The ‘Operation Warp Speed’ $1.6 billion funding boost will help support the large-scale manufacture of COVID-19 vaccine candidate NVX‑CoV2373, says Novavax.
Novavax has become the beneficiary of the largest funding by Operation Warp Speed – the US government’s response to the expedite vaccines and therapeutics against the novel coronavirus – to date, receiving $1.6 billion it says will be used to aid clinical development and secure manufacturing for NVX‑CoV2373.
“In addition to establishing scale-up manufacturing capacity to deliver 100 million doses by year end (2020), the funding is expected to be sufficient to progress though the late-stage clinical studies necessary to determine the safety and efficacy of NVX-CoV2373, including a pivotal phase 3 clinical trial with up to 30,000 subjects, as well as support the work required to file submissions to the Food and Drug Administration (FDA) for Emergency Use Authorization (EUA) and a Biologics License Application (BLA) with the FDA,” a spokesperson from Novavax told this publication.
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“No further breakdown of funds is available at this time.”
Manufacturing plans
However, the company when pushed spoke more about its strategy to reach 100 million doses, based on “active discussions around the world to support manufacturing/supply of billions of doses of NVX-CoV2373 globally” along with capacity it has already secured through contract development and manufacturing organizations (CDMOs) partnerships and M&A activity.
The firm acquired Praha Vaccines for approximately $167 million in May, gaining a facility expected to provide an annual capacity of over 1 billion doses of antigen starting in 2021. While this site is in in Czech Republic, Novavax told us it is intended to serve the global production of the vaccine.
The $1.6 billion boost aims to secure US supply, we were told.
“Under this agreement with Operation Warp Speed, we will have a US-based supply chain in place. Last month we announced Polypeptide Group and AGC Biologics facilities in the US are contracted to produce Matrix-M adjuvant and its components, respectively.”
Both AGC Biologics and the Polypeptide Group have manufacturing facilities in the US and elsewhere, though from where they will both make Matrix-M, the adjuvant component of the vaccine, has not been divulged.
Emergent Biosolutions, has also been contracted by Novavax to support the project, making the drug substance and product from its plants in Baltimore, Maryland.
“We will be announcing additional manufacturing agreements related to SARS-CoV-2 spike protein antigen production for US market supply in coming days and weeks.”
Regeneron and J&J
In related Operation Warp Speed news, Regeneron has received a $450 million contract for its potential COVID-19 antibody cocktail, REGN-COV2, this week.
Keen readers will remember the firm has cleared capacity at its site in East Greenbush, New York to prepare to scale-up production with the aim to make several hundred thousand doses by the end of the summer.
Meanwhile, J&J, which received US government funds in March to support its investigational vaccine Ad26 SARS-CoV-2, has also bulked up its manufacturing options this week. The firm has penned a five-year deal with CDMO Emergent worth $480 million for the large-scale drug substance manufacture of the product from the Bayview, Maryland plant. This expands upon a $135 million deal signed in April between the two companies to support the project.