Brazilian prosecutors call on govt to suspend 20 million-dose deal with India’s Covaxin jab over lack of Phase 3 trial data

The Public Prosecutor’s Office in Brazil has asked the Federal Audit Court to suspend an order for 20 million doses of the Covaxin Covid-19 jab made by India’s Bharat Biotech, ahead of a vaccine factory inspection next week.

Just one day earlier, Brazil’s health ministry inked a deal with the private Indian firm worth 1.6 billion reais ($290,000), with the first 8 million vaccine doses set to arrive in March.

However, on Friday state prosecutors in the South American nation said that the two-dose vaccine should not be rolled out because it has not yet passed large-scale phase III clinical trials.

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“The acquisition of vaccines not yet tested further delays the vaccination of Brazilians and puts the lives of millions at risk, at the moment when we face the worst phase of the disease, with the record of daily deaths recently reached,” the court submission reads.

Brazil’s drug regulator, the National Health Surveillance Agency (Anvisa), said on Friday that it had been given the green light to conduct an inspection of a Bharat Biotech factory in India from March 1 to 5.

The inspection is set to cover the factory’s production lines, storage facilities and quality control laboratories, Anvisa said in a press release.

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The regulator has not yet been asked, though, to conduct clinical studies or to authorize the emergency use of the Covaxin vaccine.

Brazil has recorded the second-highest Covid-19 death toll of the pandemic after the US.

Last week the country cut some of the red tape around its procurement rules in order to circumvent traditional bidding procedures and get Covid-19 jabs into the arms of Brazilians.

More than 250,000 deaths from the virus have been recorded in Brazil. On Thursday it reported 65,998 new cases and another 1,541 deaths.

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