SAO PAULO, Jan 9 (Reuters) - Brazilian health authority
Anvisa said on Saturday 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.
(Reporting by Carolina Mandl; Editing by Leslie Adler)