COVID-19 ⚕️💉 Novavax Nuvaxovid COVID-19 Vaccine Approved in Canada for Use as a Primary Series in Adolescents

Thursday, 15 December 2022 02:27.PM

Novavax, Inc., a biotechnology company dedicated to developing and commercializing next-generation vaccines for serious infectious diseases, today announced that Health Canada has approved a supplement to a New Drug Submission (sNDS) for Nuvaxovid™ (COVID-19 Vaccine (Recombinant protein, Adjuvanted)) (NVX-CoV2373) for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) as a primary series of two doses in adolescents aged 12 through 17.

"With the winter COVID-19 surge upon us, it's more important now than ever to ensure adolescents have access to COVID-19 vaccine options, including Nuvaxovid," said Stanley C. Erck, President and Chief Executive Officer, Novavax. "Our vaccine is developed using an innovative approach to traditional vaccine technology and may have a special role to play in adolescent vaccination based on parents' and caregivers' familiarity with protein-based vaccines used in other disease areas."

The approval of the sNDS 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 75 sites in the U.S., to evaluate the safety and effectiveness of Nuvaxovid. In the pediatric expansion, the effectiveness analysis was based on antibody titers that were shown to be higher in adolescents than in young adults. Effectiveness was supported by clinical efficacy showing that Nuvaxovid provided clinical protective efficacy of 79.5% (95% CI: 46.8%, 92.1%) overall at a time when the Delta variant was the predominant circulating SARS-CoV-2 strain.

Preliminary safety data from the pediatric expansion showed the vaccine to be generally well-tolerated. Serious and severe adverse reactions (AR) 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 frequent ARs in participants aged 12 through 17 were injection site tenderness (71%), injection site pain (67%), headache (63%), myalgia (57%), fatigue (54%), malaise (43%), nausea or vomiting (23%), arthralgia (19%), injection site swelling (19%), pyrexia (17%), and injection site redness (17%). Most were mild-to-moderate in severity and lasted less than two days. No new safety concerns were observed through the placebo-controlled portion of the pediatric expansion.

In the 12 through 17-year-old population, Novavax' vaccine has been authorized in more than 10 markets around the world including the U.S., the European Union, and the United Kingdom.

Health Canada previously approved Nuvaxovid as a primary series in adults aged 18 and older in February 2022 and as a homologous booster in adults in November 2022. In Canada, Nuvaxovid will be manufactured locally at the Biologics Manufacturing Centre in Montreal. Engineering runs have been successfully completed and manufacturing of process performance qualification batches is expected to begin in early 2023.

Trade Name in the U.S.
The trade name Nuvaxovid™ has not yet been approved by the U.S. Food and Drug Administration (FDA).

Authorized Use of Nuvaxovid™ in Canada

Health Canada has approved registration of Nuvaxovid™ COVID-19 Vaccine (Recombinant protein, Adjuvanted) to COVID-19 caused by SARS-CoV-2 as a primary series in individuals 12 years of age and older, and as a homologous booster dose in individuals 18 years of age and older. There are no data available on the interchangeability of Nuvaxovid with other COVID- 19 vaccines to complete the primary vaccination series.

Important Safety Information: Canada

• Nuvaxovid is contraindicated in individuals who are hypersensitive to the active ingredient or to any ingredients in the formulation, including any non-medicinal ingredient, or component of the container.
• Vaccination should be postponed in individuals suffering from an acute severe febrile illness or acute infection.
• Individuals may not be optimally protected until seven days after their second dose.
• 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.
• 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 effects with Nuvaxovid may temporarily affect the ability to drive or use machines.
• Immunocompromised persons, including individuals receiving immunosuppressant therapy, may have a diminished immune response to the vaccine.
• Anxiety-related reactions, including vasovagal reactions, hyperventilation, or stress–related reactions may occur in association with vaccination. Syncope (fainting) can occur following, or even before, any vaccination as a psychogenic response to the needle injection. It is important that precautions are in place to avoid injury from fainting and manage syncopal reactions.
• Administration of Nuvaxovid in pregnancy should only be considered when the potential benefits outweigh any potential risks for the mother and fetus.
• The most common adverse reactions observed during clinical studies were injection site tenderness, injection site pain, fatigue, myalgia, headache, malaise, arthralgia, and nausea or vomiting.

For more information on Nuvaxovid, including the Summary of Product Characteristics with Package Leaflet, adverse event reporting instructions, or to request additional information, please visit the following websites:

• Health Canada
• Novavax global authorization website

Related materials: