August 13, 2022

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Novavax will provide 1.1 billion COVID-19 vaccines to COVAX countries

Novavax will provide 1.1 billion COVID-19 vaccines to COVAX countries

 

Novavax will provide 1.1 billion COVID-19 vaccines to COVAX countries.   Novavax signed a vaccine pre-purchase agreement with the Global Alliance for Vaccines and Immunization (Gavi) to provide 1.1 billion doses to countries participating in COVAX.

On May 7, Novavax, Inc. (NASDAQ: NVAX), a biotechnology company that develops next-generation vaccines for severe infectious diseases, announced that it has signed a pre-purchase agreement (“APA”) with the Global Alliance for Vaccines and Immunization (“Gavi”) ), to provide the COVAX mechanism with a recombinant protein-based candidate vaccine for new coronavirus pneumonia.

According to APA, Novavax expects to produce and distribute 350 million doses of NVX-CoV 2373 vaccine to countries participating in the COVAX mechanism (established to distribute and distribute vaccines equitably to participating countries and economies). According to another purchase agreement signed with Gavi, the Serum Institute of India (“Sera Institute”) is expected to produce and provide the remainder of 1.1 billion doses of Novavax vaccine.

  • Novavax will provide 350 million doses since the third quarter of 2021
  • Provide 1.1 billion doses of Novavax vaccine to countries participating in COVAX
  • Serum Institute of India will provide remaining dose for low- and middle-income countries
  • Emphasizes commitment to equitable access to Novavax vaccines on a global scale

Stanley C. Erck, President and CEO of Novavax, said: “This is a huge opportunity to work with global organizations that are committed to accelerating equitable access to safe and effective COVID-19 vaccines, especially in countries with low current vaccination rates. CEPI, Gavi, Serum Institute and Novavax are cooperating to provide all countries (regardless of their income level) with the urgent need to provide a large number of vaccines, and this arrangement is the result of their cooperation. Novavax thanks CEPI as the lead of the COVAX mechanism People’s long-term support and tireless work with Gavi.”

According to APA, Novavax expects to provide vaccines containing antigens and adjuvants, which will be produced in facilities directly funded by Novavax’s investment from the Alliance for Epidemic Prevention Innovation (“CEPI”). In the spring of 2020, CEPI invested nearly US$400 million in Novavax to advance the preclinical and early clinical development of NVX-CoV2373, expansion of production scale, technology transfer, and reservation of manufacturing capacity.

CEPI CEO Richard Hatchett said, “CEPI’s investment in accelerating the clinical development and production of this vaccine candidate is critical to achieving equitable access to vaccines through COVAX. With this agreement, Novavax vaccine candidates will protect all of our COVID-19 vaccines. People at risk of pneumonia (no matter where they are in the world) play an important role in their mission.”

Dr. Seth Berkley, CEO of Gavi, said: “Today’s agreement with Novavax marks an important step for COVAX to build the world’s largest and most diversified COVID-19 vaccine portfolio. It also marks the goal of achieving 2 billion safe doses by 2021. The goal of an effective vaccine has taken an important step. Novavax is not only committed to providing direct support to COVAX, but also committed to letting more people understand the end-to-end nature of COVAX and the need to control the epidemic through technology transfer through other manufacturers Cooperation.”

Novavax and the Serum Institute expect that a cumulative delivery of 1.1 billion doses will begin in the third quarter of 2021, and appropriate regulatory approvals are currently pending. According to APA, Novavax will receive an advance payment from Gavi later this month and will receive additional payment after the vaccine is included in the World Health Organization’s emergency use list of vaccines. In addition, Novavax also agreed to provide more vaccine doses if the Serum Institute cannot provide the expected vaccine dose to the COVAX mechanism.

Vaccine dosage allocation will be determined by Gavi according to the graded pricing table among participants who are eligible for AMC and self-funded.

Erck continued, “CEPI’s early support is a springboard for Novavax to establish a global supply network. We expect that this supply network can provide a significant proportion of the global vaccine supply through COVAX. We look forward to continuing cooperation with the Serum Institute to achieve our Production capacity, and can work hand in hand with the WHO to obtain the authorization of NVX-CoV2373 as soon as possible.”

 

About the COVAX mechanism

The COVAX mechanism is a global risk sharing mechanism for joint procurement and fair distribution of COVID-19 vaccines. It currently includes more than 190 participating economies and is designed and managed by the vaccine alliance Gavi. It is part of COVAX jointly led by CEPI, Gavi and the World Health Organization (WHO). CEPI, Gavi, and WHO work with vaccine manufacturers in developed and developing countries, UNICEF, the Pan American Health Organization, the World Bank, civil society organizations and other institutions to ensure fair and equal access to vaccines around the world.

 

About NVX-CoV2373

NVX-CoV2373 is a protein-based vaccine candidate, modified according to the genetic sequence of SARS-CoV-2 (the disease-causing virus of new coronavirus pneumonia). NVX-CoV2373 uses Novavax recombinant nanoparticle technology to create antigens derived from coronavirus spike protein, and also uses Novavax’s patented Matrix-M™ based on saponin to enhance immune response and stimulate high levels of neutralizing antibodies. NVX-CoV2373 contains purified protein antigen, which can neither replicate nor cause new coronavirus pneumonia. In preclinical studies, the antibody induced by NVX-CoV2373 blocked the binding of spike protein to cell receptors and provided protection against infection and disease. In phase 1/2 clinical trials, it is generally well tolerated and produced a reliable antibody response.

NVX-CoV2373 is being evaluated in two key Phase 3 trials, one of which was conducted in the UK (the results showed that the protection rate against severe illness was 100%, the effectiveness against the original virus strain was 96.4%, and the overall effectiveness was 89.7 %), another PREVENT-19 trial was conducted in the United States and Mexico in December 2020. Two existing Phase 2 studies that began in August 2020 also tested NVX-CoV2373: Phase 2b trial in South Africa (the results showed that the protection rate against severe illness was 100%, and the effective rate against emerging escape variants 48.6%) and Phase 1/2 continuous trials conducted in the United States and Australia.

NVX-CoV2373 should be refrigerated at a temperature of 2°C to 8°C, allowing the use of existing vaccine supply chain channels for distribution. It is packaged in a ten-dose vial as a ready-to-use liquid formulation.

 

About Matrix-M™

Novavax’s patented Matrix-M™ adjuvant based on saponins stimulates antigen-presenting cells to enter the injection site, enhances antigen presentation in local lymph nodes, and enhances the immune response, proving an effective and well-tolerated effect.

 

About Novavax

Novavax, Inc. (Nasdaq: NVAX) is a biotechnology company that aims to promote global health improvement through the discovery, development and commercialization of innovative vaccines for the prevention of serious infectious diseases.

The company’s proprietary recombination technology platform combines the power and speed of genetic engineering to efficiently produce highly immunogenic nanoparticles to meet the urgent global health needs.

Novavax is conducting late-stage clinical trials on NVX-CoV2373. NVX-CoV2373 is a vaccine candidate developed by Novavax against the new coronavirus SARS-CoV-2. NanoFlu™ is a quadrivalent influenza nano-vaccine that has achieved all major goals in a key phase 3 clinical trial for the elderly, and will be submitted to regulatory agencies for approval in advance.

Both vaccine candidates contain Novavax’s proprietary saponin matrix Matrix-M™ adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies.

 

(source:internet, reference only)


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