More than 200 Covid-19 vaccines are being developed worldwide and a good number of them are already in phase III trials. Knowing the processes involved, researchers said it will take several months for those vaccines to be approved. On Tuesday, Russia became the first country to officially register a coronavirus vaccine and declare it ready for use.
The vaccine (Gam-COVID-Vac),nicknamed “Sputnik V”after the space satellite, was developed by Gamaleya Research Institute of Epidemiology and Microbiology and registered in Russia on August 11, 2020 by the Ministry of Health of the Russian Federation.President Vladimir Putin said the vaccine underwent the necessary tests and was shown to provide lasting immunity to the coronavirus, although Russian authorities have offered no proof to back up claims of safety or effectiveness. Putin said that one of his daughters has already been inoculated.
The head of a Russian government-supported investment fund said that purchase requests for 1 billion doses had been received from 20 countries, and that manufacturing was in place to produce 500 million doses, with more capacity in the works.
An AP story said even as Russian doctors and teachers start getting vaccinated, advanced trials are set to start, which will involve “several thousand people” and span several countries, including the United Arab Emirates, Saudi Arabia, the Philippines and possibly Brazil. The Associated Press said it couldn’t find documentation in the Russian Health Ministry’s records indicating that permission to start the advanced trials was granted.
The AP report added that scientists in Russia and other countries sounded an alarm, saying that rushing to offer the vaccine before final-stage testing could backfire. What’s called a Phase 3 trial—which involves tens of thousands of people and can take months—is the only way to prove if an experimental vaccine is safe and really works. “Fast-tracked approval will not make Russia the leader in the race, it will just expose consumers of the vaccine to unnecessary danger,” said Russia’s Association of Clinical Trials Organizations, in urging government officials to postpone approving the vaccine without completed advanced trials.
Experts have warned that vaccines that are not properly tested can cause harm in many ways—from harming health to creating a false sense of security or undermining trust in vaccinations. The Sputnik V vaccine has been given to 76 volunteers as part of two early-stage trials listed on ClinicalTrials.gov, but no results from those trials or other preclinical studies have been published, and little else is known about the experimental vaccine.
Here’s what the experts say:
Francois Balloux, Professor of Computational Systems Biology at University College London and Director of the UCL Genetics Institute: “This is a reckless and foolish decision. Mass vaccination with an improperly tested vaccine is unethical. 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.”
Mike Turner, Head of Major Science Investments at Wellcome Trust: “Safety is the most important consideration when developing any vaccine. Covid-19 is the greatest vaccine development challenge in history, but speed should not compromise safety. Without the data on this vaccine being released, it is impossible to assess its efficacy or safety—even in early testing—but this data must be shared openly and transparently to maintain public trust.”
Konstantin Chumakov, a member of the Global Virus Network, an international coalition working on viral threats: “It is scientifically impossible to prove efficacy without widespread trials, known as Phase 3. Using it in general population before the results of Phase 3 trials are fully studied is a gamble… a Russian roulette, if you will.”
Professor Duncan Matthews, Professor of IP Law at Queen Mary University of London: “News of a potential Covid-19 vaccine is to be welcomed but safety must be the priority. The US Food and Drug Administration and the European Medicines Agency have fast-track approval procedures for emergency humanitarian use and we need to see evidence that Russia is adopting an equally prudent approach.”