Lack of Scientific Data Released Raises International Concerns
- Sergei Sobyanin; Mayor of Moscow
- Vladimir Putin; President of Russia
- Mikhail Murashko; Russian Health Minister
Russia is the first country in the world to develop a government-approved vaccine for the COVID-19 virus. This medical breakthrough has been likened to the launch of the first satellite by the Soviet Union in 1957, thus giving the new vaccine its name. “Sputnik V,” also known as Gam-COVID-Vac, uses a modified common cold-causing adenovirus to “introduce” the spike protein on the coronavirus to the body. However, on August 11, 2020, the Russian president’s announcement that the vaccine had already been approved by the nation’s government took the world and its medical community by surprise.
Vaccine Development & Testing
Developed by the Gamelya Institute in Moscow, the new COVID-19 vaccine first began its human tests in mid-June. However, no official scientific data surrounding these trials has been released. According to the Nationals Institutes of Health, despite the vaccine’s approval for use, it has not yet fully completed Phase I of trials. Typically, before a vaccine can be approved for use, it must go through a long process of routines and testing. This process, with at least three phases of trials, can take an average of 10-15 years to complete.
Phase I and II involve a relatively small number of participants – healthy people or those who fit the characteristics of the vaccine’s intended receivers. Phase III allows for far more extensive data to be gathered by testing tens of thousands of people and comparing rates of infection between vaccinated and unvaccinated participants. The FDA requires data from Phase III in order for a vaccine to be approved, something that researchers of the Russian vaccine have not yet provided.
On August 31, 2020, Health Minister Mikhail Murashko said that the first round of mass deliveries of its coronavirus vaccine will begin in September. In October, a “mass vaccination campaign” will begin among Russian volunteers, where healthcare workers and teachers will receive first priority. Murashko says around 2,500 volunteers out of 40,000 have been recruited so far for Phase III trials. According to a registration certificate on the Russian Health Ministry website, the vaccine is expected to reach civilians in January 2021.
Vladimir Putin made two announcements on August 11, 2020: Russia had approved a new COVID-19 vaccine, and that one of his adult daughters had already been inoculated with it. Sergei Sobyanin, the mayor of Moscow, insisted that the vaccine is safe and has been researched extensively, although providing no scientific trial data. He referred to the vaccine as having been “proven efficient” and that it “forms a stable immunity.” In inviting residents of Moscow to join the trials, Sobyanin has said that “…Moscow residents have a unique chance to become the main participants in clinical research that will help defeat the coronavirus.”
The Russian Health Ministry expects that the vaccine will “provide immunity for up to two years,” referencing vaccines being developed with a similar technology in Oxford and in companies in China.
Moscow’s COVID-19 Situation
Moscow, Russia’s capital, currently has the most COVID-19 cases in the country. As of August 31, 2020, there are 43,376 active cases and 4,821 deaths. The total number of cases is 262,418.
As mentioned by Mayor Sobyanin, a Russian vaccine is “highly anticipated”. A vaccine would likely be well received, but the lack of any Phase III data raises some concerns about the safety and efficiency of the vaccine. It is unknown if any side effects will arise in vaccinated people in the future, whether it is before or after contact with the coronavirus.
In light of the atypical testing process undergone by the Russian vaccine, these very questions have been brought up by the medical community, stirring up skepticism and some disapproval from experts. Some have said that approving an untested vaccine for use could ultimately do more harm than good. Francois Balloux, a computational systems biology professor at University College London and Director of the UCL Genetics Institute, called mass vaccination with an untested vaccine “unethical,” and “a reckless and foolish decision.” He noted that any issues that may arise during this process would cause even more distrust of vaccines among the public.
The uncertain situation surrounding the COVID-19 vaccine in Russia continues to unfold as scientists race to find a reliable solution to the current global pandemic. Although several vaccines, including those developed by Oxford University in Britain and CanSino Biologies in China, are in stages of advanced testing, whether they will yield results is yet to be seen. “Sputnik V” is still in anticipation of much testing and extensive observation by both researchers in Russia and around the world.
Campbell, Molly. “Russia’s COVID-19 Vaccine ‘Approved’ Despite No Phase III Data.” Biopharma from Technology Networks, Technology Networks, 13 Aug. 2020, www.technologynetworks.com/biopharma/news/russias-covid-19-vaccine-approved-for-mass-production-despite-no-phase-iii-data-338471.
Elagina, D. “Russia: Coronavirus Status.” Statista, 31 Aug. 2020, www.statista.com/statistics/1102935/coronavirus-cases-by-region-in-russia/.
Isachenkov, Vladimir. “Moscow Announces Advanced Trials for New COVID-19 Vaccine.” ABC News, ABC News Network, 26 Aug. 2020, abcnews.go.com/Health/wireStory/moscow-announces-advanced-trials-covid-19-vaccine-72625831.
Lanese, Nicoletta. “Russia Approves ‘Sputnik V’ COVID-19 Vaccine with Little Human Testing.” LiveScience, Purch, 11 Aug. 2020, www.livescience.com/russian-covid19-vaccine-sputnik-v-approved.html.
The Moscow Times. “Russia to Start Mass Deliveries of Coronavirus Vaccine Next Month.” The Moscow Times, The Moscow Times, 31 Aug. 2020, www.themoscowtimes.com/2020/08/31/russia-to-start-mass-deliveries-of-coronavirus-vaccine-next-month-a71285.
Reuters. “West Accepts Moscow Was Right to Approve COVID Vaccine – Russian Official.” National Post, National Post, 31 Aug. 2020, nationalpost.com/pmn/health-pmn/west-accepts-moscow-was-right-to-approve-covid-vaccine-russian-official.
“Vaccine Testing and Approval Process.” Centers for Disease Control and Prevention, Centers for Disease Control and Prevention, 1 May 2014, www.cdc.gov/vaccines/basics/test-approve.html.