Putin announces the launch of sputnik v

In a surprising and confusing development, Russia claimed on Tuesday that it had approved the world’s first COVID-19 vaccine, as the Ministry of Health released the so-called Vaccine Candidate Registration Certificate, which was tested in only 76 people. However, scientists around the globe have criticized the approval of the vaccine as premature and unethical, as the Gamaleya vaccine has yet to complete a trial that appears to be safe and effective in a wide number of people.
The Candidate Registration certificate allows the vaccine, developed by the Gamaleya Research Institute of Epidemiology and Microbiology in Moscow, to be offered to “a small number of disadvantaged groups of citizens,” including medical staff and the elderly; reports ScienceInsider. Nevertheless, the authorization stipulates that the vaccine cannot be widely used until 1 January 2021, possibly after the completion of larger clinical trials. These trials include administering a vaccine or a placebo injection to thousands of participants and then monitoring them to see if the vaccine prevents the disease. The studies also allow researchers to confirm the safety of the vaccine and to check for unusual side effects that may not have been identified in smaller, earlier-stage trials.
To date, more than 200 COVID-19 vaccines have been produced worldwide and some are already in phase III trials, with more front runners expected to launch early. Nevertheless, researchers believe that even the earliest such vaccines would not be accepted for months. The Russian COVID-19 vaccine website reports that a Phase III efficacy trial involving more than 2,000 people will begin on 12 August in Russia, the United Arab Emirates, Saudi Arabia, Brazil and Mexico. Mass development of the vaccine is expected to begin in September.
Scientists around the world have, however, quickly criticized the approval of the vaccine as premature and unethical, as the Gamaleya vaccine has yet to complete a trial that appears to be safe and successful in a wide number of people. Researchers also criticize the decision as unnecessarily hurried, as the use of an inadequately tested vaccine could endanger the people who obtain it. It may also delay global efforts to improve quality immunizations for COVID-19, they say.
“That the Russians may be skipping such measures and steps is what worries our community of vaccine scientists. If they get it wrong, it could undermine the entire global enterprise,” says Peter Hotez, a vaccine scientist at Baylor College of Medicine in Houston, Texas.
Gamaleya has already produced vaccines, and Mikhail Murashko, Russian Minister of Health, said in a government press release that the COVID-19 vaccine demonstrated “high effectiveness and safety” and that there were no significant side effects. The same report indicated that the vaccine confers 2 years of immunity to SARS-CoV-2, the virus that causes COVID-19. Apparently, this calculation is based on Gamaleya vaccines with similar technologies.
The vaccine will be given in two doses, 21 days apart. All shots contain modified adenoviruses, which would usually induce a common cold. Both have been given a spike protein gene from the SARS-CoV-2 coronavirus. This protein makes it possible for the virus to invade human cells. Theoretically, this would give priority to the immune system for meeting the real coronavirus. Known as a viral vector, this is a relatively common vaccine technique, and other organizations are following similar approaches.
Any conflict with the Russian vaccination program would be catastrophic, not just because of its adverse health consequences, but also because it would further decrease the population’s acceptance of vaccines. “This is a reckless and foolish decision,” Francois Balloux at University College London said in a statement. “Any problem with the Russian vaccination campaign would be disastrous both through its negative effects on health, but also because it would further set back the acceptance of vaccines in the population.”
Public-health experts have described a variety of directions in which Russia’s move could be reversed. Most importantly, the vaccine can cause harmful side effects. Vaccines based on adenovirus have been commonly used, so the risk is likely to be small, but without data from the study, there is no way to be certain.
The vaccine does also not offer protection against coronavirus. When people take it and feel that they are resistant when they are not, the virus could spread more widely and cause even more deaths. There is also a socio-political danger. Some countries are also having trouble controlling emerging diseases through vaccination, so people are unwilling to vaccinate themselves or their children. This is due to the misleading allegations of the anti-vaccination movement that current vaccines are harmful. The introduction of an untested vaccine could worsen the problem.
By Jumana Jabeer