In a startling and confusing move, Russia claimed today it had approved the world's first COVID-19 vaccine, as the nation's Ministry of Health issued what's called a registration certificate for a vaccine candidate that has been tested in just 76 people. The certificate allows the vaccine, developed by the Gamaleya Research Institute of Epidemiology and Microbiology in Moscow, to be given to "a small number of citizens from vulnerable groups," including medical staff and the elderly, a Ministry of Health spokesperson tells ScienceInsider. But the certificate stipulates that the vaccine cannot be used widely until 1 January 2021, presumably after larger clinical trials have been completed.

Scientists around the world immediately denounced the certification as premature and inappropriate, as the Gamaleya vaccine has yet to complete a trial that convincingly shows it is safe and effective in a large group of people. Even some within Russia challenged the move. "It's ridiculous," says Svetlana Zavidova, a lawyer who heads the Association of Clinical Research Organizations in Russia. "I feel only shame for our country." Zavidova, who has worked on clinical trials for 20 years and anticipated the approval, yesterday sent an appeal to the Ministry of Health to postpone registering the vaccine until proper efficacy trials are completed. "Accelerated registration will no longer make Russia a leader in this race, it will only expose end users of the vaccine, citizens of the country of the Russian Federation, to unnecessary danger," she wrote on behalf of the clinical research group.

Gamaleya has developed vaccines before, and Mikhail Murashko, the Russian minister of health, said in a government press release that the COVID-19 vaccine showed "high efficacy and safety" and there were no serious side effects. The same release suggested the vaccine would confer 2 years of immunity to SARS-CoV-2, the virus that causes COVID-19. That estimate is apparently based on vaccines Gamaleya has made with similar technology.

Russian President Vladimir Putin reportedly endorsed the use of the vaccine, which is dubbed "Sputnik V," saying it had "passed all necessary steps" and noting that one of his adult daughters had received it. (Putin has not clearly acknowledged his children in public, but he does sometimes refer to them; one is a medical doctor in Moscow.) Putin, who apparently made these comments at a government meeting, added, "I hope we can start a massive release of this vaccine soon."

The Russian registration certificate gives few details about the vaccine, which is being manufactured by Binnopharm in Zelenograd. The company says it can produce 1.5 million doses of the product per year and hopes to expand its manufacturing capacity. More information is available in descriptions of two small trials of the candidate vaccine that appear on ClinicalTrials.gov, a website run by the U.S. National Institutes of Health. The vaccine consists of two shots that use different versions of adenoviruses, some of which cause the common cold, that Gamaleya researchers have engineered to carry the gene for the surface protein, or spike, of SARS-CoV-2. Apparently, the studies are comparing a single shot of adenovirus 26 with the spike gene to a scheme, known as prime-boost, that also gives a second dose 21 days later of a vaccine that contains the spike gene in adenovirus 5.

Some vaccine experts have raised concerns about COVID-19 vaccines that use adenovirus 5 in this way. In 2007, researchers stopped an HIV vaccine trial that used adenovirus 5 to shuttle in the gene for the surface protein of that virus after they found that it increased the likelihood of its transmission.

In 2017, Gamelaya received approval in Russia for a vaccine that also used the adenovirus 5 vector to deliver the surface protein gene from the virus that causes Ebola. Researchers there used a similar strategy for a vaccine for Middle East respiratory syndrome, a disease caused by a coronavirus like the one responsible for COVID-19. It is still under development and has entered early stage clinical trials.

In the United States, the Food and Drug Administration (FDA) can approve the use of medicines prior to the completion of efficacy trials through what's known as an emergency use authorization, and there has been growing concern that President Donald Trump will push for this with a COVID-19 vaccine to help his re-election prospects in November. Zavidova says Russia's certification process is similar to FDA's emergency use. But FDA has an independent advisory committee, largely consisting of academics, that routinely reviews vaccine approval applications.

Alexey Chumakov, a researcher who works at an institute in Moscow named after his famous virologist father, says the Ministry of Health doesn't seek input from the Russian scientific community the way FDA does. "It's not a structure that has any feedbacks or internal coherence," Chumakov says. "They might have a good result and it may show that it works-that's among the best outcomes-but I'm thinking there's probably like a 20% chance [the vaccine] will make things worse." He also says regulations in Russia are easily bent. "As a very old and classic saying goes: 'The strictness of Russian laws is compensated by the fact that it's not necessary to follow them.'"

Chumakov says the Russian scientific community also has a shrinking community of virologists who could weigh in on a COVID-19 vaccine decision. "There's so little science left in Russia after the last 30 years that not many people are eager to say anything against the trend," says Chumakov, who worked on cancer research in the United States for more than 2 decades.

Chumakov notes that "it's very easy to make a vaccine" and very difficult to properly test it and show that it works. "This is really a gamble and I don't know how this can be decided in advance."

A website for Sputnik V says a phase III efficacy trial involving more than 2000 people will begin on 12 August in Russia, the United Arab Emirates, Saudi Arabia, Brazil, and Mexico. Mass production of the vaccine is slated to begin in September.

From: www.sciencemag.org