GAITHERSBURG, Md., Feb. 23, 2022 /PRNewswire/ — Novavax, Inc. (Nasdaq: NVAX), a biotechnology company dedicated to the development and commercialization of next-generation vaccines against serious infectious diseases, today announced the first doses of Nuvaxovid™ COVID -19 vaccines (recombinant, with adjuvant) have started shipping to member states of the European Union (EU). Nuvaxovid, also known as NVX-CoV2373, is the first protein-based COVID-19 vaccine authorized for use in Europe.
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Permitted use of Nuvaxovid™ in the European Union
The European Commission has granted conditional marketing authorization for Nuvaxovid™ COVID-19 vaccine (recombinant, adjuvanted) for active immunization to prevent COVID-19 caused by SARS-CoV-2 in people aged 18 and over.
Important Safety Information
- Nuvaxovid™ is contraindicated in people with hypersensitivity to the active substance or to any of the excipients
- Cases of anaphylaxis have been reported with the administration of COVID-19 vaccines. Appropriate medical treatment and monitoring should be available in the event of an anaphylactic reaction
- Anxiety-related reactions including vasovagal reactions (syncope), hyperventilation or stress-related reactions may occur in association with vaccination in response to needle injection. It is important that precautions are in place to avoid injury from fainting
- Vaccination should be postponed in persons with severe acute febrile illness or acute infection
- Administer Nuvaxovid with caution to people receiving anticoagulant therapy or those with thrombocytopenia or any bleeding disorder (such as haemophilia) as bleeding or bruising may occur after intramuscular administration in these people.
- The effectiveness of Nuvaxovid may be lower in immunocompromised people
- The duration of protection offered by the vaccine is unknown as it is still determined by ongoing clinical trials
- Individuals may not be fully protected until 7 days after their second dose. As with all vaccines, vaccination with Nuvaxovid may not protect all vaccinees
- The most common adverse reactions observed in clinical studies (frequency category of very common ≥ 1/10) were headache, nausea or vomiting, myalgia, arthralgia, injection site tenderness/pain, fatigue and discomfort.
NVX-CoV2373 is a protein-based vaccine designed from the genetic sequence of the first strain of SARS-CoV-2, the virus that causes COVID-19 disease. NVX-CoV2373 was created using Novavax’s recombinant nanoparticle technology to generate an antigen derived from the coronavirus spike (S) protein and is formulated with the patented saponin-based Matrix-M™ adjuvant of Novavax to enhance the immune response and stimulate high levels of neutralizing antibodies. NVX-CoV2373 contains a purified protein antigen and cannot replicate or cause COVID-19.
Novavax’s COVID-19 vaccine is packaged as a ready-to-use liquid formulation in a vial containing ten doses. The vaccination schedule provides for two doses of 0.5 ml (5 mcg of antigen and 50 mcg of Matrix-M adjuvant) administered intramuscularly 21 days apart. The vaccine is stored between 2° and 8° Celsius, allowing the use of existing vaccine supply channels and the cold chain. The use of the vaccine should be in accordance with official recommendations.
Novavax has established partnerships for the manufacture, marketing and distribution of NVX-CoV2373 worldwide. The existing clearances leverage Novavax’s manufacturing partnership with the Serum Institute of India (SII), the world’s largest vaccine manufacturer by volume. They will later be supplemented with data from additional manufacturing sites throughout Novavax’s global supply chain.
About Matrix-M™ Adjuvant
Novavax’s patented saponin-based Matrix-M™ adjuvant has demonstrated a potent and well-tolerated effect by stimulating entry of antigen-presenting cells into the injection site and enhancing antigen presentation in the injection site. local lymph nodes, thereby stimulating the immune response.
Novavax, Inc. (Nasdaq: NVAX) is a biotechnology company that promotes improved global health through the discovery, development and commercialization of innovative vaccines to prevent serious infectious diseases. The company’s proprietary recombinant technology platform harnesses the power and speed of genetic engineering to efficiently produce highly immunogenic nanoparticles designed to address pressing global health needs. NVX-CoV2373, the company’s COVID-19 vaccine, has received conditional clearance from several regulatory authorities around the world, including the European Commission and the World Health Organization. The vaccine is also under review by several regulatory bodies around the world. In addition to its COVID-19 vaccine, Novavax is also currently evaluating a combined COVID-seasonal influenza vaccine in a Phase 1/2 clinical trial, which combines NVX-CoV2373 and NanoFlu, its experimental quadrivalent influenza vaccine candidate. These candidate vaccines incorporate Novavax’s proprietary saponin-based Matrix-M™ adjuvant to enhance immune response and stimulate high levels of neutralizing antibodies.
Distributed by: Reportable, Inc.