Novavax 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.
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