Novartis Teams Up With CureVac To Make COVID-19 Vaccine
Joins Bayer As A Production Partner
Executive Summary
The Swiss major, which is already signed up to help produce Pfizer and BioNTech's COVID-19 vaccine, is offering its services to CureVac to produce its mRNA vaccine.
With Bayer AG already lending a helping hand, CureVac NV has enlisted another pharma giant in Novartis AG to assist with the production of its investigational mRNA COVID-19 vaccine.
The Swiss major has agreed to manufacture the mRNA and bulk drug product for CureVac's vaccine candidate CVnCoV, noting that "preparations for the start of production, technology transfer and test runs are already underway." Novartis plans to start production in the second quarter and first deliveries of bulk drug to the German biotech are expected in the summer.
The Basel-headquartered company added that production would take place in a new high-tech facility that was already under construction in Kundl, Austria. The site will be adapted to the needs of messenger RNA vaccine production, "the manufacturing of which is highly complex," Novartis pointed out.
It is hoping to produce up to 50 million doses of the mRNA and bulk drug product for the CureVac vaccine in 2021 and up to a further 200 million doses next year. Steffen Lang, head of Novartis technical operations, said, "We feel it is our responsibility to do everything in our power to help and we are pleased to announce our collaboration with CureVac."
He claimed that at the Kundl site, "Novartis is a pioneer and has decades of experience in pharmaceutical production of proteins and in more recent years of nucleic acids. We are currently expanding our site with additional capacities for the production of mRNA in order to best serve the increasing demand."
The link-up with CureVac comes just over a month after Novartis joined forces with Pfizer Inc. and BioNTech SE to help produce their in-demand mRNA vaccine Cominarty at its facility in Stein, Switzerland. That deal will see Novartis take bulk mRNA active ingredient from BioNTech and fill it into vials for shipment back to the German biotech for distribution. Production is due to start in the second quarter and initial shipment of finished product is expected in the third quarter (see sidebar).
The company declared that the CureVac deal was "one of several agreements Novartis is reviewing on a global basis to help support the global supply of COVID-19 vaccines and therapeutics."
As for CureVac, chief production officer Florian von der Mülbe said the firm was pleased that "we have found another highly experienced partner to support the production of our vaccine candidate. Together with Novartis we expect to increase significantly our manufacturing capacity and place our production network on an even broader base.”
CureVac started building an integrated European vaccine manufacturing network with several partners in late 2020, including the likes of FAREVA, Wacker Chemie AG and Rentschler Biopharma SE , as well as Bayer. In January, the German major formed an extensive partnership with CureVac, with an initial focus on supporting the clinical studies and approval process for CVnCoV, as well as manufacturing. (Also see "CureVac Enlists Bayer To Secure Place Among COVID-19 Vaccines ‘Second Wave’" - Scrip, 7 Jan, 2021.)
Last week, Bayer CEO Werner Baumann said at the company's annual press conference that the Leverkusen-headquartered group was "skeptical to start with" as "we're going to have to massively reprioritize our own production facilities in certain areas." However, he noted that although Bayer had not previously produced human vaccines or had any experience in mRNA activities, it had a lot of expertise in the development of biotech products, "and we were persuaded that we will be able to get this done by the end of the year." (Also see "Bayer Confident CureVac COVID Pact Will Be A Success" - Scrip, 25 Feb, 2021.)
In December, CureVac started the pivotal Phase IIb/III HERALD study with a 12µg dose of CVnCoV and earlier this month initiated a rolling submission with the European Medicines Agency. (Also see "EMA Starts Rolling Review Of CureVac’s COVID-19 Vaccine" - Pink Sheet, 12 Feb, 2021.)
The Novartis alliance is yet another big pharma partnership for CureVac. In February, it unveiled the expansion of a collaboration with GlaxoSmithKline plc to jointly develop next-generation mRNA vaccines for COVID-19 with the potential for a multi-valent approach to address multiple emerging variants in one vaccine. (Also see "The mRNA Writing On The Wall, GSK Expands CureVac Alliance Into Next-Gen COVID-19 Vaccines" - Scrip, 3 Feb, 2021.)
Last month also saw CureVac enter into a partnership with the UK Government and its Vaccines Taskforce to develop and manufacture potential vaccine candidates against variants and GSK will potentially contribute to that collaboration as well. (Also see "Coronavirus Notebook: EU Filing For Russian Vaccine, UK Links With CureVac Against Virus Variants" - Pink Sheet, 9 Feb, 2021.)
The Novartis/CureVac pact is the latest in what is becoming a long list of pharma and biotech companies working together to make sure enough doses of COVID-19 vaccines are produced. Earlier this week, under a deal brokered by US president Joe Biden’s administration, Merck & Co., Inc. announced it would manufacture Johnson & Johnson’s newly authorized COVID-19 vaccine as well as other vaccines and therapeutics for use in public health emergencies including the current pandemic, as part of a deal signed with the country's Biomedical Advanced Research and Development Authority (BARDA). (Also see "Merck & Co. Will Manufacture J&J Vaccine, Other COVID-19 Medicines Under BARDA Deal" - Scrip, 2 Mar, 2021.)