The unprecedented development of several effective COVID-19 vaccines in less than a year is an historic achievement in the annals of scientific research. No less impressive, however, is the work of the US government in organizing and subsidizing a complex supply chain for manufacturing and distributing the COVID-19 vaccine.
American policymakers made large advance purchases of potential vaccines and supported some sponsors—such as Moderna and Johnson & Johnson—carrying out clinical trials, while simultaneously working with myriad far-flung and lesser-known contract manufacturers and suppliers of equipment and ingredients (from cellular material to glass tubing to syringes), to actually produce the vaccines and related supplies. The crash effort that went from science labs to vaccine distribution began under the Trump administration’s Operation Warp Speed and has continued and expanded under the Biden administration.
As Americans prepare to emerge from the pandemic, however, much of the world is still living a nightmare. Global demand for vaccine doses dwarfs the supply. Only a handful of countries are able to manufacture these vaccines at the scale needed to overcome infections and deaths that are still growing—and shifting due to the emergence of viral variants. It is certainly problematic that the United States and some other countries are hoarding doses and critical vaccine supplies for their own domestic populations. But a focus on hoarding alone threatens to miss one crucial point. There is much that the United States can do to help replicate the success of Operation Warp Speed on a worldwide scale to get billions of doses to a global population.
The United States needs to do something new: Devote resources and engage both domestic and international sources in coordinated, targeted investments to build on the existing global infrastructure of labs and manufacturers that produce specialized inputs for the vaccines, whether the drugs or syringes or vials that contain them. The vaccine manufacturing supply chain is already global. But it needs to be better organized and subsidized at multiple levels.
Governments and philanthropists have worked together to scale up HIV medicines and pediatric vaccines, but the level of policy cooperation needed for COVID-19 vaccine production is, admittedly, unprecedented. That’s why a global coordinating body will also be needed to help some countries scale up the production of early stage ingredients and critical equipment, knowing they can incentivize other countries to subsidize expansion of later steps in the manufacturing process that will also need to be scaled up. Skillfully combining those inputs into vaccine output and then guaranteeing access to the final doses and related supplies through international trade will require trust among governments that is currently in short supply. But without guarantees and coordination, individual governments will revert to self-defeating vaccine nationalism.
One way to accomplish this goal would be to set up a new and enforceable COVID-19 Vaccine Investment and Trade Agreement (CVITA). Such a CVITA can draw some lessons from the US subsidization and coordination of its domestic vaccine manufacturing supply chain under Operation Warp Speed. It was not easy to get so many competing entities to work together in the United States. But its success is already clear. The even more complex policy challenge now is to get the rest of the world vaccinated.
How Operation Warp Speed expanded output and input capacity along the vaccine manufacturing supply chain
The US government announced the framework behind Operation Warp Speed (OWS) on May 15, 2020. In contrast to the Trump administration’s mismanagement of the public health response on procurement and distribution of personal protective equipment, social distancing, masking, as well as business and school closures, government officials succeeded in accelerating the development and manufacturing of vaccines for the American public in record time.
The federal government—through the Departments of Defense and Health and Human Services, as well as the Biomedical Advanced Research and Development Authority (BARDA) and other agencies —created OWS to coordinate clinical trials and scale up manufacturing in advance of regulatory approval of potential vaccines. This “at risk” approach—spending money that might be lost if a vaccine was not ultimately approved—was essential to making rapid progress. OWS also helped expedite the development of viable vaccines able to obtain authorization from the Food and Drug Administration for emergency public use.
OWS was not flawless, but there is still much the rest of the world can learn from the American experience. Through OWS and successor efforts in the Biden administration, the United States made large advance purchases and coordinated and matched suppliers with vaccine sponsors to ensure those purchase orders would be fulfilled. OWS subsidized input production capacity, including capital equipment, raw materials, and the syringes, vials, and other ancillary supplies needed for packaging and administering doses into arms. The United States worked with manufacturers and suppliers, invoking the Defense Production Act if necessary, to untangle potential input bottlenecks. The scope of OWS engagement varied depending on the pharmaceutical sponsor and the vaccine.
In July 2020, the United States contracted with Pfizer for 100 million future doses of the vaccine it was developing in partnership with the German biotech firm BioNTech. That sizable advance purchase was enough to help expedite the clinical trials and justify reserving and investing at risk in production capacity at three US manufacturing facilities. Pfizer produced raw materials at its Missouri plant, which were then shipped to its Massachusetts facility and turned into drug substance before being transported to its Michigan site for formulation into the vaccine and packaged for distribution.
With other vaccine candidates, OWS was more extensively involved in scaling up production along a fragmented supply chain.
Consider the further challenges involved when vaccine sponsors include smaller firms, with no prior experience in manufacturing vaccines on a global scale (see figure). In this increasingly typical business model, a biotech firm or university researchers are engaged in the early stage research and development (R&D) of a vaccine candidate before licensing it to a second company to conduct later stage clinical trials, produce the vaccine to commercial scale, seek regulatory authorization for those clinical trials, manufacture, and, ultimately, expand public use.
The process requires adequate supplies of a wide variety of specialized inputs—everything from expensive pieces of capital equipment like bioreactors and filtration pumps to single-use bioreactor bags, adjuvants and lipids—from a range of suppliers. Bulk drug production often requires recruiting partners further along the chain to complete the final “fill and finish” step of adding other ingredients and putting the correct dosage into tiny containers suitable for shipping to health care workers. And, of course, the health care workers require syringes, needles, and personal protective equipment to administer the doses.
One missing input or piece of equipment could grind the entire supply chain to a halt.