Novavax has entered an agreement with the European Commission (EC) to deliver up to 200 million doses of its Covid-19 vaccine candidate, NVX-CoV2373.
A protein-based vaccine candidate, NVX-CoV2373 is made from the genetic sequence of the original SARS-CoV-2 strain. It is adjuvanted with the company’s saponin-based Matrix-M to boost immune response and neutralising antibodies.
As per the deal, EC will initially buy up to 100 million doses of the vaccine and holds an option to procure another 100 million doses through 2023.
Currently, the company is progressing the rolling submission for the vaccine to the European Medicines Agency (EMA). The submission is anticipated to conclude in the third quarter of this year.
On obtaining approval, Novavax will commence the delivery of initial doses.
Novavax president and CEO Stanley Erck said: “We thank the European Commission for their partnership in this important step to expand vaccine options for the citizens of Europe and globally as we work to bring the first Covid-19 protein subunit vaccine to the market.
“With clinical data from our trials showing strong efficacy against variants of concern and variants of interest, we believe that our vaccine candidate will play a critical role in the effort to help control the pandemic in the EU and other regions in the world.”
In Phase III PREVENT-19 trial enrolling approximately 30,000 adult subjects in the US and Mexico, the vaccine offered complete protection against moderate and severe Covid-19 with an overall efficacy of 90.4%.
Novavax also expanded the trial in May to include a paediatric arm.
Furthermore, NVX-CoV2373 had an overall efficacy of 89.7% and 96% efficacy against the original SARS-CoV-2 strain in a Phase III UK trial enrolling nearly 15,000 adults.
In June, Novavax reported that the Covid-19 vaccine candidate generated immune response and protection against the SARS-CoV-2 Beta (B.1.351) variant first detected in South Africa.