US biotechnology company Novavax Inc (Nasdaq:NVAX) announced on Wednesday that the US Food and Drug Administration (FDA) has approved the Nuvaxovid 2025-2026 Formula for the prevention of COVID-19.
The formula was approved for adults aged 65 years and older, or individuals from 12 years with at least one underlying condition that puts them at high risk of severe outcomes from COVID-19.
Clinical and preclinical data have previously shown that Nuvaxovid is safe and effective for the prevention of COVID-19, and induces immunity across currently circulating JN.1 lineage strains, including NB.1.8.1, LP.8.1, XFG, XFC, LF.7 and XEC.
According to Novavax, Nuvaxovid is the only protein-based, non-mRNA COVID-19 vaccine available in the United States for the 2025-2026 vaccination season.
LakeShore Biopharma receives Nasdaq delisting determination letter
Valneva reports strong Phase 2 booster results for Lyme disease vaccine candidate VLA15
GC Biopharma files IND for Phase 3 trial of BARYCELA in Thailand
Novavax COVID-19 vaccine approved in US
WHO and UNICEF deploy PharmaJet's Tropis ID system in Afghanistan polio campaign
FDA grants priority review for GSK's gepotidacin gonorrhoea indication
GSK to receive USD370m and future royalties in CureVac/BioNTech settlement
FDA lifts pause on Valneva's chikungunya vaccine IXCHIQ for elderly, updates prescribing information
Anixa Biosciences begins US FDA approved IND transfer to support Phase 2 breast cancer vaccine trial
Pfizer and BioNTech receive EU regulatory backing for LP.8.1-adapted COVID-19 vaccine
Sanofi to acquire Vicebio for USD1.15bn to strengthen respiratory vaccine pipeline
Bavarian Nordic chikungunya vaccine enters Health Canada review process