US-based vaccine development firm Novavax has signed a license agreement with Serum Institute of India (SIIPL) for the development and commercialisation of its potential Covid‑19 vaccine candidate NVX‑CoV2373.

The licence agreement allows SIIPL to supply the potential Covid-19 vaccine only in low- and middle-income countries (LMIC) and India, while Novavax will retain its rights in major upper-middle and high-income countries.

Under the terms of the agreement, Novavax and SIIPL are expected to work together on clinical development, co-formulation, filling and finishing and commercialisation of NVX-CoV2373.

Novavax will provide SIIPL with both vaccine antigen and Matrix‑M adjuvant while SIIPL will take responsibility for regulatory submissions and marketing authorisations for NVX‑CoV2373. Both companies will equally share the revenue from the sale of the product.

Furthermore, the companies are in talks to let SIIPL manufacture vaccine antigen in India.

SIIPL chief executive officer Adar Poonawalla said: “We believe that Novavax’ NVX-CoV2373 has significant potential to successfully prevent Covid-19.

“Given our experience with Novavax on the development of a malaria vaccine, we know the power of their vaccine technologies. We will work urgently together to bring this vaccine to patients in these geographies.”

Novavax developed NVX‑CoV2373 using its recombinant nanoparticle technology

NVX‑CoV2373 is a stable, prefusion protein vaccine candidate developed from the genetic sequence of SARS‑CoV‑2, by leveraging the company’s recombinant nanoparticle technology.

The vaccine candidate includes antigen derived from the coronavirus spike (S) protein along with the company’s patented saponin-based Matrix-M adjuvant, which enhances the immune response and stimulates neutralising antibodies.

In the preclinical trials, NVX‑CoV2373 was generally well-tolerated and has demonstrated superior results in generating antibody responses than in human convalescent sera.

Novavax has secured $1.6bn US federal funding under the Operation Warp Speed (OWS), which is being used to complete the late-stage clinical development, including a pivotal Phase 3 clinical trial, along with large-scale manufacturing and delivering 100 million doses of NVX‑CoV2373.

Furthermore, the company has also secured $388m investment from Coalition for Epidemic Preparedness Innovations (CEPI), and up to $60m funding from Department of Defense (DoD) to advance clinical development of NVX‑CoV2373.

Novavax president and chief executive officer Stanley Erck said: “Novavax is strongly committed to ensuring a global supply of NVX‑CoV2373, including for low- and middle-income countries that are also significantly impacted by coronavirus.

“As the world’s largest vaccine manufacturer in terms of doses delivered, Serum Institute is the ideal partner to advance NVX‑CoV2373 throughout India and the LMIC countries. This partnership continues to build on our companies’ collaborative history.”