Russia last month approved its potential Coronavirus vaccine, Sputnik V. While several experts raised concerns about the effectiveness of the vaccine due to lack of evidence, according to newly published research, patients involved in early trials of the COVID-19 vaccine developed antibodies with "no serious adverse events."
Last month, the approval from Russian authorities raised concerns among Western scientists over lack of safety data, with some warning that moving too quickly on a vaccine development could be dangerous. But Kremlin denounced such criticism as an attempt to undermine Russia's research.
Sputnik V Study
The vaccine was developed by the Gamaleya National Center of Epidemiology and Microbiology and its approval was announced by President Vladimir Putin who said, "I know [the vaccine] works quite effectively, helps to develop strong immunity, and has gone through all the necessary tests."
But the announcement caused widespread concern, and the experts said that the approval is premature. At the time of approval, Sputnik V had not even started phase three trials, nor had any results on the earlier stage trials been published.
Now, a study on the vaccine was published in The Lancet — one of the world's oldest medical journals — in which a team of researchers from Russia reported on two small trials, each involving 38 healthy adults aged between 18 and 60. As per the research, these participants were given a two-part immunization.
Each of them was given a dose of the first part of the vaccine, based on two adenovirus vectors and then given a booster with the second part 21 days later. The researchers said that they monitored over these participants over 42 days and noticed that all of them developed antibodies within the first three weeks.
A 'Safe' Vaccine
As per the report, the research data showed that the Russian vaccine was "safe, well-tolerated, and does not cause serious adverse events in healthy adult volunteers." The trials conducted by the researchers were open-label and not randomized which means that there was no placebo. So, the participants knew that they were receiving the vaccine and they were not assigned to different treatment groups.
Researchers emphasized that larger and longer trial programs, including a placebo comparison, would be required to establish the long-term effect and safety of the vaccine to prevent the SARS-CoV-2 infection.
The Lancet report also said that 76 healthy volunteers who participated in the trials would be monitored up to 180 days. It added that a more rigorous phase three clinical trial was planned involving 40,000 people belonging to "different age and risk groups".
Kirill Dmitriev, the chief of Russian sovereign wealth fund RDIF which is backing the vaccine, said, "We had lots of interest in the Russian vaccine (with) publication in the Lancet, which is one of the key Western magazines on medicine." He told CNBC during an interview that the results have been "very good," and the study has shown that "there is very strong both antibodies and cell immune response."
Dmitriev also said that Russia was "on track" to start exporting Sputnik V by November 2020 and has a plan to release data related to more robust phase three clinical trials at the end of October. Human trials will be also conducted in the UAE, Saudi Arabia, the Philippines, and many other markets, said Dmitriev.