Brazil’s national drug regulator Anvisa received from the pharmaceutical company Pfizer the request for authorization for the emergency use of a second vaccine against COVID-19. The new vaccine is bivalent, that is, it acts against two strains of the virus. In this case, the vaccine consists of a mixture of the original strain, used in the ComiRNAty vaccine, administered in Brazil since February 2021, and the Ômicron strain, subvariant BA.1.
Once the request for emergency use authorization is received, Anvisa has 30 days to complete the evaluation. This period is interrupted whenever it is necessary to ask the company for complementary information or clarification on the quality, efficacy, and safety data presented.
The UK was the first country to approve a vaccine developed to combat Omicron. The bivalent vaccine, manufactured by the US laboratory Moderna, was approved this week. The decision by the British drug regulator, equivalent to Anvisa, was based on clinical trials that showed a “strong immune response” against Omicron triggered by the immunizer.
Source: Agência Brasil