Novavax Inc Stock Price, News & Analysis

Novavax, Inc. (Nasdaq: NVAX) announced the submission for conditional marketing authorization (CMA) of its COVID-19 vaccine candidate NVX-CoV2373 to Swissmedic on February 14, 2022. The vaccine, utilizing a recombinant nanoparticle protein-based approach with Matrix-M™ adjuvant, has demonstrated efficacy in pivotal Phase 3 trials comprising approximately 45,000 participants in the U.S., Mexico, and U.K. Novavax aims to address vaccination gaps in Switzerland. The vaccine has already received conditional authorizations from multiple global regulatory agencies, including the European Commission and WHO.

Novavax, a biotechnology company, will participate in a fireside chat at the 11th Annual SVB Leerink Global Healthcare Conference on February 16, 2022. The discussion will focus on NVX-CoV2373, its recombinant nanoparticle protein-based COVID-19 vaccine candidate. The chat is scheduled from 11:20 to 11:50 a.m. EST, moderated by David Risinger, featuring executives Filip Dubovsky and John J. Trizzino. A recorded replay will be available on the company’s website for 90 days.

Novavax (NVAX) announced that its COVID-19 vaccine, NVX-CoV2373, met primary effectiveness endpoints in the PREVENT-19 trial's pediatric expansion for adolescents aged 12-17. The trial, involving 2,247 participants, demonstrated 82% clinical efficacy against the Delta variant and showed robust immune responses, significantly higher than those in adults. The vaccine displayed a reassuring safety profile with no safety signals identified. Novavax plans to submit pediatric data for regulatory filings in Q1 2022, aiming for broader vaccine access in over 170 countries.

Novavax, Inc. (Nasdaq: NVAX) has received provisional approval from New Zealand's Medsafe for its COVID-19 vaccine, NVX-CoV2373, branded as Nuvaxovid. This approval allows the vaccine to be used for individuals aged 18 and older. The decision follows extensive evaluations from two pivotal Phase 3 trials, showing efficacy rates of 90.4% and 89.7% in the U.S. and U.K. respectively. The vaccine, supplied through a partnership with Serum Institute of India, is part of an advance purchase agreement for 10.7 million doses. Novavax remains committed to monitoring the vaccine's safety and effectiveness.

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.