GAITHERSBURG, Md. , Nov. 9, 2022 /PRNewswire/ — Novavax, Inc. (Nasdaq: NVAX), a biotechnology company committed to advancing and commercializing next-generation vaccines for serious infectious diseases, announced that drugs and fitness products The regulatory firm (MHRA) of the United Kingdom (UK) has extended the conditional marketing authorization (MAC)i for the Nuvaxovid vaccine (NVX-CoV2373) COVID-19 as a dose of homologous and heterologous reinforcement after vaccination number one of Nuvaxovid (six months) or an mRNA vaccine or adenoviral vector for active immunization to save you from coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in adults 18 years of age and older.
“Our protein-based vaccine, which evolved from cutting-edge technique to classical technology, can play a leading role in stimulating COVID-19,” said Stanley C. Erck, president and chief executive officer of Novavax. “As we continue to explore most productive practices for long-term COVID-19 management, we have ongoing trials further exploring the immunogenicity of Nuvaxovid as a booster dose. The clinical and preclinical knowledge currently available implies that our vaccine induces physically powerful immune responses opposed to Omicron variants, adding BA. 4/5. “
The MHRA resolution was based on knowledge from the Novavax phase 2 trial conducted in the US. The U. S. and Australia (1283 participants), a separate phase 2 trial conducted in South Africa (4404 participants), and the UK-sponsored VOC-BOOST trial (2878 participants). 1,2 In phase 2 trials, a booster dose of Nuvaxovid was administered to single individuals to healthy adult participants approximately six months after their first two-dose series of Nuvaxovid. 1,2 The third dose produced opposite responses to the original ancestral strain of SARS-CoV. -2 comparable or higher grades related to coverage in phase 3 clinical trials. 1,2 In the VOC-BOOST trial, the highest antibody titers of Nuvaxovid when used as a third heterologous booster dose following a two-dose number one vaccination of mRNA or adenoviral vaccine vector. 2
In Novavax-sponsored trials, after withdrawal, local and systemic reactions had a median duration of approximately two days. 1,2 Adverse reactions were mild to moderate in severity. 1,2 Safety reports of reactogenicity occasions showed an increased occurrence of all 3 doses. Medically assisted adverse occasions (AEs), potentially immune-mediated medical conditions, and severe AEs occurred infrequently after the booster dose and were balanced between the vaccine and placebo groups. 1,2
Nuvaxovid is also available for withdrawal use in adults 18 years of age and older in the United States, the European Union, Japan, Australia, New Zealand, Switzerland, and Israel. In addition, several countries have policy recommendations that allow the vaccine to be used as a heterologous or homologous booster dose.
The MHRA had in the past awarded a MAC for Nuvaxovid as the number one series in adults over 18 in February 2022, and in adolescents aged 12-17 years and older in August 2022.
? This medication is subject to additional monitoring. This will allow new security data to be temporarily identified. If you are involved in an adverse event, report it on a yellow card. Bureaucracy and reporting data can be discovered on https://coronavirus-yellowcard. mhra. gov. uk/ or search for the MHRA yellow card on Google Play or Apple App Store. When reporting, include the vaccine logo and batch number if available.
I. Se are gathering additional knowledge on effectiveness and protection.
The Nuvaxovid industry call has not yet been approved by the U. S. Food and Drug Administration (FDA).
Important protection information: United Kingdom
To learn more about Nuvaxovid, add the summary of product characteristics with the package leaflet, instructions for reporting adverse events, or request more information, please visit the following websites:
About Nuvaxovid (NVX-CoV2373) Nuvaxovid (NVX-CoV2373) is a protein-based vaccine made from the genetic series of the first strain of SARS-CoV-2, the virus that causes COVID-19 disease. The vaccine was created using Novavax technology. generation of recombinant nanoparticles to generate an antigen derived from the coronavirus spike (S) protein and is formulated with Novavax’s patented saponin-based Matrix-M adjuvant for immune reaction and stimulating higher levels of neutralizing antibodies. Nuvaxovid comprises a purified protein antigen and may not reflect or cause COVID-19.
Nuvaxovid is packaged as a ready-to-use liquid formula in a vial containing ten doses. The vaccination schedule consists of two doses of 0. 5 ml (5 mcg antigen and 50 mcg Matrix-M adjuvant) administered intramuscularly 21 days apart. stored between 2° and 8° Celsius, allowing the use of existing vaccine source channels and bloodless chain. The use of the vaccine should be in accordance with official recommendations.
Novavax has established partnerships for the manufacture, marketing and distribution of Nuvaxovid worldwide. The existing approvals leverage Novavax’s production partnership with the Serum Institute of India, the world’s largest vaccine manufacturer by volume. Subsequently, they will be complemented by knowledge of other Novavax global production sites. Source Chain
About Phase Trials of Novavax COVID-19 Vaccine (NVX-CoV27) The Novavax COVID-19 vaccine (NVX-CoV27) continues to be evaluated in two pivotal phase trials.
PREVENT-19 (the Novavax PRE|COVID-19 Fusion Protein Subunit Vaccine Efficacy Trial) is a 2:1 observer-blind, placebo-controlled, randomized trial to assess efficacy, protection, and safety. Immunogenicity of the Novavax COVID-19 vaccine with the adjuvant Matrix-M in 29,960 participants older than 18 years at 119 sites in the United States and Mexico. The number one PREVENT-19 endpoint was the first occurrence of symptomatic PCR-confirmed COVID-19 (mild, moderate, or severe) with onset at least seven days post-dose at the time in adult participants who were serologically negative (a SARS-CoV). -2) at the beginning of the study. The statistical criterion of good fortune included a decrease limit of 95% CI >30%. A momentary endpoint was prevention of moderate or severe symptomatic COVID-19 confirmed by PCR. Both parameters were assessed at least seven days after the time of vaccination screening in volunteers who had not been infected with SARS-CoV-2 in the past. In the trial, the Novavax COVID-19 vaccine achieved an overall efficacy of 90. 4%. It was well tolerated and elicited a physically powerful antibody reaction after the point dose in any of the studies. The full effects of the trial have been published in the New England Journal of Medicine (NEJM).
The pediatric expansion of PREVENT-19 is a randomized, 2:1, placebo-controlled, blinded, observer-controlled trial to compare the safety, efficacy, and efficacy of the Novavax COVID-19 vaccine with the Matrix-M adjuvant in 2247 adolescent participants 12 to 17 years of age at 73 sites in the United States, compared to placebo. In the pediatric trial, the vaccine reached its number one efficacy endpoint (non-inferiority of neutralizing antibody reaction compared to young adults 18 to 25 years of age of PREVENT-19) and demonstrated 80% overall efficacy at a time when the Delta variant, the main strain circulating in the United States, It was a cause for concern. to all variants studied.
In addition, a UK trial of 14,039 participants aged 18 years and older, designed as a randomised, placebo-controlled, observer-blind study, achieved an overall efficacy of 89. 7%. occurrence of symptomatic COVID-19 (mild, moderate, or severe) with onset at least seven days after the time vaccination was examined in serologically negative adult participants (SARS-CoV-2) at baseline-negative. The full effects of the trial were published in the NEJM.
About the Matrix-M adjuvant 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 to local lymph nodes, thereby stimulating the immune response.
About Novavax Novavax, Inc. (Nasdaq: NVAX) is a biogeneration company advancing 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 gained approval from multiple regulatory governments around the world, including the US FDA, European Commission and WHO. The vaccine is lately undergoing review through various regulatory agencies around the world, being added for other populations and indications, such as adolescents and as a booster. In addition to its COVID-19 vaccine, Novavax is also lately comparing its combined influenza and COVID-19 vaccine candidate in a phase 1/2 clinical trial, its investigational quadrivalent influenza vaccine candidate, and a vaccine based on the Omicron strain (NVX-CoV2515) as well as an Omicron-founded/parent-strain-founded bivalent vaccine. These candidate vaccines incorporate Novavax’s proprietary saponin-based Matrix-M adjuvant for immune response and stimulate higher levels of neutralizing antibodies.
For more information, visit www. novavax. com and connect with us on LinkedIn.
Forward-Looking StatementsDetailed statements regarding Novavax’s long-term, operating plans and prospects, partnerships, the outlook for upcoming US Government orders for additional doses of NVX-CoV2373 and other forward-looking formulations, the timing of effects of clinical trials, continued progression of NVX-CoV2373 , adding NVX-CoV2515 and the original strain-based/Omicron-based bivalent vaccine, an investigational COVID seasonal influenza vaccine candidate, its vaccine candidate investigational quadrivalent influenza vaccine, scope, timing and final results of long-term regulatory filings and actions, adding any recommendations and prospective authorizations from JVCI, MHRA or any other regulatory authority, Novavax plans to complete existing authorizations with the knowledge from other global supply chain production sites from No vavax, plus international approvals of NVX-CoV2373 for use in adults and adolescents, and as a stimulant, the potential influence and success of Novavax and NVX-CoV 2373 in access to vaccines, pandemic control, and protection of the population, efficacy, safety and intended use of NVX-CoV2373 and intended management of NVX-CoV2373 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 safety, efficacy, and product characterization, as well as those similar to procedural qualification and validation. testing, as required to satisfy applicable regulatory authorities; unforeseen difficulties or delays in conducting clinical trials; 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; 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:InvestorsErika Schultz | 240-268-2022ir@novavax. com
MediaAli Chartan or Giovanna Chandler| 202-709-5563media@novavax. com
References
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