Anvisa (National Health Surveillance Agency) reported that the Butantan Institute, during a meeting held this Friday (3) to discuss the use of CoronaVac, did not present data or studies on the 3rd booster dose against covid-19 . “For Anvisa to decide on the third dose/booster using the Coronavac vaccine, there is a need to present studies and data that support this indication and dosage. These data were not presented by the Butantan Institute”, says the note published on its website.
At the At the end of last month, Anvisa had already requested this information from Butantan before the meeting was scheduled. The agency highlighted that it has been meeting with laboratories involved in the development of vaccines and drugs to fight covid-19. “The objective is to monitor and guide on the products in development and also on the monitoring and complementation of data for those vaccines that are already in emergency use”, informs the note from Anvisa.
The agency noted that Butantan also did not present data on the immunogenicity — that is, the ability to generate an immune response (antibodies) to covid-19 — of CoronaVac. “During the approval of the emergency use of the CoronaVac vaccine in Brazil, the Butantan Institute signed a Term of Commitment for the presentation of data that were not sent with the request for emergency use. So far, the Institute has not presented this data to Anvisa”.
Anvisa recalled that, so far, there is no request for definitive registration of CoronaVac. Because of the coronavirus pandemic, the immunizing agent is only authorized for emergency use. “After the period granted for emergency use, the product will be required to be registered, under penalty of apprehension determined by Anvisa”, concludes the note from the agency.