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An experimental COVID-19 vaccine manufactured through a Russian institute of study wants more evidence, many scientists say.
Science’s COVID-19 reports are supported by the Pulitzer Center and the Heising-Simons Foundation.
In an unexpected and disconcerting move, Russia said today that it had approved the world’s first COVID-19 vaccine, while the country’s fitness ministry had issued what is known as a registration certificate for a candidate vaccine that was tested on only 76 people. The certificate allows the vaccine, developed through the Gamaleya Research Institute for Epidemiology and Microbiology in Moscow, to be administered to “a small number of citizens of vulnerable groups,” adding medical staff and the elderly, ScienceInside told a spokesperson for the ministry of fitness. But the certificate states that the vaccine cannot be widely used until January 1, 2021, probably after the final touch of larger clinical trials.
Scientists around the world promptly denounced certification as unwelcome and inadequate, because the Gamaleya vaccine has not yet completed a trial that convincingly proves that it is safe and effective in a giant organization of people. Even some in Russia have defied this decision. “It’s ridiculous,” says Svetlana Zavidova, a lawyer who heads the Association of Clinical Research Organizations in Russia. “I’m not ashamed of our country yet.” Zavidova, who has worked in clinical trials for 20 years and was awaiting approval, called on the Ministry of Health to postpone the registration of the vaccine until the appropriate efficacy trials are completed. “Accelerated registration will no longer make Russia a leader in this race, it will only disclose to the end-users of the vaccine, the citizens of the country of the Russian Federation, an unnecessary danger,” he wrote on behalf of the organization of clinical studies. .
Gamaleya has already developed vaccines and Mikhail Murashko, Russia’s health minister, said in a government press release that the COVID-19 vaccine showed “high efficacy and safety” and that there were no serious side effects. The same publication cautioned that the vaccine would confer 2 years of immunity to SARS-CoV-2, the virus that causes COVID-19. This estimate is based on vaccines that Gamaleya made with similar technology.
Russian President Vladimir Putin reportedly approved the use of the vaccine, called “Sputnik V,” saying he had “crossed all the obligatory steps” and noting that one of his adult daughters had won it. (It is clear that Putin has not identified his youth in public, but he refers to them; one is a doctor in Moscow.) Putin, who allegedly made the comments at a government meeting, added: “I hope we can post a vaccine be-release.”
The Russian registration certificate provides some main points about the vaccine, which is manufactured through Binnopharm in Zelenograd. The company says it can produce 1.5 million doses of the product consistent with the year and hopes to expand its production capacity. More information can be found in the descriptions of two small trials of the candidate vaccine that appear on ClinicalTrials.gov, an online page found at the U.S. National Institutes of Health. The vaccine is composed of two injections that use other versions of adenovirus, some of which cause colds, which Gamaleya researchers designed to bring the surface protein gene, or tip, from SARS-CoV-2. Apparently, studies compare a single injection of adenovirus 26 with the complex gene with a pattern, known as prime-boost, which also provides a moment dose 21 days after a vaccine containing the complex gene in adenovirus 5.
Some vaccine experts have expressed fear about COVID-19 vaccines that use adenovirus five in this way. In 2007, researchers stopped a trial of an HIV vaccine that used adenovirus five to come and go from the virus’s surface protein gene after locating that the likelihood of transmission increased.
In 2017, Gamelaya obtained approval in Russia for a vaccine that also used the vector adenovirus five to administer the surface protein gene of the Ebola-causing virus. Researchers used a strategy for a vaccine opposed to Middle East Respiratory Syndrome, a disease caused by a coronavirus such as coVID-19’s culprit. It is still in progression and has entered the first clinical trials.
In the United States, the Food and Drug Administration (FDA) may approve the use of drugs before efficacy trials are completed through what is known as an emergency use authorization, and there is a growing fear that President Donald Trump is pressuring him with a COVID-19 Vaccine to help his re-elected customers in November. Zavidova states that the Russian certification procedure is similar to the FDA’s emergency use. But the FDA has an indefinite advisory committee, made up largely of academics, that reviews vaccine approval applications.
Alexey Chumakov, a researcher working at a Moscow institute named after his prominent vicelogist father, says the Ministry of Health is not requesting input from the Russian clinical network as the FDA does. “It’s not a design that has comment or internal consistency,” Chumakov says. “They can have a smart result and can prove it works, it’s one of the most productive effects, but I think there’s probably a 20% chance [that the vaccine] will make things worse.” He also says that regulations in Russia are changed smoothly. “As a very old saying goes: “The rigour of Russian law is offset by the fact that it is not obligatory to stick to them.”
Chumakov says the Russian clinical network also has an increasingly small network of virologists that can influence the decision of the COVID-19 vaccine. “There is so little science left in Russia after the last 30 years that few people are willing to say anything that opposes the trend,” says Chumakov, who has worked in cancer studies in the United States for more than two decades.
Chumakov points out that “it’s very easy to make a vaccine” and very complicated to prove it well and prove that it works. “It’s a bet and I don’t know how you can make a decision beforehand.”
A for Sputnik V says that a Phase III efficacy trial involving more than 2,000 other people will begin on August 12 in Russia, the United Arab Emirates, Saudi Arabia, Brazil and Mexico. Mass production of the vaccine is expected to begin in September.
Jon is an editor of Science.
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