From Nature News, 7 July 2021:
Russia’s COVID-19 vaccine, Sputnik, has been the subject of fascination and controversy since the Russian government authorized its use last year, before early-stage trial results were published. Evidence from Russia and many other countries now suggests it is safe and effective — but questions remain about the quality of surveillance for possible rare side effects.
Sputnik V — also known as Gam-COVID-Vac — was the first COVID-19 vaccine to be registered for use in any nation, and it has since been approved in 67 countries, including Brazil, Hungary, India and the Philippines. But the vaccine — and its one-dose sibling Sputnik Light — has yet to receive approval for emergency use from the European Medicines Agency (EMA) or the World Health Organization (WHO). Approval by the WHO is crucial for widespread distribution through the COVID-19 Vaccines Global Access (COVAX) initiative, which is providing doses for lower-income nations.
Developed by scientists at the Gamaleya National Research Center of Epidemiology and Microbiology in Moscow, the vaccine was authorized for use by the Russian Ministry of Health on 11 August 2020, more than a month before phase I and II trial results were published, and before the phase III trial had even begun.
The scientific community greeted Russian President Vladimir Putin’s announcement of the vaccine’s registration with outrage. “If the government’s going to approve a vaccine before they even know the results of the trial, that does not build confidence,” says epidemiologist Michael Toole at the Burnet Institute in Melbourne, Australia. Read more.