Analysis: Wary of Russian vaccine, Brazil plans its own additional study for more safety data

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Wed, 2021-06-09 12:03 — mike kraft

Analysis: Still wary of Russian vaccine, Brazil clears its own 'study' for more data Russian vaccine developers cheered hard-won access to Brazil's market last week, but with less than a million doses cleared for import, public health experts say the approval is more like a late-stage trial for the Sputnik V shot. Lisandra Paraguassu Reuters

Russian vaccine developers cheered hard-won access to Brazil's market last week, but with less than a million doses cleared for import, public health experts say the approval is more like a late-stage trial for the Sputnik V shot.

Late Friday, Brazilian health regulator Anvisa, which was under pressure from state governors and the country's Supreme Court, ruled that states could import the Russian COVID-19 vaccine, but included some 20 strict conditions. read more

Those restrictions undercut the impact of the approval and echo a cautious approach to the Russian vaccine among many Western regulators, including the European Medicines Agency. Previously, Anvisa had rejected Sputnik V in April.

"What will be done is practically a reproduction of a Phase 3 study in Brazil," said former Anvisa president Gonzalo Vecina, who did not take part in the agency's decision. "We'll have to do the work the Russians didn't, the whole drug safety study."

Brazil's raging coronavirus outbreak has taken nearly 475,000 lives, the worst recorded death toll outside the United States, and its national immunization program has lost steam due to a lack of imported vaccines and active ingredients. read more

Against that dire backdrop, a consortium of Brazilian states in the poorer northeast region have booked orders for Sputnik V directly and sought import approval from Anvisa under emergency provisions of a new law, backed by Supreme Court decisions. ...

The Russian vaccine, already in use in Latin American peers such as Mexico and Argentina, will undergo quality checks in Brazilian labs. And state health authorities must report granular data on efficacy and adverse events to Anvisa, which was not satisfied with disclosures from Russian developers. ...