Sept. 4 (UPI) — Critical data for the COVID-19 vaccine announced by Russia last month were published Friday in a major medical journal for scientific review, a key step in the approval process.
British medical journal The Lancet published the early-stage data that shows the Sputnik V vaccine didn’t produce serious adverse effects among 76 adults participating in a pair of 42-day trials.
The vaccine elicited an antibody response in all participants, it added, as well as responses in T cells and neutralizing antibodies with in 28 days.
“Large, long-term trials including a placebo comparison and further monitoring, are needed to establish the long-term safety and effectiveness of the vaccine for preventing COVID-19 infection,” the authors at the Gamaleya National Center of Epidemiology and Microbiology in Moscow state in the study.
Russia announced the vaccine last month and said it had been registered for use, the first COVID-19 vaccine in the world to do so. Russian President Vladimir Putin said he’d even given it to one of his daughters.
The announcement was criticized by most health experts, however, because none of the data had been published and no larger, late-phase testing of the vaccine had been done.
Dr. Anthony Fauci, the top U.S. expert on infectious diseases, said last month he had “serious doubts” about the Russian vaccine.
“I hope that the Russians have actually definitively proven that the vaccine is safe and effective,” he said. “I seriously doubt that they’ve done that.”
Russian scientists said late last month they were submitting test data for publication for peer-review and that a new round of tests involving 40,000 people had started. The first results from those trials are expected in October or November.
The Lancet is one of the world’s oldest medical journals. Positive data for a competing vaccine being developed by Novavax appeared in the New England Journal of Medicine earlier this week. Publishing data for peer review is a major step in the approval process for any vaccine.
Kirill Dmitriev, CEO of the Russian Direct Investment Fund, which has helped fund development of the vaccine, said the published results are “the final answer in the round of questions directed against Russia.”
Dmitriev told reporters that Russia is on track to export the vaccine, if it’s fully approved for use against COVID-19, by November.