Vaccine generics: international production and access issues

There’s no such thing as a "generic vaccine" in the way there’s a generic version of aspirin or metformin. That’s not a technicality-it’s a fundamental barrier to global health equity. Unlike small-molecule drugs, vaccines are living products. They’re made from viruses, bacteria, or genetic material grown in cell cultures, purified, stabilized, and packaged under conditions so precise that even a tiny variation can ruin a batch. This isn’t chemistry. It’s biology on an industrial scale. And that’s why, despite decades of progress in generic drug production, billions of people still wait months-or years-for vaccines they need.

Why vaccines can’t be copied like pills

Generic drugs are copies. They use the same active ingredient, in the same dose, with the same effect. The FDA lets manufacturers prove they’re equivalent through lab tests and bioavailability studies. No need to repeat clinical trials. That’s the Hatch-Waxman Act, and it’s been working since 1984. But vaccines? They’re not chemical compounds. They’re complex biologicals. You can’t just dissolve them in water and test if they behave the same. Their structure, their purity, their stability-all matter. A single change in the cell line used to grow the virus, or a shift in temperature during purification, can alter how the immune system responds. That’s why every vaccine, even if it’s based on the same antigen, needs a full new license. No shortcuts. No abbreviated applications.

The manufacturing wall

Building a vaccine factory isn’t like setting up a pill生产线. It takes $200 million to $500 million. It takes five to seven years. You need biosafety level 2 or 3 labs. You need ultra-cold freezers for mRNA vaccines-down to -70°C. You need specialized raw materials: lipid nanoparticles, cell substrates, growth media, adjuvants. Only five or seven companies in the world make the critical lipids used in mRNA vaccines. If one shuts down, supply chains crack. During the pandemic, India’s export ban on vaccine ingredients in April 2021 caused a global production drop of nearly 50%. That wasn’t politics. That was physics. No one else had the materials.

Who makes the world’s vaccines?

India produces 60% of the world’s vaccines by volume. The Serum Institute of India alone can churn out 1.5 billion doses a year. It’s the largest vaccine maker on Earth. But here’s the twist: India imports 70% of its vaccine raw materials from China. That’s not independence. That’s vulnerability. Meanwhile, the top five companies-GSK, Merck, Sanofi, Pfizer, and Johnson & Johnson-control 70% of the global vaccine market. They set the prices. They control the supply. And they don’t have to compete on cost. In 2022, Gavi, the global vaccine alliance, still paid over $10 per dose for pneumococcal vaccine in low-income countries-even though the same vaccine cost less than $2 in some high-income markets. There’s no race to the bottom here. No generic price collapse. Just a take-it-or-leave-it model.

Where the gaps are

Africa produces less than 2% of its own vaccines. It imports 99%. During the pandemic, 83% of the 1.1 million COVID-19 doses delivered to Africa through COVAX went to just 10 countries. Twenty-three African nations vaccinated less than 2% of their populations. Health workers in the Democratic Republic of Congo got doses that would expire in two weeks-because there was no cold chain to store them. Meanwhile, the WHO’s mRNA technology transfer hub in South Africa, launched in 2021 with help from BioNTech, didn’t produce its first batch until September 2023. And even then, it’s only capable of 100 million doses a year. That’s less than 1% of global demand. The African Union estimates it will take $4 billion and 10 years just to get to 60% self-sufficiency by 2040. That’s not progress. That’s a delay.

The false promise of technology transfer

The idea that you can just hand over the recipe and someone else will build it is a myth. The WHO’s hub in South Africa had access to the exact mRNA sequence, the protocols, the training. Still, it took 18 months just to get the equipment. Why? Because the machines that mix lipid nanoparticles don’t come from Amazon. They’re custom-built, single-source, and often controlled by Western suppliers. Export restrictions on those machines? They exist. And they’re not always public. When India faced its second wave, U.S. export controls on critical raw materials slowed global production. That’s not negligence. That’s policy. The same companies that own the patents also own the supply chains. And they’re not incentivized to break them.

Who pays the price?

Low-income countries pay more per dose than rich ones. They wait longer. They get expired doses. They get leftovers. Meanwhile, the manufacturers who make these vaccines-many of them based in the U.S., Europe, or Japan-earn billions. Pfizer made $37 billion from its COVID-19 vaccine in 2021 alone. The Serum Institute of India made the same vaccine for $3-$4 a dose, but still barely broke even after accounting for capital costs. That’s not charity. That’s survival. And it’s not scalable. No one can afford to build a $500 million plant for a product that sells for $4. The economics don’t work unless you’re selling to rich markets.

The path forward isn’t generics-it’s sovereignty

We don’t need generic vaccines. We need local production. Real, independent, sovereign manufacturing. Not just assembly lines. Full-cycle facilities that can grow cells, purify proteins, formulate doses, and test quality-all within one country. India did it for generic drugs. It can do it for vaccines. But it needs support: investment, technology sharing without strings, and global rules that force transparency in pricing and supply. The U.S. FDA’s 2025 pilot to fast-track generic drugs made in America shows they know where the risk lies. But that pilot doesn’t touch vaccines. And it doesn’t help Africa. The world needs more Serum Institutes-not more patents. More factories-not more promises.

What’s next?

By 2025, low- and middle-income countries will still be 70% dependent on imported vaccines, according to Gavi. That’s not a forecast. That’s a failure. The tools to change this exist. The knowledge is there. The technology can be shared. But without political will, without investment, and without breaking the grip of a handful of corporations on supply and pricing, the gap won’t close. It will widen. And the next pandemic won’t wait for patents to expire. It will come for the unvaccinated first.