BRASILIA (Reuters) – Technical staff at Brazilian health regulator Anvisa on Friday recommended conditions for any approval of the Russian COVID-19 vaccine Sputnik V, such as restricting use to healthy adults.
Anvisa’s technical staff made the same recommendations for the Covaxin shot, made by Bharat Biotech, a private company based in the Indian city of Hyderabad.
The recommendations came ahead of deliberations by Anvisa’s board later on Friday over whether to uphold, overturn or modify a ruling in late April rejecting imports of the Sputnik V shot requested by state governors desperate for vaccines.
At the time, Anvisa’s five-member board voted unanimously not to approve the Russian vaccine after technical staff had highlighted “inherent risks” and “serious” defects, citing a lack of data guaranteeing its safety, quality and effectiveness.
That rejection kicked off a testy exchange with the Russian developers, who threatened to sue the Brazilian agency for defamation, accusing them of buckling under to U.S. pressure.
Moscow’s Gamaleya Institute and the Russian Direct Investment Fund said at the time that Sputnik V is 97.6% effective against COVID-19 in a “real-world” assessment based on data from 3.8 million people.
Brazil’s vaccination program has been blighted by delays and procurement failures, turning the country into one of the world’s deadliest COVID-19 hot spots this year and pushing the national health system to the brink of collapse.
Brazil has so far vaccinated 47.6 million people with a first dose, equivalent to 22.6% of the population, but only 22.7 million with two doses, or 10.8% of the population.
Brazil has registered 16.8 million confirmed cases of the virus and almost 470,000 deaths since the onset of the pandemic. Daily deaths have decreased from the peak of the second wave in April, but remain far higher than even the worst of 2020.
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