Novavax, Inc. (Nasdaq: NVAX), a biotechnology company dedicated to developing and commercializing next-generation vaccines for serious infectious diseases, today announced that the Singapore Health Sciences Authority (HSA) has issued interim authorization for Nuvaxovid™ COVID-19 Vaccine (recombinant, adjuvanted) for active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals 18 years of age and older. The vaccine, also known as NVX-CoV2373, is the first protein-based vaccine to be authorized for use in Singapore.

"We thank the HSA for its partnership, and we are proud that Singapore is now part of the growing list of regions to have authorized the Novavax vaccine and will have a protein-based option," said Stanley C. Erck, President and Chief Executive Officer, Novavax. "This authorization demonstrates our commitment to deliver our COVID-19 vaccine, built on a well-understood vaccine platform, worldwide to help combat the evolving pandemic."

The clinical trial data submitted to HSA for review includes two pivotal Phase 3 clinical trials: PREVENT-19, which enrolled approximately 30,000 participants aged 18 years and older in the U.S. and Mexico and was published in the New England Journal of Medicine (NEJM); and a trial with almost 15,000 adult participants in the U.K. which was also published in NEJM. In both trials, NVX-CoV2373 demonstrated efficacy and a reassuring safety and tolerability profile. Serious and severe adverse events were low in number and balanced between vaccine and placebo groups. The most common adverse reactions observed during clinical studies (frequency category of very common ≥1/10) were headache, nausea or vomiting, myalgia, arthralgia, injection site tenderness/pain, fatigue, and malaise. Novavax will continue to collect and analyze real-world data, including the monitoring of safety and the evaluation of variants, as the vaccine is distributed.

Initial doses of Nuvaxovid are expected to arrive in Singapore by the end of March. For more information on Nuvaxovid, including the Summary of Product Characteristics, Prescribing Information and Important Safety Information, or to request additional information please visit the following websites:

• Novavax global authorization website
• Singapore Health Sciences Authority

The brand name Nuvaxovid™ has not yet been authorized for use in the U.S. by the FDA.

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. 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 stress–related 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.
• 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 fetus.
• The effects with Nuvaxovid may temporarily affect the ability to drive or use machines.
• Individuals may not be fully protected until 7 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 (frequency category of very common ≥ 1/10), were headache, nausea or vomiting, myalgia, arthralgia, injection site tenderness/pain, fatigue and malaise.

For additional information, please visit www.NovavaxCovidVaccine.com for the full Summary of Product Characteristics with Package Leaflet, Prescribing Information and Important Safety Information, adverse event reporting instructions, or to request additional information.