Editor's note: According to a report by Science Magazine, the Sputnik V vaccine has actually only been approved for use in a small group of people, including health care workers. Live Science posted a new article on Aug. 13 reflecting this information.
Russia just approved a coronavirus vaccine for use in tens of thousands of people, though it has not been thoroughly tested for effectiveness, according to news reports.
Russia named the newly approved vaccine "Sputnik V," in reference to the world's first artificial satellite, launched during the space race, Reuters reported. Russian state television has framed the worldwide effort to develop a coronavirus vaccine as a similar "race," and in announcing the approval of Sputnik V, President Vladimir Putin essentially proclaimed Russia the frontrunner, according to The New York Times.
"We must be grateful to those who made that first step very important for our country and the entire world," Putin said in a cabinet meeting Tuesday morning (Aug. 11) in reference to the vaccine developers, according to The Associated Press.
"I know [the vaccine] has proven efficient and forms a stable immunity," Putin noted, despite there being no published data from early human tests of the vaccine and no late-stage human trials currently underway. The rush to approve the vaccine has raised concerns from scientists within Russia and abroad, who say that only carefully designed human trials, which include thousands of people, can clearly demonstrate that a vaccine is safe and effective enough for public use.
"Fast-tracked approval will not make Russia the leader in the [vaccine] race, it will just expose consumers of the vaccine to unnecessary danger," Russia's Association of Clinical Trials Organizations said in a statement on Monday (Aug. 10), The Associated Press reported.
"It is not possible to know if the Russian vaccine has been shown to be effective without submission of scientific papers for analysis and then there may be problems on data quality," Keith Neal, emeritus professor of the epidemiology of infectious diseases at the University of Nottingham in England, said in a statement posted to the Science Media Centre, an organization that provides expert commentary on scientific studies and news coverage. Early human tests of the Russian vaccine began in mid-June and included 76 participants, but no data from those trials has been released, according to The Associated Press.
Beyond this lack of transparency, scientists worry that there was no "phase 3" clinical trial — the final stage of testing required for a vaccine to be approved.
Phase 1 and 2 trials usually include a few hundred participants, and test whether a vaccine provokes an immune response without triggering dangerous short-term side effects, Live Science previously reported. While these early trials provide hints about how well a vaccine works, only phase 3 trials, which include thousands to tens of thousands of volunteers, can compare rates of infection between vaccinated and unvaccinated people.
In other words, only phase 3 trials can demonstrate that a vaccine prevents COVID-19 infection. To approve a vaccine in the U.S., the Food and Drug Administration (FDA) requires that a COVID-19 vaccine should at least halve the chances of a person getting infected with the virus when compared with a placebo, or inert injection.
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Russia plans to begin such tests of its already approved vaccine on Aug. 12, Kirill Dmitriev, chief executive of the Russian Direct Investment Fund (RDIF), told reporters, according to The Associated Press. (The RDIF funded development of the vaccine.) The phase 3 trial will include "several thousand" participants from the United Arab Emirates, Saudi Arabia, the Philippines and possibly Brazil, Dmitriev said. But before any data from that trial becomes available, Russia will offer the vaccine to tens of thousands of people, he added.
"People outside of clinical trials will have access to the vaccine in August, and some, already on the massive scale, in October," Dmitriev said. Specifically, Deputy Prime Minister Tatyana Golikova said that doctors can begin to be vaccinated this month, according to The Associated Press. Russian minister of health Mikhail Murashko said that the country will soon begin a mass campaign to distribute the vaccine, and that both medical workers and teachers will be prioritized to receive it first, The New York Times reported.
Without phase 3 data, however, there's no way to know the vaccine will protect most people who receive it; in addition, rare side effects associated with the vaccine may only emerge as more and more individuals get the injection.
Due to their small size, and short length of only a few months, phase 1 and 2 trials are most useful for studying common, short-term side effects, such as skin redness, mild fever and swelling or soreness at the injection site, Live Science previously reported. One of Putin's daughters participated in an early trial of the Sputnik V and experienced a transient fever after the injection, according to The Associated Press.
Short-term effects like fever occur as a vaccine jumpstarts the immune system — however, some side effects may only emerge once a vaccinated person encounters the coronavirus in real life.
One such side effect is known as antibody dependent enhancement (ADE), a phenomenon that paradoxically leaves the body more vulnerable to infection after vaccination, Live Science previously reported. Vaccine candidates for animal coronaviruses and SARS-CoV, which caused outbreaks of severe acute respiratory syndrome in the 2000s, caused ADE-like effects in animals, making it possible a COVID-19 vaccine might do the same. Evidence of ADE could emerge in animal studies, before a vaccine ever reaches humans, but it could also crop up in phase 3 trials as more participants are likely to be exposed to the virus in such large trials as compared with earlier ones.
"A sign of ADE, or a similar problem, would be if the people who got the vaccine in the trials actually had higher attack rates of COVID-19 than the people who got placebo," meaning the virus was more likely to infect the vaccinated group, Dr. Sarah George, an associate professor of infectious diseases and immunology at Saint Louis University, told Live Science in July. Such trends would not be evident within only two months of human testing, as was conducted in Russia.
Despite not sharing solid proof that its vaccine is both safe and effective, Russia has reportedly received requests from more than 20 countries for access to Sputnik V, Dmitriev said, according to Reuters.
The contentious vaccine, developed by the Gamaleya Institute in Moscow, uses two strains of adenovirus as its base, according to The Associated Press. Adenoviruses typically cause symptoms of the common cold in humans, but those used in the vaccine have been modified so as not to cause illness. After tweaking the viruses, the developers then added genes that code for the coronavirus's "spike" protein — a structure that plugs into cells to trigger infection — which the immune system should recognize and use to target the pathogen should the body ever become exposed.
The vaccines developed by CanSino Biologics in China and Oxford University and AstraZeneca in Britain also use adenoviruses as their base, Live Science previously reported. These vaccines are now in phase 3 trials.
Originally published on Live Science.