Pakistan, despite being home to one of the world’s largest birth cohorts, lacks significant domestic vaccine manufacturing capabilities. Given its population of 250 million, such a deficiency in vital healthcare infrastructure is deemed inadequate. Hence, investing in vaccine manufacturing capacity could serve as the initial stride towards cultivating the production of advanced, high-value pharmaceuticals in Pakistan.
There is a shortage of insulin and other essential medications in the pharmaceutical market of Pakistan. This news has caused concern among the population, especially those who rely on these medicines for their health. Some individuals have even tried to acquire rabies vaccines from the National Institutes of Health (NIH), only to be informed that the production of rabies vaccines has been halted for a year due to a lack of raw materials. This situation highlights the challenges faced by the country's pharmaceutical sector and the urgent need for addressing the shortages.
In the 1960s, National Institute of Health (NIH) Pakistan was established with the goal of aiding programs to combat infectious diseases, producing vaccines and medicines such as anti-rabies, and anti-venom, and collaborating with the World Health Organization (WHO). Additionally, it had a mandate to serve as the only regional laboratory for viruses like polio and the flu. However, NIH faced challenges in maintaining and developing its capacity for vaccine production, leading to a decline in its performance over time. There is only one producer of the lifesaving vaccines and anti-sera for immunization in the whole country, which is the Biological Production Division (BPD) at NIH. This sole producer failed to cater to the ever-increasing demand in the market because of lack of investment in management systems, staff, infrastructure, technology, quality assurances, and quality control system.
Due to limited domestic production capabilities, the government heavily relies upon international acquisition of vaccines. The production of vaccines is primarily outsourced by subsidizing prices from donor agencies like GAVI (Global Alliance for Vaccines and Immunization). These agencies provide vaccines under long-term agreements. In the local market, private sector participation in vaccine production and distribution is minimal, making the government a near-exclusive buyer. The government procures vaccines in bulk directly from manufacturers or through coordinated multi-country programs funded by donors like GAVI. The Expanded Program for Immunization (EPI) creates the biggest demand for vaccines, making up over 85% of the total vaccine market.
The production of vaccines is primarily outsourced by subsidizing prices from donor agencies like GAVI (Global Alliance for Vaccines and Immunization). These agencies provide vaccines under long-term agreements.
In the next five years, around 1.5 billion vaccines will be needed just to fulfill simple EPI vaccine coverage. Although local companies have the capacity to serve the substantial domestic vaccine market, they face difficulties competing with the subsidized prices offered by the GAVI Alliance. To ensure they can operate at a sufficient scale, local companies require a government guarantee to buy back vaccines, as setting up a vaccine production facility costs around 20 million Pakistani Rupees.
The production of vaccines relies on a collaborative public-private partnership (PPP) model due to the government's primary role as a buyer in the limited market for vaccines. This partnership has proved successful in various instances. In Pakistan, private sector involvement in manufacturing vaccines can complement the existing capabilities of the National Institute of Health (NIH) and address the challenges that prevent output expansion. This approach strengthens the overall health system's ability to meet national demands and achieve self-sufficiency in vaccine and immunoglobulin production.
Pakistan relies on imported finished vaccine products, mostly obtained through international organizations like GAVI and UNICEF. A few local facilities are involved in labeling and packaging imported vaccines. This heavy dependence on imports leads to shortages when demand spikes, as it is influenced by global supply variations. To attain self-sufficiency, the vaccine manufacturing industry needs assistance in acquiring vaccine product manufacturing capabilities.
This includes the ability to make vaccines from imported materials (fill & finish), as well as the production of active pharmaceutical ingredients and excipients. This effort is driven by domestic demand, global demand, production capacity validated by industry, security situation, health concerns of public, and all other stakeholders. Industry insiders believe it will take around 5 years to transition from importing completed vaccines to manufacturing everything locally, including active ingredients and products for vaccine production. This time would allow local producers to comply with World Health Organization (WHO) standards, ensuring quality and integrity throughout the vaccine supply chain.
To achieve the Sustainable Development Goals (SDGs) in Pakistan, particularly in the context of universal vaccination, purchase agreements for vaccines produced locally in the long-term are essential.
Apart from the mentioned factors for local vaccine production, collaborations among significant partners including public sector agencies, international and local private sector companies, and the Drug Regulatory Authority of Pakistan (DRAP) are crucial. Public sector involvement includes the government of Pakistan and provincial governments, as vaccines are considered a public good and universal immunization is a government objective. Private market participation in vaccine sales is typically limited compared to the public procurement system.
To achieve the Sustainable Development Goals (SDGs) in Pakistan, particularly in the context of universal vaccination, purchase agreements for vaccines produced locally in the long-term are essential. This can enable domestic production to become a reality. Therefore, the Planning Commission, the custodian of SDGs in the country, can initiate a public-private partnership (PPP) involving the private sectors, Ministry of National Health Services (MoNHS), and Regulation & Coordination. The NIH’s data can help identify antigens that should be prioritized for local production and develop a sustainable PPP framework.
Efforts should be made to engage international manufacturers of WHO-approved vaccines in negotiating agreements with the Pakistani government to facilitate technology transfers to local companies. Priority should be given to manufacturers who produce original vaccines or another manufacturer approved by the WHO. For successful technology transfer from international vaccine companies, local partners with validated biological production facilities or a willingness to invest in the necessary standards are ideal. These capabilities can be achieved through government contracts with leading global producers of vaccines, who generally prefer working with governments institutions over private entities. Additionally, local firms can also establish proprietary arrangements with multinational corporations (MNCs) through linkages among firms, technology licensing agreements, or hiring the consultants to upgrade and enhance their existing facilities.