Brazil's Anvisa approves Russian Sputnik V vaccine, with conditions

BRASILIA (REUTERS) – Brazilian health regulator Anvisa on Friday (June 4) gave the green light for states to import the Russian Covid-19 vaccine Sputnik V, but with conditions attached.

Anvisa’s board voted 4-1 to grant the conditional approval after more than seven hours of deliberation, following the recommendation of its technical staff earlier in the day.

Anvisa also voted to approve, again with conditions, the Covaxin shot made by Bharat Biotech, a private company based in the Indian city of Hyderabad.

“SputnikV will arrive in Brazil in July,” tweeted Kirill Dmitriev, chief executive of the Russian Direct Investment Fund (RDIF), which markets the Sputnik V vaccine abroad.

Sputnik V tweeted that Brazil becomes the 67th country to authorise the vaccine.

Earlier on Friday, Anvisa’s technical staff had recommended approving the vaccine but only on certain conditions, such as that it be used only on healthy adults.

The rulings come after the health regulator rejected in late April imports of the Sputnik V shot requested by state governors desperate for vaccines. States had originally wanted 37 million doses.

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.

The rejection kicked off a testy exchange with the Russian developers, who threatened to sue the Brazilian agency for defamation, accusing them of buckling under US pressure.

Moscow’s Gamaleya Institute and the RDIF said at the time that Sputnik V is 97.6 per cent effective against Covid-19 in a “real-world” assessment based on data from 3.8 million people.

A source involved in the vaccine analysis process told Reuters that Anvisa’s decision on Friday was “an attempt to come up with a solution that guarantees a minimum degree of safety. Let’s see real-life data and effectiveness now.”

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The Brazilian government signed a contract in February to buy 20 million doses of Covaxin, and Bharat Biotech applied for emergency use of the vaccine in Brazil in early March. However, Anvisa ruled on March 31 that the vaccine did not meet its manufacturing standards.

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 per cent of the population, but only 22.7 million with two doses, or 10.8 per cent of the population.

Brazil has registered 16.84 million confirmed cases of the coronavirus and more than 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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