Novavax Inc - NVAX STOCK NEWS

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.

Novavax (Nasdaq: NVAX) has expanded its collaboration with SK bioscience to enhance the manufacturing of its COVID-19 vaccine, NVX-CoV2373. The agreement allows SK bioscience to reserve additional manufacturing capacity through 2022, supporting a previously made agreement to supply 40 million doses to the Korean government. SK bioscience is also now authorized to sell NVX-CoV2373 to Thailand and Vietnam. Novavax anticipates a total global manufacturing capacity of 2 billion doses in 2022, demonstrating its commitment to increasing vaccine access globally.

Novavax announced promising results for its COVID-19 vaccine NVX-CoV2373 regarding cross-reactive immune responses against the Omicron variant. A two-dose regimen demonstrated effective immune responses, which were enhanced with a third booster dose, showing a 9.3-fold increase in anti-spike IgG and 19.9-fold increase in ACE2 inhibition. Immune responses in adolescents surpassed those in adults. The development of an Omicron-specific vaccine is on track for GMP manufacturing in January 2022. An investor conference call will be held today.

On December 21, 2021, Novavax (Nasdaq: NVAX) announced the administration of the first booster doses of its COVID-19 vaccine, NVX-CoV2373, in an extension of the PREVENT-19 Phase 3 clinical trial. This trial evaluates the safety and efficacy of a third booster dose administered to prior participants, at least six months after their initial vaccinations. The primary endpoint focuses on the first occurrence of PCR-confirmed COVID-19 at least seven days post-booster. NVX-CoV2373 has shown 90.4% efficacy in the PREVENT-19 trial.

WHO SAGE recommends a primary two-dose vaccination series of NVX-CoV2373 for individuals 18 and older. An additional third dose is advised for immunocompromised persons. This follows the Emergency Use Listing granted by WHO for Novavax's vaccine, branded as Nuvaxovid™ in Europe and COVOVAX™ in India. Novavax's trials have shown high efficacy, with overall efficacy rates of 89.7% in the UK trial and 90.4% in the US trial. The vaccine is anticipated to play a crucial role in the global response to COVID-19.

Novavax Announces WHO Emergency Use Listing for Nuvaxovid™

The World Health Organization has granted a second Emergency Use Listing (EUL) for Novavax's NVX-CoV2373 COVID-19 vaccine, branded as Nuvaxovid™, for individuals aged 18 and older. This follows a conditional marketing authorization from the European Commission and facilitates exports to COVAX member countries. Novavax and the Serum Institute of India have committed to supply 1.1 billion doses to COVAX. The vaccine demonstrated high efficacy in Phase 3 trials, providing a protein-based option against COVID-19 variants.

Novavax (Nasdaq: NVAX) received conditional marketing authorization from the European Commission for its Nuvaxovid™ COVID-19 vaccine. This represents the first protein-based COVID-19 vaccine approved for use in Europe, following a positive recommendation from the European Medicines Agency. An advance purchase agreement allows for up to 200 million doses through 2023, with initial supply expected in January. The vaccine demonstrated strong efficacy in pivotal Phase 3 trials, achieving 90.4% efficacy in the U.S. and Mexico, and 89.7% in the U.K.

Novavax (NASDAQ: NVAX) announced an imminent decision from the European Commission regarding the conditional marketing authorization for its COVID-19 vaccine, Nuvaxovid™ (NVX-CoV2373). This would make it the first protein-based COVID-19 vaccine available in Europe. The EMA's recommendation was based on positive clinical trial results, including a 90.4% efficacy rate in a trial with nearly 30,000 participants in the U.S. and Mexico. An advance purchase agreement for up to 200 million doses has already been established with the European Commission.