In the population aged 12 to 17, Nuvaxovid has been granted conditional authorisation in the European Union, emergency use authorisation in India and provisional registration in Australia, and is under active review in other markets.
The MHLW had previously approved Nuvaxovid for others over the age of 18 in April 2022.
The Nuvaxovid™ industry call has not yet been approved by the U. S. Food and Drug Administration. USA
To learn more about Nuvaxovid, add the summary of product characteristics with the package leaflet, life-saving and prescription data, adverse event notification instructions, or to request more information, visit the following Website:
The Novavax COVID-19 vaccine (NVX-CoV2373) is a protein-based vaccine designed from the genetic series of the first strain of SARS-CoV-2, the virus that causes COVID-19 disease. The vaccine was created using recombinant nanoparticles from Novavax. generation to generate an antigen derived from the spike protein (S) of the coronavirus and is formulated with novavax’s patented saponin-based Matrix-M™ adjuvant for the immune reaction and potentiate the highest levels of neutralizing antibodies. The Novavax COVID-19 vaccine comprises a purified protein antigen and cannot reflect or cause COVID-19.
The Novavax COVID-19 vaccine is packaged as ready-to-use liquid formulas in a vial containing ten doses. The vaccination schedule provides two doses of 0. 5 ml (5 mcg antigen and 50 mcg Matrix-M adjuvant) administered intramuscularly 21 days apart. . The vaccine is stored between 2° and 8° Celsius, so it is conceivable to use the existing vaccine source channels and bloodless chain. The use of the vaccine deserves to be in accordance with official recommendations.
Novavax has established partnerships for the manufacture, marketing and distribution of its COVID-19 vaccine worldwide. Existing approvals leverage Novavax’s production partnership with the Serum Institute of India, the world’s largest vaccine manufacturer by volume. This will later be complemented by novavax’s knowledge of more Global Origin Chain production sites.
The Novavax COVID-19 vaccine (NVX-CoV27) continues to be evaluated in two pivotal phase trials.
Prevent-19 Pediatric Expansion is a randomized, placebo-controlled, blinded 2:1 observer trial to compare the safety, efficacy, and efficacy of the Novavax COVID-19 vaccine with the Matrix-M adjuvant in 2247 adolescent participants aged 12 to 17 years. years of age at 73 sites in the United States, compared to placebo. In the pediatric trial, the vaccine met its primary efficacy endpoint (non-inferior neutralizing antibody reaction compared to young adults aged 18 to 25 years of PREVENT-19) and demonstrated an overall efficacy of 80% at a time when the Delta variant main strain circulating in the United States of concern. In addition, immune reactions were approximately two to three times higher in adolescents than in adults unlike all variants studied.
In addition, a trial conducted in the United Kingdom with 14,039 participants over the age of 18, designed as a randomized placebo-controlled study without the wisdom of observers, achieved an overall efficacy of 89. 7%. The primary endpoint based on the first occurrence of symptomatic COVID-19 demonstrated through CRP (mild, moderate, or severe) with onset at least seven days after the time of screening vaccination in hivologically negative adult participants (SARS-CoV-2) at baseline. The full effects of the trial were published in the NEJM.
Novavax’s patented saponin-based Matrix-M adjuvant demonstrated a potent and well-tolerated effect by stimulating the access of antigen-presenting cells at the injection site and presenting the antigen in local lymph nodes, thereby stimulating the immune response.
Novavax, Inc. (Nasdaq: NVAX) is a biogeneration company that promotes advanced global fitness through the discovery, progression and commercialization of cutting-edge vaccines to save you from serious infectious diseases. The company’s proprietary recombinant generation platform harnesses the power and speed of genetic engineering to successfully produce highly immunogenic nanoparticles designed to address pressing global fitness needs. The Novavax COVID-19 vaccine has received approval from several regulatory governments around the world, in addition to the United States, the European Commission, and the World Health Organization. The vaccine is lately undergoing review through various regulatory agencies around the world, adding for other indications and populations such as adolescents and as a booster. In addition to its COVID-19 vaccine, Novavax is also lately comparing a combined seasonal influenza and COVID vaccine candidate in a phase 1/2 clinical trial, combining NVX-CoV2373 and NanoFlu*, its quadrivalent influenza vaccine candidate in research, and is also comparing an Omicron-based vaccine (NVX-CoV2515), as well as a bivalent Omicron-based/parent strain-based vaccine. These candidate vaccines incorporate Novavax’s proprietary saponin-based Matrix-M adjuvant for immune reaction and stimulate higher levels of neutralizing antibodies.
*NanoFlu identifies an influenza vaccine candidate based on recombinant hemagglutinin (HA) protein nanoparticles produced through Novavax. This experimental candidate was evaluated in a Phase 3 controlled trial conducted during the 2019-2020 influenza season.
Statements in this document relating to Novavax’s long term, its operating plans and outlook, its partnerships, the outlook for upcoming US Government orders for additional doses of NVX-CoV2373 and other prospective formulations, the timing of effects clinical trials, the ongoing progression of NVX-CoV2373, adding an Omicron strain-based vaccine and an Omicron-based/parent strain-based bivalent vaccine, an investigational COVID seasonal influenza vaccine candidate, the scopeFix the timing and effects of long-term regulatory filings and actions, adding Novavax’s plans to supplement authorizations with information from other Novavax global source chain production sites, plus global authorizations of NVX-CoV2373 for use in adults and adolescents, and as a reminder, the evolution of the COVID-19 pandemic, the potential impact and scope of Novavax and NVX-CoV2373 to address vaccine access, pandemic control and population protection, efficacy, protection and intended use of NVX-CoV2373 and NVX-CoV2373 management forecasts are forward-looking statements. Novavax cautions that such forward-looking statements are subject to threats and uncertainties that may cause actual effects to differ materially from those expressed or implied by such statements. These threats and uncertainties include, but are not limited to, difficulties in assembly, alone or with partners, various needs for protection, efficacy and product characterization, adding those similar to the qualification and validation of procedures. testing, as required to satisfy applicable regulatory authorities; difficulty obtaining scarce cloth and raw supplies; resource limitations, adding human capital and production capacity, on Novavax’s ability to adhere to expected regulatory pathways; unforeseen difficulties or delays in conducting clinical trials; difficulties in assembling control needs under agreements with multiple commercial, governmental and other entities; and other known threat items in the “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” sections of Novavax’s Annual Report on Form 10-K for the fiscal year ended December 31, 2021 and subsequent quarterly reports on Form 10-Q, as filed with the Securities and Exchange Commission (SEC). Investors are cautioned against placing significant reliance on the forward-looking statements contained in this press release. We invite you to read our SEC filings, available at www. sec. gov and www. novavax. com, for a discussion of these and other threats and uncertainties. The forward-looking statements contained in this press release speak only as of the date hereof, and we do not assume any legal responsibility to update or revise any of the statements. Our business is subject to truly extensive threats and uncertainties, in addition to those discussed above. Investors, potential investors, and others deserve to pay special attention to those threats and uncertainties.
Contacts:InvestorsAlex Delacroix | 240-268-2022ir@novavax. com
MediaAli Chartan or Giovanna Chandler | 202-709-5563media@novavax. com
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SOURCE Novavax, Inc.