Novavax Inc. develops and partners vaccine technologies built around Matrix-M adjuvant technology and protein-based nanoparticles. Company news centers on marketed vaccine products, including Nuvaxovid and R21/Matrix-M, licensing and material-transfer agreements with pharmaceutical companies, and research programs for infectious disease and other vaccine applications.
Recurring updates also cover quarterly financial results, revenue from product sales and partner arrangements, R&D prioritization such as its C. difficile vaccine candidate, operating-efficiency initiatives, investor conference participation, and leadership changes within research and development.
Novavax announced that the European Medicines Agency (EMA) has started evaluating its application for conditional marketing authorization (CMA) of its COVID-19 vaccine, branded as Nuvaxovid™, in the EU. This move aims to enhance global access to the vaccine. Novavax's NVX-CoV2373 vaccine, developed using a nanoparticle protein-based technology, has shown efficacy rates of up to 100% against moderate to severe disease. The company anticipates that the EMA will provide an opinion within weeks, with ongoing regulatory submissions in various countries including the U.S. and Australia.
Novavax, Inc. (Nasdaq: NVAX) and Serum Institute of India Pvt. Ltd. announced that the Philippine FDA has granted Emergency Use Authorization (EUA) for Novavax's protein-based COVID-19 vaccine, COVOVAX™, which will be produced by SII. The vaccine's approval aims to boost vaccination rates in the Philippines, where less than a third of the population is fully immunized. COVOVAX™ can be stored at standard refrigeration temperatures, facilitating its distribution. Novavax also anticipates additional authorizations globally and plans to submit more filings, including for the U.S. FDA by year-end.
Novavax and SK bioscience have submitted a Biologics License Application (BLA) for NVX-CoV2373, the first protein-based COVID-19 vaccine candidate for BLA in South Korea. This submission signifies the first full approval request for the vaccine globally. Novavax aims to provide broad access to the vaccine, with a deal to supply 40 million doses to the South Korean government. The vaccine shows high efficacy in various trials, promising a vital tool in combating COVID-19.
Novavax, Inc. (NASDAQ: NVAX) reported its third-quarter 2021 results with a revenue of $178.8 million, up from $157.0 million year-on-year. The company faced a net loss of $322.4 million or $4.31 per share, compared to a loss of $197.3 million or $3.21 per share last year. Highlights included emergency use authorization for its COVID-19 vaccine in Indonesia and advanced purchase agreements for 20 million doses with the European Commission. Cash reserves as of September 30, 2021, reached $1.9 billion, primarily from advance purchase payments.
On November 4, 2021, Novavax (Nasdaq: NVAX) announced the completion of its rolling submission to the World Health Organization (WHO) for emergency use listing (EUL) of its COVID-19 vaccine candidate, NVX-CoV2373. This submission includes clinical data from pivotal Phase 3 trials showing 90.4% overall efficacy. The vaccine demonstrated 100% protection against severe disease and has received authorization in Indonesia. Novavax also plans to submit a complete package to the U.S. FDA by year-end to broaden global access through the COVAX Facility.
Novavax has submitted its protein-based COVID-19 vaccine, NVX-CoV2373, for provisional approval to New Zealand's Medsafe, marking a significant step in global vaccine distribution. The submission includes all necessary modules, such as Chemistry, Manufacturing, and Controls (CMC), backed by phase 3 trial data showing 100% protection against moderate and severe disease and 90.4% overall efficacy. With additional regulatory filings in the UK, Australia, and Canada, Novavax is focused on optimizing its global vaccine strategy while thanking the New Zealand government for its partnership.
Novavax, Inc. (Nasdaq: NVAX) and Serum Institute of India have received Emergency Use Authorization (EUA) from Indonesia's National Agency of Drug and Food Control for COVOVAX™, a protein-based COVID-19 vaccine. This marks a significant milestone as it is the first regulatory approval globally for a protein-based COVID-19 vaccine based on Phase 3 clinical data. Novavax expects additional authorizations soon in various countries, including India and the Philippines. The vaccine's stable storage conditions will enhance distribution accessibility in Indonesia.
Novavax, Inc. (Nasdaq: NVAX) has completed its rolling submission to Health Canada for its COVID-19 vaccine candidate, marking the first protein-based vaccine submitted for regulatory review in Canada. Additionally, all required data modules for the European Medicines Agency (EMA) have been submitted. The vaccine, NVX-CoV2373, showed 100% protection against moderate and severe disease and 90.4% efficacy overall in a Phase 3 trial with 30,000 participants. The company aims to file for Conditional Marketing Authorization in the EU and anticipates submitting a complete package to the U.S. FDA by year-end.
Novavax, Inc. (Nasdaq: NVAX) has completed its rolling submission to the Therapeutic Goods Administration (TGA) for provisional approval of its protein-based COVID-19 vaccine candidate, NVX-CoV2373, in Australia. This marks the first complete application for a protein-based COVID-19 vaccine in the country. The TGA submission includes data from pivotal Phase 3 trials, demonstrating efficacy rates of 96.4% against the original virus strain and 90.4% overall. Novavax plans further submissions in key markets, including the U.S., U.K., and Europe, with a goal to enhance global access to its vaccine.
Novavax, Inc. has completed its regulatory submission to the U.K. Medicines and Healthcare products Regulatory Agency (MHRA) for its protein-based COVID-19 vaccine, NVX-CoV2373. This marks the first authorization submission for a protein-based COVID-19 vaccine in the U.K. The vaccine demonstrated high efficacy rates of 96.4% against the original virus and 89.7% overall in trials involving ~45,000 participants. Novavax plans to submit to additional global authorities, including the EU, Canada, and Australia, soon, with FDA submission expected by the end of 2021.