Executive Summary
Vaccines are a key aspect of national security and underpin U.S. strategies for public health, biosecurity, and pandemic preparedness. Routine vaccinations keep the American public healthy, decrease healthcare spending, and increase workforce productivity. In a public health emergency, vaccines are an important line of defense against new and emerging threats.
Despite the importance of a secure vaccine supply, our analysis finds two major vulnerabilities in the biomanufacturing landscape for U.S. vaccines: a reliance on foreign manufacturers and a lack of manufacturing redundancy. Together, these two factors limit the country’s ability to respond to emerging health threats.
Key findings include:
- The United States relies on foreign vaccine manufacturers for the majority of its vaccines—fewer than one third of the vaccines in this analysis are manufactured domestically. Vaccines that are not made in the United States are produced in Canada, Israel, and across Europe. The United States will face long supply chains that limit timely distribution in a public health emergency if it cannot control the production of its own vaccines, even if they are produced in allied countries.
- The majority of the vaccines in this analysis do not have redundant manufacturing supply chains and instead are entirely produced at a single manufacturing site. Twenty-nine of the 73 vaccines in this analysis are made at one of just four facilities. Redundancy in the manufacturing process would allow continual vaccine production even if one facility shuts down during a crisis.
- Vaccines on the U.S. Food and Drug Administration’s list of Essential Medicines—which identifies the most critical medicines to have available for acute care in emergencies—are vulnerable to manufacturing disruptions. Of the 33 vaccines on the list, 19 have no domestic manufacturing capability and 22 have no manufacturing redundancy.
- The U.S. government spent nearly as much on foreign-made vaccines as American-made vaccines in 2020—approximately $930 million and $1 billion respectively—through Medicare and Medicaid. Onshoring vaccine manufacturing would allow these taxpayer dollars to support American manufacturing jobs at U.S. facilities.
The vulnerabilities to the U.S. vaccine supply outlined in this report highlight where market forces and national security goals diverge. Biomanufacturers make decisions aimed at recouping large initial investments while maximizing return. The U.S. government, on the other hand, must consider vaccine supply as a matter of national security. Long-term strategies will need to take into account the private sector’s economic interests, the economic challenges presented by developmental timelines and large initial investments, and U.S. public health and biosecurity needs.
Government action in the following three areas would help to address these challenges and have the most significant impact:
1. Protect the existing vaccine supply. Current vaccine manufacturing should be protected now, before long-term strategies have time to take effect. Recommendations include designating manufacturing facilities as critical infrastructure, including routine and seasonal vaccines in the Strategic National Stockpile, and developing a quality management maturity rating system for biologics to reward manufacturers who implement robust quality systems.
2. Identify and monitor vaccine manufacturing vulnerabilities. U.S. policymakers, regulators, and consumers need visibility into the vaccine manufacturing landscape to identify vulnerabilities and develop risk-mitigation strategies. The United States could require manufacturers to disclose manufacturing locations on vaccine labels, or create a public-facing dashboard of manufacturing resiliency that does not disclose specific facility information.
3. Increase vaccine manufacturing resiliency. Efforts to make the U.S. vaccine supply more resilient need to include both increased domestic manufacturing and manufacturing redundancy. Specific recommendations include implementing talent development programs to expand the biomanufacturing workforce, using public procurement funds to encourage new manufacturers to enter the market, using export financing to secure a market for American-made vaccines, and investing in innovative biomanufacturing technologies.