Preliminary Submission of Sputnik V Vaccine Sent to Brazil Regulators

Source: Sputnik V Official website

The Russian Direct Investment Fund (RDIF), which is backing the development and roll-out of Russia’s Sputnik V COVID-19 vaccine, said on Friday it had completed the pre-submission of preliminary documents to Brazil’s health regulator, Reuters reported.

The pre-submission, conducted together with RDIF’s local partners – the Brazilian state of Paraná and União Química Farmacêutica Nacional – is necessary for registration of the Russian vaccine for use in Brazil.

“Production of the first batches of the Sputnik V vaccine will soon be launched in Brazil as part of the technology transfer agreement between RDIF and União Química,” the Russian fund said in a statement.

Brazil health regulator ANVISA said in a statement that the submission by email on Thursday was not sufficiently documented to be considered a formal request to conduct clinical trials and register the vaccine in Brazil.

“The documents were sent with a request for ANVISA to make a prior analysis, before the formal submission of the research request,” the statement said.

RDIF Chief Executive Kirill Dmitriev said registration would enable the start of production and distribution of the vaccine in Brazil.

The Russian sovereign fund and Moscow’s Gamaleya Research Institute, which is developing the vaccine, last month entered an agreement with Paraná state government test and produce it in Brazil.

The Brazilian state of Bahia has also signed an agreement to conduct Phase III trials of Sputnik V and plans to buy 50 million doses for use in northeastern Brazil.

União Química, a private pharmaceutical company with nine plants across Brazil and one in the United States, plans to produce the vaccine at its facility in Brasilia.

The company declined to comment to Reuters on its plans. But CEO Fernando de Castro Marques told local media it hopes to sell Sputnik V in Brazil and all over Latin America for about $3 a dose.

Marques told the Brasilia news portal Metrópoles that production could start in the first quarter of 2021.

“If ANVISA insists on new Phase III trials, we will do them. We have that lined up with the states,” he said.