MercoPress. South Atlantic News Agency

Pfizer files for emergency clearance of bivalent C-19 vax in Brazil

Pfizer's ComiRNAty vaccine has been applied in Brazil since February 2021, but the new one would also target the Omicron variant

Brazil's National Health Surveillance Agency (Anvisa) has received a request for the emergency use of Pfizer's newest vaccine against COVID-19 which would be active against both the original and the Ômicron strain, subvariant BA.1.

 Pfizer's ComiRNAty vaccine has been applied in Brazil since February 2021.

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 designed to combat Omicron. The bivalent vaccine, manufactured by US laboratory Moderna, was confirmed for approval this week.

The decision by the British regulatory body, equivalent to Anvisa, was based on clinical trials that showed a “strong immune response” against Omicron triggered by the immunizer.

Moderna's COVID-19 vaccine with a new formula will be used in the UK primarily as a booster for people aged 50 and over starting in the fall.

The Medicines and Healthcare Regulatory Agency (the British equivalent to Anvisa) said the updated Moderna drug protects users against the initial version of SARS-CoV-2 as well as from the more contagious Omicron lineage. It also pointed out the new chemical met British standards of safety, quality, and effectiveness. The agency said it based its decision on trials that showed a “good immune response” against Omicron sub-variants BA.4 and BA.5. (Source: Agencia Brasil)