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

• The Russian coronavirus vaccine may not be available soon in the US or the UK.
• According to the data published on Tuesday, the shot was 91.6% effective in preventing COVID-19.
• Going through the U.S. regulatory process is “honestly not a priority for us,” Kirill Dmitriev, chief executive of the Russian Direct Investment Fund, told Insider.
• Visit Business Insider’s homepage for more stories.

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

Applications for approval in the US and UK are not a priority, a leader of Russia’s vaccination program said in an exclusive interview on Tuesday. Russia has instead entered into deals to sell doses to countries that are more receptive to the vaccine, he said.

The two-dose vaccine, called Sputnik V, was 91.6% effective in preventing COVID-19 in a trial of 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 should not make decisions from US or UK health regulators anytime soon.

Kirill Dmitriev, CEO of the Russian Direct Investment Fund, said “it is not a priority for us to go through the US regulatory process. He added that no discussions had yet taken place with regulators at the U.S. Food and Drug Administration, the agency responsible for investigating drugs.

The RDIF is one of the world’s largest sovereign wealth funds and oversaw and funded the development of Sputnik V. While scientists from the Gamaleya Institute in Russia developed the shot, the RDIF took the lead on the final stages of development, including working with regulators, negotiating supply deals and building up manufacturing.

Although the US and UK markets are not priorities, the European Union remains a possibility, Dmitriev said. German Chancellor Angela Merkel has offered help 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 to tango,” says Dmitriev

Leaders of the Russian vaccination program spoke to officials from Operation Warp Speed ​​in August 2020, the ambitious vaccination initiative launched by President Donald Trump, Dmitriev said. The Russian team offered to cooperate, especially to test Sputnik V in combination with other precursors of vaccines.

“It really did not go well, I think, due to obvious political constraints to cooperate with Russia,” he said.

“We are open to this, but there are two to tango,” Dmitriev added. “We put our openness out there through Business Insider and see if the US is willing to tackle it.”

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. While vaccine experts have since expressed skepticism about the program, Dmitriev hopes the data published in The Lancet will earn more confidence in the shot.

In the UK, Dmitriev said the application for approval depends on the success of a planned trial using Sputnik V in combination with a vaccine developed by AstraZeneca and the University of Oxford. The combination study could begin enrolling volunteers as early as next week, he said.

“If it shows a high level of efficiency, we would like to approach the UK with it, of course with AstraZeneca,” he said.

The study will take months to complete, and before that time, Dmitriev said Russia would not apply for British authorization.

Russia expects to produce 700 million doses by 2021

Alexander Zemlianichenko Jr / Russian Direct Investment Fund via AP

Russia has already reached a handful of supply agreements with other countries, none of which are the largest Western powers. Dmitriev said he expects to produce 700 million doses of the two-dose shot by 2021, and the program has already been ‘overwritten’ with supply with other countries.

“For now, we’re focused on markets that look at who we are on the merits of data, on the merits of our platform,” Dmitriev said, “and of course something with the UK, something with Europe, something with the US a great political not of us, but of them.

Sixteen foreign 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 expected Sputnik V to be registered in 25 countries by next week.