MOSCOW, Russia — Russia on Tuesday became the first country to approve a coronavirus vaccine, a move that was met with international scepticism and unease because the shots have only been studied in dozens of people.
President Vladimir Putin announced the Health Ministry’s approval and said one of his two adult daughters already was inoculated. He said the vaccine underwent the necessary tests and was shown to provide lasting immunity to the coronavirus, although Russian authorities have offered no proof to back up claims of safety or effectiveness.
“I know it has proven efficient and forms a stable immunity,” Putin said. “We must be grateful to those who made that first step very important for our country and the entire world.”
However, scientists in Russia and other countries sounded an alarm, saying that rushing to offer the vaccine before final-stage testing could backfire. What’s called a Phase 3 trial — which involves tens of thousands of people and can take months — is the only way to prove if an experimental vaccine is safe and really works.
By comparison, vaccines entering final-stage testing in the U.S. require studies of 30,000 people each. Two vaccine candidates already have begun those huge studies, with three more set to get underway later this year.
“Fast-tracked approval will not make Russia the leader in the race, it will just expose consumers of the vaccine to unnecessary danger,” said Russia’s Association of Clinical Trials Organisations, in urging government officials to postpone approving the vaccine without completed advanced trials.
While Russian officials have said large-scale production of the vaccine – dubbed “Sputnik V” after the Soviet satellite – wasn’t scheduled until September, Deputy Prime Minister Tatyana Golikova said vaccination of doctors could start as early as this month. Officials say they will be closely monitored after the injections. Mass vaccination may begin as early as October.
“We expect tens of thousands of volunteers to be vaccinated within the next months,” Kirill Dmitriev, chief executive of the Russian Direct Investment Fund that bankrolled the vaccine, told reporters.
The vaccine developed by the Gamaleya Institute in Moscow with assistance from Russia’s Defence Ministry uses a different virus – the common cold-causing adenovirus – that’s been modified to carry genes for the “spike” protein that coats the coronavirus, as a way to prime the body to recognise if a real Covid-19 infection comes along.
That’s a similar technology as vaccines being developed by China’s CanSino Biologics and Britain’s Oxford University and AstraZeneca — but unlike those companies, Russian scientists haven’t published any scientific information about how the vaccine has performed in animal tests or in early-stage human studies.
Dmitriev said even as Russian doctors and teachers start getting vaccinated, advanced trials are set to start Wednesday that will involve “several thousand people” and span several countries, including the United Arab Emirates, Saudi Arabia, the Philippines and possibly Brazil.
Putin said one of his daughters has received two doses, and had minor side effects such as slight fever, and is now “feeling well and has a high number of antibodies.” It wasn’t clear if she was one of the study volunteers.
The Health Ministry said in a statement Tuesday that the vaccine is expected to provide immunity from the coronavirus for up to two years, citing its experience with vaccines made with similar technology.
However, scientists around the world have been cautioning that even if vaccine candidates are proven to work, it will take even more time to tell how long the protection will last.
“The collateral damage from release of any vaccine that was less than safe and effective would exacerbate our current problems insurmountably,” Imperial College London immunology professor Danny Altmann said in a statement Tuesday.
The World Health Organisation has urged that all vaccine candidates go through full stages of testing before being rolled out, and said Tuesday it is in touch with the Russian scientists and “looks forward to reviewing” Russia’s study data. Experts have warned that vaccines that are not properly tested can cause harm in many ways — from harming health to creating a false sense of security or undermining trust in vaccinations.
Becoming the first country in the world to approve a vaccine was a matter of national prestige for the Kremlin as it tries to assert the image of Russia as a global power. Putin repeatedly praised Russia’s effective response to the outbreak in televised addresses to the nation, while some of Moscow’s top officials – including the country’s prime minister and Putin’s own spokesperson – became infected.
And the U.S., Britain and Canada last month accused Russia of using hackers to steal vaccine research from Western labs. Russia has denied involvement.
Russia has so far registered 897,599 coronavirus cases, including 15,131 deaths.
The Gamaleya Institute’s director, Alexander Gintsburg, raised eyebrows in May when he said that he and other researchers tried the vaccine on themselves before the start of human studies.
Those trials started June 17 with 76 volunteers. Half were injected with a vaccine in liquid form and the other half with a vaccine that came as soluble powder. Some in the first group were recruited from the military, which raised concerns that servicemen may have been pressured to participate. The test was declared completed earlier this month.
“It’s a too early stage to truly assess whether it’s going to be effective, whether it’s going to work or not,” said Dr. Michael Head, senior research fellow in global health at England’s University of Southampton.
It’s not Russia’s first controversial vaccine. Putin has bragged that Russian scientists delivered an Ebola vaccine that “proved to be the most effective in the world” and “made a real contribution to fighting the Ebola fever in Africa.” However, there is little evidence either of the two Ebola vaccines approved in Russia was widely used in Africa. As of 2019, both of those vaccines were listed by the WHO as “candidate vaccines.”
With Russia’s announcement that it had become the first country to approve a vaccine against Covid-19, here is a look at the more than two dozen other candidates currently in development:
The WHO says there are 26 “vaccine candidates” currently undergoing clinical trials worldwide.
Several are in the final phase 3 stage, whereby developers — testing on large cohorts, up to tens of thousands of people — monitor for efficacy and potential toxicity prior to eventual submission for approval.
These include a European project being developed at Oxford University in tandem with AstraZeneca and a Chinese variant from biopharmaceutical company Sinovac in collaboration with Brazilian research institute Butantan.
The latter is being tested on 9,000 health professionals in Brazil.
A vaccine developed by Germany’s BioNTech and US pharma giant Pfizer entered phase 3 last month, with the companies planning to test it on 30,000 young volunteers.
The American firm Moderna also says it plans to trial its vaccine among 30,000 people.
Since mid-July China’s Sinopharm has begun testing its candidate on 15,000 people in the United Arab Emirates.
Beyond the tests already under way, the WHO is monitoring a further 139 potential vaccines which are still at the pre-clinical evaluation stage, involving testing in the lab or on animals.
US biotech company Novavax said last week its experimental Covid-19 vaccine had elicited a robust immune response, producing more antibodies than are present in recovered patients.
It said the candidate vaccine was generally well tolerated among volunteers.
The final stage Phase 3 trial of the product, called NVX-CoV2373, is set to take place this autumn.
The European Union has ordered 300 million doses of potential vaccine from French drug producer Sanofi, and the US has said it will pay $2.1 billion for its development.
Britain has also ordered 60 million doses of the Sanofi vaccine, developed in conjunction with GSK. – AP/AFP