President Vladimir Putin has announced that Russia has become the first to register a vaccine to eliminate COVID-19.
Putin said the vaccine, approved by Russia’s health department, was named Sputnik V, after the Russian satellite Sputnik 1 that beat the US into orbit in 1957 during the Cold War.
He also said one of his two adult daughters already was inoculated and that the vaccine underwent the necessary tests and was shown to provide lasting immunity to the coronavirus, Associated Press reported.
“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 the vaccine, made by the Gamaleya Research Institute, has only been tested in relatively small groups of people. It has not yet completed the third phase of clinical trials, which are designed to demonstrate that vaccines can work safely in the general population. Russia plans to vaccinate volunteers, including medical workers and teachers, while those phase III trials are underway.
“Why are all corporations following the rules, but Russian ones aren’t? The rules for conducting clinical trials are written in blood. They can’t be violated,” Svetlana Zavidova, executive director of Russian nonprofit Association of Clinical Trials Organizations, told Bloomberg News on Monday. “This is a Pandora’s Box and we don’t know what will happen to people injected with an unproven vaccine.”
The Russian vaccine uses a live, weakened virus to inject genetic material from the coronavirus into human cells. This triggers an immune response that should help protect people against coronavirus infection in the future. It’s the same method being used by Oxford University and AstraZeneca in their vaccine. It’s also the same technique used in China’s CanSino vaccine, which was recently approved for use in China’s military, even after seeing mixed results in earlier trials.
Russia was reported to be behind disinformation campaigns to sow doubts in U.S. about our Covid vaccines; and today’s news that they “approved” a vaccine on the equivalent of phase 1 data may be another effort to stoke doubts or goad U.S. into forcing early action on our vaccines https://t.co/WR6xPkFcfJ
— Scott Gottlieb, MD (@ScottGottliebMD) August 11, 2020
The vaccine has been tested in phase 1 studies, according to the World Health Organization’s COVID-19 vaccine tracker. Vaccine expert Florian Krammer tweeted that he “certainly would not take a vaccine that hasn’t been tested in Phase 3,” adding that Russia is putting healthcare workers and others at risk.
AstraZeneca has stated it might be known by the end of this month whether or not the vaccine is effective. A single successful trial showing efficacy would allow a regulator to approve the vaccine for emergency use — which would probably pave the way for use in high-risk groups around October.
Ugur Sahin, BioNTech’s CEO and Co-founder, said at the company’s second quarter results that it could seek approval “as early as October” for its vaccine BNT162, created in partnership with Pfizer.