Novavax Pens 40 Million Vaccine Dose Deal With Australia

Novavax announced Wednesday that it has reached an agreement with Australia that will see the company supply 40 million doses of its COVID-19 vaccine candidate for the country.

Financial terms of the supply deal were not disclosed, but the Maryland-based company said it will begin delivering supplies of its vaccine candidate, NVX-CoV2373, to Australia as early as the first half of 2021 if its phase 3 trials are successful and the vaccine is cleared by the country’s Therapeutic Goods Administration (TGA). The final product is expected to require two doses administered three weeks apart, Novavax said.

The latest supply deal comes as the company evaluates its investigational vaccine in a phase 3 trial in the UK and prepares for a late-stage U.S./Mexico trial anticipated to start by the end of the month (DID, Oct. 28). Novavax expects to enroll 15,000 participants by the end of November in the ongoing UK trial and 30,000 participants in the upcoming U.S./Mexico trial.

While it’s unknown when the first data will be seen from the U.S./Mexico trial, interim data from the UK trial is expected in the first quarter of 2021. The data could arrive after a COVID-19 vaccine has been authorized by the FDA, with both Pfizer and Moderna aiming to file for Emergency Use Authorization for their vaccine candidates later in November.

Novavax has been hammering out vaccine supply arrangements around the world to ensure its vaccine will be available should it prove itself in late-stage trials and earn regulatory approval. Those deals include a $1.6 billion U.S. agreement for 100 million doses, a 60 million-dose deal with the UK, and a 76 million-dose deal with Canada, among other countries. It has also been granted $388 million in funding from the Coalition for Epidemic Preparedness Innovations (DID, May 13) for the development of the company’s vaccine.

Novavax announced early this week that it will expand its Gaithersburg, Md., facility to help meet the massive manufacturing demands for its vaccine (DID, Nov. 3). — James Miessler