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)

India approves Russia’s Sputnik V COVID-19 vaccine

By Nigam Prusty and Krishna N. Das

NEW DELHI/MOSCOW (Reuters) -India has approved the use of Russian Sputnik V COVID-19 vaccine, the Russian Direct Investment Fund (RDIF) said on Monday, confirming earlier reports of its imminent endorsement.

India overtook Brazil to become the nation with the second highest number of infections worldwide after the United States, as it battles a second wave, having given about 105 million doses among a population of 1.4 billion.

The RDIF, which is responsible for marketing the vaccine abroad, said the Drug Controller General of India (DCGI) had approved the use of Sputnik V.

“India, the world’s 2nd most populous nation, became the 60th country to register #SputnikV after positive results of local Phase 3 clinical study. Sputnik V is now authorized in 60 countries with population of over 3 bln people,” a post on the Sputnik V official Twitter account said.

Earlier on Monday, two people familiar with the matter said the panel of the Central Drugs Standard Control Organization (CDSCO) had recommended the authorization.

The RDIF has signed deals to produce more than 750 million doses of Sputnik V in India with six domestic firms.

India has so far used two vaccines, one developed by AstraZeneca and Oxford University, and the other by domestic firm Bharat Biotech.

Sputnik V, developed by Moscow’s Gamaleya Institute, has proved 91.6% effective against COVID-19 and has been approved for use in more than 50 countries.

The Indian drugs regulator did not respond to a request for comment on the expert panel’s approval of the Russian vaccine.

Indian pharmaceutical firm Dr. Reddy’s, which is marketing the vaccine in India, said it was awaiting formal word from the authorities.

“Dr. Reddy’s and RDIF are working diligently with the Indian regulatory authorities to obtain the approval for Sputnik V. We are fully committed to playing our part in India’s fight against COVID,” the company said.

Shares of Dr. Reddy’s ended up 5% after the Economic Times newspaper first reported the news.

The firm has helped run a small domestic trial to test the vaccine’s safety and ability to generate an immune response.

(Additional reporting by Rama Venkat and Shivani Singh in Bengaluru, Polina Ivanova and Vladimir Soldatkin in Moscow; Writing by Sachin Ravikumar; Editing by William Maclean and Angus MacSwan)