Author: Sara Habibipour
Last week, Russian president Vladimir Putin announced that the country has approved a vaccine against the Sars-Cov-2 virus, which causes COVID-19. Russia apparently intends to distribute the vaccine for widespread use by this October, and make it available to other countries such as Brazil and the Philippines by this November, as well (CNN).
This announcement has caused global concern. Scientists around the globe say that there is no way to ensure that the vaccine is safe, or even effective for that matter. To many people, Russia seems to be cutting corners, and the answer could lie in national pride and politics.
What Do We Know About the Vaccine?
The vaccine has been dubbed "Sputnik V", in reference to the first artificial satellite, Sputnik 1, which was launched by the USSR in 1957. Some have seen that as a sign that the Russian government's intents in releasing a vaccine so early is out of national pride or political motivation (New Scientist).
The vaccine, which is given in two doses, is made of adenoviruses, which cause a common cold. The first dose contains an Ad26 virus, the same strain used in an experimental vaccine being developed by the pharmaceutical company Johnson & Johnson and its subsidiary Janssen. The second, "booster" dose is made of an Ad5 virus, similar to vaccine being developed CanSino Biologics in Tianjin, China (Nature).
Besides this information, we don't actually know much else. Russia hasn't released any official data from the study leading many to be skeptical of Putin's claims. Health officials and sponsors are now calling for the data to be released.
Is it Safe and Effective?
New vaccines normally pass three phases of human study before being used by the public. A phase I trial involves a small number of volunteers, and is intended to determine a safe dose. Phase II requires more people, because it tests whether the vaccine triggers an immune response, and also looks more carefully for side effects. Then a large phase III trial is used to find out whether the vaccine actually protects against infection. Not only is this done to collect accurate scientific data, but to ensure that the vaccine is actually safe enough to be given to the general population (New York Times).
The Russian researchers have preregistered phase I and phase II trials; these trials were completed in early August. It claims that there were no adverse effects, and that the vaccine triggered the desired immune response. But no detailed results have been released. And due to the short amount of time that it took to release a vaccine, it seems as if Russia skipped Phase III testing completely. In fact, there's no published protocol regarding Phase III testing. This is a really dangerous move. Without this phase of testing, we don't know if the vaccine even works, let alone if it's safe to give to the general population. So there's a very high chance that this vaccine isn't safe or effective, and the announcement was solely a nationalistic plot (New Scientist).
On Tuesday, Dr. Anthony Fauci, director of the US National Institute of Allergy and Infectious Diseases, said he had serious doubts the Russian vaccine is ready for widespread use. He told ABC News and National Geographic, "I hope that the Russians have actually, definitively proven that the vaccine is safe and effective. I seriously doubt that they've done that" (CNN).
He also said that having a vaccine and proving it is safe and effective are two different things."We have half a dozen or more vaccines," he said. "So if we wanted to take the chance of hurting a lot of people or giving them something that doesn't work, we could start doing this, you know, next week if we wanted to. But that's not the way it works" (CNN).