Flu Vaccine Production Using a Novel Pandemic Response and Prevention Manufacturing Method

PROJECT SUMMARY/ABSTRACT The current global pandemic has highlighted the need to develop new methods for creating vaccines. Many approaches today face limitations with breadth and duration of protection; flexibility and adaptability for emerging strains; manufacturing speed and safety; and storage and distribution. SolaVAX™ inactivation technology offers an elegant solution for quickly generating highly effective vaccines by using a combination of a photosensitizer (riboflavin/vitamin B2) and UV light to disrupt pathogen genetic material while preserving target antigens. Likely advantages of SolaVAX-derived vaccines include: more complete antigen presentation using whole pathogens; multiple virus strains/ multiple antigen variants, i.e. multivalent; rapid manufacturing pivot to address emergent strains; no toxic inactivating chemicals that potentially compromise antigen conformation and add to manufacturing complexity; low cost, geographically distributed manufacturing; applicable to viral, bacterial and parasitic pathogens. In recent work supported by BARDA and NIH, Drs. Raymond Goodrich and Izabela Ragan demonstrated that a SolaVAX™-SARS-CoV-2 vaccine dramatically decreased viral load, reduced lymphocytic infiltration and neutrophil accumulation, and maintained lung alveolar air space after virus exposure. From these studies, the SolaVAX™-SARS-CoV-2 investigational vaccine is estimated to be up to 20,000x more effective on a weight/weight basis of dose compared to other inactivation methods. This SBIR project will focus on the evaluation of the SolaVAX approach for creating improved influenza vaccines composed of whole inactivated virions. Although global attention has been focused on COVID-19 since 2020, the pandemic threat of influenza still exists. Moreover, the risk of a pandemic influenza may be exacerbated by SARS-CoV-2, given the burden on global healthcare systems and increased number of individuals with pre- existing conditions, such as compromised respiratory systems. Current flu vaccines provide sub-optimal protection (40-60%) and improved approaches for multi-strain and/or universal protection are needed. In promising preliminary in vitro studies, a SolaVAX-generated influenza vaccine provided 70-80% retention of hemagglutinin (HA) activity, as compared to 40-45% after inactivation by formalin. Phase I of this project will build on these studies to establish the vaccine development process that yields full inactivation with maximal antigen integrity (AIM 1). Then, we will evaluate inactivated vaccine for immunogenicity in mice (AIM 2) and efficacy against live viral challenge in ferret (AIM 3).