The first COVID-19 vaccine approved in Russia, WHO emphasises on safety processes

Russia // 16 August, 2020

Updated 16 August: Vaccine production has been launched, as per the Russian News Agency.

Posted 12 August: Russia has approved its experimental COVID-19 vaccine, called Sputnik V. This is the first COVID-19 vaccine to be approved in the world. A website for the vaccine has been launched.

The vaccine underwent early Phase 1 and 2 human clinical trials in Russia during June and July – with 76 people receiving the vaccine. A Phase 3 trial is set to begin on 12 August, involving over 2,000 people in Russia, UAE, Saudi Arabia, Brazil and Mexico.

Vaccination of front-line health staff and teachers is set to begin this month. Mass production of the vaccine is expected to begin in September 2020, with state media previously reporting millions of doses will be produced each month by early 2021.

There is some concern among public health experts that the approval is premature. The usual course for drug and vaccine development has regulators reviewing the Phase 3 trial results before approval. These late stage results from Phase 3 trials determine the safety and efficacy in larger groups of people. The American Cancer Society explains the phases of clinical trials here. As of 10 August, there are six vaccines which the World Health Organization reports are currently undergoing Phase 3 trials.

The WHO emphasised that processes ensuring safety and efficacy should not be sacrificed while fast tracking vaccines. Speaking at a virtual press conference from Geneva, a WHO spokesperson stated that WHO is in contact with the Russian health authorities to discuss the processes involved in the development of the COVID-19 vaccine. The Russian vaccine project was not a part of registered COVID-19 vaccine projects with the WHO.

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