Promoting a risk-based approach for the regulatory oversight of vaccines used in pandemics

Global guidelines on regulatory preparedness for pandemic influenza vaccines have been revised to strengthen the regulating of vaccines risk-based approaches to vaccine regulation in the event of a pandemic.

During the 2009 H1N1 influenza pandemic, the deployment of pandemic influenza vaccines in importing countries was delayed or disrupted due to the lack of regulatory preparedness. This resulted in WHO developing guidelines for non-vaccine producing countries on the appropriate regulatory approaches to the marketing authorization and lot release of pandemic influenza vaccines in public health emergency conditions. These guidelines were developed in the context of the Pandemic Influenza Preparedness (PIP) Framework’s Partnership Contribution High Level Implementation Plan, covering regulatory capacity-building and strengthening of pandemic preparedness and response.

However, subsequent public health emergencies such as the Ebola epidemic and COVID-19 pandemic further exposed gaps in regulatory preparedness for other types of pandemic vaccines. The role of national regulatory authorities was not acknowledged in national pandemic preparedness plans, thereby hindering their ability to provide appropriate regulatory oversight.

Using lessons learned from these emergencies, stakeholder feedback, as well findings from WHO Global Benchmarking assessments, WHO initiated the revision of the Guidelines on regulatory preparedness for provision of marketing authorization of human pandemic influenza vaccines in non-vaccine-producing countries. The aim was to expand the scope to cover not just influenza but all pandemic vaccines, and to recommend a harmonised, systematic, risk-based approach for regulating vaccines during a pandemic or other public health emergency in importing countries.

The revised Guidelines empower national regulatory authorities to ensure the timely availability of lifesaving, quality-assured vaccines promoting public health. In particular, these guidelines emphasized the implementation of recognition and reliance principles throughout the entire regulatory system .

The process, supported by the PIP Partnership Contribution, began at the end of 2021 with the development of a concept note and approval from the WHO Expert Committee on Biological Standardization (ECBS) to update the guideline. A drafting group of experts was established in June 2022, with the draft guidelines undergoing three rounds of public consultation including a stakeholder workshop held in Turkiye in April 2023. The revised guideline was approved by the ECBS in October 2023 and will soon be published and available for Member States to implement.

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