Serbia’s efforts in developing and sustaining local vaccine production over the past ten years are helping to secure the country an assured and independent supply of influenza vaccines when the next influenza pandemic strikes.
A decade in the making
In August 2020, the Torlak Institute of Virology, Vaccines and Sera in Serbia received market authorization for its trivalent seasonal influenza vaccine. This event was the culmination of a decade of effort, investment and support to reestablish local production of influenza vaccines in the country.
The journey began in 2009, when the institute was selected as a technology transfer grantee under the Global Action Plan for Influenza Vaccines (GAP)to increase the global availability and equitable access to influenza vaccines in the event of a pandemic. Under GAP, the Torlak Institute received technical and financial support from a range of international partners and the Serbian government to refurbish its influenza vaccine manufacturing facility, establish a modern process for influenza vaccine production, and design and implement clinical trials.
Although GAP formally sunset in 2016, WHO continued to support the Torlak Institute (and other grantee manufacturers) to sustain local production of influenza vaccines.
Sustaining success
Today the institute continues to work with WHO and the Serbian government to ensure that these gains in influenza vaccine production remain sustainable over the long term.
Between 2019 and 2020, using a WHO sustainability checklist, stakeholders from the Serbian government and the Torlak Institute assessed their combined strengths, gaps, and opportunities for sustaining production across six areas: policy environment and health system; influenza surveillance, early detection, and evidence; product development and manufacturing; product approval and regulations; communications to support influenza vaccination; and financing.
This sustainability assessment identified priorities for action, including:
- updating the national seasonal influenza vaccination policy based on current evidence;
- strengthening the business case for local production, including increasing domestic demand and seeking opportunities for export;
- strengthening vaccine distribution and logistics;
- creating new seasonal influenza vaccination campaigns; and
- emphasizing the Torlak Institute’s role within the national influenza pandemic preparedness plan.
In addition to these recommended activities, building on lessons learned from the COVID-19 pandemic, the Torlak Institute is also exploring options to expand its influenza vaccine production capacity, pursue the production of a quadrivalent seasonal influenza vaccine, and assess the feasibility of using newer technologies.