Russia to conduct Coronavirus vaccine trials from next week

Mass testing of Russia’s first potential coronavirus vaccine to get domestic regulatory approval will involve more than 40,000 people and will be overseen by a foreign research body when it starts from next week, said backers of the project on Thursday.

These were the first details on the shape and size of the upcoming final stage trial of the vaccine given by its manufactures, who are aiming to allay concerns among some of the scientists about the lack of data provided by Russia so far.

The vaccine, called “Sputnik V” in honor to the world’s first satellite launched by the Soviet Union, which has been hailed as safe and effective by Russian authorities and scientists following two months of small scale human trials, the results of which have not been made public yet.

But Western experts have been more sceptical, gave warning against its use until all internationally approved testing and regulatory steps have been seen to be taken and proved a success.

“A range of countries is running an information war against the Russian vaccine,” Kirill Dmitriev, head of the Russian Direct Investment Fund (RDIF) that is backing the vaccine, stated a briefing.

He said that, the vaccine data will be published in an academic journal later this month.

Russia has received requests for up to a billion doses of the vaccine from aross the world and has capacity to produce 500 million doses per year through manufacturing partnerships, he said.

A director at Moscow’s Gamaleya Institute, who developed the vaccine, said 40,000 people would be involved in the mass testing at more than 45 medical centers around Russia.

Dmitriev said, the data is being provided to the World Health Organization and to several countries that are considering participating in the final stage trial, including the United Arab Emirates, India, Brazil, Saudi Arabia and the Philippines.

Sputnik V has already received approval from domestic regulators, leading President Vladimir Putin and other officials to name Russia the first country to license a coronavirus vaccine.

However,the registration took place, ahead of the start of the large scale trial, known as a Phase III trial, considered by many as a necessary precursor to registration. At least four other potential coronavirus vaccines are currently in Phase III trials globally, according to the records of WHO.

Two-shot inoculation

But Russia’s early registration of the vaccine will permit it to begin administering it to people in high-risk groups, such as healthcare workers, alongside the late-stage trial, from October, said  Dmitriev.

He also said that the process would be conducted on a voluntary basis and participants would have regular medical check-ups.

The trial itself will be supervised by a foreign clinical research organisation, informed Dmitriev, ensuring the data collection is fully in line with international standards. He did not give details of the research organisation.

The Sputnik V vaccine will involve a two-shot jab, using two different vectors of the human adenovirus. As this vector had a significant track record of use in previous vaccines, it had more historic data supporting its safety than some other potential coronavirus vaccines, Dmitriev said.

This has been echoed by researchers outside Russia. A virologist at Britain’s Reading University, Ian Jones said on the Russian vaccine, “I think there is enough general background data on recombinant adenovirus-based vaccines to assume the vaccine itself will be safe at the usual doses.”

Russian researchers have said that early trials showed the vaccine eliciting a significant immune response, but how long protection would last remains is unclear.

“Each person may react differently,” Vladimir Chulanov, the head specialist in infectious diseases at the Russian Health Ministry said in an interview with Gazeta.Ru on Thursday.

“Some may develop very strong protective immunity, while others may not. In such cases, (coronavirus) infection may be possible, but the illness should, theoretically, have light symptoms. And in general the share of such people will be very small.”

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