(Bloomberg) – Russia’s race to allow civilian use of a potential coronavirus vaccine before clinical trials are complete could put people at risk, according to a local association of multinational pharmaceutical companies.
The government plans to grant a vaccine developed by the Moscow Gamaleya Institute conditional registration already this week, which would open the door for civilian use. Still, less than 100 people had officially received the inoculation against the epidemic in early August and its widespread use could be dangerous, the Association of Clinical Trials Organizations said in a letter sent to Health Minister Mikhail Murashko on Monday.
“Why do all companies follow the rules, but not Russia? The rules for conducting clinical trials are written in blood. They can not be violated, said ACTO Executive Director Svetlana Zavidova by telephone. “This is a Pandora’s Box and we do not know what will happen to people who are injected with an unproven vaccine.”
The Gamaleya vaccine, which is being developed together with the Russian Direct Investment Fund, began phase 3 testing last week. Prime Minister Mikhail Mishustin said on Monday that he hoped it would be registered “soon”, while one of his deputies said production was likely to start next month and the health ministry said mass vaccinations could begin in October.
World Health Organization spokesman Christian Lindmeier told reporters last week in Geneva that vaccines should undergo all testing stages before being licensed.
“We see this as part of the competitive behavior of some Western pharmaceutical companies that want to dominate the vaccine market and do not want competition,” said RDIF CEO Kirill Dmitriev. “Russia’s Ministry of Health will follow all necessary procedures for approval, no corners will be cut.”
Many of Russia’s business and political elite have already had access to the experimental vaccine as early as April, according to people familiar with the effort. Military volunteers completed Phase 2 trials in July, according to the Department of Defense. The results have not been published in a peer-reviewed journal.
Researchers and pharmaceutical companies in other countries, including the United States, the United Kingdom, Japan and China, are also competing to develop vaccines. AstraZeneca Plc, Moderna Inc. and Pfizer Inc. have begun late-stage testing for Covid-19 vaccines, with the first results from some of the human trials expected as early as October.
ACTO represents a group of multinational companies conducting clinical trials in Russia, including Pfizer, AstraZeneca and Novartis AG.
Russia had more than 27,000 coronavirus-related deaths in the second quarter, according to Federal Statistics Service data. It has the fourth most confirmed cases in the world, with almost 900,000 people diagnosed.
“They have not published anything,” Zavidova said of the Russian effort. “This is against the rest of the world. There is a standard for publishing data even from failed studies. “
(Updates with RDIF comment in the sixth paragraph)
For more articles like this, visit us at bloomberg.com
© 2020 Bloomberg LP
Video: Pharma increases vaccine production to prepare for flu season amid Covid-19 pandemic (CNBC)
Click to expand