Brazil’s ANVISA suspends analysis of Indian vaccine Covaxin for lack of essential documents

RIO DE JANEIRO, BRAZIL – Brazil’s National Health Regulatory Agency (ANVISA) extended on Wednesday, June 30, the deadline to complete its analysis of the application for emergency use of the Indian vaccine against Covid-19 Covaxin, because of the absence of mandatory and documents essential for the evaluation of the efficacy and safety of the vaccine, the regulator said.

The vaccine is at the center of the Covid CPI investigation in the Brazilian Senate for alleged irregularities during negotiations.

ANVISA said in an official statement that it had notified Precisa Medicamentos, the author of the application, to provide the outstanding information urgently.

The agency cited several missing documents, including a report on preclinical safety and immunogenicity studies and various efficacy and safety data.

The application to use the vaccine was filed Tuesday, June 29, amid investigations by the Senate Covid CPI and other oversight bodies into alleged irregularities related to deals with the federal government to purchase Covaxin.

These suspicions brought President Jair Bolsonaro to the center of the debate in the Covid CPI. According to testimony by Congressman LuÌs Miranda (DEM-DF) and his brother, Health Ministry official LuÌs Ricardo Miranda, he had been made aware of the alleged irregularities before the CPI last week.

The Ministry of Health has decided to suspend the contract for the purchase of the Indian vaccine. The decision came after a recommendation from the Comptroller General of the Union (CGU), which proposed the suspension of the contract.

The action is precautionary and temporary “for further analysis by the agency,” the Ministry said in a statement. The agreement had been signed In February this year, for the purchase of 20 million doses of the immunizing agent manufactured by the laboratory Bharat Biotech.

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