Novavax Files for Provisional Approval of its COVID-19 Vaccine in Australia
-- Application marks the first protein-based COVID-19 vaccine submitted to regulatory authorities for provisional approval inAustralia -- In addition to today's submission to the Therapeutic Goods Administration, the company recently filed for authorization with MHRA, with additional filings in...
Novavax Files for Authorization of its COVID-19 Vaccine in the United Kingdom
* Filing marks first protein-based COVID-19 vaccine submitted to MHRA for authorization * All modules required for regulatory review, including CMC data, are now complete * Submission based on Phase 3 data from ~45K patients demonstrating high efficacy and well-tolerated safety, including a...
Novavax to Participate in World Vaccine Congress Europe
GAITHERSBURG, Md., Oct. 16, 2021 /PRNewswire/ -- Novavax, Inc. (Nasdaq: NVAX), a biotechnology company dedicated to developing and commercializing next-generation vaccines for serious infectious diseases, today announced that Vivek Shinde, M.D., Vice President, Clinical Development, will deliver a...
Results from Novavax NanoFlu Influenza Vaccine Phase 3 Clinical Trial Published in The Lancet Infectious Diseases
- Pivotal Phase 3 trial achieved all primary endpoints, demonstrating non-inferiority to a leading U.S.-licensed quadrivalent influenza vaccine - NanoFlu™ vaccine candidate induced significantly enhanced cell-mediated immune responses - NanoFlu was well-tolerated with a comparable safety profile...
Novavax and Serum Institute of India Announce Submission to World Health Organization for Emergency Use Listing of Novavax' COVID-19 Vaccine
* Novavax and Serum Institute of India file regulatory submission for World Health Organization Emergency Use Listing of Novavax' recombinant nanoparticle protein-based COVID-19 vaccine GAITHERSBURG, Md., Sept. 23, 2021 /PRNewswire/ -- Novavax, Inc. (Nasdaq: NVAX), a biotechnology company dedic...
Novavax to Participate in Fireside Chat at Devex @ UNGA 76
GAITHERSBURG, Md., Sept. 21, 2021 /PRNewswire/ -- Novavax, Inc. (Nasdaq: NVAX), a biotechnology company developing and commercializing next-generation vaccines for serious infectious diseases, today announced thatJohn J. Trizzino, Executive Vice President, Chief Commercial Officer and Chief Busin...
Novavax Initiates Phase 1/2 Clinical Trial of Combination Vaccine for COVID-19 and Seasonal Influenza
-- First participants enrolled in Phase 1 clinical trial of combination NanoFlu™/NVX–CoV2373 vaccine with Matrix-M™ adjuvant -- Phase 1/2 study will evaluate immunogenicity and safety GAITHERSBURG, Md., Sept. 8, 2021 /PRNewswire/ -- Novavax, Inc. (Nasdaq: NVAX), a biotechnology company dedicated...
Novavax Announces COVID-19 Vaccine Booster Data Demonstrating Four-Fold Increase in Neutralizing Antibody Levels Versus Peak Responses After Primary Vaccination
* Single booster dose at 6 months of NVX-CoV2373 increased wild-type neutralizing antibodies more than 4-fold versus primary vaccination series * Six-fold increase in cross-reactive functional antibodies to Delta variant compared to primary vaccination series * Analysis of sera from primary ...
Novavax and Serum Institute of India Announce Submission to Regulatory Agencies in India, Indonesia, Philippines for Emergency Use Authorization of Novavax' Recombinant Nanoparticle COVID-19 Vaccine
- Novavax and Serum Institute of India file regulatory submissions to the Drugs Controller General ofIndia and to regulatory agencies in Indonesia and Philippines for Novavax' recombinant nanoparticle COVID-19 vaccine - Filing for World Health Organization Emergency Use Listing expected in Augus...
Novavax and European Commission Finalize Advance Purchase Agreement for up to 200 million doses of COVID-19 Vaccine
GAITHERSBURG, Md., Aug. 4, 2021 /PRNewswire/ -- Novavax, Inc. (Nasdaq: NVAX), a biotechnology company developing next-generation vaccines for serious infectious diseases, today announced that it has reached an agreement with the European Commission (EC) for the purchase of up to 200 million doses...
Novavax COVID-19 Vaccine Demonstrates 90% Overall Efficacy and 100% Protection Against Moderate and Severe Disease in PREVENT-19 Phase 3 Trial
* 93% efficacy against predominantly circulating Variants of Concern and Variants of Interest * 91% efficacy in high-risk populations * 100% efficacy against variants "not considered Variants of Concern/Interest" * All COVID-19 hospitalizations/death occurred in the placebo group * Company...
Novavax Announces Memorandum of Understanding to Explore Expansion of COVID-19 Vaccine Activities in South Korea
Novavax and SK bioscience reaffirm partnership during meeting with South Korean leaders GAITHERSBURG, Md., May 23, 2021 /PRNewswire/ -- Novavax, Inc. (Nasdaq: NVAX), a biotechnology company developing next-generation vaccines for serious infectious diseases, today announced the signing of a non-...
Novavax Announces Positive Preclinical Data for Combination Influenza and COVID-19 Vaccine Candidate
- Manuscript highlights development of robust responses to both influenza and COVID-19 and protection against the SARS-CoV-2 virus - Data shared via preprint server for biology, bioRxiv, ahead of publication GAITHERSBURG, Md., May 10, 2021 /PRNewswire/ -- Novavax, Inc. (Nasdaq: NVAX), a biotechn...
Novavax and Gavi Execute Advance Purchase Agreement for COVID-19 Vaccine for COVAX Facility
* Novavax to deliver 350 million doses beginning Q3 2021 * 1.1 billion doses of Novavax vaccine to be available to countries participating in COVAX * Serum Institute of India to provide balance of doses for LMICs * Underscores commitment to global equitable access to Novavax vaccine GAITHE...
Novavax Initiates COVID-19 Vaccine Clinical Trial Crossover
* Crossover allows participants to continue in trials and remain blinded * Ensures that all trial participants receive active vaccine * South Africa and UK crossover arms initiated; US/Mexico PREVENT-19 crossover planned GAITHERSBURG, Md., April 6, 2021 /PRNewswire/ -- Novavax, Inc. (Nasdaq:...
Novavax Confirms High Levels of Efficacy Against Original and Variant COVID-19 Strains in United Kingdom and South Africa Trials
- 100% protection against severe disease - Final analysis in U.K. trial confirms 96% efficacy against original strain of COVID-19 - Efficacy against variants confirmed in U.K. and South Africa GAITHERSBURG, Md., March 12, 2021 /PRNewswire/ -- Novavax, Inc. (Nasdaq: NVAX), a biotechnolog...
AGC Biologics Expands Partnership with Novavax
Manufacturing of Novavax' Matrix-M™Adjuvant for Novel COVID-19 Vaccine Expands toSeattle SEATTLE, Aug. 11, 2020 /PRNewswire/ -- AGC Biologics, a global biopharmaceutical Contract Development and Manufacturing Organization (CDMO), announced it has expanded its partnership withNovavax, Inc. (NASDA...
Novavax Selects AGC Biologics to Manufacture Matrix-M™ Adjuvant for Novel COVID-19 Vaccine
AGC Biologics partners with Novavax to produce NVX-CoV2373 component SEATTLE, June 3, 2020 /PRNewswire/ -- AGC Biologics, a global biopharmaceutical Contract Development and Manufacturing Organization (CDMO), has announced that it will partner withNovavax, Inc. (NASDAQ: NVAX), a late-stage biot...
