The race for a SARS-CoV-2 vaccine is well underway. It’s tempting to assume that once the first vaccine is approved for human use, all the problems of this pandemic will be immediately solved. Unfortunately, that is not exactly the case.
Developing a new vaccine is only the first part of the complex journey that’s supposed to end with a return to some sort of normal life. Producing hundreds of millions of vaccines for the U.S. – and billions for the world as a whole – will be no small feat. There are many technical and economic challenges that will need to be overcome somehow to produce millions of vaccines as fast as possible.
When a coronavirus vaccine is approved, production of other vaccines will need to continue as well. With the flu season each year and children being born every day, you can’t simply reallocate all existing vaccine manufacturing capacity to COVID-19 vaccine production. New additional capacity will be needed.
Governments and other funders face a difficult choice. If they gamble and provide funding to scale up manufacturing for a particular vaccine now, they could save time and thus lives. Picking wrong, though, could end up costing much more in money, suffering and lives. Ultimately, manufacturers will seek financial assurances – like upfront payments or commitments to buy the vaccine when it is available – from governments and funders to make sure that the time, effort and resources dedicated to vaccine development and manufacturing will not be wasted. For example, the U.S. government’s $2.1 billion deal with Sanofi and GSK will include scaling up of manufacturing capacity and the purchase of 100 million doses of the vaccine.
The Size of the Problem is Unprecedented
As the saying goes, knowing is not the same as doing. Producing a completely new vaccine at such a large scale so quickly is unprecedented.
Numerous delays occurred in the production of the H1N1 flu vaccine in 2009. Consider what may happen with a novel vaccine that could require new reagents, production processes, equipment and containers, among other things. Rollouts of the smallpox and polio vaccines occurred decades ago with less urgency and when populations were significantly smaller. Today, assuming that the herd immunity threshold is at least 70%, manufacturers would need to produce at least 230 million doses to cover the U.S. population and over 5.25 billion doses to cover world’s population. And that’s if only one dose is required. Requiring two doses per person would double the doses needed.
Never before has humanity tried to produce something for every person on Earth as quickly as possible. There are going to be problems.
Economic Poker Game
Ultimately, most potential vaccine manufacturers are businesses, seeking to minimize costs and maximize revenue where possible. They will want incentives to forego other more lucrative opportunities, such as continuing to develop or produce medications that have higher profit margins.
For example, companies may not readily reveal current and potential manufacturing capacity. After all, these can be major bargaining chips in negotiating contracts with governments and other possible funders. Revealing that you have too little capacity right now may jeopardize confidence in your ability to make the vaccine. Revealing that you already have enough capacity can hinder your bargaining for more funding and resources.
The type of vaccine developed, size and location of the initial target populations, the way the vaccine is administered, the number of doses and the storage requirements for the vaccine are all interconnected and just some of the factors that affect the production requirements. For example, work done by my team at the City University of New York has shown that that the number of vaccine doses that you put in a single vial can have a variety of cascading effects on vaccination and disease control programs.
People’s lives, and life as we know it, are on the line. All of the complexities of producing a vaccine need to be addressed through open worldwide discussions and extensive mapping and modeling of these scenarios. Without proper planning and preparation, society may be left in a situation where production cannot meet demand or vaccines are shoddily produced.
These challenges of production and distribution, though large, are not insurmountable. The more planning governments and businesses do now, the better they will be able to deliver the vaccines the world so desperately needs.
ABOUT THE AUTHOR
Bruce Y. Lee, MD, MBA has expertise in systems modeling, computational and digital health, entrepreneurship, and science and health journalism and communications. He is a Professor of Health Policy and Management at the City University of New York (CUNY) Graduate School of Public Health & Health Policy where he is the Executive Director of PHICOR (Public Health Computational and Operations Research). He has over two decades experience in industry and academia developing mathematical and computational models to assist a wide range of decision makers in health and public health. This has included serving as an Associate Professor at the Johns Hopkins School of Public Health and the Carey Business School, Associate Professor at the University of Pittsburgh, and Senior Manager at Quintiles Transnational. Other experience includes working in equity research at Montgomery Securities and founding two companies. He has authored over 200 scientific publications.