There’s no such thing as a vaccine generic-not really. Unlike pills for high blood pressure or antibiotics, you can’t just copy a vaccine, swap out a few ingredients, and call it the same. Vaccines aren’t chemicals. They’re living systems. They’re grown in cells, purified under strict conditions, and packed in ultra-cold environments. Even if you have the formula, you don’t have the factory. And that’s why billions of people still wait for shots while others get boosters.
Why Vaccines Can’t Be Generic Like Pills
Generic drugs work because they’re simple molecules. If you know the chemical structure, you can recreate it in a lab with standard equipment. The FDA has a clear path for that: the ANDA process. It’s been around since 1984. Generic versions of drugs like metformin or lisinopril cost pennies because dozens of companies can make them. Vaccines? Not even close. A vaccine like Pfizer’s mRNA COVID-19 shot isn’t just a mix of ingredients. It’s a tiny lipid nanoparticle carrying genetic instructions into your cells. That particle? Made from five specialized lipids. Only seven suppliers in the world make those. If one factory in Germany shuts down, the whole supply chain stumbles. You can’t just order more from Alibaba. There’s no off-the-shelf version. And that’s before you even start the manufacturing process. It takes six to twelve months to produce one batch. You need biosafety level 2 or 3 labs. You need temperature-controlled rooms. You need sterile fill-finish lines that cost $50 million each. A single production line can cost over half a billion dollars to build. No small company can afford that. No country without decades of experience can just start.Who Makes the World’s Vaccines?
Five companies-GSK, Merck, Sanofi, Pfizer, and Johnson & Johnson-control about 70% of the global vaccine market. That’s $38 billion in 2020. These firms don’t just sell vaccines. They own the patents, the tech, the supply chains, and the regulatory relationships. But here’s the twist: India makes most of the world’s vaccines by volume. The Serum Institute of India alone produces 1.5 billion doses a year. It’s the largest vaccine maker on Earth. It made the AstraZeneca shot for less than $4 a dose, while Western companies charged $15-$20. Yet, even with that scale, India still imports 70% of its vaccine raw materials from China. That’s not independence. That’s dependency with a big factory. India supplies 60% of the world’s vaccines by volume. It provides 90% of the measles vaccine the WHO uses. It makes 40-70% of the DPT and BCG shots. But almost all of it is exported. Less than 10% stays in India for domestic use. When India stopped exports during its 2021 COVID surge, global supply dropped by half. Suddenly, the world realized: the backbone of global vaccine access was running on fumes.The Africa Paradox: Producing Nothing, Importing Everything
Africa has 1.4 billion people. It produces less than 2% of the vaccines it uses. The rest? Imported. From Europe. From India. From the U.S. In 2021, 83% of the 1.1 million COVID-19 doses delivered to Africa through COVAX went to just 10 countries. Twenty-three African nations had vaccinated under 2% of their populations. Meanwhile, African health ministers stood up at the WHO and said: “We make 60% of the world’s vaccines-but we import 99% of our own.” Why? Because building a vaccine plant isn’t like building a drug factory. It takes 5 to 7 years. It costs $200-500 million. It needs trained engineers, sterile environments, and a steady supply of ultra-pure lipids and cell cultures. Africa doesn’t have that infrastructure. It doesn’t even have the skilled workforce. The continent’s pharmaceutical industry is where Asia was in the 1980s-before India became the pharmacy of the world. The African Union wants to change that. Their plan: get 60% of Africa’s vaccines made locally by 2040. That will cost $4 billion. That’s a lot. But it’s less than what the U.S. spends on military drones in a year.
Technology Transfer? It’s Not as Simple as Sharing a Recipe
In 2021, the WHO launched a mRNA vaccine technology transfer hub in South Africa. BioNTech, the German company behind Pfizer’s vaccine, agreed to share its know-how. Sounds promising, right? It took 18 months just to get the first batch made. Why? Because BioNTech didn’t just hand over a PDF. They handed over a whole ecosystem. The South African team couldn’t find the right bioreactors. They couldn’t source the exact lipid nanoparticles. The machines they ordered from Europe were delayed by sanctions and export controls. Even the water for cleaning equipment had to meet pharmaceutical-grade standards-something no local supplier could provide. By September 2023, the hub finally produced its first mRNA vaccine. But it can only make 100 million doses a year. That’s less than 1% of global demand. This isn’t a failure of will. It’s a failure of structure. You can’t transfer a vaccine like you transfer a software license. You need factories. You need supply chains. You need regulators who understand biological manufacturing. You need money. And you need time.The Price of Equity
Gavi, the Vaccine Alliance, negotiates prices with manufacturers for low-income countries. They got the pneumococcal vaccine down to $3.50 a dose. But that’s still $3.50 per child. Multiply that by hundreds of millions of children. And then realize: that’s not a discount. It’s a concession. The manufacturer still made a profit. Compare that to generic drugs. When a drug like atorvastatin goes off-patent, prices drop 80-90%. Within a year, you’ve got 20 companies making it. Competition drives prices to near-zero. Vaccines don’t work that way. There’s no competition. There’s no rush to copy. The barriers are too high. So prices stay high. And the poorest countries pay the most in relative terms. In the Democratic Republic of Congo, health workers received doses that expired in two weeks. No cold chain. No refrigerated trucks. No way to use them. That’s not a production problem. That’s a distribution and equity problem. And it’s happening right now.