|
Novavax, Inc., a biotechnology company dedicated to developing and commercializing next-generation vaccines for serious infectious diseases, announced that the Novavax Covid-19 vaccine, Adjuvanted (NVX-CoV2373) has received expanded emergency use authorization (EUA) from the US Food and Drug Administration (FDA) to provide a two-dose primary series for active immunization to prevent coronavirus disease 2019 (Covid-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in adolescents aged 12 through 17.
"Having more vaccine options for use in both adults and adolescents, like the Novavax Covid-19 Vaccine, Adjuvanted will hopefully help increase vaccination rates, particularly as we prepare for ongoing surges of Covid-19 with the start of fall and the back-to-school season," said Stanley C. Erck, president and chief executive officer, Novavax. "We hope that our vaccine, developed using an innovative approach to recombinant protein vaccine technology, may have a special role in adolescent vaccination based on parents' and caregivers' familiarity with protein-based vaccines used in other disease areas."
The FDA EUA decision was based on data from the ongoing paediatric 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 the Novavax Covid-19 Vaccine, Adjuvanted. In paediatric expansion, the vaccine achieved its primary efficacy endpoint with clinical efficacy of 78.29% (95% CI: 37.55%, 92.45%) overall at a time when the Delta variant was the predominant circulating SARS-CoV-2 strain in the US. The efficacy analysis was supported by assessment of antibody titers that were shown to be higher in adolescents than in young adults.
Safety data from the paediatric 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. No new safety signal was observed through the placebo-controlled portion of the study. Among participants 12 through 17 years of age, solicited ARs following administration of any dose of the Novavax Covid-19 Vaccine, Adjuvanted were injection site pain/tenderness (75.0%), headache (56.9%), fatigue/malaise (57.9%), muscle pain (49.0%), nausea/vomiting (19.9%), joint pain (16.2%), fever (16.9%), injection site swelling (8.0%), and injection site redness (7.5%). Most were mild-to-moderate in severity and lasted less than two days.
The next step for the vaccine is a policy recommendation for use from the Centers for Disease Control and Prevention (CDC). Doses of the Novavax Covid-19 Vaccine, Adjuvanted are available for use in adolescents upon the CDC's recommendation.
In July 2022 the US FDA had granted EUA for a two-dose primary series in adults aged 18 and older, followed by a recommendation from the CDC Advisory Committee on Immunization Practices, and endorsement from the CDC.
This project has been supported in part with federal funds from the Department of Health and Human Services (HHS); the Administration for Strategic Preparedness and Response; Biomedical Advanced Research and Development Authority (BARDA), through the Department of Defense Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense (JPEO-CBRND) under contract number MCDC2011-001.
The Novavax Covid-19 vaccine, Adjuvanted has not been approved or licensed by the US Food and Drug Administration (FDA), but has been authorized for emergency use by FDA, under an Emergency Use Authorization (EUA) to provide a two-dose primary series to individuals 12 years of age and older to prevent coronavirus disease 2019 (Covid-19).
The emergency use of this product is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of the medical product under Section 564(b)(1) of the FD&C Act unless the declaration is terminated or authorization revoked sooner.
The Novavax Covid-19 vaccine, Adjuvanted is authorized for use under an Emergency Use Authorization (EUA) to provide a two-dose primary series for active immunization to prevent coronavirus disease 2019 (Covid-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 12 years of age and older.
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. NVX-CoV2373 contains purified protein antigen and can neither replicate, nor can it cause Covid-19.
NVX-CoV2373 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.
The PREVENT-19 trial of NVX-CoV2373 is being conducted with support from the US government, including the Department of Defense, BARDA, part of the Office of the Assistant Secretary for Preparedness and Response at the HHS, and the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health at HHS. BARDA is providing up to?$1.75 billion?under a Department of Defense agreement (number MCDC2011-001). JPEO-CBRND is also providing funding of up to $45.7 million under a separate agreement. To date, the US government has agreed to order 3.2 million doses of NVX-CoV2373 under these existing agreements. Novavax and the US government will determine the timing, pricing, and amounts for delivery of any additional NVX-CoV2373 doses. Novavax intends to pursue additional US procurement of both NVX-CoV2373 doses and other potential formulations.?
Novavax has established partnerships for the manufacture, commercialization and distribution of NVX-CoV2373 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.
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.
Novavax, Inc. is a biotechnology company that promotes improved health globally through the discovery, development, and commercialization of innovative vaccines to prevent serious infectious diseases.
|