A Russian health care regulator has become the first in the world to approve a vaccine for the coronavirus, President Vladimir Putin announced Tuesday, though the vaccine has yet to complete clinical trials.
The Russian dash for a vaccine has already raised international concerns that Moscow is cutting corners on testing to score political and propaganda points. Last week, the World Health Organization warned Russia not to stray from the usual methods of testing a vaccine for safety and effectiveness.
Putin’s announcement became essentially a claim of victory in the global race for a vaccine, something Russian officials have been telegraphing for several weeks despite the absence of published information about any late-phase testing.
“It works effectively enough, forms a stable immunity and, I repeat, it has gone through all necessary tests,” Putin said at a Cabinet meeting Tuesday morning. He thanked the scientists who developed the vaccine for “this first, very important step for our country, and generally for the whole world.”
Western regulators have said repeatedly that they do not expect a vaccine to become widely available before the end of the year at the earliest. Regulatory approval in Russia, well ahead of that timeline, could become a symbol of national pride and provide a much needed political lift for Putin.
The Russian president has seen a steady decline in his popularity under the weight of the pandemic and a faltering economy.
The Russian vaccine, along with many others under development in a number of countries in the effort to alleviate a worldwide health crisis that has killed at least 734,900 people, sped through early monkey and human trials with apparent success.
Vaccines generally go through three stages of human testing before being approved for widespread use. The first two phases test the vaccine on relatively small groups of people to see if it causes harm and if it stimulates the immune system. The last phase, known as phase 3, compares the vaccine to a placebo in thousands of people.
This final phase is the only way to know with statistical certainty whether a vaccine prevents an infection. And because it’s testing a much larger group of people, a phase 3 trial can also pick up more subtle side effects of a vaccine that earlier trials could not.
The US Food and Drug Administration has said that a new coronavirus vaccine would need to be 50% more effective than a placebo to be approved.
Russia’s President Vladimir Putin discusses the environmental situation in the town of Usolye-Sibirskoye in Irkutsk region during a video conference call with officials at the Novo-Ogaryovo state residence outside Moscow, Russia July 30, 2020. Sputnik/Alexei Nikolsky/Kremlin via REUTERSRussia’s President Vladimir Putin discusses the environmental situation in the town of Usolye-Sibirskoye in Irkutsk region during a video conference call with officials at the Novo-Ogaryovo state residence outside Moscow, Russia July 30, 2020. Sputnik/Alexei Nikolsky/Kremlin via REUTERSThe Russian scientific body that developed the vaccine, the Gamaleya Institute, has yet to conduct phase 3 tests on tens of thousands of volunteers in highly controlled trials, a process seen as the only method of ensuring a vaccine is actually safe and effective. Around the world, more than 30 vaccines out of a total of more than 165 under development are now in various stages of human trials.
The Russian vaccine uses two strains of adenovirus that typically cause mild colds in humans. They are genetically modified to cause infected cells to make proteins from the spike of the new coronavirus. The approach is similar to a vaccine developed by Oxford University and AstraZeneca that has shown promise in early testing and is now undergoing phase 3 tests in Britain, Brazil and South Africa.
Russia’s minister of health, Mikhail Murashko, has said the country will begin a mass vaccination campaign in the fall, and said Tuesday that it would start with teachers and medical workers this month.
The WHO maintains a comprehensive list of worldwide vaccine trials. In the latest version of the list, there is no Russian phase 3 trial.
The organisation is in close contact with Russian authorities and discussing its prequalification procedures, Tarik Jasarevic, a spokesman, told reporters in Geneva on Tuesday, but he emphasised that to obtain this seal of approval would require “rigorous review of safety and efficacy data” derived from clinical trials.
Last week, a spokesman for the organisation, Christian Lindmeier, cautioned that all vaccines should go through full testing before being released to the public.
“There are established practices and there are guidelines,” he said. Any vaccine, he added, “should be, of course, going through all the various trials.”
The Russian Ministry of Health did not respond to detailed written questions sent last week about human trials and research into potentially harmful side effects.
Russia has already used the vaccine race as a propaganda tool, even in the absence of published scientific evidence to support its claims as the front-runner.
For the last several months, state television has promoted the idea that Russia is leading the competition. In May, it reported that the first person in the world to be vaccinated against the virus was a Russian researcher who had injected himself even before monkey trials had been completed.
Russia tested the vaccine on soldiers, raising concerns about consent, though the Ministry of Defence said that all the soldiers had volunteered.
The United States, Canadian and British governments have all accused Russian state hackers of trying to steal vaccine research, casting a shadow over Russia’s claim to have achieved a medical breakthrough. Russian officials have denied the accusation and say their vaccine is based on a design developed by Russian scientists to counter Ebola years ago.
Kirill Dmitriev, the head of a government-controlled fund that invested in the vaccine, denied Russia had cut corners on testing or stolen intellectually property to get ahead.
In an interview last month, Dmitriev said Russia relied on a legacy of once formidable research into viruses and vaccines in the Soviet Union and focused on established technologies, like the approach already used for the Ebola vaccine.
He contrasted that history with Trump administration’s Operation Warp Speed program, which is financing research by Pfizer and Moderna for a genetic vaccine and supporting a variety of other experimental technologies.
If Russian scientists have taken an unorthodox route to the coronavirus vaccine, it would not be the first time. Back in the 1950s, a team of researchers tested a promising, and ultimately successful, polio vaccine on their own children.
