Authorization for COVID-19 vaccine may be given in up to ten days

Brazil’s national sanitary regulator Anvisa believes it may assess and grant emergency authorization for vaccines against COVID-19 in up to ten days. This permission modality was established by the agency for a quicker analysis under special immunization conditions given the current pandemic landscape.

The special permission may be granted for vaccines being studied in Brazil in Phase 3, in which efficiency and safety are appraised. In this case, vaccines are directed at government programs, and may not be traded by the companies given the permit.

Only the companies developing vaccines will be able to request authorization from Anvisa. Its capacity to manufacture or import the substance must be demonstrated. The firms interests must hold a meeting with a team from Anvisa, which is called “pre-submission.” Also required is having an Avisa-approved dossier for clinical development.

Authorization from other countries

In the statement about the ten-day term, Anvisa also mentioned the emergency authorization procedure based on approval from foreign watchdogs. This is made possible by current legislation.

The text cites the permission granted for the Pfizer vaccine by the US Food and Drug Administration (FDA), arguing that, even if the process in the US is similar, an assessment should be conducted by the Brazilian agency as well.

“Nonetheless, a portion of the data, as well as the monitoring commitments and plans that must make up the request for emergency use [to another regulator in another country], concern exclusively to domestic realities, hence the importance of having Anvisa analyze the vaccine to be used in Brazil,” the note reads.

Among the issues to be taken into account as part of the assessment to be concluded in ten days are:

– whether the vaccine to be made available to Brazilians is the same assessed in the clinical studies;

– whether the target population to be vaccinated in Brazil is the same as the one immunized in the source country;

– what the best monitoring strategies for vaccine application and possible adverse effects are.