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Russian President Vladimir Putin announced Tuesday that the country’s ministry of fitness had approved a coronavirus vaccine for emergency use.
One of his daughters has already discovered it, Putin added, with minimal effect.
At one meeting, Putin endorsed the protection and efficacy of the vaccine, which is called Sputnik V by the Soviet Union’s orbital satellite. It also congratulated its developers, the Gamaleya Institute in Moscow and the Russian Ministry of Defense.
“We will have to be grateful to those who took this first step, which is very vital for our country, in general to the world at large,” Putin said, according to the Russian news page Interfax.
The Russian Ministry of Health hopes to begin mass production of the vaccine until October and plans to offer the first doses to staff, such as teachers and fitness professionals.
But the announcement met with skepticism from experts around the world, as well as an independent Russian pharmaceutical organization, which warned that the country would rush to produce vaccines for political reasons. Because developers have not published the effects of the first trials or started complex trials, many immunologists are concerned that others may experience harmful side effects.
This is what the Russian government says about Sputnik V, to which knowledge shows so far.
The Russian vaccine introduces fragments of coronavirus protein through an adenovirus, an innocent virus related to the non-unusual cold. In theory, this warrants making the immune formula produce antibodies that respond to the coronavirus, theoretically generating coverages opposed to infections.
Putin calls Sputnik V the “first” coronavirus vaccine in the world, but that doesn’t mean it’s the first to be shown and effective.
Sputnik V is one of more than two dozen vaccine applicants worldwide who have completed or are in the middle of phase 1 and 2 trials, according to Biocentury. These early tests regularly involve administering the drug to small teams of volunteers to ensure that a candidate vaccine generates an antibody reaction and is safe.
Sputnik V’s Phase 1 and 2 trials involved a total of 76 participants, according to the archives of the U.S. National Library of Medicine. The 38 participants who won one or two doses in one of these trials produced antibodies. Side effects were generally mild; included maximum temperatures and headaches, which is a result of other vaccine trials.
But experts warn that the initial effects of Sputnik V trials have not been peer-reviewed and that their developers have not published key points that can only help researchers assess the quality of trials, such as their method and all their effects. The vaccine has also not begun its maximum and vital test.
Putin said Tuesday that Sputnik V is in a position to be widely used by citizens.
“I repeat: he’s passed all the tests,” he said.
But by the classic standards of clinical trials, this is not true. The vaccine has not yet finished its phase 3 trial, a very important step that measures the effectiveness of a candidate in a giant population and would possibly reveal rarer side effects. Phase 3 tests the protection and efficacy of a vaccine in thousands of people spread across multiple sites.
“I don’t know what Russia is doing, but in fact it wouldn’t take a vaccine that hasn’t been tested in Phase III. No one knows if it is or if it works. They put TS [health workers] and his population at risk,” said Florian Krammer, an immunologist at Mount Sinai’s Icahn School of Medicine, in a tweet.
Kirill Dmitriev, managing director of the Russian Direct Investment Fund, which funded the vaccine, said complex clinical trials are expected to begin on Wednesday and “several thousand people” in several countries, adding the United Arab Emirates and Saudi Arabia.
But phase 3 trials are maximum where many promising remedies fail. A 2016 review of 640 Phase 3 trials in the United States found that 344 failed, or about 54%. Another review found that of 302 new drug programs submitted to the FDA after phase 3 trials, 50% were rejected in the first place. However, almost some of the rejected drugs were eventually approved.
Globally, at least six other candidate vaccines, manufactured through Sinovac, Sinopharm, Pfizer and BioNTech, Oxford University with AstraZeneca and Moderna, have achieved phase 3 trials, according to the World Health Organization. A seventh, manufactured through CanSino Biologics, will soon begin a Phase 3 test in Saudi Arabia, according to the New York Times.
Russian health Ministry said Tuesday that the vaccine provides coronavirus immunity for up to two years.
But researchers still don’t know how long COVID-19 antibodies protect others from reinfection. It’s hard to say how long an antibody vaccine can also confer immunity, and it may take some time for scientists to take. Researchers are still learning how long mumps and yellow fever vaccines last, and have been around for decades.
The overall duration of vaccine-based immunity may still be mysterious, Bali Pulendran, an immunologist at Stanford University, told Science Magazine in 2019.
“I keep saying, “It’s not well understood, it’s not well understood, ” he said. “This is one of the main vaccine disorders.”
A leading pharmaceutical organization in Russia, the Clinical Trials Association, suggested to the Russian Ministry of Health to stop the registration of the vaccine in a letter published Monday on its website.
“This is a new vaccine, it has yet finished testing with many people, to name several thousand participants in the Phase III study,” the organization wrote.
The letter also stated that the developers had not met the “golden standard” of randomized, double-blind, placebo-controlled clinical trials, but attempted to act on a “heroic paradigm” at the expense of citizen safety.
“Unfortunately, the role of heroes in this case is attributed to those who did not aim to bet on it at all: Russian citizens who are in danger of COVID-19,” the letter says.
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