Russia’s unverified coronavirus vaccine



 Russia has launched a new Sputnik — this time, a vaccine to combat the coronavirus.

Russian President Vladimir Putin announced in a televised cabinet meeting August 11 that the country is ready to roll out the world’s first COVID-19 vaccine to the general public. Teachers and doctors may be among the first inoculated.

Dubbed Sputnik-V, after the first artificial satellite, the vaccine has been tested in only a small number of people. The  announcement came even though no published information is available about the vaccine’s safety and efficacy, and scientists have yet to complete the final phase of clinical testing to determine whether it works. Nonetheless the vaccine has been submitted to the health ministry for registration, comparable to applying for approval from the U.S. Food and Drug Administration.

It “works quite effectively. It forms a stable immunity,” Putin declared.

Researchers around the world have been racing to create a vaccine (SN: 7/10/20), but none have been thoroughly vetted yet. Russia has tried various tactics to get in front of the competition, with hackers in the country reportedly trying to steal vaccine data from the United States, Great Britain and Canada. Being the first to approve a vaccine may be a matter of national pride, but the declaration of victory may be premature, some vaccine researchers say.

Usually, vaccines go through three phases of clinical tests. The first two phases test the vaccine in small numbers of people for safety and may collect data on whether people make antibodies or have other responses to the vaccine. The third phase tests the vaccine in thousands of people to determine whether it lowers the infection rate. That third phase of testing has not even started for the Russian vaccine.

In an open letter to the minister of health, the Moscow-based Association of Clinical Trial Organizations urged the government to delay approval of the vaccine until after Phase III data is in.

“Without that data, it seems reckless to proceed to approving the vaccine,” says virologist Onyema Ogbuagu of the Yale School of Medicine. He is leading Phase III testing at Yale of a vaccine candidate from the drug company Pfizer.

While information is limited about Russia’s COVID-19 vaccine, here’s what we know so far.


How does the vaccine work?

Researchers at the Moscow-based Gamaleya Research Institute of Epidemiology and Microbiology, part of the Russian Health Ministry, developed the two-part vaccine. Both parts start with viruses that cause the common cold. Those viruses, adenovirus 5 and adenovirus 26, were each engineered to make the coronavirus’ spike protein. That protein helps the coronavirus latch on to cells and infect them. Since it is on the surface of the virus, it’s also a target for antibodies against the virus.

This approach is similar to other coronavirus vaccines in the works. The University of Oxford working with AstraZeneca uses a chimpanzee adenovirus. And a vaccine devised by China-based CanSino Biologics Inc. is based on adenovirus 5. Johnson & Johnson uses adenovirus 26 for its vaccine. Those vaccines have gone through initial safety tests where participants made antibodies against the virus and didn’t have any serious side effects (SN: 7/21/20).

According to the latest trial information on Sputnik-V, available at clinicaltrials.gov, a U.S. website that tracks clinical trials, 38 people first got a shot containing the engineered adenovirus 26 component. Three weeks later, they received booster injections of the engineered adenovirus 5 component. Results of the study have not yet been published.

Using two adenoviruses instead of one is unusual, but may help solve a potential problem, says Daniel Kuritzkes, a virologist and infectious diseases doctor at Brigham and Women’s Hospital in Boston. Because the body may develop antibodies to the virus carrying the spike protein, a booster shot with that same virus might be rendered useless. The two-step inoculation with different adenoviruses may sidestep that issue.


How many people have been tested?

It’s unclear. The registered trial tested 38 people. That’s “in the ballpark . . . to make sure it doesn’t kill people, essentially,” Ogbuagu says. “That’s a good number for a Phase I study, but that’s just the beginning of vaccine development,” he says.

Russian business people and politicians, including one of Putin’s daughters, have also been given access to the vaccine, Bloomberg reports. And the Russian military completed Phase II tests of the vaccine in July, First Deputy Defense Minister Ruslan Tsalikov said in an interview published in the Argumenty i Fakty newspaper.

Usually, Phase II studies test a vaccine in hundreds of people. But the letter from the clinical trials association says the vaccine has been tested in fewer than 100 people. By contrast, multiple vaccines around the world are now starting Phase III tests with 30,000 people each. Now ask yourself do you trust Russia? 

Russia’s unverified coronavirus vaccine Russia’s unverified coronavirus vaccine Reviewed by Anson Moore on August 11, 2020 Rating: 5

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