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Pfizer / BioNTech vaccine dose against covid-19 – AFP
The pharmaceutical company Pfizer He said today that he will not send his vaccine, produced in association with BioNTech, for emergency use in Brazil, and that he must rely on the so-called continuous presentation that, in practice, would speed up the protocol. The information is from UOL.
In a statement, the US company reported that it had a meeting with representatives of the National Health Surveillance Agency (Anvisa) on December 14 to clarify doubts about the presentation process, but that it found difficulties in the Presentation Guide for Emergency Use , prepared by the Brazilian agency.
“An example is the request for an analysis of data collected exclusively from the Brazilian population, which requires time and specific statistical evaluations. Other regulatory agencies that have the emergency use process analyze the study data in its entirety, without asking for a cut to assess specific populations. We understand that continuous shipping is the fastest process at the moment, ”says Pfizer.
This continuous submission is not yet the immunizer registration application, but it is a way to speed up the analysis of the data by Anvisa. In it, the results of clinical tests are presented as they are ready, and not just at the end of the investigation.
In the same statement, according to UOL, the pharmaceutical company assures that it continues “in negotiations with the federal government for the supply of its vaccine against covid.”
Read the full Pfizer press release
Regarding the negotiations with the Brazilian government and the presentation of the emergency use of the BNT162 vaccine, developed by Pfizer and BioNTech, we clarify:
On December 14, Pfizer held a meeting with Anvisa to clarify doubts about the shipping process for emergency use.
The conditions established by the agency require specific analysis for Brazil, which takes more time to prepare.
An example is the request for an analysis of data collected exclusively on the Brazilian population, which requires time and specific statistical evaluations. Other regulatory agencies that have the emergency use process analyze the study data in its entirety, without asking for a cut to assess specific populations.
The presentation for emergency use also requests details of the amount of dose and schedule that will be used in the country, points that can only be defined at the signing of the final contract.
Therefore, based on current regulations defined for emergency use, the company believes that the continuous shipping process is the fastest at this time.
Pfizer has already sent Anvisa, through the continuous submission process, the results of our Phase 3 study, which is another step towards the approval of our vaccine.
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