BRASILIA (Reuters) - The technology institute for the Brazilian state of Paraná, which has agreed to produce Russia’s “Sputnik-V” COVID-19 vaccine, said on Friday it plans to conduct phase III trials on 10,000 volunteers in Brazil at the start of next year.
Jorge Callado, head of Paraná’s Technology Institute, known as Tecpar, said approval for the trial will be requested of Brazil’s health regulator, ANVISA, by the end of this month.
Doses will be imported for the tests and Tecpar plans to start producing the vaccine for Brazil’s market in the second half of 2021. Tecpar could eventually look to export to Latin American neighbors, Callado said.
Paraná is one of several Brazilian states that have struck out on their own to secure access to COVID-19 vaccines, motivated at least in part by a distrust of the federal government’s response.
Brazil’s president, Jair Bolsonaro, has consistently minimized the gravity of the pandemic, which has infected more than 4 million people in the country and killed 124,600 in the worst outbreak outside the United States.
Callado said Friday’s publication in The Lancet medical journal of results showing the vaccine had produced an antibody response in early-stage trials was an important development. He dismissed suspicion of Russia’s decision to fast-track registration of Sputnik V.
Russia heralded the development of the world’s first registered coronavirus vaccine as proof of its scientific prowess.
Paraná’s government signed a memorandum of understanding last month with Russia’s Gamaleya National Research Institute, which is developing the vaccine, and the Russian Direct Investment Fund, which is marketing it.
Callado said the vaccine will be given in two doses 15 days apart early next year and the results will take two to three months to process before it can be registered in Brazil.
He said 200 million reais ($38 million) have been earmarked to purchase the vaccines, used firstly to inoculate the state’s population.
Reporting by Anthony Boadle; Editing by Stephen Eisenhammer and Steve Orlofsky
Our Standards: The Thomson Reuters Trust Principles.