Putin Announces Approval of Second COVID-19 Vaccine, Despite Incomplete Clinical Trials

By Dimitri Simes | October 14, 2020 | 10:15pm EDT
Russian President Vladimir Putin holds a virtual cabinet meeting on Wednesday. (Photo: The Kremlin)
Russian President Vladimir Putin holds a virtual cabinet meeting on Wednesday. (Photo: The Kremlin)

Moscow (CNSNews.com) – Russian President Vladimir Putin announced on Wednesday that Russia had approved a second coronavirus vaccine, stoking skepticism because it – like the first one at the time it was approved by Russian authorities – has yet to undergo crucial phase III clinical trials.

Putin said during a public meeting with his cabinet that the State Virology and Biotechnology Center (Vector) in Novosibirsk has registered a second Russian COVID-19 vaccine, known as EpiVacCorona, and that a third was being developed by the Chumakov Center of the Russian Academy of Sciences.

EpiVacCorona is a peptide-based vaccine developed by the Siberia-based Vector Center, a former bioweapons research lab in the Soviet era which has since become a leading medical research center. Health authorities claim is best suited for older people and those with chronic diseases.

The vaccine has gone through phases I and II of clinical trials, with the latter concluding late last month and involving just 100 people.

Several senior Russian officials have already been given EpiVacCorona, including Deputy Prime Minister Tatyana Golikova and the head of Russia’s national health watchdog, Anna Popova.

Meeting with Putin on Wednesday, Golikova said EpiVacCorona had demonstrated a “fairly high level of safety” and pledged that 60,000 doses would be produced “in the near future.” She announced that phase III trials for EpiVacCorona, involving 40,000 volunteers across Russia, would begin next month.

Along with the United States and China, Russia has emerged as a major player in the global race to develop a vaccine against COVID-19. On August 11, Putin announced that Russia had approved the world’s first coronavirus vaccine, named Sputnik V in honor of the 1957 Soviet satellite that became the first human-made object to enter space.

Developed by the Moscow-based Gamaleya Research Institute, the vaccine quickly generated controversy at home and abroad. Critics expressed concern that it had been approved before completing phase III trials, which are randomized and involve testing the vaccine on thousands of patients. The process is regarded as essential to testing a vaccine’s potential long-term side-effects.

Shortly after Sputnik V was unveiled in August, Dr. Anthony Fauci, director of the National Institute for Allergy and Infectious Diseases, said he “seriously doubts” Russian officials had  definitively verified that the vaccine was safe and effective.

Some experts have expressed similar concerns about EpiVacCorona, which was also registered prior to going through phase III trials.

Michael Kinch, director of the Centers for Research Innovation in Biotechnology and Drug Development at Washington University in St. Louis, told CNSNews.com Putin’s announcement on Wednesday “came out of the blue and frankly might undermine even further the credibility of Russia’s efforts to develop a coronavirus vaccine.”

“I don’t doubt that [the epidemiologists at Vector] have great science,” Kinsch said. “But the sheer absence of supportive data would suggest that today’s announcement is intended more for propaganda than an objective scientific contribution, particularly if the approval arose before the completion of crucial clinical trials.”

The Kremlin’s approval of EpiVacCorona came as Russia reported a record increase of 14,231 new infections on Wednesday, reaching a total of 1,340,409 confirmed cases of COVID-19, according to a Johns Hopkins University real time database.

The recent surge in new cases has put heavy pressure on the Russian healthcare system, with the country’s health ministry warning on Tuesday that almost 90 percent of the hospital beds allocated for COVID-19 patients were already occupied.

In Moscow, the epicenter of the outbreak in the country, city officials have imposed new restrictions in a bid to slow the spread of the disease. Schools were instructed to take a two-week vacation from October 5-18. Likewise, earlier this week, all companies in Moscow were required to transfer 30 percent of their workers, along with all employees over the age of 65 and those suffering from chronic diseases, to remote work until October 28.

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