FDA Fast Tracks Intranasal RSV Vaccine


This live-attenuated investigational vaccine was developed by Codagenix, which uses its codon de-optimization platform for its candidates.

According to the National Institutes of Health, nearly all children become infected with RSV by age five, and approximately 58,000 of them need hospitalization annually. This past fall, RSV cases increased dramatically, and impacted hospital capacity with this patient population.

Although there are RSV vaccines and therapies in clinical trials, there is nothing approved. Both prevention and treatment remain critical, clinical needs, and FDA sees these unmet needs as of significant importance.

In November, clinical-stage biotechnology company, Codagenix, was granted an FDA Fast Track designation for its, an intranasal, live-attenuated vaccine candidate, CodaVax-RSV, for the prevention of respiratory syncytial virus (RSV).

“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,” Codagenix Cofounder and CEO J. Robert Coleman, PhD, MBA, said in a statement at that time.
The phase 1 dose escalation study of CodaVax-RSV evaluating safety and immune responses in healthy children aged six months to five years is expected to initiate in the early part of this year, immediately after this year’s RSV season. Based on the results of this study, a phase 2 dose confirming study will explore efficacy during the RSV season in 2023-2024.

The company has built its platform around live-attenuated virus vaccines as opposed to viral vector or mRNA-based vaccines using its codon deoptimization platform.

The company also has its COVID-19 intranasal vaccine candidate, which recently entered phase 3 clinical trials as part of the WHO-sponsored studies.

In a wide-ranging interview with Contagion, Coleman talks about the advantages of traditional live-attenuated virus vaccines as opposed to mRNA-based vaccines as well as updates on their RSV and COVID-19 vaccines.

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