Brazilian Health Regulatory Agency, Anvisa, said it turned down a request by the Brazilian Butantan Institute for approval of Chinese CoronaVac to vaccinate children aged between 3 and 17.
Anvisa stated this on Wednesday that the request was not approved due to lack of sufficient data.
The Instituto Butantan biologic research centre is producing CoronaVac.
“Vaccination of children and teenagers with CoronaVac vaccine is not approved. It was impossible to prove the vaccine’s efficacy and safety for this age group, based on information by the Butantan Institute.
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“Data on immunogenicity leave unclear the duration of protection provided by the immunizing agent,” said Anvisa.
The agency also noted that there was no conclusion on side effects or vaccine efficacy among children with associated diseases, chiefly due to the insufficient number of tests’ participants.
Only the Pfizer/BioNTech vaccine has so far been approved by Anvisa for vaccinating people over 12 years old in Brazil.
However, the Janssen laboratory has received a permit to conduct experiments with children under 18 in the Latin American country