Scaling up covid-19 vaccine production: What are the problems and implications?

Increasing production of vaccines for covid-19 presents huge potential problems because of its unprecedented scale. The complex supply chain for vaccines is vulnerable to shortages of key components as well as trade restrictions. The scale-up also threatens the supply of other vaccines and therapies. What does it mean for the future, asks Charles Clift   

Last week Chatham House hosted a Global C-19 Vaccine Supply Chain & Manufacturing Summit which addressed emerging supply and manufacturing challenges in the massive scale up of vaccines for covid-19 which is currently underway. This was designed to tackle the numerous problems arising, or likely to arise, if current ambitious production targets are to be achieved. The principal sponsors were the international pharmaceutical manufacturers’ association (IFPMA) and the Coalition for Epidemic Preparedness Innovations (CEPI), a partnership established after the 2014 Ebola outbreak.  Participants included principally manufacturers, governments, and international agencies.

It is not widely known that current annual production of all vaccines in the world is about 5 billion doses. Yet this year the aim is to produce as much covid-19 vaccine as possible to meet projected demand—the organizers estimated about 9.5 billion doses which has never been done before. To date, production is less than 500 million doses so there is a very long way to go. 

Such a scale up of production will put a huge strain on the producers of the many inputs required to produce a vaccine and get it into the arms of millions of people. One participant in the summit said that their vaccine required 280 separate inputs. These range from the biological materials to grow the vaccine through a wide range of technical kit necessary for production to the vials that contain the finished product. On top of which vaccine production requires a range of highly-skilled technical personnel to manage what is, unlike most conventional medicines, a complex biological process—and such personnel are in short supply. 

Given the complexity of the task, and the myriad of different circumstances affecting the multiplicity of input suppliers, it is very difficult to anticipate exactly which critical supply problems will emerge or exactly how each of them might be dealt with. What is clear is that such problems will likely arise, given the unprecedented scale-up, and producers, regulators and governments need to be alert in addressing them.

There are a number of important concerns. Some of these related to the supply chain threats, others to the effect of the massive scale-up on other health interventions.

Creating such a large manufacturing capacity in a short time, including the diversion of existing manufacturing capacity to covid-19, inevitably means threatening the supply of the routinely supplied vaccines (e.g. for mumps, measles, or pneumonia), that save many lives each year. Not only that, there will also be an impact on other therapeutic drugs such as monoclonal antibodies, which are widely used to treat cancers. There is evidence this is already happening. 

Vaccine supply chains are inherently global in nature—no one country can produce all the inputs required for manufacture of a particular vaccine. This is both a strength in that it offers resilience where there are multiple suppliers around the globe for particular inputs, but it is also a weakness because of the vulnerability to export restrictions imposed by countries to protect their own supplies.

The recent measures taken by the European Union to require authorizations for export of vaccines themselves is one example—and a shipment to Australia from Italy has already been blocked. For producers, threats to the complex supply chain are a major concern. The world’s largest producer of vaccines, the Serum Institute of India (SII), has recently requested the Indian government to intervene because the US Defense Production Act, by prioritising supplies to US producers, threatens production elsewhere. It said “if we cannot get timely supplies of these essential products from the US, it is going to be a serious limiting factor resulting in acute shortage of covid-19 vaccines as their manufacture depends on uninterrupted supply of these raw materials, consumables and components.”

Manufacturers are also concerned about regulatory barriers. While recognizing that regulators such as the European Medicines Agency had been innovative in the speedy approval of covid-19 vaccines and in fostering more collaborative approaches to inspections and approvals, the lack of harmonization around the world remained a concern. One example is simply the differing labelling requirements each country demands which means that batches cannot easily be switched between countries.

Beyond these immediate worries about the threats to scaling up production, there are concerns about what the post-pandemic future will look like. What to do with all the extra capacity? Do we need to maintain capacity for the next pandemic, and if so who will pay? 

Charles Clift is a senior consulting Fellow at the Centre for Universal Health at Chatham House. He works as an independent consultant in the field of global health.  

Competing interests: none declared.