Brazilian regulator still unsatisfied with safety of 12 mln Coronavac doses

In the Wednesday statement, Anvisa said that Butantan had delivered a number of documents to the health authority at a Tuesday meeting, but did not submit a key inspection report. The health authority is also in the process of arranging a visit by Brazilian inspectors to the plant in question in China, it added. Anvisa said it hoped to gain a quarantine exemption for its inspectors, given that they are all vaccinated.

Brazil's federal health regulator said on Wednesday that documents provided by a Sao Paulo biomedical center attesting to the safety of over 12 million doses of the Coronavac COVID-19 vaccine were insufficient to ensure their safety. Last week, the regulator, known as Anvisa, suspended the use of millions doses of the vaccine developed by China's Sinovac Biotech Ltd, as they were produced in a plant that had not been authorized by the authority.

Anvisa said in a statement at the time that it was alerted by the Butantan biomedical institute, which has partnered with Sinovac to locally fill and finish the vaccines, that roughly 12.1 million doses sent to Brazil had been made at the plant. In the Wednesday statement, Anvisa said that Butantan had delivered a number of documents to the health authority at a Tuesday meeting, but did not submit a key inspection report.

The health authority is also in the process of arranging a visit by Brazilian inspectors to the plant in question in China, it added. Anvisa said it hoped to gain a quarantine exemption for its inspectors, given that they are all vaccinated.