The Brazilian Health Regulatory Agency (Anvisa) has granted emergency use authorization for Sinovac Biotech’s Covid-19 vaccine, CoronaVac, in children aged three to five years.
Subjects in this age group can receive the same vaccine dosage authorised in patients aged six to 17 years, as well as adults.
Furthermore, there exists no restriction on vaccine usage in immunosuppressed children aged three to five years.
The regulatory authority granted authorisation under comprehensive evaluations based on analysis findings from all available data on the vaccine and its usage in children.
Analysis was based on data submitted by the Butantan Institute, with research findings from Chile where the vaccine is being used in children of this age group, opinions from medical societies, research data on Covid-19 vaccination in Brazil, real-life data and published scientific literature data.
The Brazilian Society of Pediatrics, Brazilian Society of Pneumology and Phthisiology, Brazilian Society of Infectious Diseases, Brazilian Society of Immunizations and the Brazilian Association of Collective Health took part in the assessment activity.
The specialists from these institutions had access to technical materials and research data on the vaccine to aid Anvisa in assessing the vaccine.
In January last year, Anvisa authorised emergency use of the vaccine in adults in Brazil.
Subsequently this January, the authorisation was expanded to include vaccine usage in children and adolescents aged six to 17 years.
Till date, the vaccine received emergency use authorizations for use in minors in 14 countries and regions, including Chile, Colombia, Ecuador and Brazil.
The company received prequalification from the World Health Organization for its Poliomyelitis Vaccine (Vero Cell, Inactivated Sabin strains), last month.