Vaccine Generics: Why Global Production and Access Still Aren't Equal

There’s no such thing as a "generic vaccine" in the way there’s a generic aspirin or generic antibiotics. That’s not a technicality-it’s the core reason billions of people in low-income countries still wait months, sometimes years, for vaccines that wealthier nations received within weeks.

Unlike pills made from simple chemical formulas, vaccines are living systems. They’re grown in cells, purified with precision, and often frozen at -70°C. You can’t just copy the recipe. You need the right labs, the right machines, the right raw materials, and years of training to make them. Even if a company in India or South Africa gets the technical blueprint from Pfizer or Moderna, they still can’t just start producing. The supply chain for just one ingredient-lipid nanoparticles used in mRNA vaccines-has only five or seven suppliers worldwide. If one of them runs out, or if the U.S. blocks exports during a crisis, global production halts.

Why "Generic" Doesn’t Work for Vaccines

For small-molecule drugs, regulators like the FDA can approve generics by proving they’re "bioequivalent"-meaning they work the same way in the body. That process takes months. For vaccines? It takes years. You can’t test bioequivalence because vaccines don’t just release a chemical into the bloodstream. They trigger complex immune responses. So every new vaccine, even if it’s nearly identical to one already approved, needs a full new application. That means new clinical trials, new safety data, new manufacturing validation. It’s not a shortcut. It’s a full rebuild.

This isn’t just bureaucracy. It’s cost. Building a single vaccine production line can cost more than $500 million. That’s not a startup expense. That’s a national investment. And the return? Thin margins. The Serum Institute of India makes the AstraZeneca COVID-19 vaccine for $3-$4 per dose. Western companies sold theirs for $15-$20. But after factoring in cold storage, quality control, and compliance with international standards, the profit is barely there. No private company will risk half a billion dollars on that unless they’re guaranteed buyers.

Who Makes the World’s Vaccines-and Who Gets Them

India produces 60% of the world’s vaccines by volume. It supplies 90% of the WHO’s measles vaccines and 70% of its diphtheria, pertussis, and tetanus shots. Yet, 99% of the vaccines used in Africa are imported. That’s not a mistake. It’s a system.

India’s factories churn out billions of doses every year. But most of them are shipped to wealthy countries that pay more. When India faced its own COVID-19 surge in April 2021, it stopped exports to protect its people. Global supply dropped by nearly half overnight. Meanwhile, African nations that had been counting on those doses saw their vaccination campaigns stall. The same thing happened in 2022 when U.S. export controls on key raw materials disrupted production in India and elsewhere.

It’s not just about supply. It’s about access. In April 2021, 83% of all COVID-19 vaccine doses delivered to Africa through COVAX were administered in just 10 countries. Twenty-three African nations had vaccinated less than 2% of their populations. Health workers in the Democratic Republic of Congo received doses that would expire in two weeks-because they had no reliable cold chain to store or transport them.

The Manufacturing Gap: Years, Not Months

Setting up a vaccine factory isn’t like opening a drug packaging plant. It takes five to seven years. Even with technology transfer from a big company like BioNTech, it took South Africa’s WHO-supported hub 18 months just to get its first mRNA doses off the line. And that’s with direct support, training, and funding. Most countries don’t get that help.

Why so long? Because it’s not just about the machines. It’s about the people. You need engineers who understand bioreactors, technicians trained in sterile handling, quality control teams who can detect microscopic contamination. You need a local supplier base for cell culture media, filters, and specialized glass vials. Most countries don’t have any of that. They import 70% of their vaccine raw materials from China. If China slows down, so does the world.

The African Union estimates it will take $4 billion and 10 years to get Africa producing 60% of its own vaccines. That’s a massive investment. And it’s not happening fast enough. Right now, Africa manufactures less than 2% of the vaccines it uses. Meanwhile, the U.S. and EU are pushing to bring production home-not to help low-income countries, but to reduce their own supply risks. The FDA’s 2025 pilot program prioritizes faster approvals for generic drugs made in the U.S., not in India or Nigeria.

Who Pays? Who Decides?

Price isn’t the only barrier. It’s control. Gavi, the Vaccine Alliance, negotiates bulk deals with manufacturers to get lower prices for poor countries. But even then, the pneumococcal vaccine still costs over $10 per dose for the poorest nations. That’s more than many families earn in a month. And there’s no competition to drive prices down. Only five companies control 70% of the global market. They set the price. You take it or leave it.

Compare that to generic drugs. In the U.S., once a patent expires, dozens of companies jump in. Prices drop 80-90%. That’s what happens with pills. Not with vaccines. There’s no race to the bottom because the barriers to entry are too high. No new player can afford the factory. No investor will fund it without a guarantee of buyers. And those buyers? Mostly rich countries with deep pockets.

The Real Problem Isn’t Production-It’s Prioritization

India has the capacity. It has the expertise. It has the factories. But it doesn’t have the power to decide who gets what. When the U.S. imposed export bans on vaccine materials in 2021, India couldn’t override it. When wealthy nations bought up 86% of the first COVID-19 doses, no one forced them to share. The system isn’t broken. It’s working exactly as designed-for profit, not for equity.

There are glimmers of change. The mRNA hub in South Africa is producing vaccines. The Serum Institute is expanding. Some countries are starting to build local capacity. But these are exceptions, not systems. Without binding agreements to share technology, without funding for infrastructure in low-income countries, without rules that force manufacturers to prioritize global need over profit, we’ll keep seeing the same pattern: the rich get vaccinated first. The rest wait.

And when the next pandemic comes? We’ll be right back here-waiting for doses that were made, but never sent.