FDAnews
www.fdanews.com/articles/201712-novartis-teams-up-with-curevac-in-another-covid-19-vaccine-partnership

Novartis Teams Up With CureVac in Another COVID-19 Vaccine Partnership

March 5, 2021

Germany’s CureVac has partnered with pharma giant Novartis to potentially manufacture hundreds of millions of doses of the small company’s COVID-19 vaccine candidate, CVnCoV, which is now under review by the European Medicines Agency (EMA).

Novartis, which is also helping Pfizer/BioNTech with fill-finishing of their vaccine, said that it anticipates producing up to 50 million doses of CureVac’s two-dose mRNA-based vaccine by the end of the year and looks to make up to 200 million more doses in 2022. Deliveries from Novartis’ Kundl, Austria, site are expected to start in the summer. Specifically, the company will manufacture the mRNA and bulk drug product for the vaccine.

CureVac, a much smaller firm than many of its competitors, has teamed up with several companies to help it with the development and manufacturing of its vaccine candidate, including GlaxoSmithKline, with whom it is also working on a modified vaccine for viral variants (DID, Feb. 4). It has also partnered with Bayer, which will make 160 million doses of the vaccine at its Wuppertal, Germany, facility and help CureVac with clinical operations, regulatory clearance, supply chain management and other necessary tasks (DID, Jan. 8).

CureVac is on the hook to supply up to 405 million doses to the EU, assuming its vaccine earns regulatory clearance in Europe. The vaccine is currently under rolling review by the EMA, and if authorized, would help to boost the supply of vaccine doses to EU member states. The FDA has not yet begun evaluating the vaccine.

The CureVac-Novartis agreement comes on the heels of the White House’s announcement this week that Merck will offer significant support in manufacturing the Johnson & Johnson vaccine (DID, March 3), which recently received Emergency Use Authorization but is experiencing production delays. Toward that effort, HHS’ Biomedical Advanced Research and Development Authority (BARDA) is providing Merck with up to $268.8 million in funding to adapt a number of facilities to manufacture COVID-19 vaccines as well as therapeutics.

Pharma companies that are normally fierce rivals have shown a willingness to work together during the pandemic to increase production of COVID-19 vaccines that are seeing enormous global demand.

Results from CureVac’s phase 2b/3 vaccine study in more than 35,000 participants in Europe and Latin America are expected at the end of March or early April. — James Miessler