Covid-19: Brazil’s health regulator unanimously rejects Coronavac use in those under 18

RIO DE JANEIRO, BRAZIL – Brazilian health regulatory agency (ANVISA) director Meiruze Sousa Freitas on Wednesday (18) voted against the emergency use of the Coronavac vaccine in children and adolescents aged 3 to 17.

She was joined by ANVISA directors Romison Rodrigues Mota, Alex Machado Campos and Cristiane Rose Jourdan, and by the agency’s president Antonio Barra Torres, to form a unanimous vote.

ANVISA met on Wednesday to decide whether to authorize the vaccine’s emergency use in children and adolescents. The Butantan Institute, Sinovac’s partner in the vaccine’s production, requested the inclusion of the public aged 3 to 17 in the vaccine’s package insert.

Meiruze claimed that the immunizer’s clinical safety data on the pediatric population were considered insufficient by the agency’s technical area. “Not only is the protection conferred by the vaccine in a pediatric population unknown, but the duration of potential protection is also unknown,” she said.

The director also voted to maintain the temporary emergency use authorization for the Coronavac, considering the continuity of the benefit-risk assessment, and recommended that the Ministry of Health consider the potential indication of a booster dose for the public administered two doses of the vaccine.

Director Machado stressed the need for an institutional position and reinforced the importance of Coronavac in the vaccination process against the novel coronavirus in Brazil.

Technical area

The first opinion from ANVISA’s technical area held that there is not enough available data to approve the use of the Chinese Coronavac vaccine in the population aged 3 to 17.

Gustavo Santos, from the General Management of Drugs and Biological Products (GMED), pointed out uncertainties regarding the vaccine’s protection in the pediatric population.

According to him, the vaccine’s efficacy in protecting against Covid-19 in the pediatric population and the duration of this protection are unknown. The official also noted that there were an insufficient number of participants to determine safety in this population.

Therefore, it concluded that the risk-benefit is unfavorable for the use of Coronovac in children and adolescents.

Director Freitas pointed out that of the 47.9 million Coronavac doses administered by July 16, 2021, there are no major findings that would compromise the Chinese immunizer’s safety.

“With respect to the monitoring process, we are reinforcing and highlighting the importance of spontaneous reporting, which plays a key role in creating hypotheses for serious adverse reactions to drugs, notably those that result in hospitalization or death,” she said.