RDIF to submit more data on Sputnik V Covid vaccine to Brazilian authorities

PT Jyothi Datta Mumbai | Updated on January 18, 2021

Move follows reports of Brazil declining emergency use approval to the vaccine

The Russian Direct Investment fund (RDIF) will submit additional details on its Covid-19 vaccine, Sputnik V, to the Brazilian regulatory authority.

The clarification followed reports that Anvisa, the Brazilian authority, had declined an emergency use approval to the Russian vaccine, even as it had given the go ahead to Sinovac and AstraZeneca-OxfordUniversity vaccines.

An RDIF spokesperson told Business Line: “within a week it will deliver all the additional information requested [on January 16] by Anvisa to obtain the emergency use authorisation of the vaccine in Brazil (including the permission to start Phase III clinical trials in the country).”

Russia’s sovereign wealth fund, RDIF is responsible for the global production and distribution of the Sputnik V vaccine. And their local production partner in Brazil is União Química.

On Sunday, Russian news agency TASS said, quoting the Brazilian regulator, “The request (for emergency authorisation) was returned to Uniao Quimica, because it does not comply with the minimal criteria - in particular, due to lack of permission for third phase of clinical trials, as well as in regards to issue dealing with the advanced production methods."

The Sputnik V development assumes importance in India where there are two alliances — on the clinical trial front with Dr Reddy’s Laboratories and on production with Hetero Biopharma.

Approvals elsewhere

RDIF pointed out that besides Russia, it had received approvals in Belarus, Serbia, Argentina, Bolivia, Algeria, The State of Palestine, Venezuela and Paraguay. “In Argentina, vaccination with Sputnik V has already reached more than 200,000 people, with an initial focus on health professionals. Globally over 1.5 million people have already been vaccinated with Sputnik V,” the spokesperson said.

Earlier reacting to reports on the Brazilian authority denying Sputnik V and emergency approval, RDIF said, “Such requests (for additional information) from regulators are standard procedure and do not mean that a registration bid was rejected.”

“The Brazilian Senate is also currently considering a law which has already been approved by the country's Chamber of Deputies. If approved, the new legislation will allow the use of vaccines approved by several other countries, including Russia”, it added.

Further, the RDIF pointed out, there was a “disinformation campaign” against Sputnik V being “deliberately spread at night time or on the weekend to make it harder to verify”. Recently Sputnik V’s twitter handle had been restricted, a development that was later explained on the micro-blogging site as “a possible security breach from Virginia, USA”.

Published on January 18, 2021

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