Making vaccines in Pakistan: the new policy, the Gavi deadline and the opportunity
Pakistan’s first vaccine policy starts with fill-and-finish and aims for full production. With Gavi support ending in 2031, the clock is running.
In this article
Vaccines are one of the clearest gaps in Pakistan’s pharmaceutical industry — and one of the clearest opportunities.
The cost of importing
With help from Gavi, UNICEF and WHO, Pakistan’s vaccine import bill is about PKR 26 billion; without that help it would be almost PKR 100 billion, Profit reported in January 2026. Gavi support is due to end in 2031. In July 2026, Health Minister Mustafa Kamal warned that vaccine import costs could reach $1.2 billion by 2030.
The policy
Pakistan’s first vaccine policy sets out a staged path:
- Fill-and-finish using imported ingredients.
- Full production through technology transfer, partnerships with WHO or joint ventures.
- Exports, once WHO prequalification is achieved — which can take more than five years.
Proposed support includes a National Vaccine Alliance bringing together DRAP, manufacturers, public producers and academia; a National Vaccine Fund providing patient, risk-sharing capital; and long-term buy-back contracts in which the government shares manufacturing risk.
Early steps
Researchers at Dow University have developed a local rabies vaccine variant, and vaccine facilities were among the priorities of the Pakistan–China investment pacts signed in July 2026.
What it needs
| Need | Suppliers involved |
|---|---|
| Aseptic filling lines | Isolator and filling machinery makers |
| Cold chain | Refrigeration, logistics and monitoring |
| Quality control | Laboratories, analytical instruments |
| Regulatory readiness | Consultants, validation services |
Why vaccines are harder than tablets
Most of Pakistan’s pharmaceutical industry makes small-molecule medicines: chemicals that can be synthesised, tested precisely and formulated into tablets, capsules and syrups. Vaccines are different. Many are made from living cells, viruses or bacteria, and the product is partly defined by the process that makes it. Small changes in a fermentation or purification step can change the result, so manufacturers must control and document every stage, and regulators review not only the product but the facility and process behind it.
Three further features make vaccines demanding:
- Sterility — vaccines are injected, so filling must take place under aseptic conditions to standards such as EU GMP Annex 1 (see our Annex 1 article).
- Lot release — each batch is reviewed by the national regulator before it can be used, which needs a capable laboratory and trained staff.
- Cold chain — most vaccines must be kept refrigerated from the factory to the vaccination centre.
Why fill-and-finish comes first
The policy’s first stage — filling imported bulk vaccine into vials and packaging it locally — is the usual entry point worldwide. It builds the hardest operational skills (aseptic filling, environmental monitoring, quality systems and regulatory oversight) with lower investment and risk than making the active component. Once a plant and its people have proved themselves, technology transfer of the upstream process can follow. The same staged logic is being used for local insulin.
The role of WHO prequalification
For export and for supply through international programmes, vaccines generally need WHO prequalification, which assesses the product, the manufacturing site and the oversight of the national regulator. That links vaccine ambitions directly to DRAP’s own progress towards WHO Maturity Level 3: a well-functioning regulator is part of what buyers are relying on.
The Gavi transition
Gavi, the Vaccine Alliance, helps lower-income countries buy vaccines and expects them to take on a growing share of the cost as their economies develop, until support ends. With that deadline in view, every year of preparation counts: local capacity takes years to build, validate and approve.
What to watch
Profit’s analysis stresses that policy consistency and long-term capacity building will decide success. Sterile manufacturing standards are covered in our Annex 1 article.
