Novavax Inc - NVAX STOCK NEWS

Novavax has received conditional marketing authorization from the MHRA for its Nuvaxovid™ COVID-19 vaccine in Great Britain, marking it as the first protein-based vaccine authorized there. This decision is based on data from significant clinical trials, including a Phase 3 trial in the U.K. with nearly 15,000 participants and another in the U.S. and Mexico with approximately 30,000 participants, showcasing efficacy rates of 89.7% and 90.4%, respectively. An agreement for 60 million doses was also previously established with the U.K. Vaccines Taskforce.

Novavax, Inc. has submitted a request for Emergency Use Authorization (EUA) to the FDA for its COVID-19 vaccine candidate, NVX-CoV2373. This request is supported by pivotal clinical trial data demonstrating an overall efficacy of approximately 90% in the PREVENT-19 trial involving 30,000 participants. The vaccine has a favorable safety profile and has received conditional authorization from multiple global regulatory agencies, including the EU and WHO. Novavax aims to provide an alternative vaccine option, leveraging its proprietary protein-based technology and global partnerships.

Novavax, Inc. (Nasdaq: NVAX) announces an advance purchase agreement with Israel's Ministry of Health for its COVID-19 vaccine, NVX-CoV2373. This agreement includes an initial 5 million doses with an option for an additional 5 million. The vaccine, which has shown high efficacy in ongoing Phase 3 trials, is awaiting regulatory approvals for distribution in Israel. The company has received conditional marketing authorization from the European Union and emergency use listing from the WHO. Novavax continues to monitor safety and efficacy while expanding its manufacturing capabilities worldwide.

Novavax, Inc. (Nasdaq: NVAX) announced that Australia's Therapeutic Goods Administration (TGA) has granted provisional registration for NVX-CoV2373, its COVID-19 vaccine. This approval allows for active immunization against COVID-19 in individuals 18 years and older under the brand name Nuvaxovid™. The vaccine's registration is backed by data from pivotal clinical trials involving nearly 30,000 participants. With an advance purchase agreement for 51 million doses in place, Novavax aims to supply Australia while continuing to monitor safety and efficacy as distribution begins.

Novavax, Inc. (Nasdaq: NVAX) and SK bioscience announced the approval of their Nuvaxovid™ COVID-19 vaccine by South Korea's Ministry of Food and Drug Safety for individuals aged 18 and older. This marks Nuvaxovid as the first protein-based COVID-19 vaccine approved in South Korea. SK bioscience is set to manufacture and market the vaccine, supported by an advance purchase agreement for 40 million doses. Novavax anticipates further global authorizations in 2022, including a request for emergency use authorization from the U.S. FDA.

Novavax, Inc. (Nasdaq: NVAX) announced a submission for emergency use authorization (EUA) of its COVID-19 vaccine, NVX-CoV2373, to the South African Health Products Regulatory Agency (SAHPRA). The vaccine, developed in partnership with Serum Institute of India, leverages recombinant nanoparticle technology and has shown high efficacy in clinical trials involving over 45,000 participants. It has received authorizations in 170 countries, including the EU and WHO. The company aims to deliver the vaccine in South Africa, pending regulatory approval.

Novavax, Inc. (Nasdaq: NVAX) announced its participation in the 40th Annual J.P. Morgan Healthcare Conference on January 10, 2022, from 9:00 – 9:40 a.m. ET. The conference will focus on Novavax' COVID-19 vaccine candidate NVX-CoV2373. The presentation will be moderated by Eric Joseph, with participation from Novavax President and CEO Stanley C. Erck. Additionally, investor meetings will be held from January 10 to January 12, 2022. An audio replay will be available on Novavax's events page for 30 days.

Novavax, Inc. (Nasdaq: NVAX) announced the submission of its final data package for NVX-CoV2373 to the FDA, a key step toward emergency use authorization (EUA) for its COVID-19 vaccine. The CMC package leverages a partnership with the Serum Institute of India and will be supplemented with data from additional sites. NVX-CoV2373, which showed 90.4% efficacy in U.S. and Mexico trials and 89.7% in U.K. trials, is designed for two doses 21 days apart. The company highlights ongoing governmental support and the demand for COVID-19 vaccines amid emerging variants.

Novavax (Nasdaq: NVAX) and Serum Institute of India have received emergency use authorization (EUA) in India for their recombinant nanoparticle protein-based COVID-19 vaccine, Covovax™, featuring the Matrix-M™ adjuvant. This approval aims to expand vaccine options amid India's pandemic response. Covovax™ exhibits over 90% efficacy and a favorable safety profile, with storage requirements compatible with existing vaccine supply chains, making it accessible in hard-to-reach areas. The vaccine has also received EUA in Indonesia and the Philippines, with ongoing regulatory filings in various countries.