RIO DE JANEIRO, BRAZIL – Brazil’s National Health Regulatory Agency (ANVISA) advised that it received, this Wednesday, 24th, the request for emergency use of the vaccine from Janssen, the pharmaceutical arm of Johnson & Johnson.
The regulator has already started the screening of the documents presented in the request.
The first 24 hours will be used to screen the file and verify that the necessary documents are available. If there is important information missing, ANVISA “may request the additional information from the laboratory.”
To make its evaluation, ANVISA will use the information submitted along with the application and also the information already analyzed through continuous submission – which is the partial delivery of documents. The analysis of the emergency use request is done by a multidisciplinary team that involves specialists from the registration, monitoring, and inspection areas.
The agency’s goal, as described in a note, is to analyze the emergency use in up to seven working days, discounting any time that the process may be suspended pending information to be submitted by the laboratory.
The Ministry of Health has purchased 38 million doses of the immunizer that provides protection against Covid-19 with a single dose. Deliveries are scheduled to occur from October to December 2021.
If approved, it will be the fourth immunizer to be authorized to reach the arms of Brazilians, along with the group formed by CoronaVac, AstraZeneca/Oxford, and Pfizer/BioNTech. The last two have full registration forgeneral use, not only emergency use.
Source: Veja