Russia’s health minister dismissed rising international concerns over safety of the COVID-19 vaccine that was granted regulatory approval on Tuesday.
The announcement on Tuesday was made by President Vladimir Putin, who said the vaccine had passed all the required checks and his daughter had already been given it.
The rushed announcement with no backing evidence has tremendously worried the experts around the world.
In June, the Gamaleya Research Institute of Epidemiology and Microbiology at the Health Ministry of the Russian Federation registered a combined Phase 1 and 2 trial on a vaccine called Gam-COVID-Vac Lyo. The locally developed vaccine was set for mass manufacturing after being tested only on 76 volunteers. According to the internationally recognized standards for vaccine trials, Russian vaccine has passed only stage one out of three, which cannot guarantee its safety and efficacy. Moreover, the results of the studies on Russian vaccine or any preclinical data have not been published.
At the third stage of trials researchers give the vaccine or a placebo to tens of thousands of people, and wait for them to encounter the virus in the real world.
The Gamaleya researchers said the vaccine was made from an adenovirus, a harmless cold virus carrying a coronavirus gene, similar to what AstraZeneca and Johnson & Johnson are using in their vaccines. The technology is still relatively new: The first adenovirus vaccine for any disease was approved for Ebola in June.
According to the vaccine’s Russian-language registration certificate, all 38 participants who received one or two doses of the vaccine had produced antibodies against SARS-CoV-2’s spike protein, including potent neutralizing antibodies that inactivate viral particles. These findings are similar to results of early-stage trials of Chinese researchers at CanSino Biologics in Tianjin. Side effects were also similar, such as fever, headache and skin irritation at the site of injection.
Unlike experimental drugs given to the sick, vaccines are intended to be given to masses of healthy people. So they must clear a high bar of safety standards. On a global scale it means that the rarest side effect, observed within the first or the second phase of vaccine trials, can eventually impair thousands of people.
“This is a reckless and foolish decision. Mass vaccination with an improperly tested vaccine is unethical. Any problem with the Russian vaccination campaign would be disastrous both through its negative effects on health, but also because it would further set back the acceptance of vaccines in the population,” Francois Balloux, a geneticist at University College London, said in a statement distributed by the UK Science Media Centre.
“That the Russians may be skipping such measures and steps is what worries our community of vaccine scientists. If they get it wrong it could undermine the entire global enterprise,” says Peter Hotez, a vaccine scientist at Baylor College of Medicine in Houston, Texas.
Comments from Kremlin towards the concerns of the international medical community came as a condescending mock.
“It seems our foreign colleagues are sensing the specific competitive advantages of the Russian drug and are trying to express opinions that… are absolutely groundless,” Russia’s Health Minister Mikhail Murashko told the Interfax news agency on Wednesday.
The controversy around Putin’s announcement created suspicions of the statement being purely a part of political game.
“This is all beyond stupid,” said John Moore, a virologist at Weill Cornell Medical College in New York City. “Putin doesn’t have a vaccine, he’s just making a political statement.”
However, for Russian scientists ignoring the procedure in sake of political gain does not come as a surprise, nor does it cause any professional or ethical rejection.
In the interview for TV Rain Russian virologist Anatoliy Epstein told that he ”trusts the scientists” who worked on the Russian vaccine as he is ”personally acquainted” with a team, and does not see a problem with disregarding the required testing stages for political purposes.
The head of a Russian government-supported investment fund said the vaccine would go through phase III testing in the United Arab Emirates, Saudi Arabia and other countries, according to the state-owned TASS Russian News Agency. The official said that purchase requests for 1 billion doses had been received by 20 countries, in Latin America, the Middle East, Asia and elsewhere, and that manufacturing was in place to produce 500 million doses, with more capacity in the works.
The first clinical trials on coronavirus vaccines started in March, and now there are 29 underway,
All other Phase 3 trials of coronavirus vaccines currently underway are more than ten times larger than that, with 30,000 volunteers apiece.