Russia rushes registration of unproven coronavirus vaccine

[Karlston]

Russia rushes registration of unproven coronavirus vaccine

The drug, nicknamed ‘Sputnik V,’ has not completed critical clinical trials 

Russian President Vladimir Putin leads a government meeting on August 11th, where he announced that Russia would move forward with distributing its experimental coronavirus vaccine.

Photo by Alexey Nikolsky / Sputnik / AFP via Getty Images

Russian President Vladimir Putin announced on Tuesday that Russia had registered a coronavirus vaccine — but that vaccine is still widely considered unproven, as it has not completed critical clinical trials to prove that it is safe and effective.

 

Putin also claimed that one of his daughters had received the vaccine. “She has taken part in the experiment,” Putin said, according to The Associated Press. So far, the vaccine, made by the Gamaleya Institute, has only been tested in relatively small groups of people. It has not yet completed the third phase of clinical trials, which are designed to demonstrate that vaccines can work safely in the general population.

 

Instead, Russia plans to vaccinate volunteers, including medical workers and teachers, while those phase III trials are still underway, according to The Washington Post.

 

“Why are all corporations following the rules, but Russian ones aren’t? The rules for conducting clinical trials are written in blood. They can’t be violated,” Svetlana Zavidova, executive director of Russian nonprofit Association of Clinical Trials Organizations, told Bloomberg News on Monday. “This is a Pandora’s Box and we don’t know what will happen to people injected with an unproven vaccine.”

 

The Russian vaccine uses a live, weakened virus to inject genetic material from the coronavirus into human cells. This triggers an immune response that should help protect people against coronavirus infection in the future. It’s the same method being used by Oxford University and AstraZeneca in their vaccine. It’s also the same technique used in China’s CanSino vaccine, which was recently approved for use in China’s military, even after seeing mixed results in earlier trials.

 

Countries and research institutions all over the world are racing to be the first to create a vaccine to halt the current coronavirus pandemic. As of Tuesday morning, the virus has infected more than 20 million people worldwide and killed more than 730,000. But experts worry that rushing an untested vaccine to market could have serious consequences.

 

“I do hope that the Chinese and the Russians are actually testing the vaccine before they’re administering the vaccine to anyone,” Anthony Fauci said at a congressional hearing last month.

 

There are three major worries with releasing an unproven vaccine to the public. If the vaccine is unsafe or has severe side effects, then it could harm people, upending their lives. If the vaccine doesn’t work, then people could move through the world with a false sense of security, potentially exacerbating the spread of disease. And if either of those things happens, there’s a very serious risk that people’s distrust of vaccines will skyrocket, making it harder for public health officials to halt future disease outbreaks — not just this one.

 

“Trust in the process of developing new drugs and new medicines is fragile,” Alex John London, director of the Center for Ethics and Policy at Carnegie Mellon University, told The Verge last week. “We can’t put it in jeopardy.”

 

Russia appears to be less concerned with trust in the drug development process and more focused on being first to approve a vaccine for public use. In an echo of the Cold War, the vaccine is nicknamed “Sputnik V,” after the first satellite. Some experts worry that the move will create pressure for other countries to cut corners in similar ways. The Russian approval “may be another effort to stoke doubts or goad U.S. into forcing early action on our vaccines,” Scott Gottlieb, former head of the US Food and Drug Administration, said on Twitter.

 

 

The approval comes after accusations last month that Russian hackers were targeting vaccine development in the UK, US, and Canada. Russia denied the claims, and shortly afterward, it announced that it would quickly move its vaccine into phase III trials, with plans to distribute the vaccine widely starting in October.

 

Putin claimed during the announcement that the vaccine worked “effectively enough.” But there’s still almost no data to support that claim, which just isn’t good enough for many experts.

 

“Science takes a while,” Karen Maschke, editor of the journal Ethics & Human Research, told The Verge last week. Maschke was concerned that Russia’s plans to move ahead with vaccine approval before completing phase III trials might pressure other countries, including the US, to do the same. “We decided in this country that we’re going to go through a process that takes longer. And that’s hard to do sometimes when you have pressure because you’re saying, ‘Billy’s mom let him stay up too late. Why can’t I,’” Maschke says. “I think in the political world, that’s going to be a problem.”

 

Russia is now gambling that its unproven vaccine will work, staking the lives and well-being of its president’s daughter, a handful of soldiers, and, soon, teachers and medical workers in the process. It remains to be seen how that bet will pay off.

 

Additional reporting by Nicole Wetsman.

 

 

Russia rushes registration of unproven coronavirus vaccine

 

[Karlston]

Russia skips COVID-19 vaccine trial, says millions to be vaccinated this month

Despite lack of data, design pitfall, Putin said his daughter was already given a dose.

Enlarge / The unproven vaccine candidate has been dubbed "Sputnik V"

Aurich Lawson / Getty Images

175 with 105 posters participating

Russian President Vladimir Putin announced Tuesday that Russia is the first country in the world to grant regulatory approval for a COVID-19 vaccine—dubbed “Sputnik V.”

 

Putin claimed that one of his own daughters has already received a dose of the vaccine, according to reports from Moscow—though he didn’t note which daughter. Russian officials pledged to vaccinate millions within the month, starting with healthcare workers and teachers.

 

Little is known about Sputnik V, which was developed by researchers at the Gamaleya Institute in Moscow. There is no public data on the vaccine, let alone any published, peer-reviewed scientific studies. Public registration of two small clinical trials notes that Sputnik V uses a viral-vector-based design, but they suggest that it has only been tested in a small number of people. The trials, which began less than two months ago, each enrolled 38 healthy volunteers and have an estimated study completion date of August 15.

 

The World Health Organization, which tracks international COVID-19 vaccine development efforts, lists Sputnik V as being only in the first of three main clinical trial phases. Generally, Phase I clinical trials for vaccines are small—typically only involving dozens of people—and only assess the safety of the candidate. Phase II trials may involve hundreds of people and look further at safety, dosing, and the immune responses that the vaccine triggers, which may hint at the vaccine’s possible efficacy. Then there is the Phase III trial, which often involves tens of thousands of people and looks at whether the vaccine protects against infection and disease.

 

It appears that Russia has skipped Phase III—and possibly has not finished Phase II yet.

 

In a meeting Tuesday, Putin reportedly said that “of course, what counts most is for us to be able to ensure the unconditional safety of the use of this vaccine and its efficiency in the future. I hope that this will be accomplished.”

Dubious design

There may already be reason to doubt the efficacy of Sputnik V. The vaccine is a viral vector-based vaccine. That is, it uses two harmless adenoviruses to deliver parts of the pandemic coronavirus, SARS-CoV-2, to the immune system. This is a common design, but it's one that has a notable pitfall.

 

Adenoviruses in humans tend to cause mild infections and common colds. For vaccine delivery, they’re usually engineered so they can’t replicate, making them even more harmless. Russian researchers further tinkered with the adenovirus so that it carries the genetic coding for SARS-CoV-2’s spike protein.

 

The aptly named spike protein is a barb-like structure that juts out from the viral particle and is critical for infection. The spike protein grabs ahold of a receptor on human cells called ACE2 (angiotensin-converting enzyme 2), which allows the virus to get into the cell, take over, and churn out more viral particles. By delivering the spike protein in the adenovirus, researchers are hoping it trains antibodies and defensive immune cells to seek and destroy SARS-CoV-2 by recognizing the spike proteins.

 

Several other high-profile COVID-19 vaccine candidates use this basic strategy—but there’s a catch. Sputnik uses adenoviruses that commonly infect humans. In people who have already been infected with these common viruses, the vaccine may not prompt a strong immune response against the spike protein if immune cells recognize the adenovirus packaging and respond to it instead.

Crazy Russians

This appeared to be the case for a Chinese vaccine candidate developed in part by biotechnology company CanSino. The company’s human adenovirus-based vaccine prompted weaker immune responses to SARS-CoV-2 in people with existing adenovirus immune responses. And in some populations, up to 80 percent of people have had exposure to the human adenovirus the researchers used in the vaccine. Nevertheless, China is pushing ahead with the vaccine, which is now moving to Phase III trials and is already approved for use by the Chinese military.

 

Another high-profile vaccine developed by the University of Oxford and the international pharmaceutical company AstraZeneca also uses an adenovirus-based delivery. But they dodged the problem of adenovirus immunity by using an adenovirus that primarily infects chimpanzees. The vaccine candidate, which is largely considered more promising by experts, is already in Phase III clinical trials.

 

As for Sputnik V, Phase III trials are going to start soon, according to Kirill Dmitriev, head of the Russian Direct Investment Fund, which financially backed the vaccine’s development. Dmitriev, who spoke with a Moscow-based Washington Post reporter, also said that data from Phase I and Phase II trials will be published later this month—as the vaccine is being distributed to citizens.

 

He defended the country’s decision to distribute the vaccine before critical clinical trials, saying, “It’s not some crazy Russians using some crazy not proven stuff. Adenovirus existed with humans for thousands of years, and we made a bet on this proven platform because we understand that it takes very little time to develop, given the challenges.”

 

Last month, officials in the US, UK, and Canada accused hackers linked to Russian intelligence services of trying to steal information about candidate COVID-19 vaccines from academic researchers and pharmaceutical companies. It is “completely unacceptable that the Russian intelligence services are targeting those working to combat the coronavirus pandemic," Dominic Raab, UK foreign secretary, said at the time. A spokesperson for Putin denied the allegations.

 

 

Russia skips COVID-19 vaccine trial, says millions to be vaccinated this month

 

[dufus]

’Why didn’t Putin take it?’: Biomedical doctor explains why Russia’s vaccine ‘is a dangerous thing for them to do’  source

 

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