US and UK approvals are not a priority for the Russian vaccine COVID-19 Sputnik V

• The Russian coronavirus vaccine is unlikely to be available in the United States or the United Kingdom anytime soon.
• The injection was 91.6% effective in preventing COVID-19, according to data published on Tuesday.
• Going through the US regulatory process “frankly is not a priority for us,” said Kirill Dmitriev, CEO of the Russian Direct Investment Fund.
• Visit the Business Insider home page for more stories.

Russia’s coronavirus vaccine is highly effective, but it will not be available in the United States or the United Kingdom anytime soon, a senior Russian official told Insider.

Applying for regulatory approval in the United States and the United Kingdom is not a priority, a Russian vaccine program leader said in an exclusive interview on Tuesday. Instead, Russia struck deals to sell doses to countries that are more receptive to the vaccine, he said.

The two-dose vaccine, dubbed Sputnik V, was 91.6% effective in preventing COVID-19 in a trial of nearly 20,000 volunteers, according to provisional results published Tuesday in The Lancet, a leading medical journal. Although the vaccine has already been authorized in more than a dozen countries, do not wait for decisions soon from US or UK health regulators.

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

RDIF is one of the largest sovereign wealth funds in the world and oversaw and financed the development of Sputnik V. While scientists at the Gamaleya Institute in Russia developed the shot, RDIF took the lead in the final stages of development, including working with regulators , negotiating supply agreements and increasing production.

While the U.S. and UK markets are not a priority, the European Union remains a possibility, said Dmitriev. German Chancellor Angela Merkel offered to help sign up with the European Medicines Agency, Dmitriev said.

Read more: What’s next for COVID-19 vaccines? Here are the latest news from the top 11 programs.

‘Requires two to dance the tango’, says Dmitriev

Russia’s vaccine program leaders spoke in August 2020 with officials from Operation Warp Speed, the ambitious vaccine initiative launched by President Donald Trump, said Dmitriev. The Russian team offered to work together, mainly testing Sputnik V in combination with other pioneering vaccines.

“It wasn’t much, I think, because of the obvious political restrictions on working with Russia,” he said.

“We are open to this, but it takes two to dance the tango,” added Dmitriev. “We are publicizing our opening through Business Insider and seeing if the United States is willing to take this on.”

The Russian program gained international attention on August 11, 2020, when President Vladimir Putin announced that the injection was approved, although studies at an advanced stage have not yet been completed. Although vaccine experts have expressed skepticism about the program since then, Dmitriev hopes that the data published in The Lancet will generate more confidence in the injection.

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

“If this shows a high level of effectiveness, we would be happy to approach the UK with this, obviously in conjunction with AstraZeneca,” he said.

That study will take months to run, and before that, Dmitriev said that Russia will not seek authorization from the United Kingdom.

Russia expects to produce 700 million doses in 2021

Alexander Zemlianichenko Jr / Russian Direct Investment Fund via AP

Russia has already closed a handful of supply agreements with other countries, none of which are major Western powers. Dmitriev said he expects to produce 700 million doses of the 2-dose dose by 2021 and that the program is already “overwhelmed” with supply agreements with other nations.

“For now, we are focused on markets that look at who we are for the merit of the data, for the merit of our platform,” said Dmitriev, “and obviously something with the UK, something with Europe, something with the USA would be of great importance. political connotations not of us, but of them. “

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