By Lisandra Paraguassu

BRASILIA (Reuters) – Russian vaccine developers applauded hard-won access to the Brazilian market last week, but with less than a million doses allowed to be imported, public health experts say the approval looks more like at an advanced stage test for the Sputnik V.

Brazilian health regulator Anvisa, who was under pressure from state governors and the country’s Supreme Court, ruled on Friday evening that states can import the Russian COVID-19 vaccine, but included around 20 strict conditions .

These restrictions undermine 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 replica of a phase 3 study in Brazil,” said former Anvisa president Gonzalo Vecina, who was not involved in the agency’s decision. “We’ll have to do the job the Russians didn’t do, the whole drug safety study.”

Brazil’s raging coronavirus epidemic has claimed nearly 475,000 lives, the worst death toll outside the United States, and its national immunization schedule has run out of steam due to a lack of vaccines and imported active ingredients.

Against this dire backdrop, a consortium of Brazilian states in the poorest northeastern region placed orders directly for Sputnik V and sought approval for Anvisa to import under emergency arrangements. a new law, supported by decisions of the Supreme Court.

“The impression is that they gave their approval under pressure, within the limits they could allow,” said immunologist Jorge Kalil of the University of Sao Paulo. “At least that doesn’t kill the chances of getting the vaccine.”

But the agency has only allowed six northeastern states to import enough Sputnik V vaccines to inoculate 1% of their population – a far cry from the 37 million vaccines states have ordered across the country.

The Russian vaccine, already used by counterparts in Latin America such as Mexico and Argentina, will be subject to quality controls in Brazilian laboratories. And state health officials are to report granular data on efficacy and adverse events to Anvisa, which was not happy with the Russian developers’ disclosures.

The Russian Direct Investment Fund (RDIF), which markets the vaccine developed by the Gamaleya Institute in Moscow, did not immediately respond to questions about the conditional approval.

The RDIF said Friday via Sputnik V’s Twitter account that it had “fully answered all of Anvisa’s questions about the efficacy and safety of the vaccine.”

However, Anvisa’s board stressed during deliberations on Friday that it was failing to secure full approval due to lingering concerns over incomplete test data and inconsistent information on quality and safety. shooting.

“There are still inconsistencies, but in a controlled environment we can move forward,” said a person familiar with the thinking of the board, who requested anonymity to discuss the matter. “There has been progress on paperwork and a worsening of the pandemic in the country, so there has been a combination of factors. “

Still, the meager initial volumes will have little impact on the pandemic and agency conditions, such as lab tests, could mean no injections over the next two months, the source said.

Anvisa’s press service did not immediately respond to questions about political pressure or the timing for the vaccine.

If Anvisa is satisfied with the quality controls and safety data of controlled use in Brazil, the agency could potentially grant emergency use authorization for Sputnik V, paving the way for more imports and more. ‘dose applications produced in the country.

In the meantime, the Gamaleya Institute is expected to provide more documentation to Anvisa, whose final decision may depend on the views of European regulators and the World Health Organization (WHO).

Among Anvisa’s conditions to authorize imports of Sputnik V: The use must be suspended immediately in the event of a negative finding by the WHO.

(Reporting by Lisandra Paraguassu; Editing by Brad Haynes and Aurora Ellis)



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