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Health Canada approves Novavax’s Nuvaxovid Covid-19 vaccine for use as primary series in adolescents

Gaithersburg, Maryland
Friday, December 9, 2022, 15:00 Hrs  [IST]

Novavax, Inc., a biotechnology company dedicated to developing and commercializing next-generation vaccines for serious infectious diseases, 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 US, to evaluate the safety and effectiveness of Nuvaxovid. In the paediatric 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 paediatric expansion.

In the 12 through 17-year-old population, Novavax' vaccine has been authorized in more than 10 markets around the world including the US, 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.

The trade name Nuvaxovid has not yet been approved by the US Food and Drug Administration (FDA).

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.

NVX-CoV2373 continues being evaluated in two pivotal phase 3 trials.

PREVENT-19 (the?PRE-fusion protein subunit?Vaccine?Efficacy?Novavax?Trial | 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 over in 119 locations in?the US?and?Mexico. 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, NVX-CoV2373 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 trial were published in the?New England Journal of Medicine (NEJM).

The paediatric expansion of PREVENT-19 is a 2:1 randomized, placebo-controlled, observer-blinded trial to evaluate the safety, effectiveness, and efficacy of NVX-CoV2373 with Matrix-M adjuvant in 2,247 adolescent participants 12 to 17 years of age in 73 locations in the U.S., compared with placebo. In the pediatric trial, the vaccine achieved its primary effectiveness endpoint (non-inferiority of the neutralizing antibody response compared to young adult participants 18 through 25 years of age from PREVENT-19) and demonstrated 80% efficacy overall at a time when the Delta variant of concern was the predominant circulating strain in the US.?Additionally, immune responses were about two-to-three-fold higher in adolescents than in adults against all variants studied.

Additionally, a trial conducted in the UK with 14,039 participants aged 18 years and over was designed as a randomized, placebo-controlled, observer-blinded study and achieved overall efficacy of 89.7%. The primary endpoint was based on the first occurrence of PCR-confirmed symptomatic (mild, moderate, or severe) Covid-19 with onset at least seven days after the second study vaccination in serologically negative (to SARS-CoV-2) adult participants at baseline. Full results of the trial were published in NEJM.

Novavax' patented saponin-based Matrix-M adjuvant has demonstrated a potent and well-tolerated effect by stimulating the entry of antigen-presenting cells into the injection site and enhancing antigen presentation in local lymph nodes, boosting immune response.

 

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