The Gamaleya Research Institute, which developed Russia’s coronavirus vaccine, “Sputnik V,” has sent the scientific journal The Lancet detailed answers to the questions raised following its publication of an article about Russia’s vaccine trials, health minister’s aide Alexey Kuznetsov told Interfax, without revealing any details.
On September 7, a group of researchers from a number of different countries published an open letter addressed to both The Lancet and the authors of the article in question. The researchers reported statistical anomalies in the results of several experiments described in the article and questioned the authenticity of the data. In particular, the researchers noticed that trial participants in different groups showed similar antibody levels in their blood after immunization, despite the fact that these were different people who had received different formulations of the vaccine.
Microbiologist Denis Logunov — a deputy research director at the Gamaleya Institute, who has been leading the group developing Russia’s coronavirus vaccine — maintained that the published article didn’t contain any mistakes. He refused to respond to the open letter, but promised to provide The Lancet with an explanation.
On September 8, Russia’s Health Ministry announced that “Sputnik V” had passed quality tests conducted by the country’s federal healthcare watchdog, Roszdravnadzor, and that the first batch of the vaccine had been released for circulation among the general public. The vaccine is expected to arrive in Russia’s regions soon, after which the vaccination of at-risk groups will begin.
The Health Ministry also said that the “Sputnik V” vaccine’s Phase III clinical trials were set to begin on September 9, and that this stage of trials would involve 40,000 volunteers. Phase III clinical trials, which precede the permanent registration of a vaccine, can take anywhere from a few months to a few years.