Russia approved coronavirus vaccine, says Vladimir Putin. But questions about his safety remain


“A coronavirus vaccine has been registered for the first time in the world this morning,” Putin told state television. “I know it works quite effectively. It forms a stable immunity.”

Putin admitted that one of his daughters had already taken it; he said that after each dose she had a slightly higher temperature, but that: “Now she feels good.”

Developed by the Moscow-based Gamaleya Institute, the vaccine is named Sputnik-V, a reference to the 1957 surprise of the world’s first satellite by the Soviet Union. It has yet to go through major Phase 3 trials where it would be administered to thousands of people.

Putin’s claim of victory in the global pressure to create an effective vaccine against Covid-19 comes amid suggestions that Russia has cut key corners in its development.

Critics say the country’s pressure for a vaccine is due in part to political pressure from the Kremlin, which is envious of portraying Russia as a global scientific force.

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

Russia has not released scientific data on its tests and CNN is unable to verify the apparent security or effectiveness of the vaccine.

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

Kirill Dmitriev, head of the Russian Direct Investment Fund (RDIF), which funds the vaccine 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 by the Gamaleya Institute abroad. In addition, we have received preliminary applications for more than 1 billion doses of the vaccine from 20 countries,” he said on Tuesday.

“Together with our foreign partners, we are already ready to produce more than 500 million doses of vaccine per year in five countries, and the plan is to increase production capacity even higher. So far, countries in Latin America, the Central East and Asia have shown the greatest interest in the vaccine, and we are in the process of finalizing a number of contracts for the purchase of the vaccine. “

Dmitriev said phase 3 investigations of the vaccine would begin Wednesday in Russia, and that they would take place in other countries as well.

“We have already reached agreements on conducting the relevant investigations of the Gamaleya vaccine [abroad] with partners from the UAE, Saudi Arabia, and a number of other countries, “he said.

Concerns about safety

Vials containing the two components of the Russian Covid-19 vaccine - called Sputnik-V - developed by the Gamaleya Institute in Moscow.

Russia enacted a law in April, eliminating the requirement for key Phase 3 trials to be conducted before approval. This has allowed researchers to track the process of developing vaccines.

Experts have expressed concern over Moscow’s rapid approval process for the vaccine.

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

“It is important that every fax dispatcher has the trust of the general public, and that there is good communication about the level of effectiveness and all the likely side effects. At present, there is no data on the Russian leadership. vaccine for the global health community to control. “

Danny Altmann, professor of immunology at Imperial College London, told the Science Media Center that there were concerns about releasing a vaccine before it was fully tested.

“The bar is necessarily very set for criteria that must be met for approval after clinical three phase 3,” Altmann said. “The collateral damage by releasing any vaccine that was less than safe and effective would inexplicably increase our current problems. I hope these criteria are followed. We are all together in this.”

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

“According to the results, the vaccine has shown high efficiency and safety. All volunteers developed highly [tiers] of antibodies against Covid-19, while not showing any of its serious complications of immunization, “said Russian Public Health Minister Mikhail Murashko.

Other trials along the way

Russia is just one of many countries in a hurry to produce a vaccine for Covid-19, which has now infected more than 20 million people, and killed more than 730,000 worldwide.
An employee of the Russian biotech company BIOCAD, which is developing its own vaccine for coronavirus, is working on another one in conjunction with the Center for Virus Research.

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

Close-up vaccines in development include one from the University of Oxford and AstraZeneca and another from the biotechnology company Moderna and the US National Institute of Health. Both have shown promising results and are currently Phase 3 testing.

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

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

Earlier this month, the Kremlin denied allegations of Russian spies hacked into US, Canadian and British research laboratories to steal fax development secrets.

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

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

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