The National Health Surveillance Agency (Anvisa) received this week the application for registration of the vaccine against covid-19 Covovax. It is the first immunizer presented in Brazil that uses recombinant protein technology. The request was made by Zalika Farmacêutica Ltda., which represents the manufacturer of immunizers in Brazil, Instituto Serum, from India. The proposed indication is for adults over 18 years of age.
The request was submitted to Anvisa within the scope of the board resolution that brings extraordinary criteria and procedures for registration requests arising from the new coronavirus (covid-19). The rule provides, for example, for priority analysis and the possibility of signing terms of commitment, as was done with other vaccines against covid-19 already authorized in Brazil.
“The protocol was received this Wednesday (27/4) and is already being evaluated by the technical areas involved. The Agency’s analysis period is 60 days”, informed Anvisa in a note.
Also according to Anvisa, the process of analyzing vaccines is done jointly by three different areas. The first is the Medicines area, which evaluates safety and efficacy aspects. Next comes Pharmacovigilance, responsible for the monitoring and follow-up plans of the vaccine after its entry into use in the country. Finally, the analysis goes through the Inspection and Inspection area, responsible for the evaluation of Good Manufacturing Practices.
According to Fundação Oswaldo Cruz (FioCruz), recombinant vaccines use non-replicating chimpanzee adenovirus viral vector technology. The genome is genetically manipulated so that it can no longer replicate itself and to insert the SARS-CoV-2 spike protein (Spike or S protein) gene. Once obtained, the adenoviruses are amplified in large quantities using cells also modified, to allow the amplification of the adenovirus and the production of the vaccine in disposable bioreactors. These adenoviruses are purified, concentrated and stabilized to compose the final vaccine.
The vaccine undergoes a rigorous quality control before being sent to health centers.
Translated to english by RJ983
From Brazil, by EBC News