Novavax and Serum Institute of India Receive Emergency Approval for Covid-19 Vaccine …


03.11.2021 – 02:50

Novavax, Inc.

Gaithersburg, Maryland and Pune, India, Jan. 28 / PRNewswire /

Novavax, Inc. (Nasdaq: NVAX), a biotechnology company dedicated to developing and commercializing next generation vaccines for serious infectious diseases, and Serum Institute of India Pvt. Ltd. (SII), the world’s largest vaccine manufacturer, announced today that the National Agency for Drugs and Food Control of the Republic of Indonesia, Badan Peng was Obat dan Makanan (Badan POM), has granted an Emergency Authorization (EUA) for the recombinant Covid-19 vaccine based on nanoparticles with the adjuvant Matrix-M (TM). It is manufactured by SII in India and marketed by SII in Indonesia under the brand name COVOVAX (TM).

“The first approval of Novavax’s Covid-19 vaccine is an example of our commitment to equitable global access and will meet a vital need for Indonesia, which, while the fourth most populous nation on earth, continues to work to provide enough vaccine for its Procuring population, “said Stanley C. Erck, President and Chief Executive Officer of Novavax. “This also marks the world’s first approval of a protein-based Covid-19 vaccine based on Phase III clinical data showing efficacy and a favorable safety profile. This is a milestone for Novavax and our partner, the Serum Institute of India, and it is the first of many approvals Novavax is anticipating for our vaccine worldwide in the coming weeks and months. “

Since the vaccine is stored at 2 ° to 8 ° Celsius, existing vaccine supply channels can be used with conventional cold chains, which could increase access in hard-to-reach areas and increase vaccination rates across the country. The first shipments to Indonesia are expected to begin shortly.

“Having access to a safe and highly effective vaccine coupled with ease of distribution should be instrumental in helping Indonesia control the current coronavirus outbreak,” said Adar Poonawalla, chief executive officer of the Serum Institute of India. “We are continuing to work hard to ensure that the first protein-based Covid-19 vaccine in Indonesia is available to everyone waiting to arrive.”

Novavax and SII have already applied to the World Health Organization (WHO) for approval of the Novavax Covid-19 vaccine in India and the Philippines, as well as an Emergency Department (EUL). Novavax also recently completed ongoing regulatory filings for the Novavax vaccine with regulatory agencies in the UK, European Union, Canada and Australia. Novavax expects to see further regulatory filings for its vaccine around the world as well as an additional filing for its vaccine against EUL with the WHO shortly. Novavax expects to file its full package with the US FDA by the end of the year.

Indonesia is a member of the Pharmaceutical Inspection Co-operation Scheme (PIC / S), a non-binding collaboration agreement between more than 50 regulators, including those in the United States, the United Kingdom, the European Union, Australia and Canada, in the area of ​​Good Manufacturing Practice (GMP) for human and veterinary medicines. The aim of the PIC / S is the worldwide harmonization of inspection procedures through the development of common standards in the area of ​​GMP and the facilitation of cooperation and networking between the responsible authorities, regional and international organizations in order to strengthen mutual trust.

For more information about COVOVAX, including the Summary of Product Features, Prescribing Information, and Important Safety Information, please visit ” Indonesia’s National Medicines and Food Control Authority (Badan POM). This information will be published in the next few days.

Approved use of the Novavax Covid-19 vaccine in Indonesia

Badan POM has issued an Emergency Authorization (EUA) for Covovax / Recombinant Spike Protein of the SARS-CoV-2 virus 5 mcg for the induction of immunity to SARS-CoV-2 for the prevention of COVID-19 for adults aged 18 and over.

Important safety information

COVOVAX is contraindicated in people who are hypersensitive to the active substance or any of the excipients in this vaccine.

Information on the Phase III studies with NVX-CoV2373

NVX-CoV2373 is being investigated in two pivotal Phase III studies: the PREVENT-19 study in the United States and Mexico, which showed 100 percent protection against moderate and severe illness and an overall effectiveness of 90.4%. It was generally well tolerated and produced a strong antibody response. It is also being investigated in a study in the UK that found 96.4% effectiveness against the original strain of the virus, 86.3% against the alpha variant (B.1.1.7), and an overall effectiveness of 89.7%.

Novavax’s Covid-19 vaccine, NVX-CoV2373, is a protein-based vaccine candidate developed from the genetic sequence of the first strain of SARS-CoV-2, the virus that causes Covid-19 disease. NVX-CoV2373 was developed using Novavax’s recombinant nanoparticle technology to produce an antigen derived from the coronavirus spike (S) protein and is formulated with Novavax’s patented Matrix-M (TM) saponin-based adjuvant to boost the immune response and stimulate high levels of neutralizing antibodies. NVX-CoV2373 contains purified protein antigen and cannot replicate nor can it 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 micrograms of antigen and 50 micrograms of Matrix-M adjuvant) given intramuscularly 21 days apart. The vaccine is stored at 2 ° to 8 ° Celsius so that the existing vaccine supply and cold chains can be used.

Matrix M (TM) Adjuvant Information

Novavax’s patented saponin-based Matrix-M (TM) adjuvant has shown a potent and well-tolerated effect by stimulating the entry of antigen-presenting cells into the puncture site and increasing antigen presentation in the local lymph nodes, thereby increasing the immune response .

Information on Novavax

Novavax, Inc. (Nasdaq: NVAX) is a biotechnology company that promotes better health worldwide through the discovery, development, and commercialization of innovative vaccines for the prevention of serious infectious diseases. The company’s own recombinant technology platform combines the power and speed of genetic engineering to efficiently manufacture highly immunogenic nanoparticles that address urgent global health needs. Novavax is currently conducting late-stage clinical trials for NVX-CoV2373, its vaccine candidate for SARS-CoV-2, the virus that causes Covid-19. NanoFlu (TM), the quadrivalent flu vaccine based on nanoparticles, has achieved all primary goals in the pivotal Phase III clinical trial in older adults and is being prepared for regulatory filing. Both vaccine candidates contain Novavax’s proprietary Matrix-M (TM) saponin-based adjuvant to boost the immune response and stimulate high levels of neutralizing antibodies.

You can find more information on www.novavax.com and follow us on Twitter as LinkedIn.

About Serum Institute of India Pvt. Ltd.

Driven by the philanthropic philosophy of affordable vaccines, Serum Institute of India Pvt, Ltd. The largest vaccine manufacturer in the world in terms of the number of doses produced and sold (more than 1.5 billion doses) and supplies 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 was to bring down the prices of newer vaccines such as diphtheria, tetanus, whooping cough, Hib, BCG, r-hepatitis B, measles, mumps and rubella – Vaccines advanced. SII has brought world-class technology to India with its state-of-the-art, multifunctional manufacturing facility in Manjari, Pune; it is working with Zipline and government agencies to transform emergency medicine and critical care, and is a leader in vaccine development for the Covid-19 pandemic.

Forward-Looking Statements

Statements in this document relating to the future of Novavax, its operating plans and prospects, the ongoing development of NVX-CoV2373 and its partnerships and other Novavax vaccine candidates, the scope, timing and outcome of future regulatory filings and subsequent regulatory approvals, The anticipated timing of vaccine shipments and the role Novavax could play in fighting the Covid-19 pandemic in Indonesia are forward-looking statements. Novavax advises 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 in these statements. These risks and uncertainties include the difficulty of meeting, alone or with partners, the various safety, efficacy and product characterization requirements, including the process qualification and test validation requirements necessary to meet the requirements of the relevant regulatory authorities; Difficulties in obtaining scarce raw materials and materials; Resource constraints, including human capital and production capacity, in relation to Novavax’s ability to pursue the envisaged regulatory pathways; Challenges in meeting contractual requirements under agreements with multiple commercial, government, and other entities; and the other risk factors set out 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, located at www.sec.gov and www.novavax.com Are available. The forward-looking statements in this press release speak only as of the date of this document, and we assume no obligation to update or revise these statements. Our business is subject to significant risks and uncertainties, including the above. Investors, potential investors and others should carefully consider these risks and uncertainties.

Press contact:

Investorenkontakt
Novavax, Inc.
Erika Schultz | 240-268-2022
[email protected]
Solebury Trout
Alexandra Roy | 617-221-9197
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media
Laura Keenan Lindsey | 202-709-7521
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Original content by: Novavax, Inc., transmitted by news aktuell




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