The National Health Surveillance Agency (Anvisa) informed, last night (15), that it asked the Butantan Institute for more data to know if the release of the CoronaVac vaccine is safe to be indicated for children aged 3 to 5 years. The agency said the studies sent by the institute are insufficient to recommend the release of the immunizer against covid-19 for the age group.
The release of the vaccine was requested by Butatan to Anvisa on March 11. The institute requested a change to the CoronaVac package insert so that it is also recommended for children aged 3 to 5 years. Currently, in addition to the adult population, the immunizer is already released for children and adolescents aged 6 to 17 years.
“After evaluating the considerations of medical societies and the studies sent by the Butantan Institute, Anvisa experts concluded that the data presented are insufficient for a conclusion on the use of the Coronavac vaccine for children aged 3 to 5 years”, said Anvisa.
The regulatory agency stated that it considers the submission of complementary data on ongoing studies to be essential to characterize the benefit of the vaccine and asked Butantan for a letter detailing all the data necessary to fulfill the requirements for authorizing the use of the immunizer in the requested age group.
Among other data, Anvisa asked for more information detailing the protection provided by the Coronavac vaccine in this population after an interval of two to three months and, also, after complete vaccination with the 2-dose regimen, “in a scenario of predominance of the variant Omicron”.
The agency also wants the duration of protection against the virus pointed out in the studies and data on the clinical study protocol for evaluating the “immunogenicity and safety of the third dose or booster dose of the Coronavac vaccine in the pediatric population (all age groups).”
In addition, data from the Phase 3 clinical report of vaccine studies conducted in China were also requested from Butatan for comparative immunogenicity assessment in children and adults; and from same-phase studies conducted in South Africa, Chile, Malaysia and the Philippines to assess the immunogenicity, safety and efficacy of the vaccine in children and adolescents aged 6 months to 17 years.
The agency said that the deadline for evaluating the emergency use of CoronaVac in the population aged 3 to 5 years will be up to 30 days after sending the complementary data sent by Butantan.
