Russia Publishes First Evidence Coronavirus Vaccine Works, Weeks After Approving Sputnik V

Scientists have published early phase clinical trial data on the coronavirus vaccine approved by the Russian government last month, showing it prompts an immune response and does not cause serious side effects.

Named "Sputnik V," the vaccine developed at the Gamaleya Research Institute is made of two adenoviruses given in two doses, which express the spike protein of the coronavirus.

All of the participants produced antibodies against the coronavirus as well as a cellular immune response, according to findings published in the journal The Lancet.

Russian officials had previously claimed the vaccine produced antibodies and didn't trigger adverse events, but did not publish the information in a journal.

The non-randomized studies took place at two hospitals in Russia between June 18 and August 3, 2020, and involved 76 healthy participants in total. The participants were aged between 25 and 31. The team acknowledged that not having older volunteers was among the limitations of the study.

The authors wrote: "Both vaccine formulations were safe and well-tolerated." The most common problems were pain at the site of the injection, fever, headache, a lack of energy, and muscle/joint pain. No serious effects were detected.

Over 42 days of the study, most participants had an antibody response by day 14 and all within 21 days. The vaccine also produced a T-cell response within 28 days.

The team also looked at blood samples from 4,817 people who had recovered from mild or moderate COVID-19 to compare their immune responses with that of those who had the vaccine, and found they were more pronounced.

Experts not involved in the study said the results were encouraging. In a comment piece accompanying the article in The Lancet, Naor Bar-Zeev of the International Vaccine Access Center at Johns Hopkins Bloomberg School of Public Health said the findings were "encouraging but small" and nothing can be inferred about the immune response of older people. He pointed out no COVID-19 vaccine has been shown to be effective.

"Licensure in most settings should depend on proven short-term and long-term efficacy against disease (not just immunogenicity) and more complete safety data," he said. "Safety assurance will then require further large-scale surveillance after licensure."

Daniel Davis, professor of immunology at the University of Manchester, U.K., told Newsweek said it was "important and encouraging" that the vaccine triggered an immune response.

"We don't yet know if the immune response triggered by this vaccine is powerful enough to protect us from the actual disease. We don't yet know, for example, if this vaccine would stop symptoms of COVID-19 or prevent transmission of virus. So the next stages in testing this and other vaccines are exceptionally important."

Michael Head, senior research fellow in Global Health at the U.K.'s University of Southampton, said in a statement the manuscript confirms some of the public statements from a few weeks ago.

"Concerns do remain around some of the previously-made ambiguous comments that this vaccine is about to be formally approved and licensed. At this stage, we do not know if the vaccine actually works—that is what the phase 3 trials will tell us. Public confidence in any licensed vaccine is vital, and suggestions from both Russia and the USA that a vaccine may be fast-tracked without the proper research having taken place are problematic.

"We must be open and transparent about the effectiveness and safety profiles of all vaccine candidates. Ultimately, we must not pour additional fuel on the anti-vaccine lobby fires," he said.

Ian Jones, professor of virology at the U.K.'s University of Reading, said in a statement: "The study confirms what has been seen with Adenovirus vectors elsewhere, that they are generally safe and that they generate an immune response to the Sars-CoV-2 protein that is incorporated. While the numbers are relatively low, the double serotype approach seems to have generated good levels of neutralizing antibodies and T-cell activity. What everyone wants to know is if this translates to protection in the field and the recently announced phase 3 trials should provide that."

The results come after Russia approved its coronavirus vaccine two weeks before starting Phase III clinical trials, after being tested in humans for less than two months and not publishing its data in a peer-reviewed journal, prompting criticism from experts.

In Phase I trials, the vaccine is given to a small group of people to determine dosage and to see whether it triggers the immune system. Phase II tests safety and the immune response, but the preparation is given to more people, representing different populations, such as the elderly, to monitor the effects. Phase III trials involve thousands of people given either the vaccine or a placebo to check whether it protects against the disease in question. The U.S. Food and Drug Administration (FDA), for instance, has stated that it would expect a vaccine to prevent disease or decrease severity in at least 50 percent of people who are vaccinated to be deemed effective.

Currently, nine vaccines are in Phase III trials by: Moderna and the U.S. National Institutes of Health; BioNTech and Pfizer; CanSinoBio; Russia's Gamaleya Research Institute; AstraZeneca and the University of Oxford; Sinovac Biotech; the Wuhan Institute of Biological Products; Sinopharm; and the Murdoch Children's Institute.

When Russia approved its vaccine without starting Phase III trials, experts expressed concerns about the approach.

Francois Balloux, professor of computational systems Biology at University College London, said at the time Russia's approval was "a reckless and foolish decision."

"Mass vaccination with an improperly tested vaccine is unethical," he said. "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."

This article has been updated with comment from Daniel Davis.