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Awaiting EMA review outcome after MAA validation; reaffirmed 2026 sales guidance of 135-150 million euros in its August 13 earnings update
The vaccine, now formally designated PF-07307405 (also called LB6V, and previously known as VLA15), cleared its first regulatory hurdle since March's Phase 3 results. On August 14, 2026, the European Medicines Agency validated Pfizer and Valneva's marketing application, meaning the dossier is complete and formal review can begin.
Updated Aug 15
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