Vaccine Generics: Why Global Access Still Falls Short Despite High Production

There’s no such thing as a vaccine generic in the way we think of generic pills. You can’t just copy a vaccine the way you copy a blood pressure medication. Vaccines aren’t chemicals. They’re living systems-complex biological products made from viruses, bacteria, or mRNA instructions that tell your cells to build a defense. That’s why no country can simply start making them overnight, even if they have the technical know-how.

Why Vaccines Can’t Be Generic Like Pills

Generic drugs work because they’re chemically identical to the brand-name version. The FDA can approve them quickly by proving they’re bioequivalent-same active ingredient, same absorption rate, same effect. But vaccines? They’re too intricate. Even two vaccines made from the same virus strain can behave differently if the cell line used to grow it changes, if the purification process shifts by a single degree, or if the lipid nanoparticles in an mRNA vaccine aren’t sized just right.

The World Health Organization says vaccine manufacturing involves 6 to 12 months per batch. Each step-cell culture, viral inactivation, purification, formulation, fill-and-finish-requires extreme precision. A single error can ruin an entire batch. That’s why regulators demand a full new biological license application for every new vaccine maker. No shortcuts. No abbreviated pathways. Not like with pills.

This isn’t just bureaucracy. It’s biology. And it’s why only a handful of companies control most of the world’s vaccines. GSK, Merck, Sanofi, Pfizer, and Johnson & Johnson together made up 70% of the $38 billion global vaccine market in 2020. Their factories are locked down with proprietary tech, specialized equipment, and tightly controlled supply chains.

The Manufacturing Maze: What It Actually Takes to Make a Vaccine

Building a vaccine plant isn’t like opening a generic drug factory. You need biosafety level 2 or 3 labs. Ultra-cold freezers that hit -70°C for mRNA vaccines. Clean rooms that cost millions just to build. And you need materials no one else can easily supply.

Take lipid nanoparticles-the tiny fat bubbles that carry mRNA into your cells. Only five to seven suppliers worldwide make them. If one factory in Germany or China shuts down, the whole pipeline stalls. During the pandemic, the U.S. restricted exports of these materials under the Defense Production Act. India, which was producing millions of AstraZeneca doses, had to pause exports because it couldn’t get enough raw materials. Global supply dropped by half.

Even the world’s biggest vaccine maker, India’s Serum Institute, can’t just scale up on demand. It runs 11 facilities across four sites and churns out 1.5 billion doses a year. That sounds massive-until you remember that in 2021, the world needed over 11 billion COVID-19 doses. Serum Institute made 2 billion of them. Still, it wasn’t enough.

And the cost? One new vaccine production line can run $500 million. That’s not a startup expense. That’s a national investment. No private company will risk that without guaranteed buyers. And governments? They’re often more focused on protecting their own populations than building global capacity.

India: The Hidden Engine of Global Vaccines

India produces 60% of the world’s vaccines by volume. It supplies 90% of the WHO’s measles vaccine. 70% of its DPT and BCG shots. Four out of five kids in low-income countries get their vaccines from an Indian factory.

But here’s the catch: India doesn’t make the raw materials. It imports 70% of its vaccine-grade ingredients from China. That’s a massive vulnerability. When China slowed exports during the pandemic, Indian production dipped. When the U.S. blocked lipid nanoparticles, Indian factories ran dry.

Indian manufacturers also operate on razor-thin margins. They sold the AstraZeneca vaccine for $3-$4 per dose while Western firms charged $15-$20. That’s not because they’re cheap-it’s because they have no pricing power. They’re contract manufacturers. They don’t own the IP. They don’t set the price. They just make it.

And yet, India still can’t meet its own needs. During its second wave in 2021, it stopped exporting vaccines entirely to protect its people. The world lost half its supply in weeks.

Africa: 99% Dependent on Imports

Africa produces less than 2% of its own vaccines. Yet it supplies 60% of the world’s vaccine volume through raw materials and contract manufacturing. That’s a paradox. The continent imports 99% of what it uses.

In 2021, 83% of the 1.1 million COVID-19 doses sent to Africa via COVAX were administered in just 10 countries. Twenty-three African nations had vaccinated less than 2% of their people. Health workers in the Democratic Republic of Congo received doses with two weeks left before expiration-no cold chain, no way to use them.

The African Union wants to change that. Their plan: get 60% of vaccines made locally by 2040. That’ll take $4 billion and a decade. They’ve started a manufacturing hub in South Africa with support from BioNTech and the WHO. But even after 18 months, they were still struggling to get the right equipment and materials. The first mRNA doses rolled off the line in September 2023. Capacity? 100 million doses a year. Global demand? Over 5 billion.

Why Prices Don’t Drop Like They Do for Drugs

When a generic drug hits the market, prices crash. Often by 80-90%. Why? Because the active ingredient is simple. Anyone can make it. Competition floods in.

Vaccines don’t work that way. Even when multiple manufacturers make the same vaccine, they’re not competing on price. They’re competing on supply. Gavi, the global vaccine alliance, reports that the pneumococcal vaccine still cost over $10 per dose for low-income countries-even after manufacturers promised lower prices for poorer nations.

Why? Because the barriers to entry are so high, there’s no real competition. Only a few players can make it. And when they do, they control the market. There’s no “generic” version because there’s no way to replicate it quickly or cheaply.

Technology Transfer Isn’t Enough

You can’t just hand someone a recipe and expect them to bake the cake. Vaccine technology transfer requires more than documents. It needs trained engineers, calibrated machines, approved suppliers, and regulatory alignment. The WHO’s mRNA hub in South Africa got the science from BioNTech. But they couldn’t get the right bioreactors. The right filters. The right lipid nanoparticles. The delays weren’t about knowledge. They were about logistics.

Even if a country builds a factory, it still needs the U.S. FDA or European Medicines Agency to approve it. That process takes years. And most low-income countries don’t have the inspectors or labs to meet those standards.

The Real Barrier: Investment, Not Knowledge

The biggest problem isn’t that poor countries don’t know how to make vaccines. It’s that no one will pay them to build the factories.

The U.S. FDA’s 2025 pilot program aims to speed up generic drug approvals for manufacturers in America. Why? Because 91% of active pharmaceutical ingredients come from outside the U.S.-mostly China and India. The U.S. government is scared of supply chain shocks. But they’re not funding vaccine factories in Africa or Southeast Asia.

Dr. Chris Elias of the Gates Foundation said it plainly: “For vaccine equity in low-income nations, expand manufacturing.” But he also admitted the capital requirements are too high for private investors. And governments aren’t stepping in.

What Needs to Change

We need three things:

• Public funding for vaccine factories in low- and middle-income countries-not just grants, but long-term investment. Think of it like building highways or power grids.
• Shared IP pools for vaccines, not just patents. The Medicines Patent Pool has done this for HIV drugs. It needs to do it for vaccines.
• Global supply chain resilience. We can’t rely on five companies for lipid nanoparticles or one country for cell culture media. We need multiple, geographically diverse suppliers.

Right now, we treat vaccines like commodities. They’re not. They’re public goods. And if we keep treating them that way, we’ll keep seeing the same failures: rich countries hoarding doses, poor countries waiting, and pandemics exposing how fragile our system really is.

Looking Ahead: 2025 and Beyond

By 2025, low- and middle-income countries will still be 70% dependent on imported vaccines, according to Gavi. That’s not progress. That’s a broken system.

The Serum Institute, BioNTech, Oxford, and others have shown it’s possible to scale fast. But scaling for equity? That’s a political choice. Not a technical one.

The next pandemic won’t wait. We can’t afford to wait for another crisis to fix this. We need factories. We need funding. We need a new model. Not generics. Not copies. But real, sustainable, global production.