BioNTech Results Presentation Deck slide image

BioNTech Results Presentation Deck

Preparing for Launch of Omicron-Adapted Bivalent Vaccines in Early October 2022 11 Regulatory Engagement Clinical Development loc CO ЮСП 00 Manufacturing Scale-Up FDA, EMA and other regulators recommended Omicron-adapted bivalent vaccines Submissions ongoing worldwide for both BA.1- and BA.4/5-adapted bivalent vaccines ● • FDA: Provided guidance for bivalent vaccine encoding Omicron BA.4/5 spike protein ● ● ● ● EMA: Omicron BA.1-adapted bivalent vaccine submission finalized; preparing submission of preclinical and CMC data package for Omicron BA.4/5-adapted bivalent vaccine Clinical trial of Omicron BA.4/5-adapated bivalent vaccine expected to initiate in August BA.1- and BA.4/5-adapted bivalent vaccines manufacturing initiated Planning to supply both vaccines in time for fall booster campaign CMC, chemistry, manufacturing, and controls Planned Launch First shipments expected as early as October subject to regulatory approval BIONTECH
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