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Russia Just Approved The First Coronavirus Vaccine Without Completing Crucial Clinical Trials

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Russian President Vladimir Putin said the vaccine "passed all necessary tests," but it has not yet undergone a key step in trials to determine how safe and effective it is.

 

Russian President Vladimir Putin announced Tuesday that the country has approved a coronavirus vaccine despite not having completed crucial clinical trials to determine its efficacy and safety.

Developed at Moscow's Gamaleya Institute, the vaccine, called Sputnik V, has not yet undergone Phase 3 of testing, a key, monthslong trial involving administering a vaccine to a large group of people that can reveal previously unknown side effects.

 

Russia has not published any scientific data on its vaccine testing, and Sputnik V is not among the eight currently undergoing Phase 3 trials, according to the New York Times coronavirus vaccine tracker.

Putin, however, called the vaccine "quite effective" and said it had "passed all necessary tests." One of his two daughters has been vaccinated, he added.

 

The announcement has been met with skepticism and concern from public health experts outside Russia who say approving a vaccine that may not be safe or effective will erode trust in the scientific community at a time when it's needed most.

 

Paul Offit, the director of the Vaccine Education Center at the Children’s Hospital of Philadelphia, who sits on the FDA vaccine advisory committee, told BuzzFeed News "it's like reading the tea leaves."

"I am certain that they could not have possibly completed a phase 3 trial for efficacy. At most, they have limited immunogenicity data," Offit said. "Putin has made this political. And when he says the vaccine is effective, he can't possibly know that."

 

Offit also noted that he was concerned about how President Donald Trump, who some have feared might rush a vaccine to save his own presidency, will respond to Putin's announcement.

 

Tarik Jasarevic, a spokesperson for the World Health Organization, told reporters Tuesday that prequalification of a vaccine from the agency requires "rigorous review and assessment of all the required safety and efficacy data."

 

In Russia, a group of pharmaceutical companies have also cautioned against rushing a vaccine, saying in a letter to the health ministry that doing so may cost lives.

 

Kirill Dmitriev, the CEO of the Russian Direct Investment Fund that financed the country's vaccine research, dismissed concerns about the vaccine and said he, his wife, and his elderly parents have taken it, the Washington Post reported.

 

In his announcement Tuesday, Putin spoke of Sputnik V as a point of pride for the country at a time when laboratories around the world are racing to develop a coronavirus vaccine.

 

Russia has reported 895,691 coronavirus cases and 15,103 deaths to date.

 

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Posted (edited)
11 minutes ago, Thaivisa Web Content Team said:

Putin, however, called the vaccine "quite effective" and said it had "passed all necessary tests." One of his two daughters has been vaccinated, he added.

I guess that political expediency trumps parental responsibility.

Remember this <deleted> ...

image.jpeg.4790083005a0c803c570ea6ea9e22dac.jpeg

 

John Selwyn Gummer MP, feeding his daughter a burger during the "mad cow" beef scare.

Edited by chickenslegs
OK - bad language is not accepted here, but the term T w 4 t is entirely appropriate in this case.

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1 minute ago, chickenslegs said:

I guess that political expediency trumps parental responsibility.

Remember this <deleted> ...

image.jpeg.4790083005a0c803c570ea6ea9e22dac.jpeg

 

John Selwyn Gummer MP, feeding his daughter a burger during the "mad cow" beef scare.

Don't mean to make fun of you but...she eventually grew to be a fine young lady, didn't she...or maybe it was a vegetarian burger

Let's hope it works the same way for the Russian president's daughter ( which brings me to thinking...why hasn't the other daughter been vaccinated ? too young ? )

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1 minute ago, alyx said:

Don't mean to make fun of you but...she eventually grew to be a fine young lady, didn't she...or maybe it was a vegetarian burger

Let's hope it works the same way for the Russian president's daughter ( which brings me to thinking...why hasn't the other daughter been vaccinated ? too young ? )

No offence taken.

At the time JSG didn't know whether the disease could be transfrerred via cooked meat or not. But, he was willing to feed the burger to his child (who was way too young to give her informed consent). He did so for political reasons.

 

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555 ok I was expecting that one actually, thanks

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19 minutes ago, chickenslegs said:

No offence taken.

At the time JSG didn't know whether the disease could be transfrerred via cooked meat or not. But, he was willing to feed the burger to his child (who was way too young to give her informed consent). He did so for political reasons.

 

Thanks for the explanation

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52 minutes ago, Thaivisa Web Content Team said:

In Russia, a group of pharmaceutical companies have also cautioned against rushing a vaccine, saying in a letter to the health ministry that doing so may cost lives.

As opposed to the lives being lost to the virus itself.

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I'll give it a miss and any Chinese produced one. What are you taking? As it says, it is political. If the Oxford one is successful I'd probably also pass unless one absolutely must have it on a certificate to travel.  

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1 hour ago, alyx said:

Let's hope it works the same way for the Russian president's daughter ( which brings me to thinking...why hasn't the other daughter been vaccinated ? too young ? )

The other one wasn't adopted and expendable probably

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1 hour ago, timendres said:

As opposed to the lives being lost to the virus itself.

 

This vaccine has a chance to kill 100%.

 

 

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This sounds like the plot of a new horror movie. No clinical trials, unexpected long-term effects, zombie apocalypse, etc.

 

I’d be more worried about the effectiveness of an untested vaccine but, still, it’s 2020… who knows what’s next?

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10 hours ago, John435 said:

This sounds like the plot of a new horror movie. No clinical trials, unexpected long-term effects, zombie apocalypse, etc.

 

I’d be more worried about the effectiveness of an untested vaccine but, still, it’s 2020… who knows what’s next?

Clinical trials were done. Only the third clinical trial is still missing.

 

Third clinical trial means thousands are vaccinated and then the waiting starts because the test subjects must be infected with the virus randomly in normal daily life. This can take years.

A lot of people volunteered in western countries to be infected with the virus intentionally in a third clinical trial, so no waiting for the virus "in the wild" is necessary. But WHO raised ethical concerns. Hard to believe.

 

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3 minutes ago, Berti said:

Clinical trials were done. Only the third clinical trial is still missing.

 

Third clinical trial means thousands are vaccinated and then the waiting starts because the test subjects must be infected with the virus randomly in normal daily life. This can take years.

A lot of people volunteered in western countries to be infected with the virus intentionally in a third clinical trial, so no waiting for the virus "in the wild" is necessary. But WHO raised ethical concerns. Hard to believe.

 

Therefore, as the clinical trials were not completed the vaccine is probably not worth issuing world wide until it is proven to be safe with no nasty side effects.

 

Do you remember this drug?

 

https://en.wikipedia.org/wiki/Thalidomide

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