On September 4, CNBC reported on a new Lancet study showing both “no serious adverse” effects and an antibody response from Russia’s vaccine. The trials involved 76 healthy volunteers; and the authors say that, “Large, long-term trials including a placebo comparison, and further monitoring are needed.” The chief of RDIF, Russia’s sovereign wealth fund, reported that the nation was “on track” to export vaccines by November. He notes that the UK and US are “following in Russia’s footsteps” as they consider approving Sputnik V. Early results showed no major side effects per the peer-reviewed article in The Lancet. “The two 42-day trials – including 38 healthy adults each – did not find any serious adverse effects among participants, and confirmed that the vaccine candidates elicit an antibody response,” the study noted.
Sputnik V Moves Forward
Sputnik V was the first vaccine “registered” worldwide after approval by Russia’s health regulators in the last month. At the time, President Putin said that full-scale production would start in September. World-wide criticism ensured, as at the time no data had been published, not to mention skipping over Phase 3. TrialSite acknowledges the concerns of how the study was managed based on an outside looking-in point of view.
The Lancet study is the first publication is a well-respected publication. Kiril Dmitriev, RDIF’s chief, said the report was validation of his nation’s efforts. “We had lots of interest in the Russian vaccine (with) publication in The Lancet, which is one of key Western magazines on medicine,” Dmitriev said. He continued, “It is very important to share information with the world … the results have been very good but basically the study showed there is very strong both antibodies and cell immune response.”
He added that Phase 3 data should be released at the end of October. “Right now, we have 40,000 clinical trials going on in Russia, we started it at the end of August, and there will also be clinical trials in the UAE, Saudi Arabia, Philippines and many other markets,” Dmitriev opined. “So basically, we’re on track to have registration not only available in Russia … but also available to key other countries already around November.”
TrialSite still maintains the “Gamaleya” vaccine now known as Sputnik V was driven via an unorthodox process at best. However, this peer review update merits publication; it would appear that the Russians could very well be on track with their national vaccine, crushing historical records if all of this unfolds to be fully accurate.