Vaccine Experts’ Voice at the 2024 PDA Week

We are still full of energy and ideas after the amazing Vaccine Interest Group (VIG) session held during the 2024 PDA Week last March and after successfully publishing our PDA Technical Report No.89: Strategies for Vaccine Development and Lifecycle Management last year!

Prior to the session, the PDA VIG taskforce hosted last February the webinar PDA Technical Report No.89: Strategies for Vaccine Development and Lifecycle Management where the following topics discussed in TR 89 were reviewed with the participants:

• Control strategy from process development to vaccine lifecycle management
• Comparability assessments (as enabler for changes during development and after approval)
• Nonregulatory and regulatory considerations for vaccines lifecycle management

The input from the participants shaped the proposal for the VIG session at the 2024 PDA Week. During the VIG session, several vaccine experts from all over the world joined the discussion by contributing significant ideas to shape PDA VIG objectives as well as some activities for 2024. The following proposed discussion topics:

• Implementation of digital solutions in vaccine process development and/or manufacturing
• Vaccines platforms
• Implementation of risk-based approach in vaccine development and/or lifecycle management
• Innovation in vaccines
• Opportunities in vaccines lifecycle management

Based on the feedback received, some priority areas were identified to support the introduction of innovations that enable rapid and sustainable development and the supply of safe and efficacious vaccines.

One of the topics has been the development of advanced control strategies for vaccines, encompassing, for instance, digital twins and the use of process analytical technologies. The technical challenges and the need for cross-industry and regulatory acceptance make these themes relevant for PDA VIG, stimulating reflection on the opportunity for examples sharing and consensus building.

In addition, another point raised during the VIG session has been related to platform knowledge and how this can be used from a technical and regulatory point of view. Despite the complexity and diversity of vaccine categories, emerging vaccine types like mRNA are prompting new perspectives in this space. For instance, a comparative assessment of different platform elements across vaccine technologies and how these can be used to accelerate de-risk development is worth discussing.

A final main reflection has been made on vaccine delivery and presentation, including alternative approaches to parenteral administration. For example, an increased exploration and use of micro-needles/patches would be extremely relevant for the effective delivery of vaccines in developing countries and remote areas where limited medical professionals are available. Consolidating these approaches requires more visibility on technical progress in the field, including clarification of quality expectations and mechanisms of action.

Thanks to all the participants for your input and commitment to enable vaccines reaching all geographies and patients worldwide.

PDA VIG is organizing a series of webinars related to these topics, involving deep experts in these fields. Our first webinar, Vaccine Manufacturing and the Adoption of Novel PAT Analytics, will take place June 25^th. Senior vaccine manufacturing industry experts, including Merck's manufacturing scientists (Merck Sharpe and Dohme outside of the U.S. and Canada) and LumaCyte's scientific leadership, will share case studies and novel insights about a new process analytical technology platform (Laser Force Cytology™). Further discussion will also take place at key upcoming PDA conferences, such as the PDA BioManufacturing Conference 2024 and the PDA/FDA Joint Regulatory Conference 2024.

Thanks to all the participants for your input and commitment to enable vaccines reaching all geographies and patients worldwide. If you would like to contribute to our work, please contact us and join the PDA Vaccines Interest Group Community. Stay tuned!