The US biotech’s candidate is awaiting approval for emergency use in the UK after it submitted real time data to the country’s Medicines and Health Regulatory Authority (MHRA) at the end of October.

In a statement, Fujifilm Diosynth Biotechnologies CEO Martin Meeson said what he called “the largest investment in British biopharmaceutical manufacturing for decades” signals his company’s intent to offer multi-modal options to respond to customers’ needs with flexibility and agility.

“With a strong growing demand for microbial, cell culture and viral gene therapy services, we are adding the capacity and latest technologies within one campus to offer a range of modalities to build an offering that will deliver novel promising treatments to patients for years to come,” the CEO added.

In mid-November, the European Medicines Agency (EMA) began evaluating a formal application from Novavax for conditional marketing authorization of the recombinant nanoparticle protein-based vaccine the company now brands as Nuvaxovid. Last summer, the European Commission ordered an initial 100 million doses, with an option to take an additional 100 million more by 2023.

The EMA said that if the benefits of Nuvaxovid are shown to outweigh its risks in protecting against Covid 19, it will recommend that the Commission fast-track the approval process toward authorization valid in all EU and EEA member states.  It is unclear where the EU doses would be made. Novavax collaborates with US CDMO Baxter International, which recently announced plans to spend roughly $100 million to expand a sterile fill & finish facility at Halle in the German state of North Rhine-Westphalia.

Novavax has not yet filed with the US Food and Drug Administration (FDA) for an Emergency Use Authorization (EUA). After repeated delays due to squabbles with the US regulator over manufacturing standards the company last said it planned a filing during the ongoing fourth quarter after filing in the UK first and potentially beginning commercial manufacture there.

Author: Dede Williams, Freelance Journalist