September 9, 2020 -- The Russian Health Ministry said Tuesday that a coronavirus vaccine is now being circulated into the population, apparently before results of the third phase of clinical trials were published.
In a terse statement on its website, the Health Ministry said the vaccine “passed the necessary quality tests in the laboratories of Roszdravnadzor and (was) released into civil circulation. The delivery of the first batches of vaccine to the regions is expected in the near future.”
The health ministry didn’t say how much vaccine was being distributed. Health Minister Mikhail Murashko recently said the first deliveries would be small and that workers and teachers would be the first to get it, according to the Moscow Times.
Only last Friday that the medical journal The Lancet published a study saying the Russian vaccine appears to be safe and produced protective antibodies in phase I and phase II clinical trials.
It also did not cause any serious side effects, the study said.
The study said doctors conducted the trials on 76 adult volunteers at two hospitals.
The clinical trials suggested the vaccine also produced T cells -- another part of the immune system’s response against the coronavirus -- within 28 days, the release said.
Phase I trials determine if a vaccine is safe, and phase II trials determine if the vaccine works.
Critics noted that the trial was small and did not have a control group to compare it to. In non-randomized trials, participants know they’re getting the vaccine. A randomized, controlled trial, where something is compared to a placebo, is considered the gold standard.
Sputnik V, the vaccine named after the Russian satellite launched in 1960, is in the third and final phase of the clinical trial process. Russia says about 40,000 people will be involved in phase III.
Russian President Vladimir Putin said last month that the National Health Ministry has approved the vaccine and production will begin at two sites in Russia.
Kirill Dmitriev, the leader of the Russian sovereign wealth fund RDIF, which is backing the vaccine, told CNBC that Russia was “on track” to release data from the phase III trials at the end of October and to export the vaccine by November.