VACCINE INSIGHTS

Spotlights 2024

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Respiratory diseases

What’s next for COVID vaccines?
- Prospects for developing next-gen vaccines capable of generating durable, broad-based antibody and T cell immunity
Respiratory syncytial virus (RSV):
- What will be the impact of newly approved RSV vaccines?
- Determining the most appropriate schedule of RSV and other respiratory vaccines to maximize uptake and effectiveness
Invasive pneumococcal disease:
- the impact of new low-cost vaccines in a competitive market
- the race for higher valency—where is the limit?
- harmonizing pneumococcal vaccine schedules
Quantifying the risk from avian influenza and developing vaccines

Manufacturing: Upstream and Raw Materials

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Manufacturing: Upstream and Raw Materials

Guest Editor:

Cleo Kontoravdi, Professor of Biological Systems Engineering at Imperial College London

How can manufacturers mitigate supply chain disruption?
Localized vs centralized manufacturing
Optimizing manufacturing footprint
- In-house manufacturing vs CMO
- Could combined/flexible facilities improve efficiency?
Scaling up vaccine manufacturing
Novel expression systems for vaccine production
Toward 100% chemically defined media, and easier generation of chemically defined media for individual processes
Stainless steel vs single-use bioreactors for vaccine manufacture
Maintaining “warm base” capacity for pandemic preparedness
Challenges for training and tech transfer in vaccine manufacturing

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RNA vaccines: research directions

What will be the next testing ground for RNA vaccines? Where, when, and how will it prove its capabilities, and how much optimization will be needed on a case-by-case basis?
Will RNA be broadly applicable or only suited to narrow applications such as pandemic vaccines?
Evolving knowledge on mechanisms of action—decreasing reactogenicity while retaining potency
Modifying mRNA vaccines to induce mucosal immune responses
Adapting mRNA for use in personalized cancer vaccines
How will the drive towards cancer vaccines impact infectious disease applications?
Latest on next-gen RNA vaccine platforms
Regulatory expectations for RNA vaccines—a platform technology?

Understanding & enhancing immune responses

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Understanding & enhancing immune responses

Guest Editor:

Marios Koutsakos, NHMRC Emerging Leader Fellow at University of Melbourne

Addressing immune imprinting/original antigenic sin for COVID-19 and other circulating RNA viruses
Advances in immune profiling and understanding mechanisms of action
- Profiling immune cells with single-cell analysis tools
- Applying tools such as NGS, flow cytometry, CyTOF
Systems serology to decode vaccine-induced immune responses
Understanding individual immune response to vaccination
Standardizing data recording, storage, and sharing
Embracing AI and machine learning for resolving immunological data and antigen design
Understanding and targeting mucosal immunity
Novel adjuvants, adjuvant platforms, and combinations

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CMC & analytics

Greater connection of CMC with clinical design and understanding quality expectations to avoid bottlenecks
How will control strategy evolve with digital twin and digitalization?
Patient-centric specifications
What is needed from a CMC perspective to achieve CEPI’s 100 days goal for pandemic vaccines? Risk-based approaches and innovativations
Advances in process analytical technology
- Monitoring online in real-time
- Overcoming limitations of current technology (e.g., sensitivity)
- Lowering barriers for implementation
- Increased automation
High-throughput tools for process development and analytics— forward-looking methods while remaining QC-compliant

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Preclinical & clinical research

Closing the gap between preclinical and clinical results: better animal and in vitro models
Measuring a wider range of immune markers
Could evidence from human infection models support approvals?
Clinical trials in populations with varied levels of immune competence
Correlates of protection—regulators and licensure criteria
Vaccine development for special populations
Use of AI to clean up clinical data sets and reduce protocol deviations
Making the most of real-world vaccine efficacy data
Safety—understanding adverse events after vaccination
What is a platform technology and how will they be regulated?
Regulatory harmonization between regions

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RNA vaccines: formulation & production

Sourcing and supply of raw materials—addressing the cost of goods
Addressing expense, manufacturing complexity, and IP hurdles of LNPs with next-gen delivery particles
Toward temperature-stable formulations
Overcoming hurdles in production
- Traditional vs cell-free plasmid DNA production
- Streamlining IVT and capping
- Optimizing purification, especially of larger RNA constructs— chromatography, TFF
Analytical methods and control strategy for mRNA-LNPs
- Evolving tools (e.g., NGS & mass spectrometry) for characterization
- Moving to next-gen assay panels, specific to RNA products
- Improved methods for detecting residual dsRNA (e.g., dPCR)

Manufacturing: downstream, fill/finish, & delivery

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Manufacturing: downstream, fill/finish, & delivery

Exploring the need for better purification solutions across platforms
The environmental sustainability of vaccine manufacturing operations
Shared challenges and solutions for vaccines, biologics, and advanced therapy manufacturers
Addressing extremes of volume
- Challenges of small-scale cancer vaccine production
- Efficient scale-up to meet pandemic preparedness needs
Challenges and solutions in cold chain/controlled temperature chain:
- Routine and corrective maintenance
- Sustainability
- Role of automation and AI