“Unfortunately, we have very little information,” said Dr. Vasily V. Vlassov, a professor of epidemiology and vice president of the Russian Association for Evidence-Based Medicine. His organization had opposed approval of the vaccine before testing it.
“We cannot understand how much is P.R. and how much is a violation of medical ethics,” he said of the announcement that the vaccine had been approved for use outside a clinical trial. If few Russians are receiving the vaccine, the early approval appears less troubling, he said.
“Maybe nothing scary is happening in reality and only the announcement was scary,” he said.
Svetlana Zavidova, the director of a pharmaceutical trade group, the Association of Clinical Trial Organizations, which also opposed the hasty approval, said the limited use was encouraging news, even as its reasons are unclear.
“Is it a question of limited production or more of a political decision?” she said. Either way, “of course from my point of view it is better they limit their activity to only clinical trials, as we said from the beginning.”
The trial in Russia began on Sept. 9, and Russian officials have said they expect early results before the end of the year, though the Gamaleya Institute, the scientific body that developed the vaccine, has scheduled the trial to continue until May.
That timeline is similar to the testing schedules announced by the three pharmaceutical companies testing potential vaccines in the United States, AstraZeneca, Moderna and Pfizer.
AstraZeneca paused its trial this month after a test subject experienced symptoms of a neurological disease, transverse myelitis, as a possible side effect. The trial has since resumed in Britain but not the United States.