As companies and institutions around the world race to develop a vaccine against the strain of coronavirus sweeping around the world, Cepi has come forward with an estimate of how much money it might take to cross the finish line: $2bn.
The not-for-profit foundation, whose full name is the Coalition for Epidemic Preparedness Innovations, wants funds for an extensive research programme aiming to have at least three candidates submitted for approval in 2021. Commercial developers are typically reluctant to discuss development costs of individual products, so this call for funding is interesting as it puts a figure of sorts of what level of investment might be required.
Back in 2008, when avian H5N1 flu was the pandemic of the moment, Glaxosmithkline said it had spent $2bn developing a vaccine. Establishing manufacturing is likely to be a very big part of this cost estimate, something that the Cepi figures seem to support.
|Cepi's call for funding|
|Cost and timing||To support….|
|$100m immediately||Phase I trials of eight candidates.|
|$375m by end of Mar 2020||Manufacturing of clinical trial material for phase 2/3 trials for 4-6 candidates, and prep for those trials.
Initial investments to expand global manufacturing capacity.
|$400m by end of Jun 2020||Run phase 2/3 trials for at least two candidates, trial prep for global studies, and production of clinical trial materials.
Further investments in global manufacturing capacity.
|$500-750m in 2021||Completion of clinical testing and regulatory filings for at least three candidates.
Establish global manufacturing capacity at three geographically distributed locations for up to 3 candidates.
Developing vaccines against both avian and swine H1N1 flu was also a costly global preoccupation – EvaluatePharma Vision* estimates that $745m was spent on trials of the various candidates that entered the clinic. This estimate only includes studies that were listed on clinicaltrials.gov, so the real number could be higher still.
The table below singles out some of the more costly products that actually made it to market; several other programmes were abandoned before reaching regulators. And not all are still available: Arepanrix has been withdrawn owing to lack of demand after governments cancelled large orders as the threat of swine flu receded.
|Estimated cost of selected pandemic flu clinical programmes|
Total estimated trial cost ($m)*
|Arepanrix; swine (H1N1) influenza||Glaxosmithkline||95|
|Prepandrix; avian (H5N1) influenza||Glaxosmithkline||80|
|Vepacel; avian (H5N1) influenza||Baxter (subsequently sold to Ology Bioservices)||71|
|Focetria; swine (H1N1) influenza||Novartis (subsequently sold to CSL)||68|
|Audenz; avian (H5N1) influenza||Novartis (subsequently sold to CSL)||60|
|Total cost of H1N1/H5N1 pandemic flu programmes||745|
|Source: EvaluatePharma Vision.|
Since 2007 Glaxosmithkline has split out what it spends on vaccine R&D, and it is notable that this investment ticked higher in the late-2000s, both in real terms and as a proportion of total R&D spend, when much of its work into the avian and swine flu products would have been going on.
For the current pandemic the UK pharma giant has pledged to contribute its adjuvant platform technology to Cepi and other developers working on coronavirus; a deal is in place with China’s Clovis Biopharmaceuticals, for example.
The length of time that traditional vaccines take to develop means that many are hoping that alternative technologies will respond more quickly. Not that Glaxo hung around with its pandemic work: the company put its first H5N1 candidate into the clinic in early 2006, and this became available a little over 12 months later.
Big hopes rest with Moderna and its RNA-based approach, which according to reports will be moving into the clinic today. With luck, early immunogenicity data could emerge in the summer. And other RNA specialists are accelerating work: Biontech said today it planned to start a trial of its candidate next month.
The furore over another developer in this space, Germany's Curevac, shows that progress with this approach is being monitored closely, at all levels. The company was reportedly offered $1bn by the US president, Donald Trump, for exclusive access to any successful vaccine.
*EvaluatePharma Vision’s R&D cost model estimates the cost of individual clinical programmes using real-world data. Company disclosed product-level spend and clinical trial patient numbers are combined to create cost per patient benchmarks by technology and therapy type. Utilising a matching algorithm, these benchmarks are applied to all commercially relevant clinical trials to estimate their cost, which can then be aggregated by product to estimate the cost of development of all products.