anvisa Sets 2026 Flu Vaccine Composition, Signals Gradual Phase-Out of Quadrivalent Shots
Brasília, Brazil – Brazil’s National Health Surveillance Agency (Anvisa) has published Normative Instruction 408/2025, detailing the required composition of influenza vaccines for the 2026 season in both the Southern and Northern Hemispheres. The directive, released today, specifies the influenza strains that vaccine manufacturers must include in their formulations to ensure optimal protection for the Brazilian population.
The decision impacts all vaccines administered in Brazil from February 1, 2026, and comes alongside a broader global trend toward phasing out quadrivalent influenza vaccines due to the lack of circulating B/Yamagata strain activity. Though, Anvisa has persistent that an immediate withdrawal of quadrivalent vaccines in Brazil woudl risk compromising national vaccination coverage, given current market supply.
Southern Hemisphere Vaccines (2026)
Vaccines intended for use in the Southern Hemisphere during the 2026 season must contain the following strains:
* Trivalent Vaccines: A/Missouri/11/2025 (H1N1)pdm09, A/Singapore/GP20238/2024 (H3N2), and B/Austria/1359417/2021 (Victoria lineage).
* Quadrivalent Vaccines: The above three strains, plus B/Phuket/3073/2013 (yamagata lineage).
* Non-Egg-based Vaccines: A/Missouri/11/2025 (H1N1)pdm09, A/Sydney/1359/2024 (H3N2), and B/Austria/1359417/2021 (Victoria lineage).
All Southern Hemisphere vaccines must be clearly labeled with “CEPAS 2026 SOUTHERN HEMISPHERE.”
Northern Hemisphere Vaccines (2025-2026)
Vaccines intended for use in Ministry of health campaigns targeting specific regions of Brazil during the 2025-2026 Northern Hemisphere season must include:
* Trivalent Vaccines: A/Victoria/4897/2022 (H1N1)pdm09,A/Croatia/10136RV/2023 (H3N2),and B/Austria/1359417/2021 (Victoria lineage).
* Quadrivalent Vaccines: The above three strains, plus B/Phuket/3073/2013 (Yamagata lineage).
* Non-egg-Based Vaccines: A/Wisconsin/67/2022 (H1N1)pdm09, A/District of Columbia/27/2023 (H3N2), and B/Phuket/3073/2013 (Yamagata lineage).
These vaccines will be labeled with “CEPAS 2025-2026 NORTHERN HEMISFÉRIO.”
Quadrivalent Vaccine Phase-Out
Following World Health association (WHO) recommendations, Anvisa acknowledges the declining prevalence of the B/Yamagata strain, with no confirmed circulation since 2020. While the WHO anticipates discontinuing quadrivalent vaccines by 2027, Anvisa has decided to maintain the supply of these vaccines throughout 2026 in Brazil to avoid potential disruptions to vaccination programs.The agency will continue to assess the situation and adjust its policies as needed,balancing global recommendations with national healthcare needs.
