BRASILIA (Reuters) – A Brazilian company has begun test production of the active ingredient for Russia’s Sputnik V coronavirus vaccine and plans to reach full manufacturing in April, which would make it the first shot for which Brazil would not be dependent on imports.
“This week we started making a pilot lot of the active ingredient for learning purposes, not for use,” Miguel Giudicissi, chief science officer at União Quimica told Reuters.
Full local production of the Russian vaccine could be a lifeline for Brazil, which is struggling to get export permits for vaccine supplies stuck in China and India to fight the world’s deadliest COVID-19 outbreak outside the United States.
Brazil’s public-sector laboratories have said they will not be making active ingredients for vaccines until the second half of the year – August for the AstraZeneca vaccine and late September for the shot made by China’s Sinovac Biotech.
Giudicissi said União Quimica’s contract with the Russian Direct Investment Fund (RDIF), which is marketing Sputnik V, provides for a 100% transfer of technology that is well underway. Cells and virus clones have arrived to allow vaccine production in Brazil without the need to import the active ingredient.
“This will give Brazil autonomy in COVID-19 vaccine supplies,” he said by videoconference.
Executives are to meet with Brazilian health regulator Anvisa later on Thursday to provide additional information the agency requested before authorizing emergency use of Sputnik V.
RDIF’s chief executive said in Moscow that União Quimica is starting to fill and finish the vaccine and will step up output in February. He said he expected regulatory approval in Brazil to be resolved in the next few weeks.
The Brazilian partners will provide additional Phase III clinical trial data involving 22,000 volunteers in Russia from the 44,000-subject program that should convince Anvisa that Sputnik V is safe and has an efficacy of 90%, Giudicissi said.
RDIF has 400,000 doses ready to be shipped to Brazil once Anvisa authorizes emergency use, followed by 4.6 million doses in February and 6 million in March to be filled and finished by União Quimica at its Sao Paulo production line, he said.
The company expects to turn out 8 million doses a month once production is up and running, international business director Rogerio Rosso said.
The human and animal health company, which has nine plants in Brazil and one in the United States, plans to produce Sputnik V for Brazil and Latin American countries, he said.
União Quimica is one of several foreign producers on which Russia will rely to fulfill its large-scale vaccine export deals, which exceed production capacity in Russia.
Twelve countries have approved the use of Sputnik V, including Paraguay, Bolivia, Venezuela and Argentina, where public immunizations have begun.
(Reporting by Anthony Boadle; Editing by Brad Haynes and Bill Berkrot)