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Vials and syringes of the BioNTech / Pfizer coronavirus vaccine at the Schott glass factory in Mainz, Germany, on November 20, 2020 – AFP / Archives
The National Sanitary Surveillance Agency (Anvisa) updated this Tuesday (29) the guidelines for the analysis and approval of the emergency use of vaccines against COVID-19. These changes come a day after Pfizer said it would not ask the agency for authorization for the emergency use of its vaccine in Brazil. Information is from G1.
+ Pfizer Says It Will Not Send Vaccine For Emergency Use Approval
Among the changes to the Anvisa guidelines is the end of the need for the laboratory to report a schedule of availability of doses of the immunizer in the country, as well as the amount available. It would be enough to provide only a forecast of the total.
Anvisa also begins to suggest the model of UK or even the company itself of the Free and Informed Consent Form (ICF) to be signed by the vaccinated patient in emergency use.
In a note, Anvisa says that it updated the guidelines to “facilitate understanding of the document submission process, as well as speed up the process,” but did not mention any laboratory in the statement.
On Monday (28), Pfizer reported that it had a meeting with representatives of the National Sanitary Surveillance Agency (Anvisa) on December 14 to clarify doubts about the submission 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 the US laboratory.
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