Russia’s race to allow civilian use of a potential coronavirus vaccine before clinical trials are completed could put people at risk, according to a local association of multinational pharmaceutical companies.The government plans to give a vaccine developed by the Gamaleya Institute in Moscow this week, which would open the door to 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 the Russians? The rules for conducting clinical trials are written in the blood. They cannot be raped, ”ACTO Executive Director Svetlana Zavidova said over the phone. “It’s a Pandora’s Box and we don’t know what will happen to people who receive an unproven vaccine.”
The Gamaleya vaccine, in development with the Russian Direct Investment Fund, began phase 3 testing last week. Prime Minister Mikhail Mishustin said on Monday he hoped it would be registered “soon”, while one of his deputies said production was due to start next month and the health ministry said the Mass vaccinations could start by October.
World Health Organization spokesman Christian Lindmeier told reporters last week in Geneva that vaccines would have to go through all stages of testing before being licensed.
“We see this as part of the competitive behavior of some Western pharmaceutical companies who want to dominate the vaccine market and don’t want to have competition,” said Kirill Dmitriev, director of RDIF. “The Ministry of Health of Russia will follow all the procedures required for approval, no corners will be cut.”
Many Russian companies and political elite have already beenhad access to the experimental vaccine in April, according to people close to the effort.Military volunteers completed phase 2 trials in July, according to the defense ministry. The results have not been published in a peer-reviewed journal.
Researchers and pharmaceutical companies in other countries, including the United States, United Kingdom, Japan and China, are also fighting to develop vaccines. AstraZeneca Plc, Moderna Inc. and Pfizer Inc. have started advanced stage testing for Covid-19 vaccines, with the first results of some of the human trials expected as early as October.
ACTO represents a group of multinational companies that conduct clinical trials in Russia, including Pfizer, AstraZeneca and Novartis AG.
Russia recorded more than 27,000 coronavirus-related deaths in the second quarter,according to data from the Federal Statistical Service. It has the fourth most confirmed case in the world, with nearly 900,000 people diagnosed.
“They haven’t published anything,” Zavidova said of Russian efforts. “It goes against the rest of the world. There is a standard for publishing data even from unsuccessful studies. ”
(Updates with RDIF Commentary in Sixth Paragraph)