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
BIONTECHView entire presentation