Russia approves vaccine, Putin hopes to begin mass production

Critic calls decision to proceed without thorough testing ‘dangerous and grossly immoral’

President Vladimir Putin said Russia cleared the world’s first COVID-19 vaccine for use and hopes to begin mass inoculation soon, even before clinical testing has finished.

“The first registration has taken place,” Putin said Tuesday at a televised government meeting, adding that one of his daughters has already been given the vaccine. “I hope that we can soon begin mass production.”

The move paves the way for widespread use of the vaccine among Russia’s population, with production starting next month, although it may take until January to complete trials. Medical workers could begin receiving the drug by the end of the month, Deputy Prime Minister Tatyana Golikova said at the meeting.

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The announcement represents a propaganda coup for the Kremlin amid a global race to develop vaccines against the coronavirus pandemic and accusations that Russian hackers sought to steal international drug research. The disease has killed nearly 750,000 people, infected more than 20 million and crippled national economies. Companies including AstraZeneca Plc and Moderna Inc. are still conducting final-stage trials of their vaccines in studies that are expected to soon yield results.

“Making a vaccine available before even publishing something in a peer-reviewed journal is a violation of Basic Vaccinology 101,” said Arthur Caplan, the director of medical ethics at NYU School of Medicine. “What they are doing is dangerous and grossly immoral.”

Russia indicated how it regards the development, naming the vaccine Sputnik V in a nod to the Soviet Union’s achievement in launching the world’s first satellite into space in 1957.

Russia has nearly 900,000 people diagnosed with COVID-19, the fourth-most confirmed cases in the world. It had more than 27,000 coronavirus-related deaths in the second quarter, according to Federal Statistics Service data published this week.

The speed with which the vaccine has received regulatory approval has drawn criticism, with a local association of multinational pharmaceutical companies calling the rushed registration risky.

“This is a political decision by Putin so he can claim that Russia was the first in the race to develop a COVID-19 vaccine,” said Svetlana Zavidova, executive director of Russia’s Association of Clinical Trials Organizations. “I can’t understand why Russia needs to build this Potemkin village.”

The vaccine is being developed by Moscow’s Gamaleya Institute, the Defense Ministry and the sovereign Russian Direct Investment Fund, which have said it is undergoing Phase 3 trials, the final stage of testing during which thousands of people are inoculated to determine its fitness for use. A World Health Organization database lists the vaccine as still only in Phase 1 testing, the earliest stage.

RDIF chief Kirill Dmitriev has dismissed criticism that the developers haven’t published peer-reviewed results.

“This vaccine platform has been tried for the last six years, and this makes it very different from many novel approaches used by some other players,” Dmitriev said in an interview on Bloomberg TV, adding that 100 people were involved in the first two phases. “President Putin mentioned his daughter took the vaccine. Myself, my wife, my parents were also vaccinated.”

RDIF will be able to produce more than 500 million doses a year in five countries, with mass immunizations in Russia planned to begin in October, according to Dmitriev.

The fund plans to conduct Phase 3 clinical trials in Saudi Arabia, the United Arab Emirates, Brazil, India and the Philippines, according to the Sputnik V website. Mass production is lined up in India, South Korea, Brazil, Saudi Arabia, Turkey and Cuba, it said, with at least 20 countries interested in obtaining supplies.

WHO spokesman Christian Lindmeier said last week that all vaccine candidates should adhere to established practices and finish clinical trials before being made widely available.

The Russian candidate is a viral vector vaccine based on a human adenovirus —such as the common cold virus —fused with the spike protein of SARS CoV-2 to stimulate an immune response and is similar to one developed by China’s CanSino Biologics.

“Giving powerful people the first access doesn’t instill confidence, it illustrates how unfair and not scientific this project is,” said NYU’s Caplan. “This is indicative of the problems that emerge when politics drive vaccine science.”

— Jake Rudnitsky and Ilya Arkhipov

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