The pharmaceutical multinational Pfizer submitted to the National Health Surveillance Agency (Anvisa), yesterday (30), a request for temporary authorization for emergency use for a new version of the bivalent vaccine against covid-19. According to the company, the new vaccine contains a mixture of strains of the SarsCov-2 virus and promises greater protection against Ômicron, a variant of concern in the country, responsible for the highest number of deaths, especially in the first half of 2021, at the worst moment of the pandemic. yet.
According to Anvisa, Pfizer had already submitted a similar request, in August, for a bivalent version that contains the subvariant omciron BA.1. This request is under analysis by Anvisa. Now, the company requests the evaluation of the version that contains the subvariant BA.4/BA.5, in addition to the original strain of the Comirnaty vaccine, with indication for application as a booster dose in the population over 12 years of age. The Comirnaty monovalent vaccine was registered by Anvisa in February 2021 and is authorized for use from 6 months of age.
After the request at Anvisa, the agency has 30 days to complete the assessment, but this period is interrupted whenever it is necessary to request the company to provide additional information or clarifications on the quality, efficacy and safety data presented.
