RIO DE JANEIRO, BRAZIL – Brazilian health regulator Anvisa said Bharat Biotech’s Covaxin COVID-19 does not meet its manufacturing standards, according to a note in the Tuesday edition of the official gazette.
The Brazilian government signed a contract last month to buy 20 million doses of the Indian drugmaker’s vaccine. Bharat Biotech applied for emergency use of the vaccine in Brazil on March 8.
Bharat and its Brazilian partner Precisa Medicamentos said in a statement that they would appeal the decision and would present evidence that it is complying with all requirements.
Covaxin has been approved for use in five countries, including India, the statement said.