Logan Reed
The manufacturing and supply of vaccines have become critical constraints for global access and equity. The United States was quick to produce COVID-19 vaccines, with hundreds of millions of doses available by early 2021. However, US production lagged after a strong start, and by mid-2021, European and Indian vaccine production had exceeded US levels. The US government's use of the DPA to contract with vaccine manufacturers for Operation Warp Speed may have contributed to this lag. While some vaccines are manufactured in the US, many are also licensed by foreign suppliers. The landscape of vaccine manufacturing is complex and opaque, with scarce publicly available information on production, making it challenging for policymakers to make informed decisions.
| Characteristics | Values |
|---|---|
| Vaccines manufactured in the US | DTaP (Daptacel); DTaP+IPV (Kinrix); DTaP+Hepatitis B+IPV (Pediarix); Hepatitis A (Havrix), VAQTA; Hepatitis B (Engerix-B), Recombivax-HB; Hepatitis A+Hepatitis B (Twinrix); Hib (Hiberix), PedvaxHIB, ActHIB; Inactivated influenza (Fluarix Trivalent, FluLaval Trivalent), Fluzone High-Dose Trivalent, Fluzone Trivalent, Fluad Trivalent, Flucelvax Trivalent, Afluria Trivalent; Influenza A (H5N1) monovalent vaccine, adjuvanted (Arepanrix), Audenz; Meningococcal-MCV4 (Menveo); MMR (Priorix), M-M-R II; Meningococcal serogroup B vaccine (Bexsero); Meningococcal ABCWY vaccine (Penmenvy); Rabies (RabAvert), Rabivert, Imovax; RSV vaccine (Arexvy); Rotavirus (Rotarix), RotaTeq; Tdap (Boostrix), Adacel; Zoster Vaccine Recombinant Adjuvanted (Shingrix); Ebola Zaire Vaccine, Live (ERVEBO); Measles, Mumps, and Rubella (MMR+Varicella (ProQuad); Pneumococcal-PCV15 (Vaxneuvance); Pneumococcal-PCV21 (Capvaxive); Pneumococcal-PPSV23 (Pneumovax 23); RSV monoclonal antibody (Enflonsia), Beyfortus; Varicella (Varivax); Zoster (Zostavax); Poliovirus, inactivated (IPOL); Anthrax vaccine adsorbed (BioThrax); Anthrax Vaccine Adsorbed, Adjuvanted (Cyfendus); Smallpox and Monkeypox (Jynneos); Typhoid vaccine live oral Ty21a (Vivotif); Yellow Fever (YF-Vax); Chikungunya Vaccine, Recombinant (Vimkunya); Cholera vaccine (Vaxchora); Smallpox and Mpox Vaccine, Live (ACAM 2000); COVID-19 vaccines |
| Vaccine manufacturing in the US | The US has domestic producers of vaccines, but also purchases vaccines from foreign suppliers. |
| Vaccine manufacturing data | Data is scarce and fragmented, but some organisations are tracking and analysing publicly available information on manufacturing by vaccine and location. |
| US COVID-19 vaccine manufacturing | The US was quick to produce COVID-19 vaccines, but fell behind in 2021 as production in the EU and India surpassed the US. |
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What You'll Learn
Vaccines manufactured by US firms
The United States has a mix of domestic and foreign vaccine suppliers, with a large number of vaccines licensed by both types of manufacturers. Some US firms with vaccines licensed in the US include Wyeth, with 16 licensed vaccines, and Merck, with 13. Other US firms with licensed vaccines include Pfizer, Moderna, AstraZeneca, and GlaxoSmithKline.
Vaccine development often begins with research conducted by universities, biotechnology firms, or pharmaceutical companies. Two government agencies, the National Institutes of Health (NIH) and the FDA, also play a role in the approval process. Once a vaccine is approved, the production process involves high fixed costs, with costs associated with quality assurance activities, administrative labour, depreciation, and other manufacturing overhead.
The US has experienced periods of vaccine supply shortages, such as in the mid-1980s due to a product liability crisis and from fall 2000 to summer 2002, when there were nationwide shortages of five childhood vaccines. These shortages can occur due to various factors, including supply chain issues, manufacturing disruptions, and the complex nature of vaccine production, which involves the transformation of live biological organisms into safe and stable immunization components.
To ensure vaccine availability, the US government has implemented strategies such as competitive purchasing approaches, allowing states to choose their suppliers at federal contract prices. Additionally, the Veterans Administration (VA) penalizes firms for increasing prices above the consumer price index, which has helped keep vaccine prices low.
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Vaccines purchased by US states
A large number of vaccines are licensed in the United States by both domestic firms and foreign suppliers. In 1998, the CDC introduced a competitive approach to vaccine purchasing, under which states can purchase from the supplier of their choice at the federal contract price. This has resulted in a complex market, with many vaccines being maintained within a narrow temperature range during storage and delivery.
The US was one of the first countries to purchase COVID-19 vaccines, with the first purchases being made in May 2020 for the Oxford-AstraZeneca vaccine. This was followed by purchases from other high-income countries, and by the end of summer 2020, the UK, EU countries, and Canada had purchased enough doses to cover their populations. Middle-income countries such as Russia and China also developed their own vaccine candidates and secured deals, while low-income countries have struggled to purchase enough vaccines and have relied on donations from high-income countries and coalitions such as COVAX.
In the US, the federal government has played a key role in vaccine distribution, with the CDC reporting weekly updates on vaccines administered, including historical revisions from individual states. However, federal data may differ from state-reported data, as states may post on different schedules. As of October 2022, the CDC reported that providers had administered 5.05 million doses in the past seven days, including first, second, and additional or booster doses.
Vaccine purchases by US states are influenced by various factors, including the competitive market introduced by the CDC, federal contracts, and state-specific needs and priorities. States with lower adult vaccination rates, for example, tend to have reduced coverage among children and teens. Additionally, the VA penalizes firms for increasing prices charged to its non-government customers, which has resulted in low FSS vaccine prices. Overall, the US vaccine market is dynamic and involves a range of stakeholders, including federal agencies, state governments, and private-sector buyers.
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US vaccine exports
The United States has exported vaccines to other countries, including Latin America, Canada, Mexico, and countries in Central and South America. However, there have been criticisms regarding the US government's initial unwillingness to share US-produced vaccines internationally, which contributed to delays and shortages in global vaccine supplies in 2021. This prompted companies like Pfizer and Moderna to expand their production elsewhere to meet global demand.
During the COVID-19 pandemic, the United States was quick to produce COVID-19 vaccines but eventually fell behind in vaccine exports compared to the European Union and India. By the end of 2021, the EU supplied 160% more doses than the US, and India produced over 60% more. The US did export more than 50% of its local production, but it was not enough to meet global demand.
There were also accusations from Indian vaccine makers that the US imposed an ""embargo" on vital ingredients needed to manufacture COVID-19 vaccines. However, this was refuted, and data revealed that Indian companies had significantly increased imports of vaccine materials from US suppliers. The US also sent emergency vaccine-making equipment to India to support their vaccine production efforts.
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US vaccine production during COVID-19
The United States was quick to produce COVID-19 vaccines, largely due to Operation Warp Speed, a public-private partnership involving the Department of Defense and Department of Health and Human Services. The initiative relied on the Defense Production Act (DPA) of 1950 to accelerate the research, development, and early manufacturing of a diverse array of potential candidate vaccines. By early 2021, a little over a year after the pandemic began, the US had made hundreds of millions of doses of safe and effective COVID-19 vaccines available.
However, by the summer of 2021, US production of COVID-19 vaccine doses mostly stopped growing, and production in the European Union surpassed that of the United States. This was due to a variety of factors, including shortages of critical inputs, disruptions to manufacturing supply chains, and gaps in the available workforce. For example, vaccine manufacturing supply chains were strained by the global demand for certain goods and workforce disruptions caused by the pandemic. There were challenges in obtaining materials, including reagents and certain chemicals.
Operation Warp Speed (OWS) faced challenges in scaling up manufacturing and took steps to address them. Vaccine companies worked in partnership with OWS to expand production capacity. The US Army Corps of Engineers also oversaw construction projects to expand capacity at vaccine manufacturing facilities. OWS officials worked with the Department of State to expedite visa approval for key technical personnel and requested that DOD personnel be detailed to serve as quality control staff at vaccine manufacturing sites.
Despite these efforts, OWS had not yet met its production goal of 300 million doses by January 2021. By the end of 2021, the EU supplied 160% more doses than US plants, and India produced over 60% more. The US eventually exported more than 50% of its local production, but it was not enough to meet global demand due to the lag in US production.
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US vaccine manufacturing policy
The US has a competitive approach to vaccine procurement, where states can purchase from the supplier of their choice at the federal contract price. Manufacturers can increase their market share by lowering their prices during the contract period. This has resulted in FSS vaccine prices as low as $0.01 per dose.
The US has experienced two major periods of vaccine supply shortages. The first was in the mid-1980s, when manufacturers left the US market due to a product liability crisis. The second lasted from 2000 to 2002, during which there were nationwide shortages of five childhood vaccines that protect against eight of the eleven childhood diseases prevented through routine immunization.
Vaccine development in the US begins with basic research, which is usually conducted by universities, biotechnology firms, or pharmaceutical companies. The FDA requires that vaccines used in Phase III clinical trials be produced in a facility that will be used for commercial production if the vaccine is approved. As a result, manufacturers must often invest more than $30 million in the production facility before product approval. To obtain a facility license, a company must first create full production capacity for that vaccine.
During the COVID-19 pandemic, the US was quick to produce vaccines, but fell behind in sharing those doses internationally. The US government invested in a diversified portfolio of vaccine candidates and subsidized many of the costly and lengthy Phase III clinical trials. However, the use of the DPA through Operation Warp Speed created uncertainty for US plants regarding the export of doses globally, prompting companies like Pfizer and Moderna to expand production elsewhere.
To address this, the US government plans to invest billions of dollars to expand US manufacturing capacity, with the goal of producing at least one billion doses of mRNA vaccines per year beginning in mid-2022. This will help meet immediate vaccine needs overseas and domestically, as well as prepare for future pandemics.
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Frequently asked questions
No, vaccines are manufactured in many countries around the world.
Yes, vaccines are manufactured by both domestic firms and foreign suppliers for the US market.
Since 1998, US states have been able to purchase vaccines from the supplier of their choice at the federal contract price.
Manufacturers can increase their market share by lowering their prices during the contract period.
The US was initially quick to produce COVID-19 vaccines, but fell behind in 2021 when production in the European Union and India exceeded US production levels.
