Novavax Submits Amendment To FDA For Emergency Use Authorization Of Updated JN.1 COVID-19 Vaccine For Ages 12 And Older; Targets JN.1 Lineage Following Guidance From FDA, EMA, And WHO
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Novavax has submitted an amendment to the FDA for Emergency Use Authorization of its updated JN.1 COVID-19 vaccine for individuals aged 12 and older. The vaccine targets the JN.1 lineage and is effective against current strains like KP.2 and KP.3. It would be the only protein-based COVID-19 vaccine available in the U.S. and aligns with global health recommendations. Novavax plans to release the vaccine in pre-filled syringes immediately upon authorization and CDC recommendation.
June 14, 2024 | 6:07 pm
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Novavax has submitted an amendment to the FDA for Emergency Use Authorization of its updated JN.1 COVID-19 vaccine for ages 12 and older. The vaccine targets current strains and would be the only protein-based option available in the U.S. This aligns with global health recommendations and could lead to immediate release upon authorization.
The submission for Emergency Use Authorization (EUA) of the updated JN.1 COVID-19 vaccine is a significant step for Novavax. If approved, it would be the only protein-based COVID-19 vaccine available in the U.S., potentially increasing its market share and revenue. The alignment with global health recommendations and the plan for immediate release post-authorization further strengthen the positive outlook.
CONFIDENCE 95
IMPORTANCE 90
RELEVANCE 100