Novavax Files for Authorization of its COVID-19 Vaccine in the UK and Australia

Novavax announced that it had filed for authorization of its COVID-19 vaccine, NVX-CoV2373, in the United Kingdom and Australia on Oct. 27, 2021, and Oct. 29, 2021, respectively. The company’s conditional marketing authorization application filed with the UK Medicines and Healthcare products Regulatory Agency (MHRA) marks the first submission for authorization of a protein-based COVID-19 vaccine in the UK. The company’s application to the Therapeutic Goods Administration for provisional approval marks the first complete application for provisional approval of a protein-based COVID-19 vaccine in Australia.

Novavax expects to shortly complete additional regulatory filings in other key markets, including Europe, Canada, New Zealand, and the World Health Organization as well as other markets around the world. In the United States, Novavax expects to complete a submission package to FDA by the end of 2021.

“This [UK] submission brings Novavax significantly closer to delivering millions of doses of the first protein-based COVID-19 vaccine, built on a proven, well-understood vaccine platform that demonstrated high efficacy against multiple strains of the coronavirus,” said Stanley C. Erck, president and CEO, Novavax, in a company press release. “We look forward to MHRA’s review and will be prepared to deliver vaccine doses following what we anticipate will be a positive decision. We thank the clinical trial participants and trial sites in the United Kingdom, as well as the UK Vaccines Taskforce, for their support and vital contributions to this program.”

"[The Australian] submission brings Novavax significantly closer to delivering doses of the first protein-based COVID-19 vaccine to Australia and, along with this week's filing for conditional marketing authorization in the UK, brings us one step closer to our goal of ensuring broad global access to our vaccine," Erck said in the press release. "We thank the Australian clinical trial participants and trial sites, as well as the regulatory and vaccine experts, for their assistance and contribution to this vaccine program."

NVX-CoV2373 is a protein-based vaccine candidate engineered from the genetic sequence of the first strain of SARS-CoV-2. It was created using Novavax' recombinant nanoparticle technology to generate antigen derived from the coronavirus spike (S) protein. The vaccine is formulated with Novavax' patented saponin-based Matrix-M adjuvant, which is designed to enhance the immune response and stimulate high levels of neutralizing antibodies.

Source: Novavax for UK and Australia