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

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.

Posted on August 11, 2020, at 10:50 a.m. ET

Alexey Nikolsky / Getty Images

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."

🇷🇺 #Russia registers world's first #COVID19 🧪 #vaccine. 🌟 It is based on adenovirus & contains dead #coronavirus particles which cannot multiply and are therefore #safe. It has successfully passed all clinical trials stages. 🦸‍♂️ Ready or not #COVID19, here comes the vaccine!

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.

Dmitriev said Phase 3 testing for the vaccine will begin Wednesday in Russia and will also take place abroad. Officials have said teachers and healthcare workers in the country will be among the first to be able to take the vaccine.

There are two vaccines in development that are currently in Phase 3 trials and are being closely watched. The vaccines, one by the University of Oxford and AstraZeneca and one from the biotechnology company Moderna and the US National Institute of Health, both showed promising early results.

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