Russia Approves Coronavirus Vaccine, Says Vladimir Putin. But questions remain over its safety

“A vaccine against coronovirus has been recorded for the first time in the world this morning,” Putin said on state TV. “I know that it works quite effectively, it creates a stable immunity.”

Putin said that one of his daughters had already taken it; She stated that her temperature was slightly higher after each dose, but this is: “She feels better now.”

Developed by the Moscow-based Gamalaya Institute, the vaccine is named Sputnik-V, with reference to the 1957 launch of the world’s first satellite by the Soviet Union. It is yet to undergo critical phase 3 trials where it will be administered to thousands of people.

The claim of victory by Putin in a global push to create an effective vaccine against Kovid-19 comes amid suggestions that Russia has cut corners necessary in its development.

Critics say the country’s push for the vaccine is partly due to political pressure from the Kremlin, which is eager to portray Russia as a global scientific force.

Russian President Vladimir Putin announced the approval of the Sputnik-V vaccine during a teleconference meeting with members of his government on August 11, 2020.

Russia has not released any scientific data on its testing and CNN is unable to verify the claimed safety or effectiveness of the vaccine.

Despite this, Russian officials told CNN that at least 20 countries and some US companies have expressed interest in the vaccine.

Kirill Dimitric, head of the Russian Direct Investment Fund (RDIF), which financed the vaccine’s research, said interest had been received from other countries for more than a billion doses of the vaccine.

“We have seen a lot of interest in the Russian vaccine developed abroad by the Gamalaya Institute. In addition, we have received over 1 billion doses of the vaccine from 20 countries,” he said on Tuesday.

“With our foreign partners, we are already ready to manufacture more than 500 million vaccines per year in five countries, and the plan is to increase production capacity even more. So far, Latin America, the Middle East and Asia Countries have demonstrated the greatest interest in the vaccine, and we are finalizing several contracts for the purchase of the vaccine. ”

Dimitriz said the Phase III vaccine would begin in Russia on Wednesday, and they would be in other countries as well.

“We have already reached agreements on conducting relevant trials of the Gamaleya vaccine [abroad] With partners from the UAE, Saudi Arabia and many other countries, ”he said.

Security concerns

Two-component vials of Russia's Kovid-19 vaccine - named Sputnik-V - developed by the Gamalaya Institute in Moscow.

Russia enacted a law in April, which eliminated the need for critical Phase 3 trials to be conducted before approval. This has allowed researchers to fast-track the vaccine development process.

Experts have voiced Moscow’s rapid approval process for the vaccine.

“It is unclear exactly what is happening with the Russian vaccine,” Michael Head, Senior Research Fellow in Global Health at the University of Southampton, UK, told Science Medical Center.

“It is important that the general public has confidence in any vaccine roll-out, and that there is good communication of the level of effectiveness and any potential side effects. At this time, there is no data in Russian-led. The global health community’s Vaccine for investigation. ”

Danny Altman, a professor of immunology at Imperial College London, told the Science Media Center that there were concerns about releasing a vaccine before a thorough trial.

“This phase is necessarily too high for a criterion that must be satisfied for approval after Phase 3 clinical trials,” said Altman. “The collateral damage resulting from the release of any vaccine that was less than safe and effective will exacerbate our current problems. I hope these criteria have been followed. We’re all in this together.”

But Moscow has allayed concerns about the safety of the vaccine.

“According to the results, the vaccine has shown high efficiency and safety. All volunteers have developed high [tiers] Russian-Health Minister Mikhail Murashko said antibodies to Kovid-19, while neither of them showed serious complications of vaccination.

Other tests underway

Russia is one of several countries producing vaccines for Kovid-19, which has now infected more than 20 million people, killing more than 730,000 people worldwide.
An employee of the Russian biotech company BIOCAD, which is developing its own coronavirus vaccine, and doing another work in collaboration with the country's virus research center.

There are 25 other vaccines in the clinical evaluation phase of development and another 139 candidate vaccines in the preclinical evaluation phase according to the World Health Organization.

Closely watched vaccines in development include the University of Oxford and AstraZeneca, and biotechnology company Modern and the US National Institutes of Health. Both have shown promising results and phase 3 trials are currently underway.

In June, the Chinese government approved the use of an experimental coronavirus vaccine for the country’s military. The vaccine, known as Ad5-nCoV, was developed jointly by the Beijing Institute of Biotechnology – part of the Chinese government’s Academy of Military Medical Sciences – and the vaccine company CanSino Biologics.

Previous results of the Ad5-nCoV tests published in the medical journal The Lancet were met with lukewarm response by experts.

Earlier this month, the Kremlin denied allegations that Russian spies stole hacked vaccination development secrets at American, Canadian and British research laboratories.

Correction: This story has been updated to reflect the date on which Kirill Dimitrik talked about the vaccine.

CNN’s Matthew Chance and Ben Westcott contributed to this report.