Thank you.
Thank you to the members of this committee for giving me the opportunity to share my viewpoint on this very crucial topic.
We acknowledge that there is an urgent need to further scale up the production of safe, efficacious COVID vaccines, but also to keep in mind the need for versatility of the vaccine platform to deal with new COVID variants of concern and preparedness for any future pathogens.
Preliminary estimates of capacity show us that in the aggregate—that is, across all vaccine types—we may have sufficient manufacturing capacity to reach global herd immunity by quarter one or quarter two of next year. However, in the disaggregate—implying for specific vaccines such as the messenger RNA vaccines—the overall manufacturing capacity today is lower than the potential market demand.
How can we raise manufacturing capacity and expand it for specific platforms?
Expanding manufacturing capacity to additional secondary manufacturing sites is a complex process that has four main prerequisites: new manufacturing equipment or significant upgrades to existing equipment in the new site; skilled and experienced chemistry, manufacturing and controls staff and quality management professionals at the receiving site; a strong regulatory agency in the country of the new site, which can evaluate and approve the manufacturing process; and lastly, the open and free flow of international supply lines for vaccine ingredients and equipment and, in particular, single-use equipment.
All the companies that have received authorizations for their COVID-19 vaccines have already expanded manufacturing to a few additional sites. Given that the medium- and long-term demand for additional COVID-19 vaccine capacity remains uncertain and that, as such, the long-term sustainability of new manufacturing sites remains unclear, the vaccine developers may not be willing to make additional capital investment and incur the additional operating costs of adding more manufacturing sites to their network.
Public support in the form of capital subsidies or firm purchasing contracts can help resolve this medium- to long-term demand uncertainty and can incentivize the company to further expand manufacturing capacity in new locations. It will strengthen the business case for them to explore and evaluate not only vaccine manufacturing sites but also contract manufacturing sites or sterile manufacturing sites, which could be added to the global manufacturing network. In some cases, the efforts of individual companies could be further strengthened if publicly funded third parties can work to identify new sites that can meet the above-mentioned criteria and have some spare capacity.
More important, the success of existing capacity expansion efforts and of any new manufacturing capacity expansion efforts depends on the free flow of vaccine ingredients and equipment. I'm sure all of you have heard recent news about the shortages of single-use bioreactor bags and specialized filters, which could put manufacturing plants at risk of not being able to produce sufficient doses of vaccine. These would be manufacturing plants that already have the technology transfer, the manufacturing know-how, the intellectual property licence and all the other prerequisites.
Any restrictions on global supply chain flows create the risk of jeopardizing even the existing manufacturing capacity and delaying the start of new sites that are currently getting ready for COVID-19 vaccine production. This is an extremely important area to address through the World Trade Organization and other trade partnerships.
In the medium- to long-term, we need to focus on four key areas to achieve higher production capacity. The first is investing in manufacturing sites that are flexible and can easily switch from one vaccine platform to another. Second is creating a larger pool of human capital that is specialized in biologics manufacturing. Third is further strengthening regulatory co-operation across countries. Fourth is preventing trade and policy barriers in the supply chains for vaccines and other critical health products.
Thank you for the opportunity to share my thoughts. I look forward to questions or any other ways in which I can help the work of the committee.