RIO DE JANEIRO, BRAZIL – Brazilian health authority Anvisa said on Saturday, January 9th, that the application from São Paulo-based medical center Butantan for emergency use of a COVID-19 vaccine developed by China’s Sinovac Biotech lacks some relevant information for the analysis.
Anvisa said in a statement that Butantan did not inform, for instance, the age, gender or comorbidities of participants in trials with Sinovac’s CoronaVac vaccine. The application also missed data on the vaccine’s immunogenicity on Phase III trials and some details on the number of participants, the health authority said.
Butantan delivered its application on Friday.
Brazil’s state-run Fiocruz Institute also submitted on Friday an application for emergency use of the AstraZeneca COVID-19 vaccine. Anvisa said on Saturday that all required information has been delivered.