- Pfizer Inc and BioNTech SE initiated a randomized, active-controlled, observer-blind Phase 2 study to evaluate the safety, tolerability, and immune response of an enhanced COVID-19 mRNA-based vaccine candidate at a 30 µg dose level.
- This next-generation bivalent COVID-19 vaccine candidate, BNT162b5, consists of RNAs encoding enhanced prefusion spike proteins for the SARS-CoV-2 ancestral strain (wild-type) and an Omicron variant.
- The enhanced spike protein encoded from the mRNAs in BNT162b5 has been modified to increase the magnitude and breadth of the immune response that could better protect against COVID-19.
- The companies plan to evaluate this as the first of multiple vaccine candidates with an enhanced design.
- BNT162b5 will be evaluated in a U.S.-based study enrolling approximately 200 participants aged between 18 and 55 who have received one booster dose of a U.S.-authorized COVID-19 vaccine at least 90 days before their first study visit.
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