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ANVISA Drug approvals | Brazil drug approvals | January 2024 | iPharmaCenter


Sl No

Brand

Manufacturer

Indication

1

Recombinant COVID-19 vaccine

Zalika Farmaceutica

Prevention of COVID-19 infection


January 09, 2024

Recombinant COVID-19 vaccine is approved by ANVISA in Brazil to prevent COVID-19 infection


Designed for the immunization of adults and children above 12 years old against coronavirus disease 2019 (COVID-19), the recombinant COVID-19 vaccine has emerged as a crucial tool in the prevention of this viral infection.


At its core, the COVID-19 vaccine (recombinant) consists of nanoparticles featuring the recombinant spike (S) protein derived from SARS-CoV-2. The inclusion of the Matrix-M™ adjuvant in its formulation plays a pivotal role in enhancing the immune response.


Administered in a two-dose regimen, each dose-measuring 0.5 mL, the second dose is scheduled for administration 21 days post the initial dose. Additionally, a booster dose is recommended approximately six months after the primary immunization, specifically for individuals aged 18 years or older.


The vaccine's efficacy has been rigorously evaluated through two primary phase 3 randomized and controlled clinical studies involving adult participants. The data from these studies showcased the effectiveness of the recombinant COVID-19 vaccine in preventing COVID-19 when administered in a two-dose primary immunization schedule. Notably, the vaccine exhibited an efficacy of 90.40% and 89.7% in phase 3 studies conducted in North America and the United Kingdom, respectively, against symptomatic COVID-19.


The safety assessment, encompassing over 40,000 individuals across clinical studies, including the primary phase 3 trials, demonstrated that the recombinant COVID-19 vaccine is well-tolerated. Its safety profile was deemed acceptable for both the adult population and adolescents over 12 years of age.


Recognizing the dynamic nature of the SARS-CoV-2 virus, the company holding the registration, Zalika Farmaceutica, committed to updating the vaccine's composition to align with current virus variants recommended by the World Health Organization (WHO) and Anvisa. The agreement mandates the company to submit this composition update to Anvisa within 60 days of the registration's publication.

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