The modified spike protein in this next-generation bivalent candidate is part of the companies' strategy to try and provide vaccines with longer and more durable protection against the virus.
The 2 companies recently announced they had begun a phase 2 trial looking at this new candidate, BNT162b5, at a 30 µg dose level in a randomized, active-controlled, observer-blind study.
Pfizer-BioNTech are calling the candidate a next-generation bivalent COVID-19 vaccine that has 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 with the aim of increasing the magnitude and breadth of the immune response that could better protect against COVID-19.
The study will be conducted in the United States and looks to enroll approximately 200 participants between 18 and 55 years of age and who have received 1 booster dose of a US-authorized COVID-19 vaccine at least 90 days prior to their first study visit.
This is part of the companies’ strategy to look to generate longer-lasting immune responses against SARS-CoV-2 infections.