Russia’s second candidate vaccine against the coronavirus will be tested on six times the original number of volunteers as part of final clinical trials for safety and effectiveness, health authorities said Monday.
The government is expected to approve the peptide-based EpiVacCorona vaccine developed by a Siberian-based biotechnology company on or around Oct. 15. It completed trials last month on 100 volunteers who were said to be “feeling good.”
“Centers for post-registration trials will be identified after the vaccine is registered and will involve 30,000 volunteers,” said consumer safety watchdog Rospotrebnadzor, according to Interfax.
Previous reporting said EpiVacCorona’s large-scale trials would only involve 5,000 volunteers in the Novosibirsk region.
Rospotrebnadzor said the first batch of 10,000 doses for “post-registration studies” will be released in late October.
Once mass production begins, the vaccine “will be available to a wide range of citizens,” the watchdog added.
The Novosibirsk-based Vektor State Virology and Biotechnology Center, a former Soviet bioweapons research lab and EpiVacCorona’s developer, says the vaccine will require booster doses every three years.
Though the Health Ministry is reviewing EpiVacCorona for “safety and quality,” The Wall Street Journal reported Monday that officials would not answer questions about trial results or the approval process.
Russia’s first registered Covid-19 vaccine, Sputnik V, began large-scale trials on 40,000 volunteers in September. Its developer, the Moscow-based Gamaleya research center, said this week that the trials will continue for around three to four months.
Russia has seen its daily Covid-19 cases rise from under 5,000 in August to over 10,000 this week, stoking fears of a second wave similar to Europe's.
More than 1.22 million Covid-19 cases have been officially confirmed in Russia, the fourth-highest number of infections in the world.