Russia vaccine data questioned by experts worried about global distribution

9/17/20
A growing chorus of experts is calling on Russian scientists to explain potential discrepancies in the data supporting the country's COVID-19 vaccine, dubbed Sputnik V. Russia was the first country to authorize a COVID-19 vaccine, but it did so before completing proper scientific studies to show it is safe and effective. Now, with questions about Russia's vaccine swirling, experts interviewed by ABC News expressed concern about the country's swift action to disseminate the unproven vaccine to low and middle-income countries, noting that if the vaccine were to prove a failure, it could fuel vaccine skepticism globally. Russian scientists from the Gamaleya National Research Center published their findings of an early-stage study in the prestigious medical journal, The Lancet, on Sept. 4, showing that the vaccine was safe. But molecular biologist Dr. Enrico Bucci said he quickly developed "several concerns" upon looking at the data. Bucci, who heads a science integrity company called Resis, in Italy, published an open letter on his blog about Russian's vaccine study. The letter quickly gained additional signatories, and on Sept. 7, the scientists submitted their formal complaint to The Lancet.

The letter highlighted data irregularities in the study that appear to be duplicated. It has now been signed by a total of 38 experts. "We do not allege misconduct, we just want them to provide additional data," said Dr. Konstantin Andreev, one of the signatories and a microbiologist and biophysicist affiliated with the Howard Hughes Medical Institute and Northwestern University. The Gamaleya National Research Center for Epidemiology and Microbiology did not respond to ABC News' request for comment. Sputnik V has also not completed the large Phase 3 randomized control trials that are required in the United States and many other countries prior to vaccine approval. These studies traditionally compare the vaccine to a placebo in thousands of people to determine whether it works in preventing disease, and to further assess its safety profile. Russia is talking to at least 20 countries about exporting the vaccine, including Brazil, Cuba, the Philippines and Saudi Arabia. If the vaccine is given to people before it's properly tested, however, the consequences could be catastrophic.

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