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    Union Minister of Finance and Corporate Affairs Smt. Nirmala Sitharaman Highlights Key Policy Measures to Promote Export-led Growth at Exim Bank’s Trade Conclave

    Tobacco control efforts protect 6.1 billion people – WHO’s new report

    MB Patil Showcases Karnataka’s Investment Potential During Denmark Roadshow

    Roche’s Lunsumio and Polivy combination significantly prolongs remission for people with relapsed or refractory large B-cell lymphoma

    Beat the monsoon greys in style with India’s first UPF resort-wear line by Meghna Ghodawat

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    Wow! Momo Launches India’s First Gluten-Free Range of Momos – A Game-Changer for Health Conscious Foodies

    *Padma Shri Dr. Prahalad Rama Rao, Project Director (DRDO) felicitated.

    Tata ClassEdge Limited Announces Strategic Collaboration with Tata STRIVE to Bridge Education and Employability

    MiQ Sigma: Built at MiQ’s Bengaluru Centre of Excellence (CoE), the Industry’s First AI Platform That Unifies the Programmatic Ecosystem

    TECNO Gears up to Launch POVA 7 Series with Bold New Delta Interface on July 4, Exclusively on Flipkart

    60% of Indians Sleep less than 6 Hours Nightly as Sleep Supplements Surge 650%

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    Viridian Financial Group Welcomes Strategic Growth Investment from TA Associates to Expand Leading Diversified Financial Services Business in Australia

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    Syngenta to become global leader in biologicals; expanding nature inspired solutions for farmers

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    Wow! Momo Launches India’s First Gluten-Free Range of Momos – A Game-Changer for Health Conscious Foodies

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    Protect and Perfect: How Face Yoga and Sunscreen Can Transform Your Skin

    Panasonic partners with MeitY Nasscom Centre of Excellence (CoE) to accelerate innovation in Smart Residential Living

    Herbalife’s Aloin Identification Method for Aloe Vera Officially Recognized by AOAC INTERNATIONAL

    “Indian patients no longer need to look abroad for advanced treatment,” said Dr. Sharat Damodar, Senior Consultant, Haematologist and Head of Adult BMT at Narayana Health City, Bengaluru and Chairman of the Oncology Collegium at Narayana Health.

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    MiQ Sigma: Built at MiQ’s Bengaluru Centre of Excellence (CoE), the Industry’s First AI Platform That Unifies the Programmatic Ecosystem

    TECNO Gears up to Launch POVA 7 Series with Bold New Delta Interface on July 4, Exclusively on Flipkart

    Jockey Woman continues to shape India’s intimate wear landscape with strategic expansion

    AMD Unveils Vision for an Open AI Ecosystem, Detailing New Silicon, Software and Systems at Advancing AI 2025

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    Union Minister for Agriculture and Farmers Welfare Shivraj Singh Chouhan to visit Hyderabad on Monday

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    Jockey Woman continues to shape India’s intimate wear landscape with strategic expansion

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    A New Era in Luxury Weddings – Vogue Wedding Atelier Debuts in India

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    PMJ Jewels Launches PMJ SuperStar Bracelet and ‘Celebrating Daughters’ Campaign

    ‘Waves’ an OTT platform that offers clean family-friendly content: Sunil Bhatiya, Deputy Director General, Doordarshan Kendra, Panaji

    Sri Sai Gold Palace’s 7th store inaugurated in Malleshwaram,Bengaluru.

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    Wow! Momo Launches India’s First Gluten-Free Range of Momos – A Game-Changer for Health Conscious Foodies

    TECNO Gears up to Launch POVA 7 Series with Bold New Delta Interface on July 4, Exclusively on Flipkart

    60% of Indians Sleep less than 6 Hours Nightly as Sleep Supplements Surge 650%

    SOUL Festival Announces its Third Chapter – 9th to 13th October at Soneva Fushi

    Jockey Woman continues to shape India’s intimate wear landscape with strategic expansion

    Anantha Foods Opens Its Third Outlet in Bengaluru

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    Union Minister of Finance and Corporate Affairs Smt. Nirmala Sitharaman Highlights Key Policy Measures to Promote Export-led Growth at Exim Bank’s Trade Conclave

    Tobacco control efforts protect 6.1 billion people – WHO’s new report

    MB Patil Showcases Karnataka’s Investment Potential During Denmark Roadshow

    Roche’s Lunsumio and Polivy combination significantly prolongs remission for people with relapsed or refractory large B-cell lymphoma

    Beat the monsoon greys in style with India’s first UPF resort-wear line by Meghna Ghodawat

    Jamaica Tourism Launches a Brand-New Campaign “70 Days of Jamaica Love” to Celebrate 70 Years of Jamaica

  • National
    • All
    • Economy & Politics
    • Election

    Wow! Momo Launches India’s First Gluten-Free Range of Momos – A Game-Changer for Health Conscious Foodies

    *Padma Shri Dr. Prahalad Rama Rao, Project Director (DRDO) felicitated.

    Tata ClassEdge Limited Announces Strategic Collaboration with Tata STRIVE to Bridge Education and Employability

    MiQ Sigma: Built at MiQ’s Bengaluru Centre of Excellence (CoE), the Industry’s First AI Platform That Unifies the Programmatic Ecosystem

    TECNO Gears up to Launch POVA 7 Series with Bold New Delta Interface on July 4, Exclusively on Flipkart

    60% of Indians Sleep less than 6 Hours Nightly as Sleep Supplements Surge 650%

  • Business

    Viridian Financial Group Welcomes Strategic Growth Investment from TA Associates to Expand Leading Diversified Financial Services Business in Australia

    L&T Technology Services and thyssenkrupp Steering Business Unit Enter Into a Strategic Partnership to Establish a Global Software Hub in Pune, India

    Syngenta to become global leader in biologicals; expanding nature inspired solutions for farmers

  • Health

    Wow! Momo Launches India’s First Gluten-Free Range of Momos – A Game-Changer for Health Conscious Foodies

    Apollo Cancer Centres Launches ‘CanWin’.

    Protect and Perfect: How Face Yoga and Sunscreen Can Transform Your Skin

    Panasonic partners with MeitY Nasscom Centre of Excellence (CoE) to accelerate innovation in Smart Residential Living

    Herbalife’s Aloin Identification Method for Aloe Vera Officially Recognized by AOAC INTERNATIONAL

    “Indian patients no longer need to look abroad for advanced treatment,” said Dr. Sharat Damodar, Senior Consultant, Haematologist and Head of Adult BMT at Narayana Health City, Bengaluru and Chairman of the Oncology Collegium at Narayana Health.

  • Technology
    • All
    • Environment
    • Science

    MiQ Sigma: Built at MiQ’s Bengaluru Centre of Excellence (CoE), the Industry’s First AI Platform That Unifies the Programmatic Ecosystem

    TECNO Gears up to Launch POVA 7 Series with Bold New Delta Interface on July 4, Exclusively on Flipkart

    Jockey Woman continues to shape India’s intimate wear landscape with strategic expansion

    AMD Unveils Vision for an Open AI Ecosystem, Detailing New Silicon, Software and Systems at Advancing AI 2025

    U.S. Insurers to More than Double AI Investment in the Next 3-5 Years: Wipro Report

    Union Minister for Agriculture and Farmers Welfare Shivraj Singh Chouhan to visit Hyderabad on Monday

  • Auto

    Odysse Electric Clocks 344 Units Sold in June, Records 54% Monthly Growth

    DGCA carries out comprehensive surveillance at major airports, including Delhi and Mumbai

    India Opens Doors to Global EV Giants with Portal Launch under SPMEPCI

    Force Motors along with BMW Group India Celebrates the Roll-Out of its 100,000th engine from the Chennai Plant

  • Sports

    Jockey Woman continues to shape India’s intimate wear landscape with strategic expansion

    BCCI mourns the passing of Dilip Doshi

    Amruta Fadnavis Ropes in Arjun Kapoor & Nushrratt Bharuccha for Soulful Yoga Day with 1,000 Marginalised Women

    Union Minister Dr. Mansukh Mandaviya leads Fit India Sundays on Cycle in New Delhi in collaboration with Yogasana Bharat; Says Even One Pedal in cycle is Making India a Fitness Powerhouse

  • Entertainment

    A New Era in Luxury Weddings – Vogue Wedding Atelier Debuts in India

    GenS Life and Dowith Lit Present ‘Senior Spotlight’: Bengaluru’s Open Mic Celebration for the 55+

    PMJ Jewels Launches PMJ SuperStar Bracelet and ‘Celebrating Daughters’ Campaign

    ‘Waves’ an OTT platform that offers clean family-friendly content: Sunil Bhatiya, Deputy Director General, Doordarshan Kendra, Panaji

    Sri Sai Gold Palace’s 7th store inaugurated in Malleshwaram,Bengaluru.

    Lulu Mall Hosts Bangalore’s Biggest Non-Alcoholic Holi Celebration

  • Lifestyle
    • All
    • Food
    • Travel

    Wow! Momo Launches India’s First Gluten-Free Range of Momos – A Game-Changer for Health Conscious Foodies

    TECNO Gears up to Launch POVA 7 Series with Bold New Delta Interface on July 4, Exclusively on Flipkart

    60% of Indians Sleep less than 6 Hours Nightly as Sleep Supplements Surge 650%

    SOUL Festival Announces its Third Chapter – 9th to 13th October at Soneva Fushi

    Jockey Woman continues to shape India’s intimate wear landscape with strategic expansion

    Anantha Foods Opens Its Third Outlet in Bengaluru

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Novavax and Serum Institute of India File for Emergency Use Authorization of Novavax’ COVID-19 Vaccine in South Africa

by FWM
January 10, 2022
in World
0

GAITHERSBURG, Md. and PUNE, India, Jan. 10, 2022 /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 by volume, today announced a regulatory submission to the South African Health Products Regulatory Agency (SAHPRA) for emergency use authorization (EUA) of Novavax’ recombinant nanoparticle protein-based COVID-19 vaccine candidate with Matrix-M™ adjuvant. If authorized, the vaccine (known as NVX-CoV2373) will be manufactured by and commercialized by SII in South Africa under the brand name Covovax™.

“Novavax’ is thankful for our long-standing history of partnership in South Africa to advance much-needed vaccines. This is exemplified by the country’s vital role in the Phase 2b clinical trial and booster study of our protein-based COVID-19 vaccine,” said Stanley C. Erck, President and Chief Executive Officer, Novavax. “Novavax and Serum Institute remain focused on delivering the COVID-19 vaccine – built on well-understood technology – where it is needed most. We look forward to SAHPRA’s review and, if authorized, delivering the vaccine to help South Africa control the pandemic.”

The submission for the regulatory evaluation by SAHPRA of NVX-CoV2373 includes   data from two pivotal Phase 3 clinical trials: PREVENT-19, which enrolled approximately 30,000 participants in the U.S. and Mexico and was published in the New England Journal of Medicine (NEJM); and a trial with almost 15,000 participants in the U.K. which was also published in NEJM. In both trials, the vaccine demonstrated high efficacy with a reassuring safety profile. Serious and severe adverse events were low in number and balanced between vaccine and placebo groups. The most common adverse reactions observed during clinical studies (frequency category of very common ≥1/10) were headache, nausea or vomiting, myalgia, arthralgia, injection site tenderness/pain, fatigue, and malaise. Novavax will continue to collect and analyze real-world data, including the monitoring of safety and the evaluation of variants, as the vaccine is distributed.

In total, Novavax’ vaccine has received authorizations of the vaccine in over 170 countries, including conditional marketing authorization for its vaccine in the European Union and emergency use listing (EUL) from the World Health Organization (WHO). The Novavax/SII vaccine (Covovax) recently received EUA in India, Indonesia and the Philippines, as well as WHO EUL is also currently under review by multiple regulatory agencies worldwide. This includes the submission of  its complete chemistry, manufacturing and controls (CMC) data package to the U.S. Food and Drug Administration (FDA) at the end of 2021. The company expects to submit a request for EUA for the vaccine in the U.S. after one month in accordance with guidance from the FDA regarding submission of all EUA vaccines.

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For more information on NVX-CoV2373, including a full listing of where it has been authorized for use, please visit Novavax’ global authorization website,

Important Safety Information

  • NVX-CoV2373 is contraindicated in persons who have a hypersensitivity to the active substance, or to any of the excipients.
  • Events of anaphylaxis have been reported with administration of COVID-19 vaccines. Appropriate medical treatment and supervision should be available in case of an anaphylactic reaction following the administration of the vaccine. A second dose of the vaccine should not be given to those who have experienced anaphylaxis to the first dose of NVX-CoV2373.
  • Anxiety-related reactions, including vasovagal reactions (syncope), hyperventilation, or stress–related reactions may occur in association with vaccination as a psychogenic response to the needle injection. It is important that precautions are in place to avoid injury from fainting.
  • Vaccination should be postponed in individuals suffering from an acute severe febrile illness or acute infection.
  • NVX-CoV2373 should be given with caution in individuals receiving anticoagulant therapy or those with thrombocytopenia or any coagulation disorder (such as hemophilia) because bleeding or bruising may occur following an intramuscular administration in these individuals.
  • The efficacy of NVX-CoV2373 may be lower in immunosuppressed individuals.
  • Administration of NVX-CoV2373 in pregnancy should only be considered when the potential benefits outweigh any potential risks for the mother and fetus.
  • The effects with NVX-CoV2373 may temporarily affect the ability to drive or use machines.
  • Individuals may not be fully protected until 7 days after their second dose. As with all vaccines, vaccination with NVX-CoV2373 may not protect all vaccine recipients.
  • The most common adverse reactions observed during clinical studies (frequency category of very common ≥1/10) were headache, nausea or vomiting, myalgia, arthralgia, injection site tenderness/pain, fatigue, and malaise.
Tags: NovavaxSouth African Health Products Regulatory Agency (SAHPRA)

FWM

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