As the COVID-19 challenge continues unabated globally, countries across the world eagerly await vaccines that can help communities and economies get back on their feet. Biopharma companies across countries are toiling hard to accelerate vaccine development and large-scale production. Global dynamics are a telling tale of the collaboration–competition undercurrents in stakeholder engagement. Global collaboration is more important now than ever before. However, national priorities are also paramount for every Government. Hence, the global landscape is dotted by an intriguing mix of advancement procurement commitments and funding deals from several national Governments and an emphatic call for more collaboration at the other end.
On account of this active global momentum, three vaccine candidates are set to enter phase 3 trials before August – an unprecedented milestone achieved in record time in the history of vaccine development and pandemic response. With the vaccine candidates moving forward in clinical development, developers and manufacturers have actively sought partnerships to reinforce their production capacities in order to meet the overwhelming vaccine demand required by the world.” In a race to secure vaccine supplies for their countries, various Governments have been in a rush to provide advance procurement funding in lieu of committed supply volumes, catalyze local capacity creation and ensure retention of controlling stake in vaccine developers within national borders. Given the intrinsic nature of high binary risk in biotech product development and lack of clarity on which vaccine will be the first to get to finish line, quest for supply security has led to multiple such funding deals by the same Governments.”
The latest to pitch in is the US Federal government who will award USD 1.6 billion under the Operation Warp Speed to Novavax to expedite the development of its vaccine and pays towards the production of 100 million doses of the vaccine. This becomes one of the largest investments under the federal government’s project, only surpassing USD 1.2 billion investment in AstraZeneca’s vaccine. Close to USD 4 billion has been invested so far under the project, funding 6 companies to support vaccine development and production.
|COMPANIES FUNDED UNDER OPERATION WARP SPEED|
|Novavax||USD 1.6 billion|
|AstraZeneca||USD 1.2 billion|
|Moderna||USD 536 billion|
|Merck and IAVI||USD 38 million|
|Protein Sciences, Sanofi||USD 30 million|
|Janssen Research and Development||USD 456 million|
Another recent investment is from the UK government committing USD 625 million to GSK and Sanofi’s virus S-protein based vaccine to buy 60 million doses once the investigative vaccine proves to be successful. This is the first deal for the said vaccine which is due to begin clinical trials in September. The UK government has previously committed to purchase 100 million doses of Oxford-developed vaccine from AstraZeneca.
AstraZeneca has forged a series of agreements and partnerships to ramp up the global production capacity for Oxford’s vaccine AZD1222, totaling near to 2 billion doses through 2020 and 2021. The latest of these was an agreement, in June, with the Europe’s Inclusive Vaccine Alliance (IVA), a strategic collaborative alliance formed by Germany, France, Italy and Netherlands to pool vaccine demand and accelerate supply to European nations.
The developer is advancing rapidly through the clinical development and meanwhile AstraZeneca has strategically tapped on multiple deals to meet the supply in different geographies:
US Supply: In May, US Biomedical Advanced Research and Development Authority (BARDA) extended support of over USD 1 billion for the clinical development, production and delivery of the vaccine. Following this, in June, AstraZeneca inked a deal with Emergent Biosolutions worth USD 87 million to supply up to 300 million doses to USA and another a deal with New Jersey based CDMO Catalent to be the site for the final finishing and packaging of the vaccine.
LMIC Supply: A USD 750 million agreement with CEPI and GAVI to support manufacturing, procurement and distribution of up to 300 million doses. Next is the agreement with the Serum Institute of India to supply up to one billion doses for LMIC countries and a commitment to supply up to 400 million doses before the end of 2020.
EU Supply: In the EU, Germany, France, Italy and Netherlands have together created Europe’s Inclusive Vaccine Alliance (IVA) to drive a collective rapid effort for vaccine procurement. The agreement with Astra Zeneca includes a supply of up to 400 million doses of the vaccine.
In June, China based SinoVac Biotech inked a partnership with Instituto Butantan in Brazil for phase 3 trials of the vaccine. In addition to clinical development, the two are expected to enter into a collaboration for market authorization and commercialization of the vaccine and is likely to give Brazil easier access to a vaccine, once approved. Anticipating further clinical milestones, Sinovac also began the construction of a commercial vaccine plant in China that is expected to manufacture up to 100 million doses of the vaccine annually.
In an interesting structure pursued to address the dual objective of procuring vaccine supply and averting flight of controlling stake to foreign investors, the German Government made an equity investment of 300 Million Euros in CureVac AG to acquire 23% stake in the company. The announcement was made two days before the mRNA COVID-19 vaccine developer announced obtaining approvals to commence Phase I clinical trials in Germany and Belgium. This pre-empted a highly speculated funding deal with the US Government as well as with the NASDAQ listed German biotech venture. National supply security and preference to nurture domestic vaccine manufacturing base was also implicit in the France Government’s support for Sanofi’s new state-of-art vaccine plant announced in France where Sanofi explicitly stated that ‘Sanofi’s heart beats in France’.
While we are encouraged by the acceleration that such proactive funding support can provide for the COVID-19 vaccine, in the context of the globally ravaging impact of this pandemic, we stay hopeful that the spirit of collaboration will prevail, and equity access is not forgotten.