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

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 1R43AI172570-01A1
Agency Tracking Number: R43AI172570
Amount: $298,891.00
Phase: Phase I
Program: SBIR
Solicitation Topic Code: NIAID
Solicitation Number: PA22-176
Timeline
Solicitation Year: 2022
Award Year: 2023
Award Start Date (Proposal Award Date): 2023-05-01
Award End Date (Contract End Date): 2024-04-30
Small Business Information
320 E VINE DR STE 101
Fort Collins, CO 80524-2311
United States
DUNS: 118346404
HUBZone Owned: No
Woman Owned: No
Socially and Economically Disadvantaged: No
Principal Investigator
 IZABELA RAGAN
 (970) 491-3456
 izabela.ragan@solarisvax.com
Business Contact
 MARK WAGSTAFF
Phone: (479) 695-8402
Email: mark.wagstaff@solarisvax.com
Research Institution
N/A
Abstract

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).

* Information listed above is at the time of submission. *

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