Before the dust has settled from Russia’s rushed deployment of Sputnik V, the vaccine developed by the Gamaleya Institute, Phase 2 trials are now complete for a second COVID-19 vaccine, dubbed EpiVacCorona. In August, Reuters reported that Russia was “preparing” to approve its second COVID-19 vaccine. The Deputy Prime Minister Tatyana Golikova said this was planned for late in September, or else early October. At a meeting with President Putin, she said that “early-stage” trials would be done by September’s end. “As of today, there have been no complications among those vaccinated in the first and second stages of testing,” she indicated. Then on September 8, Reuters noted that Phase 2 trials were complete. The trials involved 100 volunteers, and on September 8, the last group of 20 was released out of the hospital. The subjects all completed 23 days in the hospital for monitoring, and they are “feeling good.” Results of these Phase 2 trials are expected to be published on September 30.
Development and Clinical Trial History
A helpful overview of this candidate and its history is at Precision Vaccinations. Back on March 16, 2020, researchers at the Vector institute in Siberia started studies of immunogenicity in lab animals for several vaccine prototypes using a myriad of technologies. Vector reported on March 20 that prototypes for vaccines using six different platforms and technologies “were developed in the shortest possible time.” On July 27, they started Phase 1 and 2 trials for the peptide-based candidate EpiVacCorona. According to TASS from August 6, as of then, 86 additional subjects were to be administered the vaccine as part of Phase 2 trials. Of these, 43 would get a placebo. This technology is “built of defined, small-peptide antigens engineered to induce the desired immune response” and includes no biological agent, so it should have a better side-effect profile than, e.g., a vaccine using modified viruses.
What is the Vector Institute?
EpiVacCorona was developed by The State Research Center of Virology and Biotechnology VECTOR in Siberia, often known as the Vector Institute. The institute opened in 1974 and was involved in biological warfare research during the Cold War. The facilities maintain all levels of Biological Hazard, with CDC Levels 1-4. It is one of two official repositories for the now eradicated smallpox virus, and it was once part of a laboratory network known as Biopreparat. In 2019, there was an explosion there that spooked the internet due to the presence of smallpox.
TrialSite recently reported on the East/West divide in dealing with COVID-19 vaccine development, noting concerns with the Sputnik V process. Echoing that story, we think caution is warranted about this new vaccine as well.