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- The World Health Organization updates the emergency use list for the Novavax Nuvaxovid COVID-19 vaccine as a primary series in adolescents and as a booster in adults
GAITHERSBURG, Md., Nov. 30, 2022 /PRNewswire/ -- Novavax, Inc. (Nasdaq: NVAX), a biotechnology company focused on developing and commercializing next-generation vaccines for serious infectious diseases, announced today that the World Organization Health (WHO) has issued an updated Emergency Use List (EUL) for the COVID-19 vaccine Nuvaxovid™ (NVX-CoV2373) for active immunization to prevent coronavirus disease 2019 (COVID- 19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) as a two-dose primary series in adolescents 12 to 17 years of age and as a booster in adults over 18 years of age.
"The updated WHO Emergency Use List allows us to offer our protein-based vaccine as a primary series for adolescents and as a booster for adults worldwide," said Stanley C. Erck, President and CEO of Novavax. "WHO member countries now have a vaccine option for these indications developed using an innovative approach to traditional technology that can also be stored in standard refrigeration, making it easy to transport."
Adolescent Primary SeriesThe updated EUL for Nuvaxovid as a primary series in adolescents 12 to 17 years of age was based on data from the ongoing pediatric expansion of the Phase 3 PREVENT-19 trial of 2,232 adolescents 12 to 17 years of age at 75 sites in the United States. , to assess the safety and efficacy of Nuvaxovid. In the pediatric expansion, Nuvaxovid achieved its primary efficacy endpoint, demonstrating 80% overall clinical efficacy at a time when the Delta variant was the predominant circulating SARS-CoV-2 strain in the United States.
Preliminary safety data from the pediatric expansion showed that the vaccine is generally well tolerated. Serious and severe adverse events were low in number and balanced between the vaccine and placebo groups, and were not considered vaccine related. Local and systemic reactogenicity was generally less than or similar to that in adults after the first and second doses. The most common adverse reactions observed were injection site tenderness/pain, headache, myalgia, fatigue, and malaise. There was no increase in reactogenicity in younger adolescents (12 to <15 years) compared to older adolescents (15 to <18 years). No new safety signals were observed through the placebo-controlled portion of the pediatric expansion.
Booster in Adults The updated EUL for Nuvaxovid as a booster in adults 18 years and older is supported by data from the Phase 2 trial of Novavax conducted in Australia, a separate Phase 2 trial conducted in South Africa, and the United Kingdom (UK) sponsored VOC ). -Try BOOST. As part of the Phase 2 trials of Novavax, a single booster dose of Nuvaxovid was administered to healthy adult participants approximately six months after their primary two-dose Nuvaxovid vaccination series. The third dose produced increased immune responses comparable to or greater than levels associated with protection in Phase 3 clinical trials. In the COV-BOOST trial, Nuvaxovid induced a significant antibody response when used as a third booster dose. heterologous
In the Novavax-sponsored trials, after the boost, local and systemic reactions had a median duration of approximately two days. The incidence of grade 3 or higher events remained relatively low. Safety reports of reactogenicity events showed an increased incidence at all three doses of Nuvaxovid, often seen with increased immunogenicity. Medically attended adverse events (AEs), potentially immune-mediated medical conditions, and serious AEs occurred infrequently after the booster dose and were balanced between the vaccine and placebo groups.
In the 12-17 year old population, Novavax's vaccine has been licensed in more than 10 markets, including the United States, the European Union (EU) and the United Kingdom. The vaccine has also been licensed as a booster in the US, EU, Japan, Australia, New Zealand, and Switzerland, and several other countries have policy recommendations allowing use of the vaccine as a heterologous or homologous booster. Novavax's vaccine is being actively reviewed in other markets for both indications and has ongoing trials to further explore its efficacy and safety as a booster.
WHO previously granted EUL for Nuvaxovid in adults 18 years and older in December 2021.
US Trade Name The trade name Nuvaxovid™ has not yet been approved by the US Food and Drug Administration (FDA).
Important Safety Information: WHO
For more information about Nuvaxovid, including the Summary of Product Characteristics with the Package Insert, adverse effect reporting instructions, or to request additional information, please visit the following websites:
About Nuvaxovid™ (NVX-CoV2373) Nuvaxovid (NVX-CoV2373) is a protein-based vaccine engineered from the genetic sequence of the first strain of SARS-CoV-2, the virus that causes the disease COVID-19. . The vaccine was created using Novavax's recombinant nanoparticle technology to generate an antigen derived from the coronavirus spike (S) protein and is formulated with Novavax's proprietary saponin-based Matrix-M™ adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies. Nuvaxovid contains purified protein antigen and cannot replicate or cause COVID-19.
Nuvaxovid is packaged as a ready-to-use liquid formulation in a vial containing ten doses. The vaccination regimen requires two 0.5 mL doses (5 mcg of antigen and 50 mcg of Matrix-M adjuvant) administered intramuscularly 21 days apart. Vaccine is stored between 2° and 8° Celsius, allowing use of existing cold chain and vaccine supply channels. The use of the vaccine must be in accordance with official recommendations.
Novavax has established partnerships for the manufacturing, marketing and distribution of Nuvaxovid throughout the world. The existing authorizations take advantage of Novavax's manufacturing partnership with the Serum Institute of India, the world's largest vaccine manufacturer by volume. It will later be supplemented by data from additional manufacturing sites throughout Novavax's global supply chain.
About the Phase 3 Trials of the COVID-19 Vaccine (NVX-CoV2373) The COVID-19 vaccine (NVX-CoV2373) continues to be evaluated in two pivotal Phase 3 trials.
PREVENT-19 (the PRE Fusion Protein Subunit Vaccine Efficacy Trial | COVID-19) is a 2:1 randomized, placebo-controlled, observer-blinded trial to evaluate the efficacy, safety, and immunogenicity of NVX. -CoV2373 adjuvanted Matrix-M in 29,960 participants 18 years and older at 119 sites in the United States and Mexico. The primary endpoint of PREVENT-19 was the first onset of PCR-confirmed symptomatic COVID-19 (mild, moderate, or severe) with onset at least seven days after the second dose in adult participants who were serologically negative (to SARS-CoV -2) at startup. The statistical success criterion included a lower limit of 95% CI >30%. A secondary endpoint was prevention of symptomatic and PCR-confirmed 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, the Novavax COVID-19 vaccine achieved an overall efficacy of 90.4%. It was generally well tolerated and elicited a robust antibody response after the second dose in both studies. Full trial results have been published in the New England Journal of Medicine (NEJM).
The Pediatric Extension of PREVENT-19 is a 2:1 randomized, placebo-controlled, observer-blinded trial to evaluate the safety, effectiveness, and efficacy of Novavax COVID-19 vaccine adjuvanted with Matrix-M in 2,247 adolescent participants. 12 to 17 years of age at 73 sites in the United States, compared with placebo. In the pediatric trial, NVX-CoV2373 met its primary efficacy endpoint (non-inferiority of neutralizing antibody response compared to PREVENT-19 young adult participants 18 to 25 years of age) and demonstrated an overall efficacy of 80%. % at a time when the Delta variant was the predominant strain circulating in the United States. Furthermore, immune responses were two to three times higher in adolescents than in adults against all variants studied.
In addition, a trial conducted in the UK with 14,039 participants aged 18 years and over was designed as a randomized, placebo-controlled, observer-blind study and achieved an overall efficacy of 89.7%. The primary endpoint was the first onset of PCR-confirmed symptomatic (mild, moderate, or severe) COVID-19 with onset at least seven days after the second study vaccination in serologically negative (for SARS-CoV) adult participants. -2) based. Full trial results have been published in NEJM.
About Matrix-M™ Adjuvant Novavax's proprietary saponin-based Matrix-M adjuvant has demonstrated a potent and well-tolerated effect in stimulating the entry of antigen-presenting cells into the injection site and enhancing antigen presentation in subjects. local lymph nodes, increasing the immune response
About Novavax Novavax, Inc. (Nasdaq: NVAX) is a biotechnology company that promotes better health globally by discovering, developing and commercializing innovative vaccines to prevent serious infectious diseases. The company's proprietary recombinant technology platform combines the power and speed of genetic engineering to efficiently produce highly immunogenic nanoparticles designed to address urgent health needs around the world. Novavax's COVID-19 vaccine, NVX-CoV2373, has received authorization from multiple regulatory authorities around the world, including the United States, the European Commission, and the World Health Organization. The vaccine is under review by multiple regulatory agencies around the world, including for additional indications and populations such as adolescents and as a booster. In addition to its COVID-19 vaccine, Novavax is also currently evaluating a combined seasonal flu-COVID vaccine candidate in a Phase 1/2 clinical trial, combining NVX-CoV2373 and NanoFlu*, its quadrivalent flu vaccine candidate. investigational influenza, and is also evaluating a vaccine based on the Omicron strain (NVX-CoV2515), as well as a bivalent vaccine based on the Omicron/parent strain. These candidate vaccines incorporate Novavax's proprietary saponin-based adjuvant Matrix-M to enhance the immune response and stimulate high levels of neutralizing antibodies.
For more information, visit www.novavax.com and contact us on LinkedIn.
Forward Looking Statements The statements contained herein concern the future of Novavax, its operating plans and prospects, its partnerships, the timing of clinical trial results, the ongoing development of NVX-CoV2373, an investigational seasonal influenza COVID vaccine, the scope, timing, and outcome of future regulatory filings and actions, including Novavax's plans to supplement existing authorizations with data from additional manufacturing sites in Novavax's global supply chain, additional worldwide authorizations for NVX-CoV2373 for use in adults and adolescents and as a boost, the potential impact and scope of Novavax and NVX-CoV2373 to address vaccine access, control the pandemic, and protect populations, as well as efficacy, safety, and utilization The expected administration of NVX-CoV2373 and the expected administration of NVX-CoV2373 are forward-looking statements. Novavax cautions that these forward-looking statements are subject to numerous risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. These risks and uncertainties include, without limitation, the challenges of satisfying, alone or together with partners, various safety, efficacy, and product characterization requirements, including those related to process qualification and assay validation, necessary to satisfy applicable regulatory authorities; the difficulty in obtaining scarce raw materials and supplies; resource constraints, including human capital and manufacturing capacity, on Novavax's ability to pursue anticipated regulatory pathways; challenges in meeting contractual requirements under agreements with multiple commercial, government, and other entities; and those other risk factors identified in the "Risk Factors" and "Management's Analysis of Financial Condition and Results of Operations" sections of Novavax's Annual Report on Form 10-K for the year ended December 31, 2021 and subsequent Quarterly Reports on Form 10-Q, as filed with the Securities and Exchange Commission (SEC). We caution investors not to place undue reliance on any forward-looking statements contained in this press release. We encourage you to read our filings with the SEC, available at www.sec.gov and www.novavax.com, for a discussion of these and other risks and uncertainties. Forward-looking statements in this press release speak only as of the date hereof, and we do not undertake any obligation to update or revise any such statements. Our business is subject to material risks and uncertainties, including those mentioned above. Investors, potential investors and others should carefully consider these risks and uncertainties.
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