DESPITE having a young population and a current dependence on imported vaccines, the Philippines would gain from having its own vaccine manufacturing industry. However, it will take more time and investments to make this happen, according to the World Bank.
In a Philippine case study for the Asean Vaccine Development and Manufacturing Research Project, the World Bank said the Philippines faces a number of challenges that prevent it from becoming a vaccine manufacturer in the region.
One of these primary challenges is that the Food and Drug Administration (FDA) has yet to achieve Maturity level 3 based on the World Health Organization (WHO) Global Benchmarking Tool (GBT).
“It is also preparing for an upcoming WHO GBT audit by working to address challenges identified during a previous audit. Facility and manpower needs have been identified and the PFDA [Philippine FDA] is working to address them through ongoing capacity-building efforts. Achievement of ML3 status would enable the Philippines to better support and participate in regional vaccine efforts,” the World Bank said.
Based on the WHO data, a Regional Regulatory System must attain an overall ML3 to be eligible for listing as a vaccine manufacturer and undergo the Performance Evaluation Framework (PEF).
The PEF, according to WHO documents, is designed to promote trust and reliance in regulatory systems in the context of the international supply of medicines and vaccines.
The FDA, World Bank said, has received an overall rating of ML1, though some functions received higher scores than others. The national regulatory system, registration and marketing, and clinical trials oversight were rated ML1.
In terms of vigilance, licensing establishments, regulatory inspection, and laboratory testing, the FDA was rated ML2 while only the National Regulatory Authority (NRA) lot release function was rated ML3.
“The WHO team determined that nine functions have greater than 80 percent implementation, and two have greater than 90 percent. There will be a follow-up assessment in October 2022 followed by a formal assessment scheduled for 2023,” World Bank said.
The report also noted that a number of pharmaceutical companies in the Philippines have the potential to manufacture vaccines. However, certain concerns prevent them from doing so.
These include their dependence on imported raw materials for vaccine production, as well as the difficult operating environment that leads to high labor costs and concerns about transparency in business transactions.
The local pharmaceutical industry also needs policies that support investments such as long-term advance market commitment/guarantee by the Government.
The World Bank also noted a need to capacitate human resources with required technical skills for vaccine manufacturing and to build relationships with external partners to support technology transfer.
Given these challenges, the World Bank said, the Philippines can benefit from a regional vaccine security ecosystem that allows it to source vaccines from regional manufacturers.
This is a feasible arrangement while the country focuses on building its domestic capacity in vaccine delivery and procurement planning to ensure sufficient vaccine supply.
“With its large population, a market guarantee or long-term commitment from the Philippines to procure vaccines from a regional source could help to encourage investment in vaccine manufacture in the ASEAN region,” the World Bank said.
Image credits: Pfizer via AP