Market insight in association witH

Novavax to receive $1.6B from Operation Warp Speed for the development of Covid-19 vaccine

On Tuesday 7 July, Maryland-based biotech Novavax announced it would receive $1.6bn in funding as part of the US government’s Covid-19 vaccine initiative “Operation Warp Speed” (OWS).

The funding includes support for a Phase III clinical trial, for establishing large-scale manufacturing, and to deliver 100 million vaccine doses as early as late 2020. Novavax’s Covid-19 vaccine candidate, NVX-CoV2373, a recombinant nanoparticle with adjuvant, is currently in Phase I / II clinical trials in Australia with support from the Coalition for Epidemic Preparedness Innovations (CEPI).

This is the largest amount of funding from the US Government announced to date after AstraZeneca received up to $1.2bn for the support of the Oxford University vaccine AZD1222 in mid-May. The goal to deliver 100 million vaccine doses as early as late 2020 seems very ambitious, given that NVX-CoV2373 is currently in Phase I / II clinical trials and Novavax has no experience in large-scale manufacturing and distribution of vaccines.

With promising technology but no marketed products, Novavax will have to ramp up manufacturing capacities quickly and expand collaborations with contract manufacturers in order to fulfil the goal. The need for manufacturing capacity for the adjuvant poses an additional hurdle. Novavax recently bought a vaccine manufacturing plant in the Czech Republic, but OWS funding is likely to require the company to deliver vaccines first for use in the US.

According to Novavax, the company is talking to contract manufacturers in the US for the production of both the nanoparticle and adjuvant component of its vaccine. Given the pandemic situation and the government’s ambition to move production to the US, many companies are competing for manufacturing resources, but likely not all vaccine candidates will be successful in clinical studies.

The US Department of Health and Human Services (HHS) recently signed a deal with Emergent BioSolutions for the manufacturing and fill-finish of vaccine candidates that receive OWS support, providing an additional resource for Novavax to reach the delivery goal.

Novavax’s NVX-CoV2373 is based on the company’s quadrivalent seasonal influenza vaccine candidate NanoFlu, which uses a recombinant nanoparticle with a plant-based adjuvant and targets the elderly population 65 years of age and older. NanoFlu delivered promising results in a Phase III study, showing better antibody responses than conventional quadrivalent influenza vaccines without adjuvant.

The US Government’s effort to bring 300 million Covid-19 doses to the US by early 2021, Operation Warp Speed, is a joint effort of the HHS agencies the CDC, the FDA, and the Biomedical Advanced Research and Development Authority (BARDA), with the Department of Defense. In early June, five finalists for funding were chosen: AstraZeneca, Johnson & Johnson, Merck, Moderna, and Pfizer. Other recent announcements from vaccine developers, such as Vaxart and Inovio, have been made by the companies rather by than the HHS itself.

For more insight and data, visit GlobalData's Pharmaceuticals Intelligence Centre.

Share this article

Go to article: Home | The Route to RecoveryGo to article: In this issueGo to article: MimotopesGo to article: ContentsGo to article: NewsGo to article: VEGA Company Insight Go to article: VEGA AustraliaGo to article: Covid-19 executive briefing by GlobalDataGo to article: Identifying a viable Covid-19 vaccine candidate and steps needed for its successful implementationGo to article: Impact of Covid-19 on patients with hepatocellular carcinomaGo to article: NSFGo to article: Novavax to receive $1.6B from Operation Warp Speed for the development of Covid-Go to article: FDA winners and losers in Covid-19 therapiesGo to article: Pfeiffer VacuumGo to article: Trials delayed due to Covid-19 begin to resumeGo to article: ILC Dover Go to article: The pharma industry briefingGo to article: From rare diseases to Covid-19: charting the history of Genomics EnglandGo to article: Covid-19: how will pharma cope with a looming recession?Go to article: Pandemic logistics: guaranteeing equitable accessGo to article: Pandemic logistics: Resolving manufacturing and distribution challengesGo to article: KugelmeiersGo to article: Q&A: how to find the right clinical trial participants with Innovative TrialsGo to article: Recce Pharma: a new frontier in the fight against AMRGo to article: Autism pipeline: are better therapies in sight?Go to article: How a new crystallography technique may speed up drug developmentGo to article: Psychedelics: a game-changer in mental health? Go to article: Graph technology: the remedy for broken supply chains is connected dataGo to article: Deals in brief powered by GlobalDataGo to article: The key list powered by GlobalDataGo to article: Global markets and indices powered by GlobalDataGo to article: Macro-economic indicators (1 of 2) powered by GlobalDataGo to article: Macro-economic indicators (2 of 2) powered by GlobalDataGo to article: EventsGo to article: Next issue