Vaccine manufacturing facility
Novavax’s new vaccine manufacturing facility located in Bohumil, Czech Republic will develop and manufacture the company’s vaccine candidate for Covid-19, NVX‑CoV2373.
Nanotherapeutics Bohumil designed and developed the facility for the production of seasonal flu, pandemic flu and other vaccines. It was transferred to Praha Vaccines, a subsidiary of India-based Cyrus Poonawalla Group’s Netherlands arm, in May 2017 for the production of inactivated polio vaccine.
Novavax gained ownership of the manufacturing facility with the acquisition of Praha Vaccines along with other associated assets for $167m in May 2020. The acquisition will expand the manufacturing capabilities of Novavax.
The company, alongside Serum Institute of India (SII), a subsidiary of the Cyrus Poonawalla Group, will work together to improve the production capacity at the facility by the end of 2020.
Novavax Covid-19 vaccine manufacturing facility along with other supporting buildings spans across an area of 150,000ft2. It is being renovated for the development of new vaccine candidates including the NVX CoV2373 Covid-19 vaccine candidate.
Features of the manufacturing facility include Biosafety Level-3 (BSL-3) capabilities, utilised for clinical, diagnostic, research or production functions of agents that may cause highly fatal diseases to a person and contaminate the environment. All work at the BSL-3 facility is carried out in bio-contained environments.
The vaccine manufacturing facility will produce NVX‑CoV2373, which contains stable, prefusion protein antigen designed from the genetic sequence of SARS‑CoV‑2, the Covid-19-causing virus.
The vaccine demonstrated efficacy in binding with receptors targeted by the virus in preclinical trials. The Phase I clinical trial on the vaccine began in May 2020 to evaluate its preliminary efficacy and safety profile. The initial efficacy and safety results from the trial are expected in July 2020.
Process development for the vaccine candidate will be scaled-up to enable the production of up to 100 million vaccine doses by the end of 2020. Large scale production of more than one billion vaccine doses annually in multiple countries is expected by 2021.
NVX‑CoV2373 Covid-19 vaccine candidate will be developed using Novavax’s proprietary recombinant protein nanoparticle technology, which incorporates the company’s proprietary Matrix‑M™ adjuvant.
Novavax’s nanoparticle vaccine technology allows tailored vaccine development based on key components of the pathogen. It facilitates rapid development of immunogenic vaccine formulation. The technology utilises the Sf9 / baculovirus recombinant technology platform to develop the recombinant protein nanoparticles, which improve the protective immune responses of the vaccine.
The company’s patented saponin-based Matrix-M vaccine adjuvant technology stimulates the entry of antigen cells into the injection site. The adjuvant has excellent immunostimulatory features and demonstrates a potent and well-tolerated effect. It enhances the presentation of antigen in local lymph nodes for improving immune response and induces cell-mediated as well as antibody-mediated immune response.
Matrix-M vaccine adjuvant is also being used with SII’s malaria vaccine candidate, R21 malaria vaccine under a commercial license agreement signed in March 2020.
Novavax will receive $388m in funding from the Coalition for Epidemic Preparedness Innovations (CEPI) for the advancement of the clinical development of NVX‑CoV2373 and boost the manufacturing capacity.
The US Department of Defense (DoD) provided a $60m contract to Novavax for the manufacturing of NVX‑CoV2373 in June 2020. The company will supply ten million doses of the vaccine to the DoD in 2020 to be used in Phase II / III clinical trials or under an Emergency Use Authorisation (EUA), if approved.
Novavax will collaborate with the US-based biologics contract development manufacturing organisations (CDMO) to manufacture the antigen component of the vaccine, as well as scale-up and manufacture the Matrix-M adjuvant component of the vaccine.
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