According to a local association of multinational pharmaceutical companies, Russia's plan to allow the public to use a potential coronavirus vaccine before clinical trials are complete could put people at risk.
Race for the vaccine
The Russian government plans to give a vaccine developed by Moscow's Gamaleya Institute conditional registration as early as this week. It would open the door to public use.
However, less than 100 people had officially received the inoculation against the epidemic by early August and its widespread use could be risky according to the Association of Clinical Trials Organizations that sent a letter to Health Minister Mikhail Murashko in August 10. .
ACTO Executive Director Svetlana Zavidova said that all corporations are following the rules, but Russian ones aren't. The rules for conducting clinical trials are written in blood and can't be violated.
Zavidova also said that it is a Pandora's Box and that they do not know what will happen to people injected with a vaccine that is not proven yet.
The Gamaleya vaccine is being developed together with the Russian Direct Investment Fund. The company has begun its Phase 3 testing last week.
Prime Minister Mikhail Mishustin said on August 10 that he hopes it will be registered soon while one of his deputies has said that production is likely to start in September and the Health Ministry said mass vaccinations could begin by October.
Christian Lindmeier, the World Health Organization spokesperson, told reporters last week in Geneva that vaccines should go through all stages of testing before it gets licensed and distributed for public use.
Competitive Behavior
RDIF head Kirill Dmitriev said that they see this as part of competitive behavior by some western pharma companies that want to dominate the vaccine market and do not want to have any competition. The Ministry of Health of Russia will follow all of the needed procedures for approval and no corners will be cut.
As early as April, scores of Russia's business and political elite have already been given access to the experimental vaccine, according to those familiar with the effort.
Military volunteers completed Phase 2 trials back in July, according to the Defense Ministry. The results have not yet been published in journals that are peer-reviewed so it can't be seen by the public yet.
Pharmaceutical companies and researchers in other countries including the U.K, the U.S, China, and Japan are also racing to develop vaccines. Pfizer Inc., Moderna Inc., and AstraZeneca Plc have all begun late-stage testing for COVID-19 vaccines, with initial results from some of the human trials expected as early as October.
ACTO represents a group of multinational companies that conduct clinical trials in Russia, including AstraZeneca, Pfizer, and Novartis AG.
According to Federal Statistics Service data, Russia had over 27,000 coronavirus-related deaths in the past three months. The country ranked fourth as having the most cases in the world, with more than 900,000 people diagnosed with COVID-19.
Zavidova said of the Russian efforts that they have not published anything. There is still a standard to publish data even from studies that are not successful.
