Logan Reed
Vaccines have been a critical tool in the eradication and prevention of deadly diseases in the United States. The country has played a significant role in the development, production, and distribution of vaccines, including those for COVID-19. While the US vaccine market is dominated by a handful of large pharmaceutical companies, both domestic and foreign, it has faced challenges, such as supply shortages and the need to balance speed and scale in response to public health emergencies.
| Characteristics | Values |
|---|---|
| Companies that produce vaccines in the US | Aventis Pasteur, GlaxoSmithKline, Merck, Wyeth, Pfizer, BioNTech, Moderna, Johnson & Johnson |
| Vaccines produced in the US | COVID-19, DTaP, Hepatitis A, Hepatitis B, MMR, Influenza, Rabies, Rotavirus, Zoster, Anthrax, Ebola, Typhoid, Cholera, Smallpox, Monkeypox, Polio |
| US vaccine sales | $1.5 billion per year |
| Global vaccine sales | $6 billion per year |
| US vaccine production capacity | Peak monthly supply in 2021 was half that of Europe |
| Vaccines licensed for use in the US | Vaccines, Blood & Biologics |
| US vaccination rate | 67% of the adult population had received at least one dose by July 4, 2021 |
| Impact of vaccination in the US | Prevented 1.9 million deaths, 1.6 million hospitalizations, and 27 million infections from Dec 8, 2020, to Dec 8, 2021 |
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What You'll Learn
COVID-19 vaccines
The United States was quick to produce COVID-19 vaccines, with hundreds of millions of doses made available by early 2021, just over a year after the pandemic began. This was largely achieved by 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 research, development, and early manufacturing of potential candidate vaccines.
Pfizer-BioNTech and Moderna were the two biggest COVID-19 vaccines made in the United States. Both companies announced increases in production scale in the US and the European Union in early 2021 following regulatory authorization of their vaccines. However, Pfizer-BioNTech and Moderna expanded their vaccine production much more in Europe than in the United States. By early summer 2021, US production of COVID-19 vaccine doses had largely stopped growing, and production in the European Union surpassed that of the United States.
There were several reasons for this shift in production. One factor was the failure to expand US capacity, which was partially due to the downsides of Operation Warp Speed's 2020 approach. Additionally, production and supply chain decisions made by these companies may have contributed to the expansion of European supplies. For example, both Pfizer-BioNTech and Moderna added more plants or production lines in Europe and outsourced the "fill and finish" part of the manufacturing process to contract development and manufacturing organizations (CDMOs).
The US government faced criticism for its unwillingness to share early, US-produced doses internationally, which contributed to delays and shortfalls in global vaccine supplies in 2021. By the end of 2021, the EU supplied 160% more doses than US plants, and even India produced over 60% more. However, the US experience in producing COVID-19 vaccines offers valuable lessons for policymakers in combining speed and scale to save lives during a pandemic.
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Pfizer, BioNTech, Moderna production
The Pfizer-BioNTech and Moderna vaccines were two of the biggest vaccines made in the United States. Both companies announced increases in production scale in the United States and the European Union in early 2021, following regulatory authorisation of their vaccines.
Pfizer-BioNTech and Moderna expanded their vaccine production in the European Union more than in the United States. By early summer 2021, US production of COVID-19 vaccine doses mostly stopped growing. Production in the European Union surpassed the United States, as Pfizer-BioNTech and Moderna expanded operations more in Europe.
Pfizer-BioNTech and Moderna each added more plants or production lines to manufacture the vaccine's drug substance. They also outsourced the "fill and finish" part of the manufacturing process to contract development and manufacturing organizations (CDMOs).
In the United States, monthly supplies of Pfizer-BioNTech and Moderna vaccines grew steadily over 2021, delivering 103 million doses by the end of February 2021. In Europe, monthly supplies grew at a faster rate, with peak European monthly supplies of both vaccines in 2021 reaching roughly twice their peak US monthly supplies.
The European Medicines Agency (EMA) has approved additional manufacturing sites and new manufacturing lines to increase the production of the Pfizer-BioNTech and Moderna vaccines. For example, in July 2021, the EMA approved a scale-up of the active substance manufacturing process at two sites in the US (Moderna TX, Inc. in Norwood, Massachusetts, and Lonza Biologics, Inc. in Portsmouth, New Hampshire).
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Merck and Wyeth
Merck, also known as MSD outside the US and Canada, is based in Kenilworth, New Jersey. It produces vaccines for diseases including pneumonia and meningitis. One of its vaccines, Vaxneuvance, is for diseases caused by pneumococcus bacteria. It was approved by the US Food and Drug Administration (FDA) in July 2021. Merck also distributes the VAXELIS vaccine, which is a diphtheria, tetanus, acellular pertussis, inactivated poliovirus, haemophilus b conjugate and hepatitis B vaccine.
Wyeth is a subsidiary of Pfizer and is based in New York. Its Prevnar vaccines are conjugate pneumonia vaccines.
In September 2021, Merck and Pfizer's Wyeth settled a patent dispute over their competing vaccines for preventing diseases including pneumonia and meningitis. Merck alleged that Pfizer was engaging in the aggressive pursuit of overly broad interpretations for its pneumococcal vaccines. The companies entered into a settlement and license agreement, with Merck agreeing to pay Pfizer 7.25% of its net sales from pneumococcal conjugate vaccines worldwide through the end of 2026. After that, Merck will owe a 2.5% royalty to Pfizer through the end of 2035.
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Vaccine tourism
The United States was one of the first countries to produce COVID-19 vaccines, with companies like Pfizer-BioNTech and Moderna leading the world in supplying a lot of doses early on in the pandemic. However, vaccine manufacturing in the US soon fell behind, with production in the European Union surpassing that of the US.
During the COVID-19 pandemic, "vaccine tourism" emerged as a new type of pandemic travel. People would cross state or country lines to obtain a vaccine, particularly a COVID-19 vaccine, more easily and/or earlier. Florida was one of the most popular destinations for vaccine tourism, due to its policy of vaccinating anyone over the age of 65. The state later implemented new ID rules to prioritize Florida residents. Vaccine tourism also occurred across international borders, with people travelling to countries with higher vaccine availability or different vaccine roll-out rules. Some tourism agencies even offered vaccine tourism "packages".
While the impulse to engage in vaccine tourism may be understandable, it poses several ethical issues. Critics of vaccine tourism argue that it is unfair and inequitable, as it prioritizes those who have the financial resources to travel and get vaccinated earlier, potentially taking doses away from local residents. There are also risks associated with vaccine tourism, such as the possibility of not being able to receive the second dose or follow-up care in the case of adverse events. Additionally, vaccination certificates may not be recognized in the traveller's home country, and there may be issues with continuity of care.
In the United States, the fractured healthcare system and varying vaccine eligibility criteria across states contributed to the rise of vaccine tourism. For example, in Wisconsin, mink farmers were prioritized for the vaccine, while in New Jersey, smokers could get priority access. The lack of standardized protocols and differences in vaccine availability across states led people to cross state lines in search of earlier access to the vaccine.
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Vaccine costs
Vaccines have historically been low-cost and have prevented deadly diseases in thousands of Americans. In the 2000s, the US experienced severe vaccine shortages, which could have resulted in serious outbreaks of disease. The US vaccine market is small, with only five companies producing all routinely recommended childhood and adult vaccines. Two of these companies, Merck and Wyeth, are US-based, while the others are based in Europe. The US vaccine market is estimated to be worth $1.5 billion per year, a quarter of the global vaccine market.
The costs of vaccines in the US have risen in recent decades, with both private and CDC annual costs increasing for many vaccines. The average inflation-adjusted private-sector costs rose by 0.9% and 1.4% per year for childhood and adult vaccines, respectively, while CDC-contracted costs rose by 0.9% and 1.0% for pediatric and adult vaccines, respectively.
There are three types of real-world costs that are relevant for economic healthcare decision-making: the list or wholesale price of a product or service, the contracted price or the negotiated price between government agencies, healthcare providers, and manufacturers, and reimbursement for services paid by private or public insurance.
The CDC-administered Vaccines for Children (VFC) federal program provides free vaccines for eligible children. In 2014, about half of US children were eligible for this program.
During the COVID-19 pandemic, the US was quick to produce vaccines, with Operation Warp Speed accelerating research, development, and early manufacturing. US plants delivered 103 million doses by the end of February 2021, compared to 40 million in India and 27 million in the EU. However, by early summer 2021, US production of COVID-19 vaccine doses mostly stopped growing, and production in the EU surpassed that of the US.
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Frequently asked questions
Yes, vaccines are made in the United States. The country was quick to produce and distribute hundreds of millions of doses of the COVID-19 vaccine by early 2021.
The major manufacturers of vaccines in the United States include Pfizer-BioNTech, Moderna, Johnson & Johnson, Merck, and Wyeth.
Yes, in some cases, there have been incentives for people to get vaccinated in the United States. For example, during the COVID-19 vaccination drive, some states did not require proof of residency, allowing foreigners to get vaccinated while visiting the country.
A wide range of vaccines are manufactured in the United States, including those for COVID-19, smallpox, monkeypox, cholera, rabies, influenza, polio, measles, mumps, and rubella, among others.
Vaccines have had a significant positive impact on public health in the United States. For example, COVID-19 vaccination in the United States prevented an estimated 1.9 million deaths from December 2020 to December 2021, according to a study in The Lancet. Vaccines have also helped eradicate smallpox and polio and prevented deadly and disabling diseases in thousands of Americans.
