At the World Health Summit on Friday, the G-20 and other invited leaders endorsed 10 principles, known as Rome Declaration, to strengthen global health security. Most prominent among them is a call to expand vaccine manufacturing capacity, which has become a critical bottleneck in the race to end this pandemic.
Expanding capacity is essential to achieve sufficient immunization coverage to stop the global transmission and mutation of SARS-CoV-2. Before the pandemic, vaccine manufacturers product between 3.5 billion and 5.5 billion doses of all vaccines in the world each year. There are, however, nearly 6 billion vaccine-eligible humans on the planet requiring 12 billion doses for a two-dose regimen of Covid-19 vaccines alone. The number of doses required only increases as vaccines are approved for younger age groups and booster shots are required for variants of concern.
In early 2020, Covid-19 vaccine makers, some with help from governments and nonprofit funders, began investing in additional capacity at risk, ramping up in-house manufacturing (scaling up). scale) and partnering with other manufacturers around the world (-out scale) before clinical trial results are available. These activities have in fact doubled the world’s annual capacity to 10 billion doses.
However, there are inherent limitations to the ability to increase vaccine production capacity in the short term. It usually takes 5 years to build and certify new large-scale manufacturing facilities. Some essential raw materials and equipment, such as bioreactors, are late for months and qualified bioprocess engineers are scarce. With the inherent limitations of short-term expansion, the world needs a system to optimize existing capacity.
In a vaccine-preventable global health emergency, it is in the public interest to be able to redeploy capacity as needed. Some ad hoc mixtures and pairings of abilities have already occurred independently. Merck, which recently abandoned its Covid-19 vaccine candidates, has agreed to manufacture 100 million doses of J & J’s vaccine in its factories. Sanofi, GSK, and Novartis have also agreed to manufacture mRNA vaccines for BioNTech and
Although these agreements redeploy some of the existing capacity, a laissez-faire approach is insufficient to optimize global manufacturing production in the shortest possible time. And it does nothing to ensure equitable access to the resulting vaccine doses. Given that the use of several effective vaccines is already licensed, it is worth considering whether the manufacturing capacity in the reserves for other, more slowly progressing immunization programs should be redeployed to maximize production and l ‘access to authorized vaccines.
The biggest constraint on capacity may be the raw materials and human capital required to operate a manufacturing facility. According to a investigation Led by the Coalition for Epidemic Preparedness Innovations, a nonprofit that is accelerating vaccine development for emerging infectious diseases, manufacturers are reporting untapped manufacturing capacity for an additional 2 billion doses. Facilities are often inactive because they face supply chain disruptions, fail to meet regulatory standards for good manufacturing practices, or cannot hire enough engineers in qualified bioprocesses to take advantage of voluntary licensing opportunities.
To alleviate these capacity constraints, several NGOs – CEPI, UNICEF and Knowledge Ecology International – are offering a global manufacturing network for outbreak response. Institutions participating in this network will agree in advance to pivot their day-to-day activities under contract with CEPI or others to respond to urgent requests for new vaccines in an emergency. CEPI and partner organizations, such as the Developing Country Vaccine Manufacturers Network, can provide materials, education and training to transfer the necessary technology and support manufacturing in this region. The results of the CEPI survey indicate that more than 100 companies in 30 countries – representing more than 2 billion doses of manufacturing capacity – would be willing to participate in this network.
The American experience of establishing public-private partnerships for advanced manufacturing, known as the Centers for Innovation and Advanced Development Manufacturing, is instructive. In practice, the CIADMs have fight to find daily uses to maintain and maintain high levels of quality control. A global manufacturing network would seek to avoid this ‘build and decay’ problem by ensuring that participants conduct programs of ‘peacetime’ development, clinical batch development and inventory replenishment in order to maintain a warm base and an active workforce. A center in Senegal, for example, can expect to receive vaccine research funding from Lassa to develop and share the results within the network, as well as assistance to build a scalable manufacturing facility that can be used. during local epidemics or global pandemics.
Over time, this network will strengthen the regional infrastructure and expertise that will enable low- and middle-income countries to take control of their own health security. Strengthening regional diversity in manufacturing partnerships will also help guard against supply disruptions due to factory crashes, nationalism and trade disputes. This network will also help facilities source inputs and accelerate production alongside clinical vaccine development, thereby encouraging manufacturing at the speed and scale required to maximize the social value of the vaccines produced. According to a study, installing capacity for an additional 1 billion doses of Covid-19 will accelerate global vaccine deployment by more than four months, delivering benefits worth $ 576 to $ 989 per course. The social benefits outweigh the commercial value of the vaccines, estimated at between $ 4 and $ 60 per course, arguing for public investment and coordination to increase capacity.
Even with additional manufacturing capacity and training for vaccine development, input shortages and export controls can thwart the global expansion of production. Increased public investment and coordination at the global level with the G-20 countries and other leading groups such as the World Bank or the World Trade Organization will be essential to realize the long-term vision of a network. global manufacturer. An international agreement such as offers The Covid-19 vaccine investment and trade deal could subsidize and coordinate the vaccine manufacturing supply chain for large-scale emergencies.
Many details remain to be developed in support of a manufacturing network and associated supply chain agreements, including how disputes would be resolved, but this framework could ensure that the benefits of cooperation are evident to all. Emergency vaccine manufacturing networks must be as responsive and scalable as the diseases they seek to contain. Networking across multiple regions of the world will ensure greater speed, scale and access to life-saving vaccines when they are needed most.
Kendall Hoyt is Assistant Professor in the Geisel School of Medicine at Dartmouth University.
Tom Johnston is a consultant with the Coalition for Epidemic Preparedness Innovations.