Vladimir Putin said Tuesday that his own daughter has taken a new Russian-developed coronavirus vaccine – the first in the world to be approved for use, and now set to be rolled out in a widespread public inoculation campaign.
But others aren’t so confident, amid concerns at home and internationally that Russia is cutting corners in the rush to win the global arms race for an effective COVID-19 vaccine.
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In comments broadcast on Russian state television, Putin said that the vaccine – developed by Moscow’s Gamaleya Institute, and named “Sputnik V” after a Soviet satellite – had undergone necessary testing and was safe to use.
“As far as I know, a vaccine against a new coronavirus infection has been registered this morning, for the first time in the world,” he said. “I know that it works quite effectively, it forms a stable immunity and, I repeat, has passed all the necessary checks.”
The Russian leader said one of his adult daughters had been vaccinated, developing a slight increase in temperature after both shots, before returning to normal.
“She’s feeling well and has a high number of antibodies,” he said.
Amid global desperation for a vaccine to end the pandemic, the Russian announcement has generated excitement in some quarters. Russia has reportedly received requests from more than 20 countries for 1 billion doses of the vaccine, according to Kirill Dmitriev, the head of Russia’s sovereign wealth fund, which funded the country’s vaccine efforts. Among them is the Philippines, whose president Rodrigo Duterte said he would be the first to take the vaccine when it arrived in the country.
“When the vaccine arrives, I will inject it publicly. Experiment with me, that’s fine. If it works on me, it will work on everyone,” he said in a televised speech late Monday.
But others are skeptical about the fast-tracked, experimental new vaccine, which has been granted regulatory approval for civilian use without the extensive Phase III testing that’s standard ahead of a public rollout, to ensure the product is safe and offers effective protection against a virus.
Putin had earlier ordered officials to speed up clinical trials for potential coronavirus vaccines, in pursuit of a scientific breakthrough that would be a huge boon to Russia’s national prestige.
According to the Food and Drug Administration’s Center for Biologics Evaluation and Research, which is responsible for regulating vaccines in the United States, Phase III trials typically involve thousands of subjects.
Yet the Russian vaccine has been registered after less than two months of human testing, with less than 100 people having been given the inoculation by early August, according to reports. Doses were reportedly given to the scientists who developed it, 50 members of the military and various other volunteers.
Now that the vaccine has been approved, Russian officials are planning a large-scale vaccination campaign. It will first be offered to doctors, teachers and other frontline workers, who will be asked to document how they respond to the shots, officials said.
But the fast-tracking of the vaccine — which uses adapted strains of the adenovirus, a virus that usually causes the common cold — has prompted warnings both in Russia and abroad.
A Russian association of pharmaceutical companies warned the health minister in a letter Monday that the race to release the vaccine before extensive trials were conducted could be dangerous.
“The rules for conducting clinical trials are written in blood. They can’t be violated,” Svetlana Zavidova, executive director of the Association of Clinical Trials Organizations, told Bloomberg. “This is a Pandora’s Box, and we don’t know what will happen to people injected with an unproven vaccine.”
Michael Head, senior research fellow in global health at the University of Southampton, said Russia had released no scientific data for the global health community to assess.
“It is unclear precisely what is actually happening with the Russian vaccine,” he told VICE News. He added that vaccines that are hastily released without a clear explanation of how they work risk failing to gain the confidence of the public, which could have a significant effect on public health.
Duncan Matthews, professor of intellectual property law at Queen Mary University of London, also sounded a note of caution.
“News of a potential COVID-19 vaccine is to be welcomed, but safety must be the priority,” he said. “The U.S. Food and Drug Administration and the European Medicines Agency have fast-track approval procedures for emergency humanitarian use, and we need to see evidence that Russia is adopting an equally prudent approach.”
More than 100 coronavirus vaccines are currently in development around the world, with at least four in final Phase III trials, according to the World Health Organisation.
