Russia unveils coronavirus vaccine, claiming victory in global race before final testing is complete

MOSCOW — Russian President Vladimir Putin announced Tuesday that the country has become the first to approve a coronavirus vaccine, developed by the Gamaleya Institute in Moscow, with production and tens of thousands of inoculations to follow.

SOURCE: Washington Post

Officials have pledged to vaccinate millions of people, including teachers and front line health-care workers, with the experimental coronavirus vaccine beginning this month, raising global alarm that the country is jumping dangerously ahead of critical, large scale testing that is essential to determine if it is safe and effective.

Russian officials have said that a second vaccine from the state research center in Siberia, Vector, is not far behind.

“Of course, what counts most is for us to be able to ensure the unconditional safety of the use of this vaccine and its efficiency in the future. I hope that this will be accomplished,” Putin said at a meeting with government members Tuesday, adding that his own daughter had been inoculated with the Gamaleya vaccine.

Kirill Dmitriev, head of the Russian Direct Investment Fund that bankrolled the country’s vaccination effort, said that the vaccine will be named “Sputnik,” a reference to the first orbital satellite, which was launched by the Soviet Union and started the great Cold War space race.

The aggressive strategy from a country eager to declare a victory amid one of the worst outbreaks in the world has been criticized by outside scientists who worry that shots could be harmful or give people a false sense of security about their immunity. China has already authorized one vaccine for use in its military, ahead of definitive data that it is safe and effective.

At a congressional hearing this month, Anthony S. Fauci, director of the National Institute of Allergy and Infectious Diseases testified that it would be problematic if countries made a vaccine available before extensive testing.

“I do hope that the Chinese and the Russians are actually testing the vaccine before they are administering the vaccine to anyone, because claims of having a vaccine ready to distribute before you do testing, I think, is problematic at best,” Fauci said.

The leading Russian vaccine candidate has so far been tested in small, early clinical trials designed to find the right dose and assess any safety concerns. It was given to scientists who developed it — in self-experimentation that is unusual in modern science — 50 members of the Russian military and a handful of other volunteers.

Dmitriev said last week Russia will go ahead with Phase III for the Gamaleya vaccine once it is registered by the country’s Health Ministry. In addition to the Russian trial, parallel ones will also be conducted in Saudi Arabia, the United Arab Emirates and possibly Brazil, he said. But while that testing is still ongoing, Russia intends to start vaccinating willing front-line medical workers and teachers, who will be asked to document how they’re feeling.

“We will have tens of thousands of people already vaccinated like this in August,” Dmitriev said.

The World Health Organization still lists the Gamaleya vaccine as being in Phase I. Asked about Russia’s vaccine developments, WHO spokesman Christian Lindmeier told reporters in Geneva last week that any vaccine should go “through all the various trials and tests before being licensed for rollout,” adding that “between finding or having a clue of maybe having a vaccine that works, and having gone through all the stages, is a big difference.”

Russia’s vaccine uses two doses to deliver different harmless cold viruses, or adenoviruses, that have been engineered to carry into cells the gene for the spiky protein that studs the outside of the coronavirus. The approach is also being used by scientists at the pharmaceutical giant Johnson & Johnson, the Chinese company CanSino Biologics and the University of Oxford in their vaccine candidates.

 But those other efforts have published data on how vaccines perform in animals that range from mice to monkeys, and also presented data from early human trials showing the severity of any reactions, ranging from soreness at the injection site to fevers. The CanSino vaccine uses one of the same harmless viruses the Russians are using in its vaccine, and its results have been disappointing to some scientists.

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