Anvisa changes the requirements for emergency vaccination | Vaccine

These changes come a day after the Pfizer laboratory, which produces a 95% effective vaccine against Covid-19 already distributed in the European Union, the United States and other countries, signals the withdrawal when requesting authorization from Anvisa to emergency use. of the immunizer in Brazil.

The laboratory understood that agency guidelines would take longer to be met and therefore it would be better if the company worked for the approval of the final registration, and not for the emergency use, which takes longer. (you will understand more about this later).

According to Anvisa, the changes were as follows:

• No more need the laboratory to inform a availability hours to the country.
• The company also it is no longer necessary to enter the number of doses available; it would suffice to provide a forecast of that total.
• Anvisa begins to suggest the UK model or even the company’s own form Informed consent form (ICF) must be signed by the vaccinated patient in case of emergency.

In a note, Anvisa says that it updated the guidelines to “facilitate the understanding of the process of sending documents, as well as speed up the process.” The agency did not name a laboratory in the statement.

Pfizer wants the definitive record

Pfizer in Brazil suggested Monday that it will prioritize definitive registration of the coronavirus vaccine. This is because the company claims, according to a statement, that “The conditions established by the agency require specific analysis for Brazil, which requires more time to prepare.” Among these requirements is the need to provide details on the number of doses and the schedule.

For the laboratory, the Anvisa conditions could only be met with a longer analysis, therefore, It would make more sense for Pfizer to proceed with the continuous shipment request – that is, the definitive registration with delivery of documents in time to facilitate analysis – which takes longer.

The company also reported that “it has already delivered to the agency, through the continuous submission process, the results of Phase 3 of the studies, which means another step towards approval of the vaccine.”

Anvisa published on Monday (28) the Good Manufacturing Practices certification for the company Pfizer, one of those involved in the production of the Pfizer / Biontech vaccine against Covid-19.

In total, four companies participate in the certification process for the production of this vaccine, being Pfizer one of them. Two others have already received certifications after undergoing inspections and only one has yet to send the information required by Anvisa after the initial technical analysis.

In the case of Pfizer, the technical team carried out an analysis based on information sent by the company itself, concluded on Saturday.

Anvisa clarifies that there are two forms of certification: through inspection reports prepared by regulatory authorities with regulatory equivalence to the Brazilian one, which make up the Pharmaceutical Inspection Cooperation Scheme (PIC / S, in its acronym in English), or with visits techniques, as happened with the other two associates.

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