Local vaccine production: a priority for the Eastern Mediterranean Region

REGIONAL COMMITTEE FOR THE October 2022 EASTERN MEDITERRANEAN Sixty-ninth Session Cairo, Egypt, 10–13 October 2022 LOCAL VACCINE PRODUCTION: A PRIORITY FOR THE EASTERN MEDITERRANEAN REGION Objectives of the event On 10 October 2022, a technical session will be held on local vaccine production in the Eastern Mediterranean Region. The objectives of the event are to:  brief Member States on the actions taken by WHO to promote and strengthen local vaccine production;  highlight the strategic directions for moving forward together to scale up vaccine production in the Region; and  share experiences and solicit input into the regional strategy to strengthen vaccine production in Eastern Mediterranean. Background Low- and middle-income countries in the Eastern Mediterranean Region are faced with multiple challenges in ensuring access to quality-assured COVID-19 vaccines. Enhancing local production of quality vaccines is a key pillar in improving access to all essential vaccines. Four countries in the Region are involved in producing different types of traditional vaccines, from raw materials to finished products: Egypt, the Islamic Republic of Iran, Pakistan and Tunisia. In 2012, Saudi Arabia also initiated a limited pharmaceutical operation involving secondary packaging of naked vials of WHO-prequalified vaccines, mainly pentavalent vaccine. None of the four countries are producing sufficient quantities of vaccines to cover national public health needs. Furthermore, over the last 20 years, the production of several vaccines has been suspended due to noncompliance with good manufacturing practices (GMP) and none of the vaccines manufactured in the Region are prequalified by WHO. Due to COVID-19, several countries in the Region (including those with no legacy in manufacturing vaccines) have expressed interest in developing national capacities in vaccine manufacturing, particularly COVID-specific vaccines. In Morocco and the United Arab Emirates, for example, huge investments in local vaccine production are ongoing. The WHO Regional Office therefore conducted an expert consultation in 2021 with participants from the Region and beyond, including vaccine manufactures, pharmaceutical companies, country regulatory authorities and research institutions. This was followed by a joint WHO/Coalition for Epidemic Preparedness Innovations (CEPI) meeting with vaccine manufacturers. Stakeholders requested WHO’s support to scale up vaccine production in the Region, beginning with COVID-19 vaccines. Accordingly, it was agreed to develop a regional strategy to build the capacity of national manufacturers and regulators to ensure sustainable, quality local vaccine production and make the Region better prepared to respond to any future outbreak or pandemic, as well as to meet regional vaccine needs. The strategy would identify the support required from WHO and other partners in building the needed regional capacities of vaccine producers and regulators. Previous related resolutions include EM/RC51/R.10 on vaccine development, accessibility and availability: towards self-sufficiency in the Eastern Mediterranean Region, and EM/RC67/R2 on the regional strategy to improve access to medicines and vaccines in the Eastern Mediterranean Region, 2020–2030, including lessons from the COVID-19 pandemic. 2 Challenges Several gaps and challenges prevent the scaling up of local vaccine production in the Eastern Mediterranean Region, including weak or absent political commitment and lack of support to define the strategic directions for vaccine production in countries. The high costs and long timelines required to establish the complex processes and maintain GMP compliance are further barriers that need to be addressed. Lack of financial resources and managerial issues are compounded by limited local expertise in vaccinology and biotechnology, as well as limited capabilities for sustainable production of a broad portfolio of vaccines. In addition, the ongoing sanctions/embargos and protracted emergency situations in several countries of the Region present major hurdles. Expected outcomes  Member States briefed on the actions taken by WHO to promote and strengthen local vaccine production in the Region.  Member States briefed on the strategic directions for working together to scale up local vaccine production.  Input gained into the regional strategy to strengthen local vaccine production in the Region.