Brazil grants emergency authorization to Pfizer’s bivalent vaccines

authorization Pfizer bivalent vaccines Stefan Lambauer/Shutterstock
Photo: Stefan Lambauer/Shutterstock

Anvisa, the Brazilian federal health regulator, on Tuesday granted emergency authorization to two formulations of Pfizer’s Covid bivalent vaccines.

The BA.1 and BA.4/B4.5 formulations were designed to better match the circulating Omicron variants of the novel coronavirus. Pfizer had requested authorization for each bivalent vaccine back in August and September, respectively.

The vaccines are called “bivalent” because they contain two messenger RNA (mRNA) components of the SARS-CoV-2 virus: the original formulation and one targeting at least one variant.

The new formulations were approved as a booster in people aged 12 and over. Unlike in the U.S., the use of the original monovalent vaccines as boosters was not revoked.

The Health Ministry told The Brazilian Report it would request batches of the new formulations from Pfizer, given that the current contract includes the shipment of the updated boosters. The ministry did not provide a deadline nor specified quantities of the new jabs.

In a statement to the press, Pfizer said it estimates the BA.1 and BA.4/BA.5 boosters will be shipped to Brazil “in the next few weeks.” The bivalent doses are supplied in vials with a gray cap, as opposed to the purple cap used in the original formulation from late 2020.

According to official data, Brazil has applied over 491 million Covid vaccine doses, including over 200 million Pfizer jabs.

Separately, on Tuesday also, Anvisa reinstated a mask mandate for passengers on flights and in airports.