RIO DE JANEIRO, BRAZIL – Brazilian health regulator Anvisa on Wednesday, March 31, rejected a request from the government to import doses of Covaxin, the COVID-19 vaccine developed by Indian laboratory Bharat Biotech, citing a lack of safety data and documentation.
“The importer did not present all the documents required by law,” said Anvisa board member Alex Machado Campos.
The Brazilian government signed a contract last month to buy 20 million doses of Covaxin and Bharat Biotech applied for emergency use of the vaccine in Brazil on March 8.
However, Anvisa said the vaccine did not meet its manufacturing standards.
Bharat and its Brazilian partner, Precisa Medicamentos, said they will provide the Health Ministry with all the documentation required by Anvisa, and it would then be up to ministry to decide whether to file a new request with the regulator.
The pair also said they were making “every effort to comply with Anvisa’s determinations and adapt the procedures and techniques” necessary to receive approval. They said that around 20 million doses of Covaxin have been produced and released “with no serious events reported to date.”
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