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Brazilian regulator should note Lancet publication on Sputnik V vaccine, RDIF partner says

Earlier, the Lancet medical journal published the results of Phase Three clinical trials of the Russian Sputnik V vaccine against the coronavirus according to which the preparation is one of the safest and the most effective ones worldwide

RIO DE JANEIRO, February 2. /TASS/. Brazil’s Health Regulatory Agency (Anvisa) should take note of results of interim trials of the Russian Sputnik V vaccine against the novel coronavirus published by the Lancet on Tuesday when reviewing an application to register the preparation in Brazil. This opinion was voiced by Rogerio Rosso, International Business Director of the Uniao Quimica pharmaceutical company, a partner of the Russian Direct Investment Fund (RDIF), in a conversation with TASS on Tuesday.

"The publication in the Lancet officially confirms what we, partners of the RDIF and manufacturers, have known already - Sputnik V demonstrates the best results on safety and efficacy among all existing vaccines. There is no doubt that these results will be taken into account by Brazilian regulatory bodies," he said. "Yet again, excellent Russian technologies serve the entire mankind, saving lives and filling all of us with hope for better times," he added.

Earlier, the Lancet medical journal published the results of Phase Three clinical trials of the Russian Sputnik V vaccine against the coronavirus according to which the preparation is one of the safest and the most effective ones worldwide. For instance, the efficacy of the vaccine amounts to 91.6%, among volunteers over 60 years of age - to 91.8%. Antibodies to the coronavirus after inoculation with Sputnik V were detected in 98% of volunteers. Cellular immunity was detected in all participants of the trials. The immunity after the shot was 1.3-1.5 times higher than after the coronavirus infection.

On January 15, Uniao Quimica and the RDIF registered a request with the Anvisa for a temporary limited use of Sputnik V in Brazil for vaccination in emergency conditions. On January 16, the Anvisa turned down Uniao Quimica’s application to fast-track the registration of the Russian preparation as "not complying with minimal criteria." For instance, the regulator pointed out the necessity of conducting Phase Three clinical trials of Sputnik V in Brazil which is a mandatory requirement to allow an emergency use of a preparation. The RDIF explained that this is a standard procedure of requesting additional information which does not imply a final denial of registration.

In early January, Uniao Quimica received cell material to manufacture the preparation and began production of a trial batch of active components of the vaccine for research purposes. In March, the company expects to set up full production of Sputnik V and reach output volume of 8 mln doses a month.