Russia grants new drug regulatory approval amid concerns
Russian President Vladimir Putin said on Tuesday that Russia had 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 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 percent 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 2020.
Government officials have said it will be administered to medical personnel, and then to teachers, on a voluntary basis at the end of August 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 novel 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.
Authorities hope it will allow the Russian economy, which has been battered by the fallout from the virus, to return to full capacity.
Kirill Dmitriev, head of Russia’s sovereign wealth fund, said Russia had received foreign requests for 1 billion doses, and the vaccine was also expected to be produced in Brazil.
Dmitriev said clinical trials were expected to start soon in the United Arab Emirates and the Philippines. Philippine President Rodrigo Duterte has said he is willing to participate personally.
The approval by the health ministry comes before the start of a larger trial involving thousands of participants, commonly known as a Phase III trial.
Such trials, which require a certain proportion of participants to catch the virus to observe the vaccine’s effect, are normally considered essential precursors for a vaccine to receive regulatory approval.
The Moscow-based Association of Clinical Trials Organizations (ACTO) this week urged the ministry to postpone approval until that final trial had been successfully completed.
In a letter to the ministry, it said there were high risks associated with registering a drug before that happened.
Some international experts have also questioned the speed at which Russia approved its vaccine.
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.
Russian President Vladimir Putin chairs a meeting with members of the government in a teleconference call at the Novo-Ogaryovo state residence outside Moscow, on Tuesday. Putin claims Russia has developed the first vaccine offering sustainable immunity against the novel coronavirus. Photo: AFP
