Novavax is close to finalising a COVID-19 vaccine supply deal with the EU

Novavax is planning to begin delivering doses of its investigational COVID-19 vaccine to the EU before the end of the year, Reuters has reported.

An EU official with direct knowledge of the Novavax/EU supply discussions told Reuters that the deal would be for a total of up to 200 million doses of the vaccine candidate, known as NVX-CoV2373.

Novavax also reportedly told the EU that it is planning to begin deliveries of NVX-CoV2373 to the bloc later this year, with the majority of these doses earmarked for 2022.

Earlier this year, reports emerged that Novavax has encountered issues with sourcing some raw materials used in the manufacturing process for NVX-CoV2373.

According to Reuters, Novavax is still facing the same issues with its manufacturing processes, although the company now has a more secure delivery schedule in place.

The European Medicines Agency (EMA) initiated a rolling review of Novavax’s COVID-19 vaccine in February, based on preliminary results from lab studies and early clinical studies in adults.

In March, Novavax revealed final efficacy analysis for NVX-CoV2373 from a trial of 15,000 participants, where the jab demonstrated 96.4% efficacy against mild, moderate and severe disease caused by the ancestral COVID-19 strain.

Against the B.1.1.7 strain first identified in the UK, NVX-CoV2373 was found to have 86.3% efficacy, reflecting an overall vaccine efficacy of 89.7%.

In participants aged 65 years and older, ten cases of COVID-19 were observed, with 90% of these cases occurring in the placebo group.

The UK government has already signed an advanced purchase agreement with Novavax for 60 million doses of NVX-CoV2373.

As part to the deal, Novavax conducted a phase 3 clinical trial of its vaccine candidate with support from the UK’s National Institute for Health Research (NIHR).

To support roll-out in the UK, Novavax partnered with FUJIFILM Diosynth Biotechnologies to manufacture certain components of the vaccine in the UK, including the protein antigen component.

More recently, the biotech company signed another agreement with GlaxoSmithKline to help make up to 60 million doses of NVX-CoV2373 in the UK.

The agreement between GSK, Novavax and the UK Vaccines Taskforce will see GSK provide fill and finish manufacturing capacity at its facility located in Barnard Castle, in the North East of England.