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.
1 in 5 Russian Lawmakers Have Had Coronavirus
At least one out of every five Russian lawmakers currently have or have had coronavirus, the speaker of Russia’s lower house of parliament told President Vladimir Putin on Monday.
The 450-member State Duma went partially remote last month to limit the spread of Covid-19 after more than a dozen federal lawmakers were hospitalized with the infection. Previously, Duma speaker Vyacheslav Volodin called on deputies at higher risk of a severe Covid-19 infection to work remotely from their offices.
“We’re taking certain precautions to maintain the parliament’s efficiency, but looking at the period that has passed, we have 91 deputies who have been ill or are ill today,” Volodin said.
Speaking during a rare face-to-face meeting with Putin, Volodin said 38 members of the Duma are currently hospitalized with Covid-19, including one in intensive care.
At least one Duma member contracted coronavirus despite taking Russia’s highly touted Sputnik V vaccine; he has said he believes he may have been administered a placebo.
Vakha Agayev, a 67-year-old Communist Party deputy from the republic of Chechnya, was the first and only member of the Duma to have died from complications caused by Covid-19 in September.
Volodin said that the Duma was on course despite the limitations to pass 20 bills enforcing a set of constitutional amendments that Putin put to a nationwide vote this summer.
Observers took note of Putin’s rare in-person meeting with Volodin, who had mysteriously stopped appearing at Duma sessions for around two weeks. The timing appeared consistent with reporting that the Kremlin has required a two-week quarantine for anyone scheduled to meet Putin, who has sequestered himself outside Moscow and limited public appearances.
Russia confirmed another record number of new Covid-19 cases Monday, adding 17,347 infections to its total count that surpassed 1.5 million over the weekend.
