GSK to provide fill and finish capacity for Novavax’ COVID-19 vaccine

Novavax Inc, GlaxoSmithKline (GSK) and the UK Government Vaccines Taskforce have reached an agreement in principle to support manufacturing of up to 60 million doses of Novavax’ COVID-19 vaccine candidate (NVX-CoV2373) for use in the UK.

The UK Government has secured 60 million doses of the vaccine under an advance purchase agreement with Novavax. The protein antigen component of the vaccine is currently produced in North East England by Novavax’ manufacturing partner, FUJIFILM Diosynth Biotechnologies, at their site in Billingham, Stockton-on-Tees.

Under the new agreement, GSK will provide ‘fill and finish’ manufacturing capacity at its Barnard Castle facility in the North East of England. This could start as early as May 2021, with a rapid technology transfer between the two companies beginning immediately. GSK and Novavax will negotiate a final agreement to include additional terms and conditions.

Roger Connor, President, GSK vaccines, commented: “GSK is delighted to support Novavax and the UK Vaccines Taskforce with this manufacturing arrangement for the UK and our Barnard Castle facility is now undertaking the rapid preparation work required to manufacture up to 60mn doses of this vaccine. We have ensured that we can deliver these volumes without impacting supply of our other vital medicines and vaccines and without disruption to the other COVID-19 collaborations GSK is engaged in globally.”

Health and Social Care Secretary Matt Hancock added: “We have all seen just how important onshore vaccine manufacturing capabilities are, and this fantastic deal will ensure more of these vital products can be produced here in the UK. The UK’s vaccination programme has been a national success, with over 30 million people now having received a first dose of a COVID-19 vaccine. Should the Novavax vaccine meet our medicines regulator’s high standards of safety and effectiveness, the agreement reached today will boost these efforts over the coming months.”

The Novavax vaccine candidate has demonstrated strong potential efficacy in Phase III clinical trials, including against the B.1.1.7 variant circulating in the UK. Submission of the vaccine for review by regulatory authorities in the UK is expected during the second quarter.