Russia becomes first country to approve a COVID-19 vaccine, says Putin

By Gabrielle Tétrault-Farber, Vladimir Soldatkin

 

FILE PHOTO: Russia's President Vladimir Putin discusses the environmental situation in the town of Usolye-Sibirskoye in Irkutsk region during a video conference call with officials at the Novo-Ogaryovo state residence outside Moscow, Russia July 30, 2020. Sputnik/Alexei Nikolsky/Kremlin via REUTERS

 

MOSCOW (Reuters) - President Vladimir Putin said on Tuesday that Russia had become the first country in the world to grant regulatory approval to a COVID-19 vaccine after less than two months of human testing, a move hailed by Moscow as evidence of its scientific prowess.

 

The vaccine still has to complete final trials, raising concerns among some experts at the speed of its approval, but the Russian business conglomerate Sistema has said it expects to put it into mass production by the end of the year.

 

Russian health workers treating COVID-19 patients will be offered the chance of volunteering to be vaccinated in the coming weeks, a source told Reuters last month.

 

Regulatory approval paves the way for the mass inoculation of the Russian population and authorities hope it will allow the economy, which has been battered by fallout from the virus, to return to full capacity.

 

Kirill Dmitriev, head of Russia’s sovereign wealth fund, hailed the development as a historic “Sputnik moment”, comparable to the Soviet Union’s 1957 launch of Sputnik 1, the world’s first satellite.

 

The vaccine will be marketed under the name ‘Sputnik V’ on foreign markets, he said.

 

Dmitriev said Russia had already received foreign requests for 1 billion doses. International agreements had been secured to produce 500 million doses annually, with the vaccine also expected to be produced in Brazil.

 

He said clinical trials were expected to start soon in the United Arab Emirates and the Philippines.

 

But only about 10% of clinical trial are successful, and the speed at which Russia has moved, approving a vaccine before the final stages of trials to test safety and efficacy are over, has worried some scientists, who fear Moscow may be putting national prestige before safety.

 

Speaking at a government meeting on state television, Putin dismissed those concerns, saying the vaccine, developed by Moscow’s Gamaleya Institute, was safe and that it had even been administered to one of his daughters.

 

“I know that it works quite effectively, forms strong immunity, and I repeat, it has passed all the needed checks,” said Putin.

 

He said he hoped mass production would start soon.

 

PHASE III TRIAL

 

The vaccine’s approval by the health ministry comes before the start of a larger trial involving thousands of participants, commonly known as a Phase III trial.

 

Such trials, which require a certain rate of participants catching the virus to observe the vaccine’s effect, are normally considered essential precursors for a vaccine to receive regulatory approval.

 

The Moscow-based Association of Clinical Trials Organizations (ACTO), a trade body representing the world’s top drugmakers in Russia this week urged the health ministry to postpone approval until that final trial had been successfully completed.

 

In a letter to the ministry, it said there were high risks associated with registering a drug before that happened.

 

“It is during this phase that the main evidence of a vaccine’s efficacy is collected, as well as information on adverse reactions that could appear in certain groups of patients: people with weakened immunity, people with concomitant diseases and so forth,” it said.

 

Some international experts have also questioned the speed at which Russia approved its vaccine.

 

“Normally you need a large number of people to be tested before you approve a vaccine,” said Peter Kremsner from the University Hospital in Tuebingen, currently testing CureVac’s COVID-19 vaccine in clinical trials.

 

“In that respect, I think it’s reckless to do that (approve it) if lots of people haven’t already been tested.”

 

Duncan Matthews, a professor of intellectual property law at Queen Mary University of London, said news of a potential COVID-19 vaccine was to be welcomed, “but safety must be the priority”.

 

“The U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have fast-track approval procedures for emergency humanitarian use and we need to see evidence that Russia is adopting an equally prudent approach,” Matthews said in an emailed comment.

 

More than 100 possible vaccines are being developed around the world to try to stop the COVID-19 pandemic. At least four are in final Phase III human trials, according to WHO data.

 

-- © Copyright Reuters 2020-08-11

 

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Well for the sake of the russan people I hope it’s safe and effective 

57 minutes ago, snoop1130 said:

President Vladimir Putin said on Tuesday that Russia had become the first country in the world to grant regulatory approval to a COVID-19 vaccine

if you spend more than 10 minutes researching this guy and his history, you wont believe a word he says

Wow I am impressed with Russia. They really are so forward thinking. I am sure everyone will be cured soon. I look forward to commenting on this post next year.

Edited August 11, 20205 yr by Laughing Gravy

I'll wait a bit.

hope

 

1 hour ago, YetAnother said:

if you spend more than 10 minutes researching this guy and his history, you wont believe a word he says

 

KGB,  retired ? ..

An off-topic image and replies have been removed.  This is a discussion forum.  

2 hours ago, snoop1130 said:

Russian health workers treating COVID-19 patients will be offered the chance of volunteering to be vaccinated

I wonder which country they stole it from,they have been very busy

hacking research labs around the World.

regards worgeordie

Whew, finally a vaccine. Where can I get my jab, vaccine passport stamped and start flying again?

7 minutes ago, worgeordie said:

I wonder which country they stole it from,they have been very busy

hacking research labs around the World.

regards worgeordie

I believe there were reports of them hacking labs in both the US and UK.  

 

More recent article from Reuters:

 

Scientists ask: Without trial data, how can we trust Russia's COVID vaccine? 

 

https://www.reuters.com/article/us-health-coronavirus-vaccine-russia-exp/scientists-ask-without-trial-data-how-can-we-trust-russias-covid-vaccine-idUSKCN2571TL

 

We are being asked to believes Putin's statement without a scientific study on the trials of this vaccine published yet, so basically this is currently just hearsay. 

 

That and the apparent lack of phase 3 trials is a huge red flag for any logical thinker. 

 

That said I do hope they have success in this, the world needs as many good vaccine candidates as possible.

1 minute ago, Scott said:

I believe there were reports of them hacking labs in both the US and UK.  

 

3 Key targets; Canada, UK and USA. Much of the initial Covid19  R&D had been done in Canada since this is where the initial Corona Virus vaccines  for animals were developed (University of Saskatchewan) also tarheted was the  national bio lab in Winnipeg and NRC in Ottawa.  The Oxford group in the UK  has been under constant hacking attacks by presumed  Iranian, Russian and Chinese spies since the need for a vaccine became urgent. In the USA; NIH, Pfizer, Astra Zeneca, J&J and Moderna are key targets too.

Its so safe, Putin has given it to his daughter.

Presumably his 5 year old daughter, one of the least likely candidates to need inoculation. The main category in need are the over 60 males.

Mr Putin is 67

 

 

15 minutes ago, mrfill said:

Its so safe, Putin has given it to his daughter.

Presumably his 5 year old daughter, one of the least likely candidates to need inoculation. The main category in need are the over 60 males.

Mr Putin is 67

 

 

As a father, I would have thought good old dad would take the jab first and then if found to have survived that, then the family could get one, if found not to be safe, then well at least the family lives to tell the tale, dad took it on the chin for the family. Then again, I don't think any father would allow his kid/s to get a jab unless he thought it was 110% safe, and this would probably show everyone, if I can get my kid to have a shot, so can you, but did she really get the jab, that is the question.

Edited August 12, 20205 yr by 4MyEgo

Soon enough POTUS will be touting the Putin vaccine.  I worry for the kids of the people who will believe him.  It used to be the US right wing was concerned about Russia (USSR) compromising the health of the American people via fluoridation https://en.wikipedia.org/wiki/Water_fluoridation_controversy
but now it is they who are welcoming them with open arms via a compromised president, and now this.

 

 

good luck to you all guinea pigs, as long as they don't FORCE it onto everyone

The well paid doctors are moaning about the testing being cut short, but Russia is in reality doing a huge test by distributing it.  Yes, normal protocol is to do extensive multi-stage testing first, but these aren't normal times, people are dying in their thousands every day. 

 

If this works get it out there. 

And, if it was stolen, so what?  That it works and is in use fast is sufficient justification for me.

 

All these separate labs in separate countries doing their own thing can't be speeding things up, and the consequent delays are costing lives.

Currently this Russian vaccine announcement is just a publicity stunt, its been tested on less than 100 people! However Russia has labelled it finished instead of work in progress.

 

By this standard the Russian vaccine is far behind the other half dozen vaccines that are in development in the west and in stage 3 trials.

 

Going ahead with this gives the anti vaxxers all the ammunition they need to say just how unsafe and untested vaccines are.

    Could be a killer, if the research labs gave false information on their networks to prevent such hacking. Time will tell, but if people start to die. there will be another major cover up.

16 hours ago, Laughing Gravy said:

Wow I am impressed with Russia. They really are so forward thinking. I am sure everyone will be cured soon. I look forward to commenting on this post next year.

If you are impressed with Russia, I have a few really good second hand cars I could sell you. Real investment, you understand. Going cheap. No need for paperwork - gentleman's agreement. Cash only.

3 minutes ago, Proboscis said:

If you are impressed with Russia, I have a few really good second hand cars I could sell you. Real investment, you understand. Going cheap. No need for paperwork - gentleman's agreement. Cash only.

You obviously don't understand sarcasm. You wouldn't be Russian would you. ????

Is the process moving too fast for WHO?
If the global economy is on its knees, who cares about their methodology? Unless WHO still wants to defend the interests of the laboratories that sponsor them?

Congratulations Putin, make people's lives great again! ????

I didn't realise Putin was so shallow. Never trusted him, but this is a new low.

Back to the main real contenders, and still looking good for positive phase 3 results before year end. 

All the other countries/companies are too busy fighting each other to be the first one to bring the vaccine on the market. (human greed).

If they would have worked together the vaccine would already been ready and distributed 3 months ago.

But of course making a fortune from someone else's suffering is more important.

 

 

Edited August 12, 20205 yr by spiekerjozef

This is nothing more than a step backwards for science.  There is at least a 50-50 chance it will work with no side effects.  The Russian phase 3 trial will cover millions of people.  Here's hoping it works.

18 hours ago, chickenslegs said:

They have more than enough "reserve" in their prison camps to "ask" for volunteers to test.

Same China, with millions of Uyghurs, as I presume the FalungGong followers are "used up". Happily a new wave, now from Hong Kong, is coming in.

10 minutes ago, mlmcleod said:

This is nothing more than a step backwards for science.  There is at least a 50-50 chance it will work with no side effects.  The Russian phase 3 trial will cover millions of people.  Here's hoping it works.

And if not... think of the wonderdrug Softenon.... till babies with no arms were born.

That's why the development of a new medicine lasts so long and is so expensive.