According to Codagenix, the FDA has granted Fast Track designation to the company’s CodaVax-RSV live-attenuated intranasal vaccine candidate against respiratory syncytial virus (RSV). Earlier this year, the FDA cleared an IND for CodaVax-RSV. The company now says that the Phase 1 dose escalation study in children aged 6 months to 5 years is expected to start after the end of the current RSV season, which will be in early 2023, and it expects to conduct a Phase 2 dose confirming study during the 2023-2024 RSV season.
Codagenix CEO J. Robert Coleman said, “Though RSV is the leading cause of hospitalization for children below the age of five, there are currently no vaccines approved to protect against this devastating disease. We are encouraged by the Fast Track designation for CodaVax-RSV, which recognizes the vaccine’s unique potential to address this significant unmet need. Unlike previous live-attenuated RSV vaccine candidates, CodaVax-RSV is extremely stable due to genetic edits that prevent wild-type reversion. This stability, combined with easy intranasal administration, broad systemic and mucosal immunity and preclinical efficacy in animal models, and clinically demonstrated safety, culminate in a promising profile that we look forward to investigating further in a Phase 1 study in healthy infants and toddlers.”
A Phase 3 trial of Codagenix’s CoviLiv intranasal vaccine against COVID-19 was recently initiated.
Read the Codagenix press release.
