The COVID-19 pandemic exposed weaknesses in national health systems as well as the lack of equitable and sustainable global health infrastructure, resulting in mass preventable deaths, new variants, and extreme consequences to the economy.

Dr. Jerome Kim, Director General of IVI, speaks of bridging 4 gaps in order to better prepare for the next pandemic: 1) the diagnostics gap to understand the true and current burden of disease; 2) the manufacturing gap to increase vaccine supply in all parts of the world; 3) the equity gap to ensure countries have access to vaccines regardless of their income level; 4) and finally, the leadership gap to unite the world around funding, accountability, and responsiveness. Getting populations vaccinated—not only against COVID-19 but other critical infectious diseases as well—requires significant progress on each of these fronts.

Increasing vaccine production where vaccines are needed most

Addressing this second gap in vaccine manufacturing and supply requires a skilled workforce trained in a highly technologically demanding field. Following a nomination from the World Health Organization, the Korean Ministry of Health and Welfare (MOHW) launched the Global Training Hub for Biomanufacturing (GTH-B) program to develop a comprehensive, hands-on training program and boost vaccine manufacturing capacity in low- and middle-income countries (LMICs). Subsequently, MOHW selected IVI to operate the Global Bio-Intensive Training Courses.

Alice Lee, who leads IVI’s operations of the GTH-B program, notes, “the challenge is designing and implementing training programs that suit the real needs of LMIC-manufacturers. There is often a misunderstanding that biomanufacturing workforce training only targets technicians in a production line—but for one product to receive marketing authorization, you need a wide variety of subject matter experts.”

In July 2022, over 130 participants from 25 countries, including a small cohort from the Republic of Korea, completed the first offering of the bio-intensive training series, an introductory course on biologics development and manufacturing. The two-week course took place in Seoul, covering basic principles across every stage of vaccine development, production, and licensing. Other topics included vaccine policy, patents, and intellectual property rights.

The only costs attached to participating in the training program are related to personal travel fees. However, to this end, the Partnerships for African Vaccine Manufacturing (PAVM) of the Africa Centres for Disease Control Prevention (CDC) provided travel scholarships to 50 trainees from 14 African countries. The Lead of the PAVM Secretariat says, “Participants come from a wide array of backgrounds and were selected in a competitive process, which included their commitment to advance vaccine manufacturing in their home institutions and in their respective countries.”

Following the success of the first course, the second offline offering was the Introductory Course for Standard Practice, a 3-week course held in November on standard practice covering essential skills to operate according to good standards across clinical, manufacturing, laboratory practice, and biosafety on the Seoul National University Shiheung Campus in Korea. Nearly 200 participants from 34 countries completed the coursework and joined site visits to the biomanufacturing facilities of public Korean organizations, such as the Animal Cell Culture Substantiation Center in Andong.

Select lecture materials from these courses are now available online with open access.

Another feature of the GTH-B program is providing consulting services on-site at vaccine manufacturing facilities. IVI conducted the first on-site training and consulting session with Incepta in Bangladesh and, at the close of the year, a second with Afrigen Biologics & Vaccines (Afrigen) in South Africa. A team of IVI’s researchers specializing in vaccine technology transfer, manufacturing-related biosafety, quality management, and good laboratory practice traveled to Afrigen to work alongside their biopharmaceutical production personnel at the company’s headquarters in Cape Town, the first mRNA technology transfer hub designated by the WHO in 2021.

These activities combined represent a global initiative spearheaded by the WHO to boost manufacturing capabilities in LMICs and produce safe, effective, quality vaccines and other health products. With greater self-sufficiency, the aim is to significantly reduce reliance on vaccines produced in high-income countries, which are often procured in excess with no regard to equitable distribution, even at the onset of a global pandemic.

Find more information about the Global Training Hub for Biomanufacturing here. IVI thanks the Korean Ministry of Health and Welfare for supporting GTH-B.

by Aerie Em

Last updated December 26, 2022