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Russia submits COVID-19 vaccine to WHO for emergency use listing

Russia became first country to grant approval to a COVID-19 vaccine in August

The Russian Direct Investment Fund (RDIF) has submitted its COVID-19 vaccine Sputnik V to the World Health Organization (WHO) for an emergency use listing and prequalification.

In August, Russia became the first country in the world to grant regulatory approval to a COVID-19 vaccine.

The approval came before large-scale phase 3 safety trials of the vaccine had been completed. Following the regulatory authorisation, Russian President Vladimir Putin maintained that the shot is safe for use despite concerns raised by health experts across the world.

Sputnik V – a name which refers to the first artificial earth satellite launched by the Soviet Union – was developed by Moscow’s Gamaleya Institute and marketed by RDIF.

Researchers and directors at the Institute had faced criticism after they reportedly injected themselves with a prototype of the vaccine months ago, bypassing the usual process of initiating human trials.

It is based on a platform of human adenoviral vectors, which is designed to deliver a gene from the SARS-CoV-2 virus into the body and trick it into producing protective antibodies against the infection.

A WHO emergency use listing is designed to enable potential vaccines to become available globally at a faster rate, while a prequalification indicates the quality, safety and efficacy of a vaccine.

If Sputnik V is granted these qualifications, the vaccine will go on to be included in the list of medical products that meet leading quality, safety and efficacy standards, according to RDIF chief exec Kirill Dmitriev.

“The Russian Federation was the first in the world to register a vaccine against the coronavirus, Sputnik V, which was created on a safe, effective and well-studied platform of human adenoviral vectors,” said Dmitriev in a statement.

"We express our gratitude to WHO for its active cooperation and look forward to the successful completion of the prequalification process at all major stages,” he added.

Moderna and Pfizer, which are respectively developing their own COVID-19 vaccine candidates, will likely be the first companies to seek emergency use authorisation for their shots from the US Food and Drug Administration (FDA).

The timeline for submission for both companies is dependent on the first efficacy data from large-scale phase 3 studies, which are expected to have initial results over the next few weeks.

Article by
Lucy Parsons

29th October 2020

From: Regulatory



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