RIO DE JANEIRO, BRAZIL - Pfizer pharmaceutical laboratory will not submit its immunizer, developed in partnership with German BioNTech to fight the novel coronavirus, to ANVISA for emergency use in Brazil.
The company was in contact with the National Health Regulatory Agency (ANVISA) on December 14th, for clarification on the submission procedure for emergency use, but ran into the existing constraints in the Emergency Use Submission Guide developed by the agency.
It concluded that the requirements in the program (such as an analysis of the efficacy of tests in the Brazilian population, as well as availability of the number of doses . . .