Novavax successfully concluded the Phase 1 clinical trials of the vaccine against COVID-19. The key substance of the vaccine to be produced in the Czech Republic

14/08/2020

August 14, 2020, Prague - American company Novavax, which is developing the vaccine candidate NVS-CoV2373, has announced the successful conclusion of the Phase 1 clinical trial of its vaccine. The key substance of the vaccine against coronavirus will be produced in the Central Bohemian manufacturing facility Praha Vaccines. The manufacturing process could start by the start of 2021, with an annual capacity to be generated from the site of up to 1 billion vaccine doses.

The process of the clinical trials of vaccine candidate NVX-CoV2373

Novavax during this May began the first part of the Phase 1/2 clinical trials of the candidate vaccines NVS-CoV2373. The tests took place in Australia on a sample of 131 people ranging from 18 to 59 years of age. The successful results of the first part of the testing, showing the immunogenicity and safety of the potential future vaccines, are now setting the candidate antidote to the second part of testing.

Novavax, headquartered in the United States, identified NVX-CoV2373 as its main vaccine candidate against SARS-CoV-2. Pre-clinical studies show high immunogenicity and high levels of neutralizing antibodies. The results of this testing bear strong evidence that the candidate vaccine can potentially lead to protection from COVID-19 and thus help to control the spread of the disease.

NVX-CoV2373, the Company's recombinant COVID-19 vaccine candidate adjuvanted with Matrix-M, was generally well-tolerated and elicited robust antibody responses numerically superior to that seen in human convalescent sera.

The Phase 2 clinical trials are beginning in August in global sites around the world, including South Africa, which will concentrate on the immunity, safety and COVID-19 disease reduction in a broader age range. The Phase 3 program is expected to take place in the second half of this year, also in multiple countries.

Production of the candidate vaccine NVX-CoV2373

Novavax will produce in the Central Bohemian production facility Praha Vaccines a recombinant surface S-protein of the coronavirus, which is the key substance of the candidate vaccine. In Sweden, Novavax will produce the patented adjuvant Matrix-MTM, which is the second key component of the future vaccine and increases its effectiveness. Both parts of the component will be compiled at another facility in Europe, where the vaccine will be filled into ampoules.

Besides the Czech production plant, several other cooperating facilities will also work on the vaccine production in the USA, Europe, and Asia.

About Praha Vaccines (newly Novavax CZ)

The production plant Praha Vaccines, located in Bohumil near Jevany, possesses modern production equipment with high level biological security. Currently, the production plant has about 150 employees with experience in this field and is planning to hire more people.

Novavax, which acquired Praha Vaccines as a strategic investment this May, has a long term intention to produce vaccines in this facility. The technological equipment enables Praha Vaccines to produce not only the vaccine against COVID-19 but also vaccines against flu, which Novavax plans to prospectively produce once the coronavirus pandemic fades away. Soon, the Central Bohemian production plant Praha Vaccines is expected to officially be renamed to Novavax CZ.

Factual and technical summary

  • Since May of this year, the Czech production plant, Praha Vaccines (soon-to-be Novavax CZ), has been a part of the global biotechnology company Novavax, which is headquartered in Gaithersburg. MD, USA, which develops and produces vaccines against serious infectious diseases, including COVID-19.
  • Novavax plans to produce up to 1 billion doses of coronavirus vaccine per year in Bohumil near Jevany, Central Bohemia.
  • Production of the NVX-CoV2373 vaccine in the Czech Republic is expected to begin in early 2021. The production has already started in the United States.
  • Praha Vaccines production plant will not work with live coronavirus, during the production. Only an express insect cell system and insect vector with coronavirus surface protein gene will be used in the production. Manipulation with it is not dangerous for humans.
  • Phase 1 results:
  • NVX-CoV2373 was generally well-tolerated and had a reassuring safety profile
  • The vaccine induced neutralization titers in 100% of participants
  • Both 5 μg and 25 μg adjuvanted doses generated peak geometric mean titer (GMT) greater than 1:3,300.
  • Matrix-M™ adjuvant induced robust polyfunctional CD4+ T cell responses.

About Novavax

Novavax, Inc. (Nasdaq:NVAX) 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 is undergoing clinical trials for NVX-CoV2373, its vaccine candidate against SARS-CoV-2, the virus that causes COVID-19. NVX-CoV2373 was generally well-tolerated and elicited robust antibody responses numerically superior to that seen in human convalescent sera in its Phase 1 portion of the Phase 1/2 clinical trial. 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. For more information, visit www.novavax.com, or follow Twitter and LinkedIn.

About Praha Vaccines (newly Novavax CZ)

Praha Vaccines production plant (newly Novavax CZ) was founded after the First World War. Nowadays, it has the most modern equipment for the production and testing of vaccines and biological substances. It has a high level of biological security, which. As part of the acquisition of Praha Vaccines and the subsequent rebranding, approximately 150 employees with experience in the production of vaccines joined Novavax. For more information, visit the website www.prahavaccines.cz

Contact for media:
Jana Dudrová, CommLab

jana@commlab.cz