As part of the plans, GSK will provide fill & finish capacity at its Barnard Castle site in northeast England beginning as early as May of this year – the preliminary agreement calls for a “rapid technology transfer” between the two companies. Barnard Castle is a specialized facility within the drugmaker’s global manufacturing network, supporting production of pharmaceutical and vaccine products.

The arrangement is intended as a stop-gap measure to keep the British inoculation campaign rolling. Vaccinations are threatening to slow as the Indian government has mandated that AstraZeneca’s primary manufacturing partner, the Serum Institute of India, stop exports as the populous South Asian country grapples with a new coronavirus wave.

Under an advance purchase agreement, the UK has ordered 60 million doses of the Novavax vaccine. The protein antigen component of NVX-CoV2373 is already being produced in northeast England by Novavax CDMO partner Fujifilm Diosynth Biotechnologies at its site in Billingham, Stockton-on-Tees.

UK prime minister Boris Johnson said GSK’s investment, which he said “shows the strength of UK manufacturing,” will further boost the country’s ambitious vaccine rollout. “We remain on track to offer a first jab to all over 50s by 15 April and all adults by the end of July,” he said.

GSK’s vaccines president Roger Connor said the Barnard Castle facility is now undertaking the “rapid preparation work” required to manufacture the Novavax doses. The company has sufficient resources to deliver the required volumes without impacting supply of other vital medicines and vaccines and without disruption to the other Covid-19 collaborations GSK is engaged in globally, he said.

The British pharma is working with several partners on Covid vaccines, in particular  providing access to its adjuvant technology. A collaboration with Canada’s Medicago, combining GSK’s adjuvant with Medicago’s plant-derived vaccine candidate is in Phase 3 clinical trials. The collaboration with French drugmaker Sanofi on an adjuvanted, protein-based Covid candidate is stuck in Phase 2. GSK has also signed on with Germany’s CureVac to jointly develop mRNA vaccines for Covid. The drugs giant will support manufacturing of up to 100 million doses of CureVac’s vaccine at its Belgian facilities.

Neither the Novavax nor the CureVac Covid candidates has been submitted for approval to any drug regulator as yet, but the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) and the European Medicines Agency (EMA) are both expected to grant emergency use authorization soon. Both candidates are in a rolling review with the European Medicines Agency (EMA). Novavax CEO Stanley Erck said recently he hopes the US will accept data from the company’s UK clinical trial.

Some US reports said the deal with GSK will help Novavax line up more manufacturing capability in Europe. It is unclear, however, if the EU could benefit from the UK-made output, as the British government as yet has not allowed any vaccine products to leave the country.

Novavax last week told Reuters it would delay signing its long-awaited supply agreement with Brussels – expected in February – due to pandemic-related raw materials supply shortages. This week, the news agency quoted an anonymous EU official as saying the issues were legal in nature. Novavax operates a small plant in the Czech Republic producing components of its vaccine.

At home, the US biotech has also taken CDMOs to help manufacture its vaccine. On Mar. 24, Jubilant HollisterStier said it had agreed to provide fill & finish services for the Novavax shot from its plant in Spokane, Washington. This capacity will be earmarked for the US market.

Author: Dede Williams, Freelance Journalist