Novavax Inc Stock Price, News & Analysis

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.

Novavax, Inc. (Nasdaq: NVAX) announces it will report its third quarter 2021 financial results on November 4, 2021, post-market close. The company will host a conference call at 4:30 p.m. EDT to discuss its operational highlights. Participants are encouraged to join early for a timely connection. A replay will be available from 7:30 p.m. EDT on the same day until November 11, 2021. Novavax focuses on developing innovative vaccines to combat serious infectious diseases, including COVID-19 and influenza.

Novavax, Inc. (Nasdaq: NVAX) announced that Dr. Vivek Shinde will present at the World Vaccine Congress Europe 2021 on October 20, 2021. The focus will be on the COVID-NanoFlu™ Combination Vaccine, a novel formulation that integrates the company's COVID-19 and NanoFlu™ vaccine candidates using the Matrix-M™ adjuvant.

The session is scheduled from 11:30 a.m. to 12:00 p.m. CET (5:30 a.m. to 6:00 a.m. EDT). For details, visit the Congress website.

On October 4, 2021, Novavax announced key leadership changes to strengthen its vaccine safety and clinical development teams. Dr. Denny Kim was appointed as Senior Vice President and Chief Safety Officer, with a focus on global vaccine safety. Other promotions include Dr. Raburn Mallory as Senior Vice President and Head of Clinical Development, and Dr. Marco Cacciuttolo as Senior Vice President of Process and Analytical Development. These appointments aim to enhance Novavax's capabilities as the company transitions to a commercial-stage organization, particularly in its pursuit of NVX-CoV2373, a COVID-19 vaccine.

On September 29, 2021, Novavax (Nasdaq: NVAX) announced its participation in the upcoming 2021 Maryland Life Sciences Bio Innovation Conference. The company will discuss its recombinant nanoparticle protein-based COVID-19 vaccine candidate, NVX-CoV2373, during a panel titled Health Equity and Vaccine Confidence. This panel is scheduled for October 4, 2021, from 1:00 to 1:50 p.m. EDT. Notable speakers include Lisa M. Dunkle, M.D. from Novavax, alongside other experts from the Department of Defense and the University of Maryland.