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Paraná plans to hold phase 3 tests of Russian COVID-19 vaccine

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One of Brazil’s 27 states, Paraná plans on conducting phase three tests of Russia’s vaccine against the novel coronavirus, dubbed Sputinik V. The announcement was made today (Aug. 26) by Director-President of the Technological Institute of Paraná (Tecpar) Jorge Callado, during a hearing of the external commission of the lower house on the efforts to tackle the pandemic.

After the Russian vaccine was announced, the government of Paraná signed a cooperation deal with with the Russian Direct Investment Fund (RFPI) to carry out the testing, production, and distribution of the vaccine in Brazilian territory. First, Callado said, research results from phase one and two must be submitted to Brazil’s sanitary watchdog Anvisa.

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“We’re working to do the phase three in Brazilian territory as well, after we submit to Anvisa the data on phases one and two,” Callado said. “Next, we’ll also seek the issue of manufacturing [the vaccine] in Brazilian territory, possibly via a consortium,” he added.

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In Russia, phase three trials will start next week. The Russian government plans to administer the vaccine on 40 thousand volunteers. The Russian vaccine is an intramuscular shot in two doses. The second dose should be applied 21 after the first.

During the hearing, Russia’s Gamaleya Institute for Epidemiology and Microbiology Alexander Gintsburg talked about the peculiarities of the Russian vaccine developed by the institute, which utilizes two adenoviral vectors—Ad5 and Ad26—against COVID-19.

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The other vaccines are being studied in Brazil—that of Oxford, developed by the British University of Oxford, in partnership with company AstraZeneca, and the Chinese vaccine, which should start being tested in Brazil by the Butantan Institute—avail themselves of just one.

The use of two vectors, Gintsburg said, has been studied by the institute since 2015 and has been successfully applied in vaccines against Ebola and the Middle East respiratory syndrome (MERS). He said that early studies with a thousand people indicate that the vaccine may have a long immunization period—up to two years.

Gintsburg said that the parnetship with Brazil includes the production of 60 thousand doses of the vaccine, but added that the goal of Gamleya Institute is to forge collaborations to boost production. “We’ve signed a deal to produce 60 thousand doses; we wished to manufecture up to 300 thousand doses a year,” he said. “We may test and conduct clinical trials in Brazil and produce the vaccine not just for Brazil but Latin America,” Gintsburg went to say, while stating that intention of the Russian government is to produce 120 million doses of the vaccine domestically every year.

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