Unproven vaccine? Russian COVID-19 vaccine could open a ‘Pandora’s Box’, says industry body

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’s Gamaleya Institute conditional registration as early as this week.

This would open the door for its use among civilians.

On August 11, AFP reported that Russian President Vladimir Putin said his daughter was inoculated with the new Russian coronavirus vaccine.

Yet less than 100 people had officially received the inoculation against the epidemic by 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.

‘Follow the rules on clinical trials’

“Why are all corporations following the rules, but Russian ones aren’t? The rules for conducting clinical trials are written in blood. They can’t be violated,” ACTO Executive Director Svetlana Zavidova said by phone.

“This is a Pandora’s Box and we don’t know what will happen to people 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 Monday he hopes it will be registered “soon,” while one of his deputies has said production is likely to start next month and the Health Ministry said mass vaccinations could begin by October.

World Health Organization (WHO) spokesperson Christian Lindmeier told reporters last week in Geneva that vaccines should go through all stages of testing before being licensed.

Competitive behaviour

“We 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 competition,” RDIF head Kirill Dmitriev said. “The Ministry of Health of Russia will follow all of the required procedures for approval, no corners will be cut.”

Scores of Russia’s business and political elite have already been given 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 Defense Ministry. The results haven’t been published in a peer-reviewed journal.

Researchers and pharmaceutical companies in other countries including the U.S., the U.K., Japan and China are also racing to develop vaccines. AstraZeneca Plc, Moderna Inc. and Pfizer Inc. have 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 Pfizer, AstraZeneca and Novartis AG.

Russia had over 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 nearly 900,000 people diagnosed.

“They haven’t published anything,” Zavidova said of the Russian efforts. “This runs counter to the rest of the world. There is a standard to publish data even from unsuccessful studies.”