An anesthesiologist inspects medical equipment that controls a Covid-19 patient in a Moscow hospital on May 13.
Photographer: Andrey Rudakov / Bloomberg
Photographer: Andrey Rudakov / 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 give a vaccine developed by Moscow Gamaleya Institute conditional registration so early this week, which would open the door for civilian use. However, fewer 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 Public Health Minister Mikhail Murashko on Monday.
“Why do all companies follow the rules, but Russian does not? The rules for conducting clinical trials are written in blood. They can not be broken, “said ACT Executive Director Svetlana Zavidova by telephone. “This is a Pandora’s Box and we do not know what will happen to people who have been injected with an unproven vaccine.”
The Gamaleya vaccine, which is being developed jointly 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 would likely start next month and the Ministry of Public Health said mass vaccinations could begin by October.
World Health Organization spokesman Christian Lindmeier told reporters last week in Geneva that faxes must go through all stages of testing before being licensed.
Competitive Behavior
“We see this as part of competitive behavior by some western pharma companies that want to dominate the vaccine market and do not want competition,” said RDIF chief Kirill Dmitriev. “Russia’s Ministry of Public Health will follow all the required procedures for approval, no corners will be cut.”
Scores of Russia’s business and political elite were already there given access to the experimental vaccine as early as April, according to people familiar with the attempt. Military volunteers completed the Phase 2 tears in July, according to the Ministry of Defense. The results were not published in a peer-reviewed journal.
Researchers and pharmaceutical companies in other countries, including the US, the UK, Japan and China are also racing to develop fax machines. AstraZeneca Plc, Moderna Inc. and Pfizer Inc. have begun late-stage testing for vaccines for Covid-19, with initial results from some of the human trials already expected in 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 data from the Federal Statistics Service. It has the fourth most confirmed cases in the world, with nearly 900,000 people diagnosed.
“They have not published anything,” Zavidova said of the Russian efforts. ‘This is against the rest of the world. There is a standard for publishing data, even from unsuccessful studies. ”
(Updates with RDIF comments in sixth paragraph)
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