hile the official death toll in 2020 was just over 1.8 million, the World Health Organization (WHO) now estimates that the total number of global deaths attributable to the COVID-19 pandemic in its first calendar year (2020) was at least 3 million.

In 2020, the pace of development of effective vaccines, particularly viral vector and mRNA products, was remarkable, with the first members of the public vaccinated in less than one year from the sequencing of the SARS-CoV-2 virus. But what if pandemic vaccine development and deployment had been faster—say by 100 days? Could 2 million more lives have been saved?

CEPI, the Coalition for Epidemic Preparedness Innovations, is a major global partnership working to accelerate the development of vaccines and other biologic countermeasures against epidemic and pandemic threats. One of CEPI’s key focus areas is to significantly reduce the timeframes for vaccine development in the next pandemic; in fact, to enable global health systems to respond to the next pandemic disease in just 100 days.

But to do so will require much more than words. It will require bringing together and funding public-sector, private-sector, and academic partners to accelerate the development of vaccines against emerging viral and bacterial threats. It also requires clinical testing and regulatory authorization of that vaccine to get it into the arms of people at risk.

Regulatory innovations are just as necessary as technological developments to prepare for the next pandemic and to support vaccine development for epidemics and infectious disease more generally. These include the development of “playbooks” to support pandemic preparedness and response; use of a platform technology approach can expedite vaccine development, regulatory review, and enhanced international and regional regulatory collaboration and convergence. These factors are even more important where regional vaccine manufacturing is being established to enable greater equity in vaccine access.

CEPI had determined that some work has been done within regulators, particularly in developed countries, on preparedness for public health emergencies, but that there was great interest in the subject from regulators, companies, and other vaccine developers across the broader world. In 2025, CEPI launched the CEPI Regulatory Innovations Workshop Series with three workshops that aim to share the technical and regulatory innovations most likely to enable more accelerated vaccine development and regulatory approval during future public health emergencies.

Two workshops have been held thus far and have included more than 110 people representing more than 30 countries, including heads of several regulatory agencies and regional vaccine developers. The first (involving East, Southeast, and South Asian countries as well as the US, Australia and New Zealand, and the WHO) was held in Singapore in January 2025 and the second (involving countries from across Africa and the WHO) in Cape Town in April 2025 (co-hosted by the South African Health Products Regulatory Authority, SAHPRA). The workshops included regional regulators, regional organizations, local vaccine manufacturers, and key academic and government experts.

The workshops have focused on three vaccine modalities which we believe are most readily able to be adapted in 100 days to an as-yet-unknown pathogen in a public health emergency:

• protein subunit/virus-like particle (VLP) vaccines
• RNA (including mRNA)
• viral vector vaccines

CEPI has also invested significantly in these three modalities for the further development of candidate vaccines for priority diseases include Chikungunya, COVID-19, Ebola, Lassa fever, MERS, Mpox, Nipah, Rift Valley fever, and novel viral threats with epidemic or pandemic potential (also known as “Disease X”), as well as in broader vaccine platforms.

Workshop Discussions and Recommendations

At the workshops, participants shared advances in platform manufacturing, regulatory considerations for use of those platforms, and opportunities for regulatory streamlining and enhanced collaboration and convergence. They further discussed the development process for different vaccine types and how platform technologies can reduce development time for new vaccines, particularly in pandemic situations.

They also recognized that rollout of lifesaving vaccines can be delayed through lack of capacity within some regulatory bodies, particularly in the review of products that are based on newer vaccine technologies. Participants discussed how to further develop regulatory review processes so that constraints in regulatory review capacity and expertise would not delay vaccine deployment, particularly during a public health emergency. Participants from regulatory agencies described how their COVID-19 pandemic experience increased their confidence in recognition and reliance activities with other regulators. The workshops also explored which regulatory flexibilities from the pandemic should be maintained, and the very significant potential of electronic methods for collaboration, including collaborative review of cloud-based dossiers.

Each workshop developed specific recommendations that address public health emergencies (regionally confined epidemics and serious disease outbreaks) as well as pandemic situations, including:

• Ensure that the regulatory framework in each country is ready for the next public health emergency by implementing legal mechanisms to enable emergency use authorization, facilitated regulatory pathways, and regulatory reliance or recognition for vaccines. Strengthen regulatory information sharing between agencies and between agencies and vaccine developers and regional regulatory reliance arrangements to enable rapid vaccine regulatory review. Regulatory guidance documents must be prepared, and administrative processes streamlined, in advance.
• Increase regulatory capacity by helping more agencies achieve WHO maturity level 3 (a stable, well-functioning, integrated regulatory system) status for vaccines, conducting pandemic preparedness tabletop exercises in priority countries, and increasing reviewer familiarity with novel vaccine technologies.
• Implement a “platform technology” approach for major vaccine modalities (protein, VLP, RNA [including mRNA], and viral vector). Vaccine developers should enable adaptation of steps in clinical development and manufacturing, stability modeling, and quality controls/analytical testing for other products. A platform readiness dashboard can enable vaccine developers and manufacturers to track platform suitability, comparability, maturity, adaptability, manufacturing facility readiness, and other metrics. Regulatory authorities should assess and adopt emerging international regulatory guidance documents to support development and evaluation of vaccines using the platform technology approach.
• Strengthen Good Manufacturing Practice (GMP) oversight of locally manufactured and imported vaccines to enable their rapid deployment, including support for PIC/S (Pharmaceutical Inspection Co-operation Scheme) membership by regulatory agencies. Extend use of mutual recognition and desktop GMP clearances such as those used by Australia, and ensure that key manufacturing facilities have been inspected before rather than during a public health emergency.
• Support the establishment of regional vaccine manufacturing capacity to enable nimble and equitable access to vaccines in a public health emergency. Manufacturer/regulator communication and planning are required at an early stage with scientific advice to help ensure clarity on requirements. Encourage early GMP inspections of facilities to confirm that planned manufacturing is in line with regulatory expectations.
• Support a greater number of regional clinical trials for epidemic and pandemic vaccine candidates. Regional clinical trials enable rapid familiarity by public health systems across several countries with new vaccine candidates and thus can speed deployment of successful candidates. In public health emergencies, enable agile and standardized approaches to approve clinical trials under Good Clinical Practice to enable rollout and gathering of efficacy data for vaccines after their safety has been confirmed in phase 1 trials.
• Maintain many of the regulatory flexibilities implemented during COVID-19, including greater use of scientific advice, rolling reviews of data in epidemic and pandemic submissions, collaborating on vaccine lot release testing, and avoiding country-specific regulatory requirements (including product labeling and packaging).
• Streamline development and management of product dossiers in public health emergencies including use of a single global English-language epidemic/pandemic dossier, adoption of a single harmonized eCTD structure, and provision of dossiers in a secure cloud-based collaborative space (such as under the Accumulus Synergy Consortium) to enable simultaneous review by multiple regulators.
• Recognize that public trust and social license are foundational to the success of vaccine development, deployment, and community uptake during public health emergencies. The term “social license to operate” generally refers to the ongoing approval or acceptance of an activity by the general public. In this context, this requires establishment of robust vaccine safety reporting and monitoring systems and development of transparent and culturally sensitive communication of safety data, regulatory decisions, and the concept of risk-benefit, among other things.

A third invitation-only workshop will be held in September 2025 in Buenos Aires, Argentina, co-hosted by CEPI and the Pan American Health Organization (PAHO)*. This will enable consideration of learnings from the SARS-CoV-2 pandemic, regional vaccine development and manufacturing, and international and regional regulatory collaboration in a Latin American context.

The outcome reports have been made available to the (many) organizations that took part, and there will be open publication of the outcomes at a later stage.

While focused on the next pandemic, learnings from the workshops can also be applied to regional outbreaks which can be devastating for local communities and economies. But the aspiration to be able to develop and roll out vaccines much faster in public health emergencies—potentially within 100 days—does not stop once the workshops have concluded. A range of other activities is underway or planned, such as quarterly webinars, to foster regulator-regulator and regulator-developer cooperation, and improved preparedness and follow-up activities.

Partnerships have been established to discuss the recommendations and their implementation, and a pandemic preparedness playbook has recently been finalized and is available online. Finally, CEPI teams have already visited several regulators and conducted pandemic preparedness exercises. These exercises simulate high-impact outbreak scenarios involving novel or unknown pathogens and emphasize how critical regulatory functions can be deployed, including coordinated risk-benefit assessments.