RIO DE JANEIRO, BRAZIL – Brazil’s national health regulator (ANVISA) announced that on Tuesday June 29 it received the request for emergency use of the vaccine Covaxin, of experimental character, sent by the company Precisa Medicamentos, which represents in Brazil the Indian pharmaceutical company Bharat Biotech.
The company had announced yesterday that it would apply, saying that the approval is “the last remaining step for the 20 million doses negotiated with the Ministry of Health to be introduced and used in Brazil.”
The pharmaceutical company’s decision comes amid controversy over the contract signed by the Ministry of Health with Precisa Medicamentos, which is being analyzed by the Covid CPI amid investigations into suspected irregularities in the purchase of doses. In addition, the negotiation is under suspicion because the unit value of the vaccines is considered high, about R$80.
According to ANVISA, the agency began examining the documents included in the request. The first 24 hours are used to screen the process and check if the documents needed for the evaluation are available. If important information is missing, ANVISA may request additional data from the lab, the agency said in a statement.
Analysis and deadline
Anvisa uses the information submitted with the application and the data previously submitted through continuous submission to evaluate the application.
According to ANVISA, the analysis of the emergency use application is done by a multidisciplinary team involving experts in drug registration, monitoring, and inspection. The time limit for analyzing the application can be seven or 30 days, depending on the individual case.
According to the rule, if there is clinical development of the vaccine in Brazil or if the report or technical opinion of the foreign health authority can demonstrate that the vaccine meets the standards of quality, efficacy, and safety established by the World Health Organization (W.H.O.) or the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) and the Pharmaceutical Inspection Cooperation Scheme (PIC/S), the deadline for evaluation is seven days.
However, the deadline is 30 days if there is no clinical development of the vaccine in Brazil or if the report or technical opinion of the foreign health authority does not demonstrate that the vaccine meets the quality, efficacy, and safety standards established by the W.H.O. or the ICH and the PIC/S.
ANVISA also reiterates that the deadline for evaluating the emergency use request does not consider the time of the process in the status of the technical request, that is, the time in which the laboratory must answer technical questions posed by the agency within the approval proceeding.