The MHRA in the past awarded a MAC for Nuvaxovid as the number one series in adults 18 and older in February 2022 and in adolescents aged 12-17 years and older in August 2022.
▼This medicine 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.
The Nuvaxovid™ industry call has not yet been approved by the U. S. Food and Drug Administration (FDA).
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 based on the genetic series of the first strain of SARS-CoV-2, the virus that causes COVID-19 disease. The vaccine was created using Novavax’s generation of recombinant nanoparticles to generate an antigen derived from the coronavirus spike protein (S) and is formulated with Novavax’s patented saponin-based Matrix-M™ adjuvant for the immune reaction and stimulate the highest levels of neutralizing antibodies. Nuvaxovid comprises a purified protein antigen and cannot 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
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 extension 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 aged 12 to 17 years at 73 sites in the United States, compared with placebo. In the pediatric trial, the vaccine met 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 Delta variant, the main strain circulating in the United States, of concern. In addition, immune reactions were two to three times higher in adolescents than in adults unlike 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 antigen presentation in local lymph nodes, thereby stimulating the immune response.
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 from clinical trials, continued progression of NVX-CoV2373, adding NVX-CoV2515 and the original Omicron/strain bivalent vaccine, an investigational COVID seasonal influenza vaccine candidate, its experimental quadrivalent influenza vaccine candidate a vaccine, the scope, timing and effects of long-term submissions and regulatory actions, adding any recommendations and possible authorizations from JVCI, MHRA or any other regulatory authority, Novavax plans to supplement existing authorizations with the knowledge from other production sites in the global e-Novavax sourcing chain, more about international approvals of NVX-CoV2373 for use in adults and adolescents, and as a stimulant, the potential influence and scope of Novavax and NVX-CoV2373 on vaccine access, pandemic control, and population protection, efficacy, the safety and intended use of NVX-CoV2373, and the 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
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SOURCE Novavax, Inc.