Brazil receives definitive registration request for Oxford vaccine

Brazil’s national sanitary regulator Anvisa announced it has received the request for the definitive registration of the vaccine produced by Oxford University and UK pharmaceutical company AstraZeneca in partnership with the Oswaldo Cruz Foundation (Fiocruz).

The definitive registration request is different from authorization for emergency use, already granted to the consortium. For the latter, immunization is given to specific groups, whereas under definitive request the group in charge of the vaccine is allowed to vaccinate any individual in addition to selling the product.

While the emergency authorization was granted after ten days of considerations, the definitive registration has a longer assessment process, lasting up to 60 days. In a statement, the agency declared it will seek to conclude the procedure in less time.

“Due to the stage of already conducted assessments, with a view to finishing before the deadlines established, Anvisa will maintain all its priority on the analysis in order to conclude the process as quickly as possible,” the note released by the watchdog on Friday (29) reads.

Since Anvisa has adopted a continuous dynamic, the Oxford/AstraZeneca consortium and Fiocruz have produced documents on the vaccine. The first package of data was turned in to the regulator in October last year.

After delivering 2 million doses of the Oxford/AstraZeneca vaccine imported from India, Fiocruz awaits the arrival of two shipments of the active pharmaceutical ingredient to produce new batches. Fifty million doses should be manufactured by April, and 100.4 million by July this year.