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Experts worry that the approval is prioritizing the economy and national prestige over safety.
Russia is the first country worldwide to grant regulatory approval of a vaccine for the novel coronavirus disease 2019 (COVID-19), President Vladimir Putin announced today.1
However, the vaccine, named Sputnik V, has undergone less than 2 months of testing in humans and still requires the completion of its phase 3 trial; experts have voiced concerns at the speed of the vaccine approval.1
According to a Reuters report, health care workers in Russia who have been treating COVID-19 will have the opportunity to volunteer to be vaccinated in the next few weeks.1
According to Reuters, Kirill Dmitriev, head of Russia’s sovereign wealth fund, said that Russia has already received requests from other nations in the amount of 1 billion doses for the COVID-19 vaccine. Russia has entered into international agreements securing 500 million doses annually, with production taking place in Brazil.1
“I know that it works quite effectively, forms strong immunity, and I repeat, it has passed all the needed checks,” said Putin in response to apprehensions on the safety of the vaccine and the speed of approval. The president also supported the expedited approval by assuring that his daughter was administered the vaccine.1
Gamaleya Institute, the Russian scientific body that developed the vaccine, has yet to conduct large-scale phase 3 testing in highly-controlled trials. Additional clinical trials are expected to start soon in the United Arab Emirates and the Philippines. According to WHO data, the Gamaleya vaccine is stilled listed as being in phase 1.2
Last week, the World Health Organization (WHO) cautioned that Russia should not bypass the standard means of testing vaccine safety and efficacy in the pursuit of a COVID-19 vaccine.
The Association of Clinical Trials Organizations, a trade body based in Moscow of the country’s leading drug developers, pressured the country’s health ministry to prioritize safety over national pride and competition, and to delay the approval until the final trial results can be evaluated, including data on adverse reactions in patients with weakened immunities and comorbid conditions.1
“Of course, what counts most is for us to be able to ensure the unconditional safety of the use of this vaccine and its efficiency in the future. I hope that this will be accomplished,” Putin said at a meeting with government members today.2