Novavax Inc. (NASDAQ: NVAX) recently commenced a Phase I clinical trial for their COVID-19 vaccine known as NVX-CoV2373 in Australia. Now the U.S.-based company reports they secured a contract with the U.S. Department of Defense (DoD) or the manufacturing of the COVID-19 vaccine target, a stable prefusion protein antigen made using its proprietary nanoparticle technology, including its proprietary Matrix-M™ adjuvant. The Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense (JPEO-CRBND-EB), along with funding by the Defense Health Program agreed to fund up to $60 million to support Novavax in its production of several components of the vaccine to be produced in America. The parties declared a targeted delivery in 2020 of 10 million doses of NVX-CoV2373 for DoD that could be used in Phase II/III clinical trials or under an Emergency Use Authorization (EUA) if approved by the U.S. Food and Drug Administration.
Novavax will work with a U.S.-based biologics contract development manufacturing organization (CDMO to manufacture the antigen component of NVX-CoV2373 for at least 10 million dose of vaccine. Novavax will collaborate with U.S.-based CDMOs to scale up production and manufacture of the Matrix-M adjuvant and component of the vaccine.
Current Phase I Clinical Trial
As reported by TrialSite News, working with their CRO in Australia called Nucleus Network, Novavax dosed the first patients of a two-part, randomized, observed-blinded, placebo-controlled, phase I/II study designed to evaluate the immunogenicity and safety of their vaccine candidate called SARS-CoV-22 rs nanoparticle vaccine with or without Matrix-M adjuvant in healthy participants between the ages of 18 and 59. This trial is conducted in two parts: the Phase I portion includes an evaluation of the immunogenicity and safety of the vaccine candidate—both adjuvanted and not. The trial is enrolling approximately 130 healthy participants at two sites in Australia. The protocol’s two-dose trial regimen assesses two dose sizes (5 and 25 micrograms) with Matrix-M and without.
The Phase II portion is expected to be conducted in multiple countries, including the United States; this phase would assess immunity, safety and COVID-19 disease reduction in a broader age range. This Phase I/II study has been designed to allow for rapid advancement of NVX-CoV-2373 during the pandemic.
What is JPEO-CBRND?
The Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense is the Joint Service’s lead for development, acquisition, fielding and life-cycle support of chemical, biological, radiological and nuclear defense equipment and medical countermeasures. As an effective acquisition program, we put capable and supportable systems in the hands of the service members and first responders, when and where it is needed, at an affordable price. Their vision is a resilient Joint Force enabled to fight and win unencumbered by a chemical, biological, radiological, or nuclear environment; championed by innovative and state-of-the-art solutions. JPEO Enabling Biotechnologies (EB) is an organization established for the purpose of providing medical solutions, during a crisis, against future threats.
Novavax, Inc. is a late-stage biotechnology company that promotes improved health globally through the discovery, development, and commercialization of innovative vaccines to prevent serious infectious diseases. Novavax recently initiated development of NVX-CoV2373, its vaccine candidate against SARS-CoV-2, the virus that causes COVID-19, with Phase 1 clinical trial results expected in July of 2020. NanoFlu™, its quadrivalent influenza nanoparticle vaccine, met all primary objectives in its pivotal Phase 3 clinical trial in older adults. Both vaccine candidates incorporate Novavax’ proprietary saponin-based Matrix-M™ adjuvant in order to enhance the immune response and stimulate high levels of neutralizing antibodies. Novavax is a leading innovator of recombinant vaccines; its proprietary recombinant technology platform combines the power and speed of genetic engineering to efficiently produce highly immunogenic nanoparticles in order to address urgent global health needs.