Vaccine Generics: Why Global Production and Access Remain Unequal

Haig Sandavol Jan 5 1

There’s no such thing as a vaccine generic in the way we think of generic pills. You can’t just copy a vaccine like you copy aspirin. Vaccines aren’t chemicals. They’re living systems-complex biological products made from viruses, cells, proteins, or mRNA. That means you can’t simply reverse-engineer them. Even if you have the formula, building the same vaccine from scratch takes years, millions in equipment, and a supply chain few countries can control.

Why Vaccines Can’t Be Generic Like Pills

Generic drugs work because they’re chemically identical to the brand-name version. The FDA lets manufacturers prove they’re the same through simple tests. Not so with vaccines. You can’t test a vaccine for bioequivalence like you test a blood pressure pill. Each batch is alive-grown in cells, purified, stabilized, and tested for safety and potency. One tiny change in temperature, pH, or raw material can ruin the whole batch. That’s why every new vaccine, even if it’s nearly identical to another, needs a full new approval. There’s no shortcut.

The World Health Organization calls this a fundamental mismatch. The system built for pills doesn’t work for biologics. That’s why, despite decades of generic drug success, there’s no global market for cheap, off-patent vaccines like there is for HIV or diabetes meds. The Bill & Melinda Gates Foundation says it plainly: “There’s no ‘generics’ vaccine market as there is for drugs.”

Who Makes the World’s Vaccines?

Five companies-GSK, Merck, Sanofi, Pfizer, and Johnson & Johnson-controlled 70% of the global vaccine market in 2020. That’s $38 billion in revenue, mostly from high-income countries paying premium prices. Meanwhile, low- and middle-income countries were left scrambling. During the early days of the COVID-19 pandemic, high-income nations, representing just 16% of the world’s population, bought up 86% of the first doses available.

India stands out as the exception. It produces 60% of the world’s vaccines by volume. The Serum Institute of India alone makes 1.5 billion doses a year-more than any other company on Earth. It’s the main supplier of DPT, measles, and BCG vaccines to the WHO. But even India’s massive output couldn’t keep up when global demand hit 11 billion doses during the pandemic. And here’s the twist: India makes most of these vaccines for export. It imports 70% of the critical raw materials needed to make them-from China.

The Hidden Supply Chain Crisis

Making a vaccine isn’t just about the factory. It’s about the materials that go into it. For mRNA vaccines, you need lipid nanoparticles-tiny fat bubbles that carry the genetic code into your cells. Only five to seven companies in the entire world can make these at scale. When the U.S. restricted exports of these materials during India’s 2021 surge, global vaccine production dropped an estimated 50%. That wasn’t a glitch. It was a system failure.

Temperature control is another bottleneck. Some mRNA vaccines need to be stored at -70°C. Few clinics in rural Africa or Southeast Asia have freezers that cold. In the Democratic Republic of Congo, health workers received doses that would expire in two weeks-with no way to transport or store them safely. That’s not a manufacturing problem. That’s a logistics collapse.

Even the equipment is scarce. The WHO set up a technology transfer hub in South Africa to help African countries make their own mRNA vaccines. It got technical help from BioNTech. But after 18 months, they still couldn’t get the right machines or materials. The delay wasn’t because they didn’t know how. It was because no one could ship them the parts.

An Indian vaccine factory with a wobbly supply hose from China, leaking as vials explode and exports fly away.

Why Local Production Isn’t Growing Fast Enough

Building a vaccine plant isn’t like opening a pharmacy. It takes $200 million to $500 million and five to seven years. The African Union estimates it will take $4 billion and 10 years just to get Africa making 60% of its own vaccines by 2040. That’s a long time when children are still dying from preventable diseases.

India has over 500 manufacturers of active pharmaceutical ingredients (APIs)-the raw chemical components of pills. But for vaccines, it’s different. Even though India exports 70% of its vaccine production, it still imports most of the key materials. That makes it vulnerable. When India banned vaccine exports during its own Delta wave in April 2021, global supply froze. Countries relying on Indian-made doses-like those in Africa and Latin America-were left with nothing.

And here’s the irony: Africa produces less than 2% of its own vaccines but imports 99%. Meanwhile, it’s home to some of the world’s most skilled vaccine scientists and production facilities. The problem isn’t talent. It’s capital. No bank will fund a vaccine factory in a low-income country when the return on investment is uncertain and the margins are razor-thin.

Price Isn’t the Main Problem-Access Is

People think the issue is price. That if only vaccines were cheaper, everyone could afford them. But the real issue is availability. The Serum Institute sells the AstraZeneca COVID-19 vaccine for $3-$4 a dose. Western companies charge $15-$20. That’s a big difference-but it’s not why millions went unvaccinated. It’s because the doses never arrived.

Gavi, the global vaccine alliance, reports that even after years of “differential pricing” for poor countries, the pneumococcal vaccine still costs over $10 per dose. That’s not because manufacturers won’t lower prices. It’s because they can’t produce enough to meet demand at lower margins. The economics don’t add up. Building a factory costs half a billion dollars. Selling a dose for $4 doesn’t cover that unless you make billions of doses. And no one will make billions unless they’re sure they’ll sell them.

A tiny African lab scientist struggling to build a vaccine as tools are stolen by invisible forces of supply and profit.

What’s Being Done-and Why It’s Not Enough

There are efforts to fix this. The WHO’s mRNA hub in South Africa started producing vaccines in September 2023. That’s progress. But it’s making 100 million doses a year. The world needs 11 billion. That’s less than 1% of demand.

The U.S. FDA launched a pilot in 2025 to speed up approvals for generic drugs made and tested in America. The goal? Reduce dependence on China and India for APIs. But that’s for pills. No such program exists for vaccines. And even if it did, it wouldn’t solve the core problem: you can’t just copy a vaccine. You have to build an entire ecosystem around it.

Dr. Nahathai Thitisawakulchai from the WHO says technology transfer is key-but only if it’s done right. You can’t just hand over a manual. You need training, equipment, supply chains, and regulatory support. And you need time. No country can build this overnight.

The Real Barrier: Profit vs. Public Health

The biggest obstacle isn’t science. It’s incentives. Pharmaceutical companies invest billions because they expect to recoup that money through high prices and exclusive markets. Low-income countries can’t pay those prices. So manufacturers don’t prioritize them.

Dr. Lucica Ditiu from the Stop TB Partnership puts it bluntly: “Any country potentially capable of establishing manufacture is likely to focus on national needs and not on export nor development aid.” That’s not greed. It’s survival. When a country faces its own outbreak, it will hoard what it has. That’s what happened in India in 2021. That’s what happened in the U.S. with masks and PPE.

Meanwhile, Médecins Sans Frontières found that in April 2021, 83% of the 1.1 million COVID-19 vaccine doses delivered to Africa went to just 10 countries. The other 23 African nations vaccinated less than 2% of their people. That’s not a supply issue. That’s a political one.

Where Do We Go From Here?

The path forward isn’t about making more generic vaccines. It’s about making more vaccine makers. That means funding factories in Africa, Southeast Asia, and Latin America. It means sharing not just technology-but equipment, training, and raw material access. It means governments and global institutions stepping in to guarantee demand so private companies feel safe investing.

India showed it’s possible. The Serum Institute proved you can make billions of doses at low cost-if you have the infrastructure, the supply chain, and the market certainty. But India’s model isn’t replicable without massive public investment and international cooperation.

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 truth is, we have the science. We have the talent. We even have the manufacturing capacity in places like India and South Africa. What we don’t have is the political will to treat vaccines like a public good-not a product for profit.

Can vaccines be made as generics like pills?

No. Vaccines are biological products, not chemical compounds. Unlike generic pills, they can’t be proven equivalent through simple tests. Each vaccine requires a full new approval process because even small changes in manufacturing can affect safety and effectiveness. There’s no abbreviated pathway like the FDA’s ANDA for small-molecule drugs.

Why is India so important in global vaccine production?

India produces 60% of the world’s vaccines by volume and supplies 70% of the vaccines used by the WHO. Companies like the Serum Institute of India make billions of doses annually of DPT, measles, and other essential vaccines at low cost. But India imports 70% of its vaccine raw materials from China, making its supply chain vulnerable. It also exports 70% of its production, meaning domestic shortages can disrupt global supply.

Why can’t low-income countries just build their own vaccine factories?

Building a vaccine plant costs $200-500 million and takes 5-7 years. It requires specialized equipment, ultra-cold storage, and access to rare raw materials like lipid nanoparticles-only a handful of companies make these globally. Even with technical training, countries struggle to source parts and meet regulatory standards. Without guaranteed demand or public funding, private investors won’t take the risk.

How did the pandemic expose vaccine inequity?

High-income countries bought 86% of the first COVID-19 vaccine doses, despite making up only 16% of the global population. In Africa, 83% of the 1.1 million doses delivered through COVAX went to just 10 countries. Meanwhile, 23 African nations vaccinated less than 2% of their people. Export bans, like India’s in April 2021, cut global supply by half. These weren’t accidents-they were symptoms of a system designed for profit, not equity.

Is the WHO’s mRNA hub in South Africa solving the problem?

It’s a step forward, but far from a solution. The hub began producing mRNA vaccines in September 2023 after 18 months of delays, mostly due to supply chain issues. But its annual capacity is only 100 million doses-less than 1% of global needs. It shows technology transfer is possible, but scaling it requires massive investment and international coordination that doesn’t yet exist.

What’s the biggest barrier to better vaccine access?

The biggest barrier isn’t science or cost-it’s incentives. Pharmaceutical companies invest in vaccines expecting high returns. Low-income countries can’t pay premium prices, so manufacturers don’t prioritize them. Without guaranteed global demand, public funding, and shared infrastructure, private companies won’t build factories where the market is weak. Vaccines need to be treated as a public good, not just a commodity.