Russia has become the first country to grant regulatory approval to a vaccine against Covid-19, with mass production and immunisation of key workers to begin in the next few weeks. The move, the first time a Covid-19 vaccine has been approved for civilian use, comes after just two months of human trials and underscores Moscow’s desire to rush the vaccine through testing and trial procedures at breakneck speed in an attempt to beat western pharmaceutical companies.
“This morning, for the first time in the world, a vaccine against the coronavirus infection has been registered,” announced President Vladimir Putin at a televised meeting with government officials on Tuesday. “I know that it works quite effectively, it forms a stable immunity. I repeat: it has passed all the necessary tests,” he said, adding that his own daughter had already been given the vaccine. Vaccinations of medical workers could begin as soon as this month, said Russian officials.
But western experts have cast doubt on the Russian claims, questioning Russia’s ability to develop and approve a safe and effective Covid-19 vaccine even more quickly than projects in Europe, China, and the US that are proceeding at full speed. They also criticised Russian regulators and vaccine developers for failing to make scientific and technical information available for independent assessment. “Everyone else in the world is publishing details of their vaccines and clinical trial protocols but it has been very hard to find out much about the Russian vaccine,” said Danny Altmann, professor of immunology at Imperial College London. “We need a completely open, global assessment of different vaccine candidates. ”
The Russian vaccine, which will be marketed with the name Sputnik V, was developed by the state-run Gamaleya Institute in Moscow and financed by Russian Direct Investment Fund. It was developed using the same technology as previous vaccines developed by the institute to combat Ebola and Mers.
Trials of the vaccine will continue even as it begins to be distributed to the public, the government said. Vaccinations for medical workers are expected to begin at the end of the month or in early September, according to Tatiana Golikova, deputy prime minister. But Eleanor Riley, professor of immunology at Edinburgh university, said: “There is a big difference between a large vaccine trial, with careful and frequent follow up of all vaccinated individuals, and deployment of a vaccine to the general public. “The current messaging from Russia is very unclear as to which of these two deployments – a large phase 3 clinical trial or mass vaccination of the general public – is being proposed,” she said.
Alex Azar, secretary of health and human services, also challenged the Russian announcement. “The point is not to be first with the vaccine, the point is to have a vaccine that is safe and effective for the American people and the people of the world,” he said in a television interview. “We need transparent data and it’s got to be phase three data that shows that the vaccine is safe and effective.”