What we know about Russia’s controversial coronavirus vaccine announcement

Vladimir Putin is claiming a breakthrough for Russia in the race for a coronavirus vaccine, but experts are questioning how safe and effective the vaccine actually is.

Putin announced last week that Russia had registered the world’s first coronavirus vaccine, after less than two months of human testing on fewer than a hundred people.

But it is unclear whether Russian researchers are closer than those in the United States or China, suggesting to some that Russia has circumvented regulations to approve the vaccine.

“My first reaction was that it was probably much ado about nothing,” Paul Offit, a vaccine expert at Children’s Hospital of Philadelphia, told Business Insider. “We don’t know anything about this vaccine other than the fact that Vladimir Putin came on the air and said, ‘This is going to be safe, this is going to be effective,’ he checked all the boxes. ” And we can only interpret this as a political coup. ”

So what’s missing? The maximum, an essential step to prove that a vaccine is safe, is called phase 3. This is the final phase of human trials and reaches tens of thousands of people.

“Without this Phase 3 data, I am very concerned that they could use and market a vaccine that could be potentially dangerous or even ineffective,” said Tara Smith, an epidemiologist at Kent State University.

Russia passed legislation in April that would allow companies using vaccines to pass phase 3 trials. Other countries have also replaced or accelerated the vaccine production process. China approved a vaccine for military use before publishing the results of the phase 3 trial. And in the United States, corporations funded through the Operation Warp Speed program are overlapping stages of clinical trials.  

However, Putin, with a bit of luck, claimed to have tested the Russian vaccine on his own family. The leader said his daughter was one of the control subjects of the experiment.

There are currently more than 100 coronavirus vaccines in development globally. Researchers around the world are in a race against time, and each other.

But developing a new vaccine takes years, up to a decade. So far, only a handful of teams in the U. S. and the United Kingdom have entered Phase 3.  

Its deployment plans are, for the moment, a little less ambitious than Russia’s. In the United States, the Trump administration has partnered with the personal sector to deliver three hundred million doses through January 2021. And China has already presented an experimental vaccine to workers at state-owned enterprises.

The first country to prove that it can produce an effective vaccine will get billions of dollars of foreign investment. Russia’s will be billed as Sputnik V, a nod to the world’s first satellite, Sputnik 1, which the Soviet Union introduced in 1957, intensifying the 20-year space race with the United States.  

As many as 20 countries have already expressed interest, in all likelihood putting Sputnik V at the forefront of a bloodless biotech war, something doctors like Offit fear.

“This pandemic has been an equal opportunity employer,” Offit said. “This virus affects all nations, all ethnic backgrounds, all religious groups. We should all be brought together in this effort because all of us are at risk. What Putin has done is political theater.”

The Russian vaccine is being developed at the Gamaleya Institute in Moscow.  

But in July, American, British and Canadian intelligence services accused Russian hackers of trying to borrow vaccine-related data from researchers abroad, according to the New York Times.

There have also been reports of scientists injecting themselves with the prototype and rushing to additional testing to speed up development.

Peter Hotez, a vaccine researcher at Baylor University, has studied vaccines against other coronaviruses for decades and says the way nations solve a global pandemic is by cooperating.

“When people talk about race, I tell them to be careful what they want, because history tells us that when you look at the modern history of the US vaccination program, the first vaccines distributed are replaced within a short period of time. time. one or two years with more vaccines,” he said.

“I think we have to get away from this business, of course you know, of this nationalism around vaccines — calling it the American vaccine or the Chinese vaccine or the British vaccine. It doesn’t work that way.”

Vladimir Putin says Russia has made a breakthrough in the race for a coronavirus vaccine, but experts question how safe and effective the vaccine is.

Putin announced last week that Russia had registered the world’s first vaccine for the coronavirus, after less than two months of human testing on fewer than 100 people.

But it is unclear whether Russian researchers are closer than those in the United States or China, suggesting to some that Russia has circumvented regulations to approve the vaccine.

“My initial reaction was it was probably much ado about nothing,” Paul Offit, a vaccine expert with the Children’s Hospital of Philadelphia, told Business Insider. “We don’t know anything about this vaccine other than the fact that Vladimir Putin got on the airwaves and said, ‘This is going to be safe, this is going to be effective, it’s checked all the boxes.’ And one can only interpret this as a political stunt.”

So what’s missing? The maximum, an essential step to demonstrate that a vaccine is safe, is called phase 3. This is the final phase of human trials and reaches tens of thousands of people.

“Without the Phase 3 data, I’m very concerned that they are and releasing a vaccine that could be potentially unsafe, it could just be ineffective,” said Tara Smith, an epidemiologist at Kent State University.

Russia passed legislation in April that would allow companies using vaccines to move beyond phase 3 trials. Other countries have also substituted or accelerated the vaccine production process. China approved a vaccine for military use before publishing Phase 3 trial results. And in the United States, corporations funded through the Operation Warp Speed ​​program are overlapping stages of clinical trials.  

Still, Putin has confidently claimed to have tested the Russian vaccine — on his own family. The leader said his daughter was one of the test subjects in the experiment.

Lately, there are more than a hundred coronavirus vaccines in progress around the world. Researchers around the world are competing between time and the other.

But developing any new vaccine typically takes years, sometimes up to a decade. So far only a handful of groups in the US and UK have entered Phase 3. 

Their plans for deployment are, as of now, a bit less ambitious than Russia’s. In the United States, the Trump administration partnered with the private sector to deliver 300 million doses by January 2021. And China has already offered an experimental vaccine to employees of state-run companies.

The first country to prove it can produce an effective vaccine could win billions of dollars in foreign investment. The Russian satellite will be announced as Sputnik V, a nod to the world’s first satellite, Sputnik 1, introduced through the Soviet Union in 1957, intensifying the 20-year regional race with the United States.  

As many as 20 countries have already expressed interest, putting Sputnik V at the forefront of a biotech Cold War, something doctors like Offit fear.

“This pandemic has been an equal opportunity employer,” Offit said. “This virus affects all nations, all ethnic backgrounds, all religious groups. We should all be brought together in this effort because all of us are at risk. What Putin has done is political theater.”

Russia’s vaccine is being developed at the Gamaleya Institute in Moscow. 

But in July, U. S. , British and Canadian intelligence services accused Russian hackers of trying to borrow vaccine-related data from researchers abroad, according to the New York Times.

There have also been widespread reports that scientists injected themselves with the prototype and rushed through other tests to speed up the development.

Peter Hotez, a vaccine researcher at Baylor University, has studied vaccines against other coronaviruses for decades and says the way nations solve a global pandemic is by cooperating.

“When people talk about a race, I tell them to be careful what they wish for, because history tells us that if you look at the modern history of the US vaccination program, the first vaccines are replaced in one or two years for larger vaccines. “, said.

“I think we want to move away from this history, of course, from this nationalism around vaccines, calling them the American vaccine, the Chinese vaccine or the British vaccine. It doesn’t look like that.

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