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," President Vladimir Putin announced 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.
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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 deputy prime minister Tatiana Golikova.
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 three clinical trial or mass vaccination of the general public – is being proposed,” she said.
Ripped up rules
US secretary of health and human services Alex Azar 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."
Kirill Dmitriev, head of RDIF, said western criticisms of Russia's vaccine development were designed to "discredit and conceal the correctness" of Moscow's research.
“Instead of constantly attacking Russia ... they would be better advised to enter into a constructive dialogue with us and provide their citizens in the near future with a high-quality and safe drug that actually saves lives and can halt the pandemic,” he said.
Moscow had previously vowed it would win the race to develop and approve an effective vaccine. The government has ripped up typical rules for the length of trials in an attempt to get the vaccine ready for use, as part of efforts to limit the pandemic’s damage on its economy.
Russia has also received "preliminary applications" from 20 countries for more than one billion doses of the vaccine, said Mr Dmitriev, and inked agreements with five countries to produce 500 million doses a year. Trials of the vaccine are set to take place in the UAE, Saudi Arabia and the Philippines.
Philippine president Rodrigo Duterte said in a speech on Monday evening that he had accepted an offer from Russia to supply his country with free Covid-19 vaccines once mass production began.
“When the vaccine arrives, in public, so no one will doubt, I will get injected,” he said. “If it’s okay with me, it’s okay with everyone.”
Immune systems
Research institutes, pharmaceutical companies and state agencies around the world are working on more than 100 potential vaccines to protect against Covid-19, which has infected more than 20 million people and killed more than 700,000.
The Russian vaccine uses a harmless human adenovirus to carry coronavirus genes into people and prime their immune system to recognise and resist Covid-19 infection. Moscow said its vaccine used two different adenovirus vectors across two injections, boosting its effectiveness.
Several other adenovirus vaccines are being developed around the world, including one from Oxford university and AstraZeneca, the UK pharmaceuticals group.
"Results [from clinical trials] proved the high efficiency and safety of the vaccine," said Russia's health minister, Mikhail Murashko. "All volunteers developed high levels of Covid-19 antibodies. At the same time, none of them demonstrated serious complications from the immunisation." – Copyright The Financial Times Limited 2020