FDA Fast-Tracks Codagenix RSV Vaccine Candidate
The intranasal, live-attenuated vaccine CodaVax-RSV was granted FDA Fast Track designation. Clinical trials are expected to launch soon.
Codagenix Inc. announced the US Food and Drug Administration (FDA) recently granted Fast Track designation to CodaVax-RSV, their respiratory syncytial virus (RSV) vaccine candidate.
RSV is a common, contagious respiratory virus that attacks the lungs and breathing passageways. There is currently no approved vaccine for RSV, but an ongoing uptick in cases has led to an increased fervor of development.
With the Fast Track designation, the development and review of this intranasal, live-attenuated CodaVax-RSV vaccine will likely be expedited.
“Though RSV is the leading cause of hospitalization for children below the age of 5, there are currently no vaccines approved to protect against this devastating disease,” said J. Robert Coleman, PhD, MBA, Codagenix cp-founder and CEO. “We are encouraged by the Fast Track designation for CodaVax-RSV, which recognizes the vaccine’s unique potential to address this significant unmet need.”
RSV is a growing health concern this season, and hospitals are filling up with infected younger children and older adults. Nearly all US children contract RSV by age 5, but infections are higher than usual this season. Cases, temporarily reduced due to COVID-19 precautions, have resurged.
Developing an RSV vaccine is complicated by difficulties directing the body’s immune system against the specific RSV viral protein. “Unlike previous live-attenuated RSV vaccine candidates, CodaVax-RSV is extremely stable due to genetic edits that prevent wild-type reversion,” Coleman explained.
“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.”
In early 2023, Codagenix expects to launch a phase 1 dose escalation study of CodaVax-RSV, evaluating the safety and immunogenicity of the vaccine candidate in healthy children 6 months-5 years of age. This study will be conducted immediately after the current RSV season, and depending on the results, a phase 2 dose confirming study will take place during the 2023-2023 RSV season.
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