Novavax, Inc. is an American biotechnology company based in Gaithersburg, Maryland, that develops vaccines to counter serious infectious diseases.
Prior to 2020, company scientists developed experimental vaccines for influenza and respiratory syncytial virus (RSV), as well as Ebola and other emerging infectious diseases.
[10] The ResVax trial was encouraging as it showed significant efficacy against respiratory syncytial virus (RSV) infection,[10] using a nanoparticle-based treatment using a recombinant F lipoprotein or saponin, "extracted from the Quillaja saponaria [or?]
[12] The company's difficulties in 2016 led to a three-part strategy for 2017: cost reduction through restructuring and the termination of 30% of their workforce; pouring more effort into getting ResVax to market; and beginning clinical trials on a Zika virus vaccine.
[12] Alongside the adult studies of ResVax, the vaccine was also in 2016 being tested against infant RSV infection through the route of maternal immunization.
[10] In 2019, late-stage clinical testing of ResVax failed for a second time, which resulted in a major downturn in investor confidence and a seventy percent reduction in capital value for the firm.
[13][14] As a secondary result, the company was forced to conduct a reverse stock split in order to maintain Nasdaq minimum qualification, meaning it was in risk of being delisted.
In January 2020, it was granted fast track designation by the U.S. Food and Drug Administration (FDA) to move into Phase III trials, which completed in March 2020.
[18] In 2015, Novavax received a US$89 million research grant from the Bill and Melinda Gates Foundation to support the development of a vaccine against RSV for infants via maternal immunization.
[37][40][38][39] On 1 November 2021, Novavax and Serum Institute of India announced that the National Agency of Drug and Food Control of Indonesia, or Badan Peng was Obat dan Makanan (Badan POM), has granted emergency use authorization (EUA) for Novavax' recombinant nanoparticle protein-based COVID-19 vaccine with Matrix-M adjuvant.
[6] On 20 January 2022, The Therapeutic Goods Administration (TGA) has granted provisional approval to Biocelect Pty Ltd (on behalf of Novavax Inc) for its COVID-19 vaccine, NUVAXOVID.
[7] On 13 July 2022, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the Novavax COVID-19 Vaccine, Adjuvanted for the prevention of COVID-19 caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 18 years of age and older.