The Egyptian Drug Authority (EDA) hosted a virtual regulatory workshop in partnership with the Coalition for Epidemic Preparedness Innovations (CEPI) and in collaboration with the World Health Organization (WHO), with the aim of strengthening regulatory readiness to accelerate the development and registration of Middle East Respiratory Syndrome (MERS) vaccines, and supporting the objectives of the “100 Days Mission” for vaccine availability during public health emergencies.
The workshop covered updates on ongoing MERS vaccine projects, available animal models, and the role of immuno-bridging studies in expediting vaccine registration when clinical data are limited. It also reviewed successful case studies such as the Valneva IXCHIQ™ vaccine and the Janssen Zabdeno/Mvabea vaccine. Presentations included an overview of the global epidemiological characteristics of the virus, clinical requirements for conducting studies during outbreaks, and alternative scientific evidence in the absence of active disease circulation.
On the first day, Dr. Amira El-Sayed delivered a presentation on the EDA’s regulatory framework for Emergency Use Authorization (EUA) of vaccines, rapid review procedures, rolling review mechanisms, and reliance pathways, in addition to the roadmap toward full licensure of MERS vaccines and the Authority’s regional role in supporting the preparedness of countries during health crises.
On the second day, Dr. Omnia Ayman focused on the clinical requirements necessary to initiate MERS vaccine efficacy studies during an outbreak. She highlighted the importance of utilizing safety data from established vaccine platforms to accelerate clinical phases, the need for local population safety and immunogenicity data, and the role of pre-reviewed clinical protocols in enabling rapid response. She also presented alternative sources of scientific evidence when case numbers are limited, such as animal models, immune biomarkers, and surrogate endpoints for efficacy.
Regulatory authorities from several countries participated, including the Saudi Food and Drug Authority (SFDA), the Jordan Food and Drug Administration (JFDA), and the European Medicines Agency (EMA). Discussions addressed shared challenges in evaluating scientific evidence, regulatory preparedness requirements prior to outbreaks, and approaches to supporting fast and effective decision-making regarding MERS vaccine authorization.
From the Egyptian Drug Authority, participants included:
Dr. Omnia Ayman Abdel-Khaleq, Manager of the Biological Products Protocol Unit;
Dr. Amira El-Sayed Abdel-Hafez, Manager of Technical Assessment Unit of Biological Products;
Dr. Salma Ibrahim, from the General Administration of Public Relations and International Cooperation;
in addition to attendees from the Central Administration for Biological & Innovative Products and Clinical Studies, and the General Administration of Pharmacovigilance.
From CEPI and other organizations, participants included:
Jacqueline Acquah, Regulatory Affairs Senior Lead for Africa and the Middle East – CEPI;
Dr. Alessandro Lazdins, Senior Regulatory Policy & Intelligence Manager – CEPI;
Nadia Cohen, Lead the strategy and execution of CEPI's Broadly Protective CoV Vaccines (BPCV) program;
Jenny Hendriks, Global Lead for Clinical Immunology – CEPI;
Javier Castillo Olivares, Preclinical Studies Lead – CEPI;
Dori Kovacs, Infectious Disease Epidemiologist – CEPI;
Amol Chaudhari and Saket Thaker, Clinical Development Leads– CEPI;
Suna Habahbeh, Head of Vaccines and Sera Section– Jordan Food and Drug Administration;
Manuela Moura, Scientific Officer – European Medicines Agency;
in addition to participants from WHO, the Saudi Food and Drug Authority, the South Korean Ministry of Food and Drug Safety, and other international bodies and organizations.
The workshop concluded by emphasizing that accelerating the development and authorization of MERS-CoV vaccines relies on the integration of several pillars, including national regulatory preparedness, leveraging existing vaccine platforms, and strengthening data-driven scientific assessment.