The company and its partner, Pfizer, are preparing for the potential launch of 2 variant-adapted bivalent COVID-19 vaccines assuming authorizations from FDA and EMA.
During its most recent quarterly earnings report yesterday, BioNTech said it was looking at a potential launch of COVID-19 vaccines this fall pending regulatory approval.
“Our COVID-19 product pipeline includes variant-adapted and next-generation vaccine candidates, aimed at prolonged and broad protection,” Ugur Sahin, MD, CEO and Co-Founder of BioNTech, said in a prepared statement.
The companies are looking at 2 variant-adapted bivalent COVID-19 vaccines containing the original strain and Omicron BA.1 or BA.4/5 spike protein.
In recent weeks, the companies announced they had begun a phase 2 trial looking at a new vaccine 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 study is being 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.