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 and schedule to be adopted for immunization in the country) would delay the process for adoption of the immunizer.
On the other hand, Pfizer Brasil has already submitted its phase 3 trial results to the agency, which represents a further step towards approval of its vaccine.
Pfizer expects the go-ahead in January, possibly in the first two weeks. The company is still in negotiation with the Brazilian government.
Pfizer’s full press release
“With respect to negotiations with the Brazilian government and submission of emergency use of the BNT162 vaccine, developed by Pfizer and BioNTech, we hereby clarify:
Pfizer met with ANVISA on December 14th to clarify doubts regarding the procedure for emergency use submission. The conditions established by the agency require specific analyses for Brazil, which takes a longer preparation time.
An example of this is the demand for an analysis of data collected exclusively from the Brazilian population, which requires time and specific statistical assessments. Other regulatory agencies with an emergency use procedure analyze data from the full studies, but do not request a specific population assessment.
The submission for emergency use also requires details on the quantity of doses and schedule to be implemented in the country, points which may only be defined upon entering into the final contract.
Therefore, based on the current regulations established for emergency use, the company considers that the continuous submission process is the fastest at this time.
Pfizer has already submitted to ANVISA, through the continuous submission process, our Phase 3 trial results, which represents one further step towards the approval of our vaccine.”