There’s no such thing as a generic vaccine - and that’s the problem
When you walk into a pharmacy and pick up a generic version of your blood pressure pill, you expect it to cost a fraction of the brand-name version. It works the same. It’s approved. It’s safe. That’s how generics work for most medicines. But it doesn’t work that way for vaccines. There’s no true "generic vaccine" market. Not because no one wants to make them - but because the science, the factories, and the supply chains make it nearly impossible.
Unlike a chemical pill you can copy by reverse-engineering its ingredients, vaccines are living biological products. They’re made from viruses, cells, proteins, or mRNA - things that change with every batch. You can’t just replicate them like a photocopy. You need the exact same cells, the exact same equipment, the exact same temperature-controlled environment, and the exact same rare materials. And even then, getting approval isn’t a matter of proving "bioequivalence." You have to start from scratch with a full clinical trial. That’s why the FDA doesn’t have an abbreviated approval process for vaccines like it does for pills. It’s not a loophole. It’s biology.
Who makes the world’s vaccines - and why it’s so concentrated
Just five companies - GSK, Merck, Sanofi, Pfizer, and Johnson & Johnson - control about 70% of the global vaccine market. That’s $38 billion in revenue in 2020 alone. These firms have spent decades building specialized factories, securing exclusive supply deals, and locking in patents. Their production lines cost $500 million each. That’s not a startup cost. That’s a barrier so high, most countries can’t even see it from where they stand.
India is the exception. It produces 60% of the world’s vaccines by volume. The Serum Institute of India alone can make 1.5 billion doses a year. It’s the reason why 90% of the world’s measles vaccines, and 70% of WHO’s DPT and BCG vaccines, come from India. But even India doesn’t make everything. It imports 70% of its critical raw materials from China - especially the lipid nanoparticles needed for mRNA vaccines. When the U.S. restricted exports of those materials during India’s 2021 COVID wave, global vaccine supply dropped by half. That’s how fragile the system is.
Why Africa imports 99% of its vaccines - despite being a top producer
Africa produces 60% of the world’s vaccine volume - but almost all of it is exported. The continent imports 99% of what it uses. That’s not a mistake. It’s a system designed that way. African nations don’t have the factories, the regulatory capacity, or the capital to build their own. The World Bank says local manufacturing covers less than 2% of Africa’s vaccine needs. Meanwhile, countries like South Africa, Senegal, and Rwanda are trying to change that.
The WHO set up a technology transfer hub in South Africa in 2021, partnering with BioNTech to teach local scientists how to make mRNA vaccines. Three years later, they produced their first batch. But they’re making 100 million doses a year - less than 1% of global demand. Why? Because sourcing a single piece of equipment - like a bioreactor or a cold chain container - took over a year. There are only five or seven companies in the world that make the lipid nanoparticles needed. And they’re already contracted to big Western firms. Without access to those materials, even the best-trained team can’t make a vaccine.
Price isn’t the issue - access is
People think if vaccines were cheaper, everyone could get them. But price isn’t the main problem. It’s availability. The Serum Institute sold its version of the AstraZeneca vaccine for $3-$4 a dose. Western companies charged $15-$20. Yet even at $3, the profit margin was razor-thin because of the cost of building and running the factory. That’s not a pricing strategy. That’s survival.
Meanwhile, Gavi, the global vaccine alliance, still pays over $10 per dose for pneumococcal vaccines in the poorest countries - even though the manufacturers promised lower prices. Why? Because there’s no competition. No other company can step in and offer a cheaper version. There are no generics. No alternatives. So countries are stuck taking what’s offered - when it’s offered.
During the pandemic, high-income countries bought up 86% of the first billion doses. Africa got less than 2% of its population vaccinated by April 2021. In the Democratic Republic of Congo, health workers received doses that were set to expire in two weeks - with no working refrigerators to store them. That’s not a supply chain failure. That’s a system failure.
Why building local capacity takes 10 years - and $4 billion
Setting up a vaccine factory isn’t like opening a pharmacy. It takes 5 to 7 years. You need trained scientists, sterile rooms, regulatory approvals, and a steady supply of materials that no one else can give you. The African Union estimates it will take $4 billion and a decade just to get the continent to make 60% of its own vaccines by 2040.
India’s success didn’t happen overnight. It took 30 years of investment, government support, and export-driven growth. Even now, 70% of Indian-made generics are shipped to the U.S., Europe, and Australia - markets with strict quality rules. The same factories that make vaccines for the world also serve those countries’ health systems. That’s why when India stopped exporting during its 2021 surge, the world panicked. There was no backup.
The U.S. FDA’s 2025 pilot program to fast-track domestic generic drug production shows how far behind the U.S. is. Only 9% of active pharmaceutical ingredient (API) manufacturing happens in the U.S. - 44% is in India, 22% in China. The FDA admits this is a national security risk. But fixing it for pills won’t fix vaccines. The systems are different. The stakes are higher.
What’s actually changing - and what’s not
There are glimmers of hope. The mRNA hub in South Africa is proof that technology transfer can work. The Serum Institute shows that low-cost production is possible. Gavi and the WHO are pushing for more local manufacturing. But none of this is enough.
By 2025, low- and middle-income countries will still rely on imports for 70% of their vaccines. The system hasn’t been rebuilt. It’s been patched. The same companies still hold the patents. The same suppliers still control the materials. The same countries still get first dibs on new vaccines.
Until we treat vaccine production like a global public good - not a private profit center - equity won’t happen. You can’t solve a global health crisis with a market that only works for those who can pay first.
It’s not about making more pills - it’s about building more factories
There’s no shortcut. No magic bullet. No generic version of a vaccine that can be copied and shipped overnight. The only real solution is to build more factories - in more places - with real support, not just promises. That means funding, technology sharing, and breaking monopolies on materials. It means letting countries like Kenya, Nigeria, and Indonesia make their own vaccines - not just distribute them.
Right now, the world has the science. It has the talent. It has the will. But it doesn’t have the system. And until that system changes, millions will keep waiting - not because there aren’t enough vaccines - but because the ones that exist are locked behind walls no one else can climb.