Russia to Share Preliminary Results from Ongoing Phase 3 Study of COVID-19 Vaccine

Preliminary results of the first two phases of clinical trials of the Sputnik V COVID-19 vaccine published in the Lancet journal confirmed that it stimulated the volunteers’ immune system to develop antibodies to SARS-CoV-2 and was safe for humans. Alexander Gintsburg, head of the Gamaleya Institute, told Reuters that there was a public interest argument for sharing interim results after 42 days as the data would indicate the general trend. In the Phase 3 trial, the first of 5,000 volunteers was vaccinated on September 9, which means that the interim results could be issued anytime after October 21.

Several vaccine makers are conducting final-stage trials since more than 42 days but are yet to publish any interim results as they prefer to wait until they have enough infections to get a reliable read-out from the data before publication. Russia’s plan to publish interim results based on the first 42 days of monitoring volunteers means that it could become the first country in the world to announce any data from a final-stage trial.

Gintsburg told Reuters that there had been no serious side-effects during the Phase 3 trial and minor, anticipated side-effects had been observed among 14% to 15% of the volunteers. Gintsburg said that the volunteers would be monitored for 180 days after the last of 40,000 participants was vaccinated. Six months after that, his team would tally up the final results and publish them in an international journal. A government source also told Reuters that the interim Phase 3 trial results would decide whether Russia would expand its ongoing mass inoculation drive, starting with people aged over 60 years. According to Gintsburg, the large number of participants totaling 40,000 would make the trial effective even with low levels of COVID-19 transmission in Moscow.

“It guarantees that even with a low infection rate, we would still have statistically significant data,” said Gintsburg.

Related Links:
Gamaleya Institute of Epidemiology and Microbiology