Putin claims first coronavirus vaccine without providing evidence

Unlike similar vaccines being developed elsewhere, Russia has moved ahead with approving a version before completing so-called phase 3 clinical trials.

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By Linda Givetash and Matthew Bodner

Russian President Vladimir Putin announced Tuesday that Russia has registered the world's first coronavirus vaccine with state regulators for use.

While Putin said it had “proven efficient” and “passed all the necessary tests,” no data has been published by researchers for peer review and the long-term effects of the treatment remained unclear.

The new vaccine — called Sputnik V — comes after the country boasted intentions to win the global race for a COVID-19 vaccine in recent weeks by jumping ahead of established pharmaceutical practices.

The name of the vaccine is a nod to the Space Race between Cold War rivals the Soviet Union and the United States, which that began in the 1950s with the launch of the Russian satellite Sputnik 1.

“As far as I know, this morning, for the first time in the world, a vaccine against a new coronavirus infection has been registered," Putin told a meeting of government ministers.

Russian President Vladimir Putinduring a video conference meeting at the Novo-Ogaryovo residence outside Moscow.Alexei Druzhinin / AP file

Kirill Dmitriev, head of the Russian Direct Investment Fund, which is financing the vaccine trials, applauded the vaccine in a statement on Tuesday saying it would help countries emerge from the crisis of the pandemic.

He also called for international cooperation on the vaccine, including with the United States, as the two countries did with the Apollo-Soyuz space mission in the 1970s.

Last week, Dmitriev told NBC News that the vaccine is a "copycat" of the Ebola vaccine developed five years ago by Moscow's Gamaleya Institute and a tweaked version of an earlier vaccine against the Middle East respiratory syndrome virus.

Putin said one of his two adult daughters has already taken the vaccine — although he didn't specify whether it was Maria or Katerina who received it.

She had an increased temperature on the day of the first vaccine injection, Putin said, but it dropped the following day. A second injection also caused a slight increase in temperature, but that also went away.

“She’s feeling well and has high number of antibodies,” Putin added.

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Unlike similar vaccines, such as one being developed by the University of Oxford and AstraZeneca, Russia has moved ahead with approving its version before completing so-called Phase 3 clinical trials, which are due to begin later this month.

Instead, the first groups of people to be vaccinated — doctors, teachers and high-risk individuals — will be under some kind of observation, health officials have previously said.

In effect, Russia will be conducting its Phase 3 trials live, treating it more as a demonstrator group than a control group meant to ensure there is nothing dangerous awaiting the larger population.

The first two phases involved just a few dozen volunteers.

Phase 3 trials will be conducted not only in Russia but in partner countries including the United Arab Emirates and Saudi Arabia, Dmitriev said in Tuesday's statement.

Russia, along with its foreign partners, is also preparing to manufacture 500 million doses of the vaccine annually. The country is also working with humanitarian assistance organizations to get its vaccine to poor countries, Dmitriev said.

The Russian vaccine also differs from Oxford's by using so-called adenovirus vectors from humans rather than monkeys, Dmitriev has said.

A combination of two vectors — one being tested in U.S. trials and another being tested in China — were used to make the Russian vaccine.

"The Chinese and American companies each have half of the Gamaleya vaccine. But it is the use of these two vectors at once that makes it unique, highly efficient and long-lasting," he said.

Dmitriev also addressed criticism of the vaccine, blaming Western countries for "constantly attacking Russia."

"The politicized approach to Russia’s vaccine by a number of Western countries endangers the lives of their citizens," he said.

Instead, he said, the West should "enter into a constructive dialogue with us" in order to provide the vaccine to their citizens.

Health workers can voluntarily begin to receive vaccinations this month, Russian officials said. As production ramps up in September and October, it will be offered to more at-risk groups before becoming widely available in January.

The Associated Press contributed to this report.