COVID-19 Vaccine: Novavax Gets Funding from the US Department of Defense
By Ruchi Jhonsa, Ph.D.
While the vaccine’s effectiveness in humans is still in question, Novavax is already flooded with cash flow from various sources for the testing and development of its COVID-19 vaccine, NVX-CoV2373.
On June 5, the company announced that the US Department of Defense had granted a contract under which it will receive a generous sum of $60 million for the manufacturing of its COVID-19 vaccine candidate. Not long ago, it was granted, what some call the “biggest grant to date” by the Coalition for Epidemic Preparedness Innovations (CEPI). According to the WHO, this is now one of the ten vaccines worldwide that are in human trials.
Novavax is a late-stage biotech company that promotes improved health globally through the discovery, development, and commercialization of innovative vaccines to prevent serious infectious diseases. After the success of its influenza vaccine, NanoFlu, it initiated the development of a COVID-19 vaccine. Similar to other vaccines in development, NVX-CoV2373 uses Spike protein antigen for inducing an immune response.
However, unlike others the antigen for this vaccine is derived from spike (S) protein using Novavax’ recombinant nanoparticle technology and is mixed with company’s homemade saponin-based Matrix-M adjuvant to enhance the immune response, stimulate the entry of antigen-presenting cells into the injection site and enhance antigen presentation in local lymph nodes thereby increasing the levels of neutralizing antibodies.
As part of the contract, Novavax will manufacture and scale up the production of the S protein antigen as well as Matrix M adjuvant in collaboration with the US-based biologics contract development organization (CDMO) for at least 10 million doses of the vaccine by 2020. These vaccines can be used in mid-or late-stage clinical trials or under an Emergency Use Authorization if approved by the USFDA.
“We are genuinely honored at the opportunity to protect our military personnel and their families who have devoted themselves to the needs of US citizens and others worldwide,” said Stanley C. Erck, President and Chief Executive Officer of Novavax. “Importantly, this award will allow Novavax to significantly expand its US production capacity of NVX-CoV2373, a critical step in our ability to provide vaccine support to the COVID-19 pandemic.”
Phase1/2 Clinical Trial
The clinical trials of the vaccine are based on successful preclinical data that demonstrated high immunogenicity and high levels of neutralizing antibodies. On May 25, Novavax initiated the Phase1/2 of the clinical trial for the COVID-19 vaccine that is being conducted in two parts. The Phase1 trial is a randomized, observer-blinded, placebo-controlled trial that is evaluating the immunogenicity and safety profile of the vaccine in 130 healthy participants within the age group of 18 to 59 at two sites in Australia. In order to assess the role of adjuvant in pushing the immune response further, the participants are being dosed with either 5 or 25 micrograms of the vaccine with or without the Matrix-M adjuvant.
The Phase 2 trial supported by the $388 million funding from CEPI will assess immunity, safety, and decrease in viral load in a broader age group and will be conducted in multiple countries, including the US. Novavax is expected to announce the Phase 1 results in July.
Dr. Richard Hatchett, CEO of CEPI, said, “Entering clinical trials is an important step on the path to delivering a safe, effective and globally accessible vaccine against COVID-19. Vaccines provide our best hope of permanently defeating this pandemic, so it is encouraging to see rapid progress being made in the development of Novavax’s vaccine candidate. CEPI’s priority in building our portfolio has been to focus on vaccine candidates with the potential to be developed at speed and scale and made globally accessible. Our investment in Novavax allows us to focus on manufacturing in parallel with the clinical development of the vaccine so that if the vaccine is proven to be safe and effective, we can make doses available to those who need them without delay.”
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