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Maryland's COVID-19 Vaccine Candidate Refutes Media Reporting

October 20, 2021 • 9:17 am CDT
(Precision Vaccinations News)

In response to media reporting citing anonymous sources, Maryland-based Novavax, Inc. issued a press statement on October 20, 2021, 'confirming our confidence in our ability to deliver our high-quality vaccine.'

Furthermore, we underscore our ongoing commitment to the stringent standards of production and manufacturing for our recombinant nanoparticle protein-based COVID-19 vaccine candidate with Matrix-M™ adjuvant.

Since March 2020, Novavax has worked diligently, methodically, and transparently to develop our novel COVID-19 vaccine candidate (NVX-CoV2373), taking on the challenge of developing and producing at large scale a proven biologic-based vaccine amid unprecedented circumstances.

We have made significant progress in mobilizing a global manufacturing network over the past 18 months with sites that are now routinely producing high-quality products at commercial scale across the world.

Our global supply chain is expected to achieve a capacity of 150 million doses per month by the end of the fourth quarter through:

  • Partnership with the Serum Institute of India (SII), the world's largest vaccine manufacturer,
  • A state-of-the-art, wholly-owned manufacturing site in the Czech Republic,
  • Manufacturing at established vaccine makers, including SK bioscience in South Korea and Takeda in Japan.

Moreover, 'we expect to complete multiple ongoing rolling regulatory submissions within the next couple of weeks in key markets, including the United Kingdom, Europe, Canada, Australia, and New Zealand.

The Company, along with SII, has already filed for authorization in India, Indonesia, and The Philippines and Emergency Use Listing with the World Health Organization.

The WHO EUL will allow Novavax and SII to deliver on our combined commitment to the COVAX Facility for a cumulative 1.1 billion doses of our vaccine, around which we maintain ongoing conversations with CEPI, Gavi, and UNICEF.

Additionally, we expect to file for Emergency Use Authorization in the U.S. before the end of 2021.

"We are confident that our vaccine will soon play a significant role in the global COVID-19 vaccine arsenal, differentiated by its potential to help address two major issues slowing the world's ability to end the pandemic: global distribution challenges and vaccine hesitancy," said Stanley C. Erck, President & CEO, Novavax, in the press statement.

Novavax's COVID-19 protein-based vaccine Phase 3 study data show a robust safety profile, strong immunogenicity, and high efficacy against multiple strains of the coronavirus. 

Previously, Novavax published an update regarding its COVID-NanoFlu™ combination vaccine candidate. The Company's NanoFlu™ and NVX-CoV2373 both have demonstrated strong results as standalone vaccines in Phase 3 clinical trials. 

Novavax, Inc. (NVAX) is a biotechnology company located in Gaithersburg, MD that promotes improved health globally by discovering, developing, and commercializing innovative vaccines to prevent serious infectious diseases.

Our Trust Standards: Medical Advisory Committee

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