Anvisa mandates updated COVID‑19 vaccines to target new circulating variants

Brazil’s health regulator Anvisa issued a new normative instruction on 9 July, published in the Official Gazette, that requires all COVID‑19 vaccines used in the country to be reformulated. The rules specify that vaccines must be monovalent, targeting a single SARS‑CoV‑2 lineage, and must include the variant LP8.1 as the preferred antigen. Derivatives of the JN.1 lineage (e.g., XFG, NB‑1.8.1) are allowed if they demonstrate broad neutralising‑antibody responses.

Vaccines already registered, produced or distributed before the rule may continue to be administered for up to nine months after the approval of the updated formulation; thereafter their use will be prohibited. Anvisa justified the change by citing recent reports of dozens of flu‑like syndromes linked to COVID‑19, underscoring the need for vaccination strategies that keep pace with viral evolution.

Manufacturers must submit updated dossiers for the new composition, and Anvisa will apply an accelerated review based on international criteria and existing safety data. The measure aims to improve population protection against the latest circulating variants while managing existing stockpiles during the transition period.