Novavax in Separate COVID-19 Vaccine Mfg Pacts with GSK, JubilantBy
Novavax, a Gaithersburg, Maryland-based clinical-stage vaccine company, has entered into separate manufacturing agreements with GlaxoSmithKline (GSK) and Jubilant HollisterStier, a CDMO of sterile manufacturing, for its COVID-19 vaccine candidate, NVX-CoV2373.
Deal with GSK
GSK has reached an agreement in principle with Novavax and the UK Government Vaccines Taskforce to support manufacturing of up to 60 million doses of Novavax’s COVID-19 vaccine for use in the UK.
GSK will provide fill–finish manufacturing capacity at its Barnard Castle facility in northeastern England beginning as early as May 2021. Technology transfer between the two companies is beginning immediately (as reported on March 29, 2021). The parties will negotiate a final agreement to include additional terms and conditions.
The UK government has secured the 60 million doses of the vaccine under an advance purchase agreement with Novavax. The protein antigen component of NVX-CoV2373 is also produced in the UK by Novavax’s manufacturing partner and CDMO, Fujifilm Diosynth Biotechnologies at its site in Billingham, UK.
Novavax reported that its COVID-19 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 of 2021.
Deal with Jubilant HollisterStier
Jubilant HollisterStier has entered into a non-exclusive manufacturing agreement with Novavax to provide fill–finish manufacturing services for NVX-CoV2373. Under the agreement, Jubilant HollisterStier’s Spokane, Washington facility has begun production activities of final drug product intended for commercial distribution in the US.