US, UK approvals not a priority for Russia COVID-19 vaccine Sputnik V.

• The Russian coronavirus vaccine is unlikely to be available in the US or UK any time soon.
• The intake was 91.6% effective in preventing COVID-19, according to data published Tuesday.
• Going through the US regulatory process is “frankly not a priority for us,” Kirill Dmitriev, CEO of the Russian Direct Investment Fund told Insider.
• Visit the Business Insider homepage for more stories.

The Russian coronavirus vaccine is very effective, but it will not be available in the US or the UK anytime soon, a top Russian official told Insider.

Getting regulatory approval in the US and UK is not a priority, a leader of the Russian vaccine program said in an exclusive interview on Tuesday. Russia has instead entered into agreements to sell doses to countries more receptive to the vaccine, he said.

The two-dose vaccine, called Sputnik V, was 91.6% effective at preventing COVID-19 in a trial involving nearly 20,000 volunteers, according to interim results published Tuesday in The Lancet, a top medical journal. Although the vaccine has already been approved in more than a dozen countries, you shouldn’t expect any short-term decisions from US or UK health regulators.

Going through the US regulatory process is “frankly not a priority for us,” said Kirill Dmitriev, CEO of the Russian Direct Investment Fund. He added that there have been no discussions with regulators at the U.S. Food and Drug Administration, the agency responsible for assessing drugs.

The RDIF is one of the world’s largest sovereign wealth funds and has overseen and funded the development of Sputnik V. While scientists at the Gamaleya Institute in Russia developed the shot, the RDIF has been leading the final stages of development, including working with regulators, negotiating supply agreements and ramping up production.

While the markets in the US and UK are not priorities, the European Union remains an option, Dmitriev said. German Chancellor Angela Merkel has offered assistance with applying for an application to the European Medicines Agency, Dmitriev said.

Read More: What’s Next for COVID-19 Vaccines? Here’s the latest on 11 leading programs.

“Requires two for tango,” says Dmitriev

Leaders of the Russian vaccine program spoke with officials at Operation Warp Speed, President Donald Trump’s ambitious vaccine initiative, in August 2020, Dmitriev said. The Russian team offered to cooperate, particularly in testing Sputnik V in conjunction with other vaccine frontrunners.

“It didn’t really work out much, I think, because of the obvious political limitations of the cooperation with Russia,” he said.

“We’re open to this, but tango needs two,” added Dmitriev. “We’re communicating our openness through Business Insider and seeing if the US is willing to take this on.”

The Russian program received international attention on August 11, 2020, when President Vladimir Putin announced that the shot had been approved, although studies had yet to be completed at a late stage. Although vaccine experts have since expressed skepticism about the program, Dmitriev hopes the data published in The Lancet will gain more confidence in the shot.

In the UK, Dmitriev said applying for approval will depend on the success of a planned trial using Sputnik V in conjunction with a vaccine developed by AstraZeneca and the University of Oxford. That combination study could begin enrolling volunteers next week, he said.

“If that shows a high level of efficacy, we will be happy to approach the UK with that, together with AstraZeneca, of course,” he said.

That study will take months, and before that, Dmitriev said Russia will not apply for a UK license.

Russia expects to produce 700 million doses by 2021

Alexander Zemlianichenko Jr / Russian Direct Investment Fund through AP

Russia has already signed a handful of supply agreements with other countries, none of them major Western powers. Dmitriev said he expects to produce 700 million doses of the 2-dose shot by 2021 and the program is already “oversubscribed” with supply agreements with other countries.

“For now, we’re focused on markets that look at who we are on the merit of data, on the merit of our platform,” said Dmitriev, “and obviously something with the UK, something with Europe, something with the US would be a major political overtones not ours but theirs. “

Sixteen other countries or sovereign states have already approved Russia’s shot: Belarus, Argentina, Bolivia, Serbia, Algeria, Palestine, Venezuela, Paraguay, Turkmenistan, Hungary, United Arab Emirates, Iran, Guinea and Tunisia. Dmitriev said he expects the Sputnik V to be registered in 25 countries by the end of next week.