Crazy 

[boogiewoogie]

3 hours ago, Soikhaonoiken said:

So why order a vaccine, which has no data on its success....... Crazy 

 

Today i saw a funny picture. For some reason CCSA moved Russia from red list to yellow list. Funny coincidence right now russia living thru its 3rd Rona wave.

 

So it gives a clear idea that not only Sputnik will be approved but even clear saline as a proof of russian vacination would have a go in thai MoPH.

 

Looks like russian tourists are only europeans crazy enough to go in Thailand en masse no matter what.

 

 

[friendofthai]

 

14 hours ago, placeholder said:

So you're claiming that one of the major reasons for phase 3 trials isn't to to test whether a medication is safe? 

Utter nonsense. As for Putin giving it to his daughter. That's what he claimed. 

I think Russia's gamble with innocent people's lives paid off. It looks like it is safe. But that's no excuse for violating scientific safety protocols.

I am in a Thai coffee shop now. I see 2 kind of sugar bags here. I see that most people choose the small brown sugar bags with regular sugar which has never passed neither "Phase 2" nor "Phase 3". And only one customer has chosen a small blue bag of chemically synthesized sugar that has passed "Phase 2" and "Phase 3". Of course the regular sugar brand has passed a small subset of tests to ensure its safety.
People choose the thing that are time-tested in the coffee shop because time is the most reliable tester. Much more reliable than all these "Phase 2" and "Phase 3" testers. That is why people choose Sputnik V based on the ancient adenovirus technology rather than the sci-fi mRNA things. Ancient things require much less testing to ensure their safety. It would be strange if Putin had not used this to win the vaccine diplomacy race.

Edited June 19, 2021 by friendofthai

[friendofthai]

15 hours ago, Zikomat said:

Are you serious?

Yes. These people decided to fight bravely when attacked. This is the only choice that can be respected in such situations. And they did it.

[placeholder]

1 hour ago, friendofthai said:

 

I am in a Thai coffee shop now. I see 2 kind of sugar bags here. I see that most people choose the small brown sugar bags with regular sugar which has never passed neither "Phase 2" nor "Phase 3". And only one customer has chosen a small blue bag of chemically synthesized sugar that has passed "Phase 2" and "Phase 3". Of course the regular sugar brand has passed a small subset of tests to ensure its safety.
People choose the thing that are time-tested in the coffee shop because time is the most reliable tester. Much more reliable than all these "Phase 2" and "Phase 3" testers. That is why people choose Sputnik V based on the ancient adenovirus technology rather than the sci-fi mRNA things. Ancient things require much less testing to ensure their safety. It would be strange if Putin had not used this to win the vaccine diplomacy race.

More nonsense. Even If the only thing being tested was the packaging, adenovirus may by your criteria be ancient, but they've hardly enjoyed outstanding success.

Adenoviral vectors are the new COVID-19 vaccine front-runners. Can they overcome their checkered past?

CanSino Biologics, Johnson & Johnson, and the University of Oxford are all using genetically engineered common cold viruses to make COVID-19 vaccines. The technology is more than 30 years in the making, but it’s yet to yield an effective vaccine for humans

https://cen.acs.org/pharmaceuticals/vaccines/Adenoviral-vectors-new-COVID-19/98/i19

 

And the protein spike is novel so should be subject to standard protocols.

 

And the manufacturing process also is problematic:

Brazil: Was there sloppiness with the Sputnik V COVID vaccine?

Brazil has halted approval of Sputnik V, claiming that a vector virus in the vaccine was not inactive and could cause severe colds. Russia is denying the accusation.

https://www.dw.com/en/brazil-was-there-sloppiness-with-the-sputnik-v-covid-vaccine/a-57425121

[friendofthai]

12 minutes ago, placeholder said:

Brazil has halted approval of Sputnik V, claiming that a vector virus in the vaccine was not inactive and could cause severe colds. Russia is denying the accusation.

Brazil has approved Sputnik V already. All these political bs is a part of the normal Sputnik V approval workflow. Any country that wants to use Sputnik V should be ready to pass through US-made political scandals:
https://www.washingtonpost.com/world/2021/03/16/hhs-brazil-sputnik-russia/
The same thing happened in Slovakia. And Slovakia is already using Sputnik for immunizations.

Edited June 19, 2021 by friendofthai

[friendofthai]

1 hour ago, placeholder said:

but it’s yet to yield an effective vaccine for humans

Effectiveness and safety are two totally unrelated things. 

[friendofthai]

"Russia’s Sputnik V vaccine not yet approved in Thailand due to lack of data"

The need of passing through a political scandal is by far more important reason to wait. This is the price of using the first class vaccine that really stops COVID. Brazil, Slovakia, Hungary and other countries has paid this price already. Many politicians have lost their jobs because of this. They are brave people that sacrificed themselves to save people lives.

Edited June 19, 2021 by friendofthai

[placeholder]

1 hour ago, friendofthai said:

Brazil has approved Sputnik V already. All these political bs is a part of the normal Sputnik V approval workflow. Any country that wants to use Sputnik V should be ready to pass through US-made political scandals:
https://www.washingtonpost.com/world/2021/03/16/hhs-brazil-sputnik-russia/
The same thing happened in Slovakia. And Slovakia is already using Sputnik for immunizations.

I am quite convinced that Sputnik is an effective vaccine as I've already stated. But Russia took a gamble with peoples' lives in order to score a propaganda victory.. And that's unforgiveable.

Edited June 19, 2021 by placeholder

[placeholder]

1 hour ago, friendofthai said:

Brazil has approved Sputnik V already. All these political bs is a part of the normal Sputnik V approval workflow. Any country that wants to use Sputnik V should be ready to pass through US-made political scandals:
https://www.washingtonpost.com/world/2021/03/16/hhs-brazil-sputnik-russia/
The same thing happened in Slovakia. And Slovakia is already using Sputnik for immunizations.

You neglected to mention this:

"The rulings come after the health regulator rejected in late April imports of the Sputnik V shot requested by state governors desperate for vaccines. States had originally wanted 37 million doses.

At the time, Anvisa's five-member board voted unanimously not to approve the Russian vaccine after technical staff had highlighted "inherent risks" and "serious" defects, citing a lack of data guaranteeing its safety, quality and effectiveness."

https://www.reuters.com/world/americas/brazil-health-regulator-technical-staff-recommend-conditions-any-approval-2021-06-04/

 

And as for blaming America for this, that's utter nonsense. Brazil has been in the forefront of using Sinovac and its Butantan Institute h as gone to great lengths to prove its effectiveness against Covid 19. But it's appropriate, I guess, that being Russian, you would come up with the same Pavlovian response to any questioning of a Russian vaccine.

[friendofthai]

32 minutes ago, placeholder said:

I am quite convinced that Sputnik is an effective vaccine as I've already stated. But Russia took a gamble with peoples' lives in order to score a propaganda victory.. And that's unforgiveable.

Have you ever think about what could have happened if any severe side effect had found during live trials of mRNA vaccines? The technology is totally new. So anything could have happened. In the worse scenario people had not got any vaccine because of endless cancellations and delays. This is true gambling with people lives. Russia and China, on the other side, prefer to use only time-tested safe approaches (like adenovirus or inactivated virus) to be sure that people will get their jabs.

[placeholder]

1 minute ago, friendofthai said:

Have you ever think about what could have happened if any severe side effect had found during live trials of mRNA vaccines? The technology is totally new. So anything could have happened. In the worse scenario people had not got any vaccine because of endless cancellations and delays. This is true gambling with people lives. Russia and China, on the other side, prefer to use only time-tested safe approaches (like adenovirus or inactivated virus) to be sure that people will get their jabs.

Keep on repeating your nonsense. There are 2 parts of a vaccine. The delivery system and what is being delivered. Even if the delivery system is safe, the package may not be. That's why countries that are more concerned about the safety of people than they are about propaganda victories take the time-tested approach. The Chinese companies and the Russian one still refuse to release all their testing data.

[Zikomat]

...

Edited June 19, 2021 by Zikomat

[Zikomat]

...

[friendofthai]

Just now, Zikomat said:

Adolf Hitler and Saddam Hussein -  were those “respected world leaders” in your opinion?

Hitler is an aggressor who lost the war. Nothing to respect. Saddam Kaddafi etc - they lost their wars. Not so many people respect losers.

[mistral53]

20 hours ago, placeholder said:

That's an unproveable claimi. And it certainly doesn't justify Russia's skipping the Phase 2 trial and widely vaccinating people with it.

You do realize that all Covid vaccines are not as rigorously tested as vaccines ordinarily are? Development of a vaccine on average takes 8 years - good luck with the known unknowns and the unknown unknowns for the vaccine you are so over eager to be a labrat for - I will wait and watch you for a few years and then get in line as well, that is if you have not developed some really nasty long term side effects  ????

[boogiewoogie]

2 hours ago, placeholder said:

I am quite convinced that Sputnik is an effective vaccine as I've already stated. But Russia took a gamble with peoples' lives in order to score a propaganda victory.. And that's unforgiveable.

BS.

 

Most of vaccines now approved for "emergency use". I think u know what exatcly it means.

 

Phizer went tru US FDA as a speedball. Less than a year. It takes up to 10 years to test/register. Experimental mrna vaccine? Less than a year? Give me a break and gospeed!

[placeholder]

1 hour ago, boogiewoogie said:

BS.

 

Most of vaccines now approved for "emergency use". I think u know what exatcly it means.

 

Phizer went tru US FDA as a speedball. Less than a year. It takes up to 10 years to test/register. Experimental mrna vaccine? Less than a year? Give me a break and gospeed!

First off, technology has made huge progress. For older antiviral vaccines there was no genetic analysis available. Scientists couldn't even figure out the structure of the RNA. And even when they started to be able to, it was a long and laborious effort. The full structure of the RNA of the covid-19 virus was completely mapped by early January of 2020. That's years shaved off right there. And specific targets were found. Not so in older vaccines.

From there instead of going to animal trials, as is usually the case, they went to phase 1 which consists of human volunteers to do a preliminary test for safery. . They got lots more volunteers than usual which shortened that process.

Unusually while phase 1 trials were going on Phase 2 trials started. That's to test dosage levels.

And while Phase 2 was still ongoing, they went to phase 3. Well at least most did. Some, like the Russians didn't care. Phase 3 is where large groups of people are dosed so side effects can be determined. It was a full phase 3 trial.

So, mostly the huge advancement in technology,. That and  overlapping phases.

By they way, they've started using mRNA technology on malaria. They already have some positive animal tests results. That after years of trying with older technologies to mostly no avail. Though lately there have been a few fairly positive results. 

Welcome to the 21st century!

[placeholder]

 

3 hours ago, friendofthai said:

Have you ever think about what could have happened if any severe side effect had found during live trials of mRNA vaccines? The technology is totally new. So anything could have happened. In the worse scenario people had not got any vaccine because of endless cancellations and delays. This is true gambling with people lives. Russia and China, on the other side, prefer to use only time-tested safe approaches (like adenovirus or inactivated virus) to be sure that people will get their jabs.

Ah the irony. You endorsed a post that criticized the speed of vaccine approval.

[boogiewoogie]

40 minutes ago, placeholder said:

First off, technology has made huge progress. For older antiviral vaccines there was no genetic analysis available. Scientists couldn't even figure out the structure of the RNA. And even when they started to be able to, it was a long and laborious effort. The full structure of the RNA of the covid-19 virus was completely mapped by early January of 2020. That's years shaved off right there. And specific targets were found. Not so in older vaccines.

From there instead of going to animal trials, as is usually the case, they went to phase 1 which consists of human volunteers to do a preliminary test for safery. . They got lots more volunteers than usual which shortened that process.

Unusually while phase 1 trials were going on Phase 2 trials started. That's to test dosage levels.

And while Phase 2 was still ongoing, they went to phase 3. Well at least most did. Some, like the Russians didn't care. Phase 3 is where large groups of people are dosed so side effects can be determined. It was a full phase 3 trial.

So, mostly the huge advancement in technology,. That and  overlapping phases.

By they way, they've started using mRNA technology on malaria. They already have some positive animal tests results. That after years of trying with older technologies to mostly no avail. Though lately there have been a few fairly positive results. 

Welcome to the 21st century!

 

Thalidomide. 

 

Phizer is experimental jab. 

 

Sputnik is a vector oldfart jab.

 

Also critisizing sputnik and stay quiet about other vaccines in case of Speeding up a process is a hypocrisy.

Edited June 19, 2021 by boogiewoogie