Russia Approved a COVID-19 Vaccine, but It Didn't Follow the Rules

Posted: Aug 12, 2020 1:15 PM
Russia Approved a COVID-19 Vaccine, but It Didn't Follow the Rules

Source: (AP Photo/Hans Pennink)

International media outlets displayed skepticism as Russia’s health ministry announced the approval of Russia’s coronavirus vaccine on Tuesday prior to the final round of clinical trials. The registration certificate permits developer Gamaleya Research Institute of Epidemiology and Microbiology, located in Moscow, to distribute the vaccine to doctors and vulnerable populations.

Russian officials tout the accomplishment as a political success for Russia, a sentiment underscored by the vaccine’s name: Sputnik V. The moniker references the name of the first-ever artificial earth satellite, Sputnik I, which the Russian space agency launched in 1957 and triggered the U.S.-Russia Space Race.

“The ‘Sputnik moment’ has happened,” said Kirill Dmitriev, of the Russian Direct Investment Fund that is financing vaccine research, in an op-ed on Tuesday. “Russia is open to international cooperation in fighting this and future pandemics.”

But Russia has yet to publicize the underlying data and results of previous trials, a precedent set by other developers worldwide for their candidates. Many doctors in Russia and elsewhere have voiced skepticism of the vaccine’s safety and efficacy based on the lack of results from late-stage testing, as well as the country's flexible and one-sided approval structure.

“Accelerated registration will no longer make Russia a leader in this race,” wrote Association of Clinical Research Organizations attorney Svetlana Zavidova on behalf of the group. “It will only expose end users of the vaccine, citizens of the country of the Russian Federation, to unnecessary danger.”

Dr. Anthony Fauci concurred in a National Geographic webinar: “I hope that the Russians have actually, definitively proven that the vaccine is safe and effective. I seriously doubt that they've done that."

"They are not ahead at all," said University of Pennsylvania scientist Paul Offit in an interview for Politico. 

An April rule that cut the requirement for a vaccine to undergo Phase III trials before seeking approval allowed developers to expedite the Sputnik V’s progress toward the finish line. Standard late-stage testing for vaccine candidates, or Phase III clinical trials, vaccine success in at least 30,000 human subjects. Those trials are slated to begin on Wednesday in Russia, and later this month in the United Arab Emirates, Saudi Arabia, Brazil, Mexico and the Philippines. 

Only 76 people have received the inoculation so far, including President Vladimir Putin’s adult daughter. “I know that it works quite effectively, it forms a stable immunity,” Putin said on state TV. 

According to Russian Health Minister Mikhail Murashko, “the vaccine has shown high efficiency and safety. All volunteers developed high [tiers] of antibodies to Covid-19, while none of them showed serious complications of immunization."

Sputnik V’s certificate stipulates that the inoculation won’t be widely available until January 2021, a time frame which other countries, including the U.S., have tentatively designated as sufficient to have a homegrown vaccine administered to at-risk populations. Even without a guarantee of safety from Phase III trials, Russia claims that 20 countries and some U.S. companies have submitted applications for over 1 billion doses of the vaccine.

“Skepticism among international media and politicians has surfaced just as Russia announced its plans for mass COVID-19 vaccine production,” said Dmitriev. “We view this skepticism as an attempt to undermine our efforts to develop a working vaccine, which will stop the pandemic and help to re-open the global economy.”

Russia is technically not the first to approve a vaccine, although it is the first to authorize one on a nationwide scale. In June, the Chinese military approved CanSino Biologics’ candidate for limited use among Chinese soldiers. The vaccine is currently undergoing Phase III trials along with seven other candidates from China, Germany, Australia, Great Britain and the U.S.