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Nuvaxovid™ is New Zealand’s first protein-based COVID-19 vaccine
Nuvaxovid™ can now be used as an initial or momentary booster dose for adults over the age of 18 vaccinated with any number one series vaccine
GAITHERSBURG, Md. , Aug. 17, 2022 /PRNewswire/ — Novavax, Inc. (Nasdaq: NVAX), a biotechnology company committed to advancing and commercializing next-generation vaccines opposed to serious infectious diseases, announced that Medsafe of New Zealand has granted expanded provisional approval for the COVID-19 Nuvaxovid™ vaccine (NVX-CoV2373) for active immunization to save it from coronavirus disease 2019 (COVID-19) caused by the syndrome Severe acute respiratory coronavirus 2 (SARS-CoV-2) as a heterologous booster and a homologous dose in adults over 18 years of age.
Following Medsafe,New Zealand’s expanded interim approval resolution, Americans can now opt for Nuvaxovid as their first and/or momentary COVID-19 booster DOSE after putting the finishing touch on their first number one series of legal COVID-19 vaccines. .
“We are excited to offer another booster selection and the only protein-based COVID-19 vaccine for others over the age of 18 in New Zealand,” said Stanley C. Erck, president and chief executive officer of Novavax. “As New Zealand reports winter months where thousands of COVID-19 infections are recorded every day, our vaccine is a false choice, especially given its broad immune response to a wide diversity of circulating variants. “
The application for extended provisional approval for the booster dose is supported by knowledge of the Novavax Phase 2 trial conducted in Australia, a separate Phase 2 trial conducted in South Africa, and the UK-sponsored VOC-BOOST trial. In the Novavax 2 sponsored phase trials, a single booster dose of Nuvaxovid administered to healthy adult participants approximately six months after their first round of vaccination of two doses of Nuvaxovid. The third dose produced higher immune reactions comparable to or greater than coverage-related grades in Phase 3 clinical trials. In the VOC-BOOST trial, Nuvaxovid induced a significant antibody reaction when used as a third heterologous booster dose.
In Novavax-sponsored trials, after withdrawal, local and systemic reactions lasted an average of approximately two days. The occurrence of events of grade 3 or higher remained relatively low. Reports on protection from reactogenicity events showed an increased occurrence for all 3 doses of Nuvaxovid, reflecting the increased immunogenicity observed with a third dose. Medically assisted adverse reactions, potentially immune-mediated medical situations, and serious adverse events occurred from time to time after the booster dose and were balanced between the vaccine and placebo groups.
As a reminder for adults, Nuvaxovid is also provisionally registered in Australia and approved in Japan, and is being actively studied in the markets.
In the past, New Zealand granted provisional approval for Nuvaxovid in adults over the age of 18 in February 2022. Novavax’s sponsor in Australia and New Zealand is Biocelect Pty. Ltd.
Commercial call in the Unidos. La States nuvaxovid™ industry call has not yet been approved by the U. S. Food and Drug Administration.
Important Protection Information: New Zealand
Nuvaxovid is contraindicated in other people with hypersensitivity reaction to the active substance or to any of the excipients.
Cases of anaphylaxis have been reported during the handling of COVID-19 vaccines. Appropriate medical follow-up and treatment should be performed in case of an anaphylactic reaction after vaccine management. It is recommended to close for at least 15 minutes and a moment. Doses of the vaccine deserve not to be given to those who have suffered anaphylaxis in the first dose of Nuvaxovid.
Anxiety-related reactions in addition to vasovagal reactions (syncope), hyperventilation, or stress-related reactions may occur in combination with vaccination as a psychogenic reaction to needle injection. It is important that precautions are taken for injuries caused by fainting.
Vaccination will be postponed in other people with severe acute febrile illness or acute infection. The presence of a mild infection and/or low fever does not delay vaccination.
Nuvaxovid should be given with caution in other people receiving anticoagulant therapy or who have thrombocytopenia or any bleeding disorder (such as haemophilia), as bleeding or bruising may occur after intramuscular treatment in those other people.
The efficacy of Nuvaxovid would possibly decrease in immunocompromised people.
Pregnancy management of Nuvaxovid only deserves to be considered as when the possible benefits outweigh the possible dangers to the mother and fetus.
The effects of Nuvaxovid would possibly temporarily reduce the ability to drive or use machines.
People may not be complete until 7 days after their initial dose. As with all vaccines, vaccination with Nuvaxovid may not protect all those vaccinated.
The protection and efficacy of Nuvaxovid in young people and adolescents under 18 years of age has not yet been established. Limited knowledge is available.
The maximum adverse reactions observed in the clinical studies were headache, nausea or vomiting, myalgia, arthralgia, sensitivity/pain at the injection site, fatigue and malaise.
For more information about Nuvaxovid, add the summary of product characteristics with the package leaflet, life-saving and prescription data, commands to report adverse events, or to request more information, see the following websites:
Status of Medsafe COVID-19 vaccine applications
Medsafe Information for Prescribers/Consumers
Novavax Global Authorization Website
About the Novavax COVID-19 Vaccine (NVX-CoV2373)
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.
About the Trial Phase of the 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 randomized, placebo-controlled, observer-blinded trial to assess efficacy, protection, and safety. Immunogenicity of adjuvanted Novavax COVID-19 vaccine. Matrix-M in 29,960 participants over the age of 18 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 end point was the prevention of moderate or severe symptomatic COVID-19 confirmed by PCR. Both parameters were evaluated at least seven days after the time of examining vaccination 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 blinded, placebo-controlled, randomized, 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 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 an overall efficacy of 80% at a time when the Delta variant was 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 over the age of 18, designed as a randomized placebo-controlled study without observer wisdom, achieved an overall efficacy of 89. 7%. The primary endpoint based on the first occurrence of PCR-proven symptomatic COVID-19 (mild, moderate, or severe) with onset at least seven days after the time of vaccination screening in HIV-negative adult participants (SARS-CoV- 2) at the beginning of the study. The full effects of the trial were published in the NEJM.
About 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 in local lymph nodes, thereby stimulating the immune response.
About Novavax
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 gained approval from several regulatory governments around the world, including the FDA, 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 strain vaccine (NVX-CoV2515) as well as an Omicron strain/parent strain vaccine in bivalent format. These candidate vaccines incorporate Novavax’s proprietary saponin-based Matrix-M adjuvant for immune reaction and stimulate higher levels of neutralizing antibodies.
For more information, visit www. novavax. com and connect with us on LinkedIn.
*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.
Forward-Looking Statements
Detailed statements related to Novavax’s long-term, business plans and outlook, partnerships, timing of clinical trial effects, continued progression of NVX-CoV2373, the addition of an Omicron strain-based vaccine, and a bivalent vaccine based on the original strain/founded by Omicron. , a combination of COVID seasonal influenza vaccine candidate research, the scope, timing and effects of long-term submissions and regulatory actions, adding Novavax’s plans to existing authorizations complete with knowledge from other sites of Novavax global source chain production, further international authorizations of NVX-CoV2373 for use in adults and adolescents, and as a reminder, the evolution of the COVID-19 pandemic, the prospective effect and scope of Novavax and NVX-CoV2373 to address vaccine access, pandemic control, and protection. n the populations, efficacy, 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; 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 year ended 31 December 2021 and upcoming 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.