Brazilian drugmaker completes first batch of Russian COVID-19 vaccine

By Leonardo Benassatto

GUARULHOS, Brazil (Reuters) -Brazilian pharmaceutical company União Quimica completed production of its first batch of the Sputnik V coronavirus vaccine with active ingredients and technology supplied by Russia, the company said on Thursday.

The vaccine will be exported to neighboring countries in South America, since Brazil has not yet approved the Russian shot for domestic use.

Moscow’s Gamaleya Institute, which developed the vaccine, said it had seen to quality control of the vaccine ingredients, which were put into vials and packaged for shipping – a process known as fill and finish – at the União Quimica plant in Guarulhos, just outside the city of São Paulo.

The factory’s first batch of 100,000 doses were packed into boxes labeled in Spanish, although the countries receiving them have not been decided yet by the Russian Direct Investment Fund (RDIF), executives said.

Fernando Marques, chief executive of the family-owned firm, said Paraguay, Uruguay and Argentina are interested in buying the vaccine. União Quimica will have a capacity for 8 million doses a month, when Brazil’s health regulator Anvisa approves its use in Brazil, he told Reuters.

Anvisa approval has been delayed after the agency took issue with some documents and missing trial data that the RDIF, which is marketing the shot, has been asked to provide.

Marques hopes approval will be given by June and his company will start producing the active ingredient at its biomedical lab in Brasilia instead of importing it from Russia.

RDIF said it has signed production contracts for Sputnik V with 20 manufacturing sites in India, Argentina, South Korea, China, Italy, Serbia, Egypt, Turkey, Belarus and Kazakhstan.

So far, the vaccine has already been produced in Russia, Serbia, Turkey, Egypt and Argentina, where the first test batch was produced on April 20 by Laboratorios Richmond, RDIF said.

(Reporting by Leonardo Benassatto and Anthony Boadle; Editing by Bill Berkrot)

Brazilian firm to produce Russian vaccine without regulatory approval

BRASILIA (Reuters) – The Brazilian pharmaceutical company that plans to produce Russia’s Sputnik V coronavirus vaccine will start making it next week even before health regulator Anvisa gives approval for use in Brazil, the company’s chief executive said on Friday.

União Quimica’s facility in São Paulo has been certified by Anvisa for good production practices and the vaccine will be made for export to countries that have approved it, said CEO and founder Fernando Marques.

“We intend to start production next week with a view to export,” Marques said. He said Sputnik V will not be used in Brazil until it is approved, but neighboring Latin American countries have approved the vaccine and want deliveries.

Anvisa last week held off approving imports of Sputnik V sought by Brazilian state governors amid a second wave of the virus that has killed more than 415,000 Brazilians.

In a setback for the Russian vaccine, the regulator’s technical staff warned of “flaws” in the development and clinical testing of Sputnik, said the data presented on the vaccine’s safety and efficacy was incomplete.

Marques on Friday told a Senate commission on COVID-19 that União Quimica expects to receive a batch of active ingredient from Moscow next week to start making the vaccine for export at its plant near São Paulo’s Guarulhos airport.

“So, the situation today is this: we will start production, obviously when we receive the active ingredient, and we will wait for the registration to make the local production available for use in Brazil,” he told senators.

The Russian Direct Investment Fund that is marketing Sputnik V developed by Russia’s Gamaleya Research Institute has plans to supply the vaccine to Latin American countries from Brazil.

(Reporting by Anthony Boadle; editing by Grant McCool)