Medicines and Healthcare Products Regulatory Agency Grants Conditional Marketing Authorization for Novavax COVID-19 Vaccine in Great Britain*
* Nuvaxovid™ COVID-19 Vaccine (recombinant, adjuvanted)▼ is the first protein-based COVID-19 vaccine authorized inGreat Britain * Novavax and the U.K. Vaccines Taskforce previously announced an agreement for up to 60 million doses * Authorization based on data including an ongoing pivotal Ph...
Novavax Submits Request to the U.S. FDA for Emergency Use Authorization of COVID-19 Vaccine
- NVX-CoV2373 demonstrated overall efficacy of ~90% in PREVENT-19 clinical trial conducted during the emergence of variant strains GAITHERSBURG, Md., Feb. 1, 2022 /PRNewswire/ -- Novavax, Inc. (Nasdaq: NVAX), a biotechnology company dedicated to developing and commercializing next-generation vac...
Australia Therapeutic Goods Administration (TGA) Grants Provisional Registration for Novavax COVID-19 Vaccine
Nuvaxovid™ is the first protein-based COVID-19 vaccine to receive approval for provisional registration inAustralia GAITHERSBURG, Md., Jan. 20, 2022 /PRNewswire/ -- Novavax, Inc. (Nasdaq: NVAX), a biotechnology company dedicated to developing and commercializing next-generation vaccines for seri...
South Korea Ministry of Food and Drug Safety Approves Novavax COVID-19 Vaccine
GAITHERSBURG, Md., Jan. 12, 2022 /PRNewswire/ -- Novavax, Inc. (Nasdaq: NVAX), a biotechnology company dedicated to developing and commercializing next-generation vaccines for serious infectious diseases, and SK bioscience, Co. Limited, a vaccine business subsidiary of Korea-based SK Group, today...
Novavax and Serum Institute of India Receive Emergency Use Authorization for COVID-19 Vaccine in India
GAITHERSBURG, Md. and PUNE, India, Dec. 29, 2021 /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 m...
Novavax and SK bioscience Expand Manufacturing Agreement
- Novavax secures additional manufacturing capacity through 2022 - SK bioscience secures long-term license to supply NVX-CoV2373 for the Korean market GAITHERSBURG, Md., Dec. 24, 2021 /PRNewswire/ -- Novavax, Inc. (Nasdaq: NVAX), a biotechnology company dedicated to developing and commercializin...
Novavax Announces Initial Omicron Cross-Reactivity Data from COVID-19 Vaccine Booster and Adolescent Studies
- Two-dose primary regimen of NVX-CoV2373 demonstrated cross-reactive immune responses against Omicron (B.1.1.529) and other variants - Third dose produced increased immune responses comparable to or exceeding levels associated with protection in Phase 3 clinical trials, with a 9.3-fold IgG rise...
World Health Organization SAGE Issues Interim Recommendations for Novavax COVID-19 Vaccine
- WHO Strategic Advisory Group of Experts on Immunization (SAGE) recommends primary two-dose vaccination series of NVX-CoV2373 in persons aged 18 and older - SAGE recommends additional third dose of NVX-CoV2373 administered to immunocompromised persons - Recommendation follows grant of WHO Emerg...
World Health Organization Grants Second Emergency Use Listing for Novavax COVID-19 Vaccine
- Nuvaxovid™ COVID-19 Vaccine (SARS-CoV-2 rS [Recombinant, adjuvanted]) listed for emergency use by the WHO - EUL for Nuvaxovid complements listing for Novavax vaccine manufactured and marketedby Serum Institute of India as Covovax™ - EUL by WHO is a prerequisite for exports to numerous countri...
European Commission Grants Conditional Marketing Authorization for Novavax COVID-19 Vaccine
* Nuvaxovid™ COVID-19 Vaccine (recombinant, adjuvanted) is the first protein-based COVID-19 vaccine authorized for use inEurope * Novavax and the European Commission previously announced an advance purchase agreement for up to 200 million doses through 2023 * Authorization follows positive r...
Novavax Receives Positive European Medicines Agency Recommendation for Conditional Marketing Authorization of its COVID-19 Vaccine
* European Commission decision on conditional marketing authorization expected imminently * Upon authorization, Nuvaxovid™ (also known as NVX-CoV2373) will be the first protein-based COVID-19 vaccine available inEurope GAITHERSBURG, Md., Dec. 20, 2021 /PRNewswire/ -- Novavax, Inc. (Nasdaq: NV...
Novavax and Serum Institute of India Announce World Health Organization Grants Emergency Use Listing for NVX-CoV2373 COVID-19 Vaccine
* First EUL granted by WHO for a protein-based COVID-19 vaccine * EUL vaccine manufactured and marketed by SII as COVOVAX™ * WHO EUL for Nuvaxovid™ currently under assessment; will be completed following European Medicines Agency (EMA) review GAITHERSBURG, Md. and PUNE, India, Dec. 20, 2021 ...
Novavax Announces Submission of New Drug Application in Japan for Approval of COVID-19 Vaccine
-- Takeda submits application for TAK-019/NVX-CoV2373, the first protein-based COVID-19 vaccine candidate for NDA, toJapan's Ministry of Health, Labour and Welfare (MHLW) -- Interim data from Phase 1/2 trial in Japan demonstrate robust immune response and favorable tolerability with no serious a...
Novavax Files for Interim Authorization of COVID-19 Vaccine in Singapore
GAITHERSBURG, Md., Nov. 24, 2021 /PRNewswire/ -- Novavax, Inc. (Nasdaq: NVAX), a biotechnology company dedicated to developing and commercializing next-generation vaccines for serious infectious diseases, today announced its submission to the Singapore Health Sciences Authority (HSA) for interim ...
Novavax Confirms European Medicines Agency Review of COVID-19 Vaccine Filing for Conditional Marketing Authorization
GAITHERSBURG, Md., Nov. 18, 2021 /PRNewswire/ -- Novavax, Inc. (Nasdaq: NVAX), a biotechnology company dedicated to developing and commercializing next-generation vaccines for serious infectious diseases, today announced that European Medicines Agency (EMA) has begun its evaluation of an applicat...
Novavax and Serum Institute of India Receive Emergency Use Authorization for COVID-19 Vaccine in the Philippines
GAITHERSBURG, Md. and PUNE, India, Nov. 17, 2021 /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 m...
Novavax Announces Submission of Biologics License Application in South Korea for Approval of NVX-CoV2373
GAITHERSBURG, Md., Nov. 15, 2021 /PRNewswire/ -- Novavax, Inc. (Nasdaq: NVAX), a biotechnology company dedicated to developing and commercializing next-generation vaccines for serious infectious diseases, and SK bioscience, Co. Limited (SK bioscience), a biotechnology company inSouth Korea, today...
Novavax Files COVID-19 Vaccine for Emergency Use Listing with World Health Organization
All modules required for regulatory review of Novavax vaccine, including CMC data, are now complete for WHO GAITHERSBURG, Md., Nov. 5, 2021 /PRNewswire/ -- Novavax, Inc. (Nasdaq: NVAX), a biotechnology company dedicated to developing and commercializing next-generation vaccines for serious infec...
Novavax Files COVID-19 Vaccine for Provisional Approval in New Zealand
- Submission to New Zealand's Medsafe marks the first protein-based COVID-19 vaccine submitted for authorization to regulatory authorities inNew Zealand - All modules required for regulatory review of Novavax vaccine, including CMC data, are now complete for Medsafe GAITHERSBURG, Md., Nov. 3, 20...
Novavax and Serum Institute of India Receive Emergency Use Authorization for COVID-19 Vaccine in Indonesia
GAITHERSBURG, Md. and PUNE, India, Nov. 1, 2021 /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 ma...
