Takeda Pharmaceuticals is a recent manufacturing partner in Japan. NVX-CoV2373 is being manufactured in South Korea by SK Bioscience, but SK has its own Phase III (NCT05007951) protein subunit Covid-19 vaccine candidate GBP510. But SII also manufactures Covishield (SII-ChAdOx1 nCoV-19) from a technology transfer with AstraZeneca and the University of Oxford. Novavax has a manufacturing partnership with Pune-based Serum Institute of India (SII). In the past 18 months, Novavax said it made progress in mobilising a global manufacturing network that now routinely produce vaccines at a commercial scale. While a UK-based Fujifilm facility has been established to specifically manufacture NVX-CoV2373, 12 October news reports show there is increasing anxiety about the sustainability of this site since NVX-CoV2373 is yet to be authorised anywhere. Novavax also has a partnership with North Carolina-headquartered CDMO Fujifilm Diosynth Biotechnologies, but Dai pointed out that this deal is under the Biomedical Advanced Research and Development Authority (BARDA), and the CDMO is also manufacturing other vaccines. The CDMO was also examined by the FDA for contamination issues that led to manufacturing delays with other products. But Emergent also has contracts with AstraZeneca and Johnson & Johnson for their respective vaccines. Novavax has a manufacturing collaboration with contract development and manufacturing organization (CDMO) Emergent BioSolutions. In fact, it is not so much that Novavax’s vaccine is uniquely challenging to manufacture, but it does not have any exclusive manufacturing deals, noted Johns Hopkins University Carey Business School professor of operations management and business analytics Tinglong Dai. While companies like Novavax can outsource their manufacturing needs, it could be expensive and slow as these manufacturing firms are also in high demand, said Massachusetts Institute of Technology professor of chemical engineering J. But existing manufacturing delays may be due to Novavax being a relatively smaller-sized company with no products in the market and comparatively less experience in manufacturing at a large scale, Moore added. Novavax expects its global supply chain to achieve a capacity of 150 million doses per month by the end of Q4. While Novavax has a headstart, there are lingering questions on the number of doses it can realistically deliver considering the time needed to scale up manufacturing, said University College Cork vaccines principal investigator Ann Moore. Iran-based CinnaGen is another player that expects Phase III data of Australia-designed SpikoGen in the coming months, this news service reported 16 September. Clover, Sanofi, and GSK did not respond to a comment request. Sanofi and GSK’s Phase III vaccine trial (NCT04904549) started in May and is still recruiting as per. Meanwhile, Clover reported positive Phase II/III (NCT04672395) data on 22 September, with the company announcing plans to file for authorization this quarter. Experts this news service interviewed noted how Novavax, being a relatively smaller player in the vaccine world, is at the mercy of outsourcing its manufacturing needs and has no exclusive partnerships. A Novavax spokesperson pointed to a 20 October statement underscoring its stringent standards of production and manufacturing of its vaccine. Novavax’s NVX-CoV2373 was thought to have an edge because it was the first to report positive Phase III data, but it is yet to secure regulatory support anywhere due to authorisation or filing interruptions stemming from manufacturing checks. This traditional vaccine technology may be a powerful tool to convince hesitant individuals to be vaccinated, particularly ones who have reservations about the newness of widely authorized mRNA and adenovirus-vectored vaccines. The world has its eyes on the Covid-19 protein subunit vaccine race. Despite competitors with the same technology taking longer to collect data, they may have manufacturing edge over Novavax. Novavax may be at risk of losing its frontrunner status of being the largest distributor of protein subunit Covid-19 vaccines. Long-term investment by Sanofi, GSK in vaccine development is an advantage during pandemics but pre-existing production challenges in making protein subunit vaccines remain.But they could target different countries and so there would be room for both vaccines. Clover and Novavax’s timeline gap is narrowing, with Clover recently revealing late-phase data. ![]() With Novavax being a relatively smaller player in the vaccine world, it is dependent on outsourcing its manufacturing needs, which can delay its progress momentum.
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