Shots:
- FDA has approved sBLA of Comirnaty (LP.8.1-adapted monovalent COVID-19 vaccine) for active immunization in adults (≥65yrs) & individuals (5–64yrs) with ≥1 high-risk condition for severe COVID-19 outcomes; FDA recommends LP.8.1 for fall 2025, with vaccine shipping immediately for US availability soon
- Approval was backed by extensive data, incl. trial in children (5–11yrs.), & preclinical data showing superior immune responses against XFG, NB.1.8.1, & other sublineages vs JN.1 & KP.2-adapted monovalent vaccines
- BioNTech holds marketing authorizations for Comirnaty & adapted vaccines in the US, EU, UK, & other regions, as well as emergency use authorizations globally
Ref: Pfizer | Image: BioNTech and Pfizer | Press Release
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