MOSCOW, December 24. /TASS/. The obtained results of clinical trials of the Sputnik V vaccine against the coronavirus are sufficient to stop recruiting new volunteers. The planned parameters of effectiveness of the preparation have been reached and no further changes are expected, Director of the Gamaleya National Research Center for Epidemiology and Microbiology of the Russian Healthcare Ministry that developed the vaccine Alexander Gintsburg told TASS on Thursday.
The press service of the Russian Healthcare Ministry reported that the ministry had made a decision to stop recruiting the volunteers for trials of the vaccine preparation. To date, over 31,000 people participate in the study with a quarter of them having received a placebo.
"Trials do not end, simply the amount of proof that was [obtained] as a result of vaccinating 31,000 people became sufficient in order to state that we achieved all the parameters that were planned. These figures won’t change anymore one way or another. <...> Not a single individual among the inoculated got sick with a severe or a moderate form compared [to those who received] a placebo," the developer said.
Earlier, the Gamaleya National Research Center and the Russian Direct Investment Fund after analyzing the data in the concluding control point within the framework of Phase Three clinical trials of the Sputnik V vaccine announced that the effectiveness of the preparation amounted to 91.4%, while its effectiveness against severe cases of COVID-19 came to 100%.
The decision to stop recruiting the volunteers was also influenced by the fact that mass inoculation has already been launched in Russia. "Especially since 31,000 [volunteers] surpass the volume of sampling of all other foreign companies that conducted similar studies which they completed using much smaller samplings," he added. The scientist noted that observation of the volunteers will continue as planned. "Six months that were planned for the observation of possible long-term consequences which are actually absent but we will still observe, they remain unchanged. There will be a constant monitoring of [the volunteers]," he added.
On August 11, Russia became the first worldwide to register the vaccine against the coronavirus which was named Sputnik V. The preparation was developed by the Gamaleya National Research Center and passed clinical trials in June-July. Post-registration trials began in Moscow on September 7, the first vaccine was administered to volunteers on September 9. In all, 40,000 people were supposed to participate in the program, with 10,000 of them receiving a placebo instead of the vaccine.