Long before the first Covid-19 vaccines were authorized, it was known that equitably supplying them to populations around the world would be an enormous challenge. Now the failure to do so is readily apparent, with the catastrophe in India as a case in point. The world needs to now regroup in order to greatly accelerate the manufacture and distribution of vaccine supplies. This article offers four tactics to do so.
The scarcity of Covid-19 vaccines in many countries around the globe puts everyone in the world in peril. That’s because as long as large populations around the world remain unvaccinated, variants of the virus will continue to emerge, including some that might be able to evade existing vaccines. Therefore, the only way to end the pandemic is global vaccination. However, economic models of vaccine manufacturing indicate many countries won’t be likely to achieve widespread immunization until the end of 2022.
We must do more than wring our hands. We can take actions now to add order to the vaccine market, mitigate bottlenecks, and increase the global supply of and access to the portfolio of Covid-19 vaccines. The horrific situation in India underscores the need to expand investment and coordination of the worldwide supply chain and the infrastructure for responding to future pandemics.
The manufacturing of Covid-19 vaccines and auxiliary supplies has emerged as a daunting global challenge. The early competitive procurement of vaccines by the United States and other high-income countries has fed a widespread assumption that each country will be solely responsible for its population, a stance that has sparked protests outside Moderna’s headquarters in Cambridge, Massachusetts. It is clear that this vaccine nationalism was shortsighted.
In April 2020, we shared how to prepare for an equitable global deployment of a portfolio of Covid-19 vaccines by making investments in available technology and infrastructure. Unfortunately, many of those actions didn’t happen, which partly explains the current supply-demand mismatch around the world.
The events of 2021 reinforce the need for governments to conduct scenario planning to inform procurement and pricing negotiations and distribution planning. While having more capacity may ease the situation, it is not necessarily sufficient to achieve high vaccination coverage equitably. For example, India is the world’s largest manufacturer of vaccines, but the following issues have contributed to the drastically low availability of Covid-19 vaccines in that country: inadequate advanced purchasing, insufficient government investment in expanding manufacturing capacity, and inadequate coordination regarding the doses flowing from the factory to vaccination sites, information on how much is needed, and the provision of money for buying vaccines.
We recommend four tactics to address existing problems and expand global supplies of Covid-19 vaccines.
1. Improve the Flow of the Raw Materials
Manufacturing the Covid-19 vaccine portfolio is complex and requires specialized production capacity, including reagents and equipment produced by U.S. and EU-based companies. The market for vaccine materials includes consumables, single-use reactors bags, filters, culture media, and vaccine ingredients. Export blockages on raw materials, equipment, and finished products hurt the overall output of the vaccine supply chain, and in the medium term, everyone loses as a result.
The Biden administration recently announced that U.S. government would remove impediments to the export of vaccine raw materials to India as part of a set of actions to assist that country. In addition, the U.S. government and global agencies that facilitate trade, such as the World Trade Organization and the International Chamber of Commerce, should help forge an international agreement that requires all countries to remove or not create trade barriers that disrupt the global flow of both materials for making vaccines and ancillary supplies.
2. Harmonize Regulatory Processes
In routine times, each country’s drug regulatory agency evaluates the safety, quality, and effectiveness of vaccines before they are authorized for use in the country. For example, the U.S. Food and Drug Administration (FDA) carries out this role for the United States and the European Medicines Agency for the EU’s member countries. But each country’s or bloc’s requirement that a company conduct clinical trials on local populations and that its regulator then perform a full evaluation of the results before authorizing the use of a vaccine delays the rollout of newly developed vaccines.
While the World Health Organization’s (WHO) emergency-use-listing procedure provides a global mechanism to streamline regulatory pathways, many countries still require local bridging studies (local clinical trials) and additional steps before authorizing a vaccine for use in their jurisdictions. During a pandemic, such local trial requirements for vaccines that have already been approved by stringent regulatory bodies in other countries should be waived.
3. Expand Vaccine-Manufacturing Capacity
As Operation Warp Speed in the United States has demonstrated, investing in manufacturing capacity in parallel with clinical trials makes a huge difference in getting large quantities of vaccines quickly. Governments and international public-private partnerships, such as Gavi and the Coalition for Epidemic Preparedness Innovations (CEPI), should use advanced purchase agreements, capacity subsidies, grants, and “concessional loans” with favorable terms to encourage vaccine manufacturers to expand capacity.
With a range of new promising vaccines on the horizon, they should act now to ensure that those that are proven to be safe and effective in clinical trials can be made readily available immediately after the results of the clinical trials are in. These vaccines in clinical trials include one developed by the Baylor College of Medicine; NDV-HXP-S, a vaccine that uses a new molecular design that may create more potent antibodies than the current generation of vaccines; CureVac; and Novavax. CEPI, which has taken a global leadership role in funding the development of and manufacturing capacity for Covid-19 vaccines, could play a central role in resolving shortages of materials needed to make vaccines and orchestrating technology-transfer efforts in order to increase the number of companies producing vaccines.
Expanding manufacturing networks in developing regions is especially important. For such plants to be sustainable in the long term so they are available when needed down the road, they need to achieve cost economics comparable to large plants in the United States, the European Union, and India. This could be achieved by making these plants flexible so they can manufacture not just vaccines for Covid-19 but also others for combating diseases such as Zika, yellow fever, diphtheria, pertussis, tetanus, hepatitis B, and Haemophilus influenzae type B.
There have been widespread calls for governments to waive the patents of Covid-19 vaccines in order to expand their production around the world, and Katherine Tai, the U.S. trade representative, just announced U.S. support for the patent waiver proposal. However, even if companies were to issue voluntary licenses to others to make and distribute their vaccines, many would need government support to identify candidate manufacturers in developing countries, create the legal structure, supply the necessary manufacturing equipment and expertise, and so on. The U.S. International Development Finance Department is providing such assistance to pave the way for Indian pharmaceutical company Biological E to produce at least 1 billion doses of Covid-19 vaccines, including Johnson & Johnson’s.
But as the number of vaccines increases, including some whose inventors have waived royalties, patents may not be the biggest obstacle to quickly expanding supplies. Additional obstacles in many developing countries include the need to install new manufacturing equipment or upgrading existing equipment, a shortage of skilled and experienced chemistry, manufacturing, and controls and quality management professionals, the lack of a strong national regulatory agency to evaluate and approve the manufacturing process, and difficulties in obtaining from abroad adequate supplies of vaccine ingredients and equipment, especially single-use equipment such as bioreactor bags and filters.
4. Establish a Supply Chain Infomediary
The supply and demand scenario around the world has been anything but predictable. Some of the reasons include the ups and downs with some of the authorized vaccines due to complications suffered by some patients, the addition of new vaccines, demand volatility, and new data on differential efficacy of vaccines against new viral variants. This means the manufacturers of different types of vaccines — many of them third-party contract manufacturers such as Lonza, Emergent, and Catalent — must deal with a high degree of uncertainty about what they will be turning out on their production lines in a few months from now. Demand for vaccine supplies, such as the type of syringes and vials, also keeps changing, depending on the vaccine type.
The fact that country governments are purchasing their vaccine doses through multiple channels — the globally coordinated mechanism COVAX (which is co-led by Gavi, CEPI, and WHO), regional purchasing mechanisms such as the African Unionn vaccine purchasing platform, and direct bilateral deals with manufacturers — only makes it more difficult for manufacturers to understand demand and match it with supplies.
The establishment of a supply-chain infomediary could help suppliers and purchasers navigate this turbulent environment. To ensure that all groups share their data with the infomediary, it should be a neutral organization that is not involved in vaccine purchasing, financing, or advocacy. The infomediary would serve as a central repository of demand and supply data, including information on the needs of countries or other purchasers, confirmed purchase orders, supplies of and manufacturing capacity for input materials and finished products, delivery times, and so on. Such information exists but currently resides with different organizations such as Gavi, CEPI, WHO, and UNICEF and individual governments of wealthy countries.
The challenges to vaccinating populations around the world against Covid-19 are enormous. Making matters worse, they are anything but constant and predictable. Consequently, countries and international organizations need to be able to adapt their tactics and must act in a much more coordinated fashion than they have to date. We cannot let national policies impede the expansion of vaccine manufacturing capacity and the equitable distribution of vaccines globally. Addressing supply chain bottlenecks and sustainably expanding manufacturing capacity around the world will not only help address immediate needs but will also ensure that the world is much better prepared to combat the next pandemic.