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Novavax Submits Request to EMA for Conditional Marketing Authorization for COVID-19 Vaccine

November 18, 2021 ( Newswire) Shares of Novavax Inc. traded 10% higher after the firm confirmed that the European Medicines Agency is now reviewing its COVID-19 vaccine filing for conditional marketing authorization. The firm advised that an opinion from the agency is expected within a few weeks.

Biotechnology company Novavax Inc. (NVAX:NASDAQ), which is actively engaged in developing and commercializing the next generation of vaccines for infectious diseases, today announced that “the European Medicines Agency (EMA) has begun its evaluation of an application for conditional marketing authorization (CMA) for Novavax’ COVID-19 vaccine.” the company stated that it plans to market the vaccine in the EU under the brand name Nuvaxovid(TM).

The company’s President and CEO Stanley C. Erck remarked, “Today’s announcement from EMA brings Novavax another step closer to our goal of ensuring broad global access to our protein-based COVID-19 vaccine across Europe…Novavax looks forward to providing an additional vaccine option in Europe, built on a proven, well-understood technology platform, and thanks the European Commission for its ongoing partnership and confidence in our COVID-19 program.”

The firm noted that it submitted an application for NVX-CoV2373, its recombinant nanoparticle protein-based COVID-19 vaccine, to the EMA for accelerated regulatory evaluation and approval earlier this month. The company noted that that the NVX-CoV2373 vaccine candidate incorporates its proprietary Matrix-M(TM) adjuvant. Novavax commented that it expects that a potential ruling from the EMA may be issued within a few weeks.

The company stated that it initially intends to manufacture the vaccine with its partner, the Serum Institute of India Pvt. Ltd., and later will expand manufacturing and distribution from other manufacturing operations in its existing supply chain.

Novavax advised that NVX-CoV2373 is now being evaluated in two separate Phase 3 clinical studies. The first trial, which is being conducted in the U.K., so far has demonstrated a 96.4% efficacy rate against the original strain of the virus. The firm added that in the trial it also has shown 86.3% effectiveness against the Alpha (B.1.1.7) variant with an overall effective rate of 89.7% across all strains. The company listed that Phase 3 PREVENT-19 study carried out in the U.S. and Mexico demonstrated an overall efficacy rate of 90.4% and provided 100% protection against moderate and severe disease.

The company listed that “NVX-CoV2373 is a protein-based vaccine candidate engineered from the genetic sequence of the first strain of SARS-CoV-2, the virus that causes COVID-19 disease.” The firm explained that NVX-CoV2373 generates antigen derived from the coronavirus spike (S) protein that is combined with Novavax’s patented saponin-based Matrix-M(TM) adjuvant to elevate immune response and activate neutralizing antibodies.

The company’s COVID-19 vaccine is packed and shipped in 10-dose, ready-to-use liquid vials. Vaccine recipients are to be given two equal 0.5 ml doses via injection 21 days apart.

The company stated that “its patented saponin-based Matrix-M(TM) adjuvant has demonstrated a potent and well-tolerated effect by stimulating the entry of antigen-presenting cells into the injection site and enhancing antigen presentation in local lymph nodes, boosting immune response.”

In a separate news release today, Novavax and Serum Institute of India Pvt. Ltd. (SII), announced that “the Philippine Food and Drug Administration (FDA) has granted emergency use authorization (EUA) for Novavax’ recombinant nanoparticle protein-based COVID-19 vaccine with Matrix-M(TM) adjuvant.” The companies advised that SII, the largest (by volume) vaccine manufacturer globally, will produce and market the vaccine in the Philippines under the brand name COVOVAX(TM).

The report indicated that the Philippine FDA’s EUA was issued for COVOVAX(TM) for active immunization of those who are 18 years of age and older.

Novavax CEO Erck, stated, “With less than a third of the Philippine population fully immunized, we expect the option for a protein vaccine, built on a well-understood technology platform, to contribute substantially to increased vaccination rates…Novavax looks forward to SII’s delivery of the vaccine to the Philippines, and with additional authorizations expected elsewhere soon, to helping control the COVID-19 pandemic around the globe.”

The report pointed out that as the vaccine only requires to be transported and stored with standard refrigeration at 2? to 8? Celsius, it can easily be distributed in the Philippines via the existing vaccine supply chain which should facilitate access to remote areas in the country.

The Serum Institute of India’s CEO Adar Poonawalla, commented, “The approval of COVOVAX in the Philippines is another step forward in the global fight against the coronavirus…We are proud to deliver the first protein-based COVID-19 vaccine to the Philippines.”

The report advised additionally that the Novavax/SII vaccine also recently received EUA in Indonesia. The companies have also now filed similar requests in India, Australia, Canada, New Zealand, the U.K. and with the World Health Organization (WHO). Novavax also filed a Biologics License Application (BLA) in South Korea and plans to submission to in the U.S. by year-end 2021.

Novavax is a biotechnology company based in Gaithersburg, Md. that utilizes its proprietary recombinant nanoparticle vaccine technology platform to discover, develop and commercialize new and innovative vaccines designed to prevent serious infectious diseases. Novavax’s leading vaccine candidates both utilize the firm’s

proprietary saponin-based Matrix-M(TM) adjuvant which is engineered to enhance immune response and stimulate high levels of neutralizing antibodies. The company is now conducting late-stage clinical trials for its SARS-CoV-2 vaccine candidate, NVX-CoV2373 and mentioned that its quadrivalent influenza nanoparticle vaccine, NanoFlu(TM), successfully achieved all primary objectives in a Phase 3 study in older adults.

Novavax began the day with a market cap of around $12.9 billion with approximately 75.6 million shares outstanding and a short interest of about 10.9%. NVAX shares opened higher today at $172.89 (+$2.40, +1.41%) over yesterday’s $170.49 closing price. The stock has traded today between $171.455 and $190.10 per share and is presently trading at $187.82 (+$17.33, +10.16%).


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