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A laboratory at the Gamaleya Research Institute in Moscow. August 6, 2020.

‘Sputnik V’ launches in October Russia is planning a mass immunization campaign during the coronavirus vaccine’s final phase of clinical trials

Source: Meduza
A laboratory at the Gamaleya Research Institute in Moscow. August 6, 2020.
A laboratory at the Gamaleya Research Institute in Moscow. August 6, 2020.
RDIF / Xinhua / imago / Scanpix / LETA

Russia is planning to launch a mass immunization campaign against COVID-19 in October 2020, using the “Sputnik V” vaccine developed by scientists at the Gamaleya Research Institute in Moscow, announced Kirill Dmitriev, the head of the Russian Direct Investment Fund (RDIF), which sponsors the vaccine’s research and development.

Dmitriev made the announcement during an online conference attended by international journalists. He didn’t specify how many doses will be made available in Russia this fall.

The immunization campaign will run at the same time as the vaccine’s Phase III clinical trials. The number of volunteers participating in this stage of testing was made public for the first time during the conference — according to Dmitriev, Phase III is set to include 40,000 volunteers.

Dmitriev also clarified that the third phase of testing will be carried out according to the standards of a randomized, double-blind study — meaning neither the volunteers nor the medical workers observing them will know who received the real vaccine and who was given a placebo. That said, there is no record of the Gamelaya Institute’s new study in the state register as of yet.

In an earlier interview with Meduza, microbiologist Denis Logunov, who leads the team developing the Gamaleya Institute’s coronavirus vaccine, said that by the end of 2020, the research center is expected to produce 3-5 million doses annually. During the conference, Dmitriev said that it will also go into production at other Russian biotech companies, including Binnopharm, Generium, and R-Pharm. According to Dmitriev, different countries around the world have already sent in orders for a billion doses of the vaccine. He didn’t specify how the drug would be distributed among Russian and international consumers, however. 

The Gamaleya Institute received “provisional approval” for the two-staged coronavirus vaccine on August 11, on the condition that they carry out a full-fledged study to confirm its effectiveness. The approval issued to the Gamaleya Institute expires on January 1, 2021. 

Since the vaccine was registered before the completion (or even the start) of Phase III clinical trials, now it can be given not only to volunteers, who are compensated for participating in the trials and insured against serious side effects, but also to ordinary people between the ages of 18 and 60 years old. 

Despite promises from the manufacturers, the Gamaleya Institute has yet to publish any information about the results of its vaccine research in peer-reviewed journals. There is also no data publicly available about the results of the combined Phase I/II trials on the dedicated website that the RDIF created to provide information about the development of the vaccine. 

Text by Alexander Ershov

Translation by Eilish Hart

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