Russia has become the first country to grant regulatory approval to a COVID-19 vaccine after less than two months of human testing, a move Moscow likened to its success in the Cold War-era space race.
The Russia COVID-19 vaccine, which will be called “Sputnik V” in homage to the world’s first satellite launched by the Soviet Union, has however not yet completed its final trials.
Moscow’s decision to grant approval before then has raised concerns among some experts. Only about 10% of clinical trials are successful and some scientists fear Moscow may be putting national prestige before safety.
Putin and other officials have said it is completely safe. The president said one of his daughters had taken it as a volunteer and felt good afterwards.
“I know that it works quite effectively, forms strong immunity, and I repeat, it has passed all the necessary checks,” Putin told a government meeting.
The Russian business conglomerate Sistema has said it expects to put the vaccine, developed by Moscow’s Gamaleya Institute, into mass production by the end of the year.
Government officials have said it will be administered to medical personnel, and then to teachers, on a voluntary basis at the end of this month or in early September. Mass roll-out in Russia is expected to start in October.
The vaccine is administered in two doses and consists of two serotypes of a human adenovirus, each carrying an S-antigen of the new coronavirus, which enter human cells and produce an immune response.
The platform used for the vaccine was developed by Russian scientists over two decades and had formed the basis for several vaccines in the past, including those against Ebola.
U.S. Health Secretary Alex Azar, asked about Russia’s announcement, said safety was paramount and late-stage trials were key. He said the United States was on track for an effective vaccine by the end of the year, with six candidates under development.
“The point is not to be first with a vaccine. The point is to have a vaccine that is safe and effective,” Azar said on ABC News’ “Good Morning America” programme.
“We hope it’s true, but as is so often the case with Russia: trust but verify,” White House Council of Economic Advisers Acting Chairman Tyler Goodspeed said on Fox Business Network, referencing a Russian proverb cited by former U.S. president Ronald Reagan in negotiations with the Kremlin.
More than 100 possible COVID-19 vaccines are being developed around the world. At least four are in final Phase III human trials, according to WHO data.