Novavax and partner SK bioscience will provide the first protein-based COVID-19 vaccine approved for use in adolescents aged 12 through 17 years in South Korea GAITHERSBURG, Md., Aug. 12, 2022 /PRNewswire/ -- Novavax, Inc. (Nasdaq: NVAX), a biotechnology company dedicated to developing and commercializing next-generation vaccines for serious infectious diseases, today announced that partner, SK bioscience, has received a Post Approval Change Application approval from the Korean Ministry of Food and Drug Safety (KMFDS) for Nuvaxovid (NVX-CoV2373) COVID-19 vaccine for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in adolescents aged 12 through 17. "Today's approval in South Korea is an important step in ensuring broad global access to a protein-based vaccine option," said Stanley C. Erck, President and Chief Executive Officer, Novavax. "We are pleased to collaborate with SK bioscience to offer our vaccine to adolescents aged 12 through 17 in South Korea." Jaeyong Ahn, CEO of SK bioscience said, "We are responding to the ongoing COVID-19 pandemic by expanding the use of Nuvaxovid for adolescents and as a booster. With CDMO manufacturing of global COVID-19 vaccines, including Nuvaxovid, we will do our best to promote human health in the world." The approval was based on data from the ongoing pediatric expansion of the Phase 3 PREVENT-19 trial of 2,247 adolescents aged 12 through 17 years across 73 sites in the U.S., to evaluate the safety, effectiveness (immunogenicity), and efficacy of Nuvaxovid. In the trial, Nuvaxovid achieved its primary effectiveness endpoint and demonstrated 80% clinical efficacy overall at a time when the Delta variant was the predominant circulating SARS-CoV-2 strain in the U.S. Preliminary safety data from the trial showed the vaccine to be generally well-tolerated. Serious and severe adverse events were low in number and balanced between vaccine and placebo groups, and not considered related to the vaccine. Local and systemic reactogenicity was generally lower than or similar to adults, after the first and second dose. The most common adverse reactions observed were injection site tenderness/pain, headache, myalgia, fatigue, and malaise. There was no increase in reactogenicity in younger (12 to <15 years old) adolescents compared to older (15 to <18 years old) adolescents. No new safety signal was observed through the placebo-controlled portion of the study. In the 12 through 17 year-old population, Nuvaxovid has been granted authorization in India, the European Union, Australia, Thailand, and Japan, and is actively under review in other markets. KMFDS approved Nuvaxovid for use in adults aged 18 and older in January 2022. In Korea, SK bioscience signed a licensing agreement with Novavax and is manufacturing drug substance and drug product of Nuvaxovid for domestic use. Trade Name Use in the U.S. The trade name Nuvaxovid has not yet been approved by the U.S. Food and Drug Administration. Important Safety Information Nuvaxovid is contraindicated in persons who have a hypersensitivity to the active substance, or to any of the excipients. Events of anaphylaxis have been reported with administration of COVID-19 vaccines. Appropriate medical treatment and supervision should be available in case of an anaphylactic reaction following the administration of the vaccine. Close observation for at least 15 minutes is recommended and a second dose of the vaccine should not be given to those who have experienced anaphylaxis to the first dose of Nuvaxovid. Anxiety-related reactions, including vasovagal reactions (syncope), hyperventilation, or stressrelated reactions may occur in association with vaccination as a psychogenic response to the needle injection. It is important that precautions are in place to avoid injury from fainting. Vaccination should be postponed in individuals suffering from an acute severe febrile illness or acute infection. The presence of a minor infection and/or low-grade fever should not delay vaccination. Nuvaxovid should be given with caution in individuals receiving anticoagulant therapy or those with thrombocytopenia or any coagulation disorder (such as haemophilia) because bleeding or bruising may occur following an intramuscular administration in these individuals. The efficacy of Nuvaxovid may be lower in immunosuppressed individuals. Administration of Nuvaxovid in pregnancy should only be considered when the potential benefits outweigh any potential risks for the mother and foetus. The effects with Nuvaxovid may temporarily affect the ability to drive or use machines. Individuals may not be fully protected until seven days after their second dose. As with all vaccines, vaccination with Nuvaxovid may not protect all vaccine recipients. The most common adverse reactions observed during clinical studies were headache, nausea or vomiting, myalgia, arthralgia, injection site tenderness/pain, fatigue, and malaise. For more information on Nuvaxovid, including the Summary of Product Characteristics with Package Leaflet, Prescribing Information and Important Safety Information, adverse event reporting instructions, or to request additional information, please visit the following websites: KMFDS SK bioscience Novavax global authorization website About the Novavax COVID-19 vaccine (NVX-CoV2373) The Novavax COVID-19 vaccine (NVX-CoV2373) is a protein-based vaccine engineered from the genetic sequence of the first strain of SARS-CoV-2, the virus that causes COVID-19 disease. The vaccine was created using Novavax' recombinant nanoparticle technology to generate antigen derived from the coronavirus spike (S) protein and is formulated with Novavax' patented saponin-based Matrix-M adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies. The Novavax COVID-19 vaccine contains purified protein antigen and can neither replicate, nor can it cause COVID-19. The Novavax COVID-19 vaccine is packaged as a ready-to-use liquid formulation in a vial containing ten doses. The vaccination regimen calls for two 0.5 ml doses (5 mcg antigen and 50 mcg Matrix-M adjuvant) given intramuscularly 21 days apart. The vaccine is stored at 2- 8 Celsius, enabling the use of existing vaccine supply and cold chain channels. Use of the vaccine should be in accordance with official recommendations. Novavax has established partnerships for the manufacture, commercialization and distribution of its COVID-19 vaccine worldwide. Existing authorizations leverage Novavax' manufacturing partnership with Serum Institute of India, the world's largest vaccine manufacturer by volume. They will later be supplemented with data from additional manufacturing sites throughout Novavax' global supply chain. About the Novavax COVID-19 vaccine (NVX-CoV2373) Phase 3 Trials The Novavax COVID-19 vaccine (NVX-CoV2373) continues being evaluated in two pivotal Phase 3 trials. PREVENT-19 (thePRE-fusion protein subunitVaccineEfficacyNovavaxTrial | COVID-19) is a 2:1 randomized, placebo-controlled, observer-blinded trial to evaluate the efficacy, safety and immunogenicity of the Novavax COVID-19 vaccine with Matrix-M adjuvant in 29,960 participants 18 years of age and older in 119 locations inthe U.S.andMexico. The primary endpoint for PREVENT-19 was the first occurrence of PCR-confirmed symptomatic (mild, moderate or severe) COVID-19 with onset at least seven days after the second dose in serologically negative (to SARS-CoV-2) adult participants at baseline. The statistical success criterion included a lower bound of 95% CI >30%. A secondary endpoint was the prevention of PCR-confirmed, symptomatic moderate or severe COVID-19. Both endpoints were assessed at least seven days after the second study vaccination in volunteers who had not been previously infected with SARS-CoV-2. In the trial, the Novavax COVID-19 vaccine achieved 90.4% efficacy overall. It was generally well-tolerated and elicited a robust antibody response after the second dose in both studies. Full results of the