Russia has a coronavirus vaccine. Whether it works is anybody’s guess.
Russian President Vladimir Putin announced Tuesday that Russia had approved a coronavirus vaccine, becoming the first country to do so. The news has been met with strong skepticism, with experts raising concerns that the experimental vaccine has yet to complete clinical trials designed to test its safety and effectiveness.
Putin promoted the new vaccine — which Russia dubbed Sputnik V — by saying it works “effectively enough” and was “proven efficient.” Yet by skipping Phase 3 trials, which are crucial to showing that a vaccine candidate can successfully prevent infections and not produce serious side effects, it’s too soon to know if this or any potential vaccine is ready to be rolled out.
“The Russian vaccine gamble is reckless and foolish, whether ‘it works’ or not,” Francois Balloux, a systems biologist at University College London’s Genetics Institute in the U.K., wrote Tuesday on Twitter.
Scientists around the world have been working nonstop to develop a coronavirus vaccine, which is widely seen as a crucial step in getting the world back to normal. That has meant figuring out ways to speed up what is usually a yearslong process while ensuring proper testing and safety protocols are still followed.
That rush has already spurred some concern about making sure any vaccines that reach the public are safe and effective, particularly as coronavirus misinformation has run rampant on the internet. Russia’s introduction of its vaccine could further complicate the broader discussion around coronavirus vaccines.
One of the biggest concerns about approving a new vaccine before clinical trials are complete is that it could jeopardize public trust in the vaccine development process, according to Ayfer Ali, an assistant professor of strategy at Warwick Business School in the U.K., who specializes in drug research.
“There’s a lot of mistrust of vaccines for various reasons and we don’t want to feed into it,” she said. “Being first isn’t really important. If there is a vaccine that ends up having serious side effects, we will not be able to convince people to trust it, and possibly other vaccines as well, so we really don’t want to make a mistake here.”
In a statement Tuesday, the World Health Organization said it is “in touch with Russian scientists and authorities, and looks forward to reviewing details of the trials.”
Few details have been made available about the Russian vaccine so far, but its approval was based on only the first two phases of clinical trials, which are designed to make early assessments on whether a potential vaccine can induce an immune response, and whether it’s safe to administer in humans.
Russia has said it intends to conduct Phase 3 trials of its already-approved vaccine later this month, but did not provide much additional information. The tests will be conducted in Russia, the United Arab Emirates and Saudi Arabia, according to Kirill Dmitriev, head of the Russian Direct Investment Fund, which is financing the research.
Phase 3 trials focus on a vaccine candidate’s efficacy, by studying whether it can actually prevent infections. This step is also designed to evaluate whether a potential vaccine is safe by significantly expanding the pool of study participants and monitoring for any adverse side effects.
“In Phase 3, you can begin testing on thousands or tens of thousands of people, and you start to build up an understanding of any rare side effects,” said Eleanor Riley, a professor of immunology and infectious diseases at the University of Edinburgh in Scotland. “If you only vaccinate a few hundred people, you won’t see that.”
Skipping that stage of research, or conducting it without proper controls, makes it extremely difficult to evaluate whether a vaccine is safe and effective, she said.
It’s not known what criteria Russian regulators used to judge the performance of the new vaccine. In the U.S., these standards are set by the Food and Drug Administration. The agency has said that any potential coronavirus vaccine will need to be at least 50 percent effective to be approved, which means the vaccine would need to prevent infections in at least 50 percent of the people who receive it.
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Riley said that there are instances in which emergency approval of an experimental vaccine may be appropriate, but that the current state of the coronavirus pandemic probably doesn’t apply. In 2018, for instance, an Ebola vaccine was used in the Democratic Republic of the Congo before it had completed clinical trials.
“In that case, the risk to an individual of having the vaccine was less than their risk of contracting and dying of Ebola,” Riley said.
Ebola’s fatality rate is much higher than COVID-19, the disease caused by the coronavirus, and in the case of this pandemic, there are other effective public health measures that can curb the spread of the pathogen.
“I don’t think anybody would reasonably argue that we’re in the same type of emergency situation with the coronavirus,” she said, referring to the Ebola outbreak. “There are arguments for getting through Phase 3 trials as quickly as we can, but those are socioeconomic arguments more than public health ones.”