29.12.2021 - 15:26
Novavax, Inc.
Gaithersburg, Maryland and Pune, India, June 10 /PRNewswire/
Novavax, Inc. (Nasdaq: NVAX), a biotechnology company dedicated to the development and commercialization of next-generation vaccines against serious infectious diseases, and Serum Institute of India Pvt. ltd (SII), the world's largest vaccine manufacturer, announced today that the Indian Medicines Agency, Drugs Controller General of India (DCGI), has granted an Emergency Use Authorization (EUA) for the nanoparticle-based recombinant vaccine COVID-19 with the adjuvant Matrix-M™. The vaccine is manufactured and marketed in India by SII under the brand name Covovax™.
“No one is safe until everyone is safe. Today's approval is an important step in that for India, which needs additional vaccine options and millions of doses to support the country's ongoing efforts to control the pandemic," said Stanley C. Erck, President and Chief Executive Officer of Novavax. "Novavax and SII will not rest in our partnership to get our vaccine to the people of India and around the world as we work to protect the health of people everywhere"
Since the vaccine is stored with standard refrigeration at 2° to 8° Celsius, it can be transported and stored via the existing vaccine supply chain, which could improve access in hard-to-reach areas.
"The approval of Covovax in India is an important milestone in strengthening our immunization efforts in India and LMICs," said Adar Poonawalla, Chief Executive Officer, Serum Institute of India. "We are proud to bring a protein-based vaccine to our nation against COVID-19 based on phase 3 clinical data demonstrating greater than 90% efficacy and a favorable safety profile."
Novavax/SII vaccine recently received the EUA in Indonesia and the Philippines, as well as the World Health Organization (WHO) Emergency Use Listing (EUL). Novavax has also received conditional marketing authorization from the European Commission and an EUL from the WHO for its vaccine, which Novavax will market as NuvaxovidTM. Novavax has also announced regulatory submissions for its vaccine in several countries around the world, while partners SK bioscience and Takeda have submitted regulatory submissions in South Korea and Japan, respectively. Novavax expects the full package to be submitted to the FDA by the end of the year.
For more information about Covovax, please visit the following websites in the coming days:
Approved Use of Novavax Covid-19 Vaccine in IndiaThe Drugs Controller General of India (DCGI) has an Emergency Use Authorization (EUA) for Covovax / recombinant spike protein of SARS-CoV-2 -Virus 5 mcg for inducing immunity against SARS-CoV-2 for the prevention of COVID-19 for adults 18 years and older.
Authorization in the United States. NVX-CoV2373 is not yet approved in the United States and the trade name Nuvaxovid has not yet been approved by the American FDA.
Important Safety InformationCovovax is contraindicated in people who are hypersensitive to the active substance or to any of the excipients of this vaccine.
About NVX-CoV2373 NVX-CoV2373 is a protein-based vaccine developed from the genetic sequence of the first strain of SARS-CoV-2, the virus that causes the Covid-19 disease caused. NVX-CoV2373 was engineered using Novavax's recombinant nanoparticle technology to generate an antigen derived from the coronavirus spike (S) protein and is formulated with Novavax's patented saponin-based Matrix-M™ adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies. NVX-CoV2373 contains purified protein antigen and cannot replicate nor cause Covid-19.
Novavax's Covid-19 vaccine is packaged as a ready-to-use liquid formulation in a ten-dose vial. The vaccination schedule is two 0.5 ml doses (5 mcg antigen and 50 mcg Matrix M adjuvant) administered intramuscularly 21 days apart. The vaccine is stored at 2° to 8° Celsius, allowing use of existing vaccine supply and cold chains. The current assigned shelf life of the vaccine is 9 months.
Novavax has partnered for the manufacturing, commercialization and distribution of NVX-CoV2373 worldwide.
Information on the phase III studies with NVX-CoV2373
NVX-CoV2373 is currently being investigated in two pivotal phase III studies.
A study conducted in the UK with 14,039 participants was designed as a randomised, placebo-controlled, observer-blinded study and achieved an overall efficacy of 89.7%. The primary endpoint was based on the first occurrence of PCR-confirmed symptomatic (mild, moderate, or severe) Covid-19 symptoms occurring at least seven days after the second study vaccination in serologically negative (for SARS-CoV-2) adult participants at baseline. The full results of the study were published in the New England Journal of Medicine (NEJM).
PREVENT-19, a study in the US and Mexico with 25,452 participants, achieved an overall efficacy of 90.4%. This is a 2:1, randomized, placebo-controlled, observer-blinded study to evaluate the efficacy, safety and immunogenicity of NVX-CoV2373. The primary endpoint for PREVENT-19 was first occurrence of PCR-confirmed symptomatic (mild, moderate, or severe) Covid-19 disease starting at least 7 days after the second dose in serologically negative (for SARS-CoV-2 ) adult participants at the start of the study. The statistical success criterion included a lower limit of 95% CI > 30% The key secondary endpoint is the prevention of PCR-confirmed, symptomatic moderate or severe Covid-19 cases. Both endpoints were evaluated at least seven days after the second study vaccination in volunteers not previously infected with SARS-CoV-2. It was generally well tolerated and elicited a robust antibody response in both studies. The full results of the study were published in the NEJM.
About Matrix-M™ AdjuvantNovavax' patented saponin-based Matrix-M™ adjuvant has demonstrated a potent and well-tolerated effect by inhibiting the entry of antigen-presenting cells into the Stimulates puncture site and increases antigen presentation in local lymph nodes, enhancing immune response.
About NovavaxNovavax, Inc. (Nasdaq: NVAX) is a biotechnology company promoting better health worldwide through the discovery, development and commercialization of innovative vaccines that prevent serious infectious diseases. The proprietary recombinant technology platform harnesses the power and speed of genetic engineering to efficiently produce highly immunogenic nanoparticles that address urgent global health needs. NVX-CoV2373, the Company's Covid-19 vaccine, has received conditional marketing authorization from the European Commission, an emergency room visit from the World Health Organization, an emergency room visit in Indonesia and the Philippines, and has been submitted for approval in multiple markets worldwide. The Company's NanoFlu™ quadrivalent influenza nanoparticle vaccine met all primary objectives in its pivotal Phase III clinical trial in older adults. Novavax is currently evaluating a COVID-NanoFlu combination vaccine combining the company's NVX-CoV2373 and NanoFlu vaccine candidates in a Phase I/II clinical trial. These vaccine candidates contain Novavax's proprietary Matrix-M™ saponin-based adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies.
For more information, visit: www.novavax.com and on Twitter, LinkedIn, Instagram and Facebook.
About Serum Institute of India Pvt. ltd Driven by the philanthropic philosophy of affordable vaccines, Serum Institute of India Pvt, Ltd. the world's largest vaccine manufacturer by number of doses produced and sold (more than 1.5 billion doses), supplying the world's cheapest and WHO-approved vaccines to 170 countries. It was founded in 1966 with the aim of manufacturing life-saving immunobiological drugs and vaccines worldwide. With a strong commitment to global health, the institute's goal has been achieved by reducing the prices of newer vaccines such as diphtheria, tetanus, whooping cough, Hib, BCG, r-hepatitis B, measles, mumps and rubella -Vaccines further advanced. SII has brought world-class technology to India with its state-of-the-art, multi-functional manufacturing facility in Manjari, Pune; it works with Zipline and government agencies to transform emergency medicine and critical care and is at the forefront of vaccine development for the Covid-19 pandemic.
Forward-Looking StatementsStatements herein relating to the future of Novavax, its operational plans and prospects, the ongoing development of NVX-CoV2373 and its partnerships, the scope, timing and outcome of future regulatory filings and -related actions, the role COVOVAX can play in increasing immunization rates and combating the COVID-19 pandemic in India and globally, the continued efforts of Novavax and SII to deliver COVOVAX to the people of India and globally, and the potential of COVOVAX to improve access to vaccination in hard-to-reach areas 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 these statements. These risks and uncertainties include the difficulty of meeting, alone or with partners, the various safety, efficacy and product characterization requirements, including process qualification and test validation requirements, necessary to meet the requirements of the relevant regulatory authorities; difficulties in obtaining scarce raw materials and supplies; resource limitations, including human capital and manufacturing capacity, related to Novavax's ability to pursue planned regulatory pathways; challenges in meeting contractual requirements under agreements with multiple commercial, government and other entities; and the other risk factors discussed 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 December 31, 2020 and subsequent quarterly reports on Form 10-Q filed with the Securities and Exchange Commission (SEC). We caution investors not to place undue reliance on the forward-looking statements contained in this press release. For a discussion of these and other risks and uncertainties, you should read our filings with the SEC, which are available at www.sec.gov and www.novavax.com. The forward-looking statements in this press release speak only as of the date of this document, and we undertake no obligation to update or revise these statements. Our business is subject to significant risks and uncertainties, including those set forth above. Investors, prospective investors and others should carefully consider these risks and uncertainties.
ir@novavax.com
aroy@soleburytrout.com
media@novavax.com
mayank.sen@seruminstitute.com
Contacts:
Novavax, Inc.Erika Schultz | 240-268-2022 ir@novavax.comSolebury TroutAlexandra Roy | 617-221-9197 aroy@soleburytrout.com Ali Chartan | 240-720-7804 Laura Keenan Lindsey | 202-709-7521 media@novavax.comSerum Institute of India Mayank Sen | +919867974055 mayank.sen@seruminstitute.comLogo - https://mma.prnewswire.com/media/1506866/Novavax_High_Res_Logo.jpg
Original content from: Novavax, Inc., transmitted by news aktuell
