Developing a Vaccine Manufacturing Process and Control Strategy During the SARS-CoV-2 Pandemic - Workshop Session One

The SARS-CoV-2 pandemic has challenged conventional paradigms to traditional vaccine development,
manufacturing, approval, and supply. A vision for all the elements necessary to a successful global
immunization program is essential, including considerations of the variety of vaccines platforms, such as
virus-like particles, subunit protein-based antigens, novel nucleic acid and vector-based vaccines, as well
as vaccines control strategies necessary to ensure continued supply of safe and effective product.

At the root of the development activities for each class of vaccine is scientifically sound characterization
of the vaccine, including vaccine components, such as lipid nanoparticles and adjuvants. Adherence to
principles associated with Quality by Design are important in an accelerated vaccine development
program, to guide process and analytical development studies. These are grounded in product
specifications and further supported by a risk-based life cycle change management program.

This session will focus on the work performed by several vaccine manufacturers to optimize their vaccine
candidates and develop commercial control strategies to facilitate the worldwide delivery of sufficient
safe and effective vaccines, which hold the promise of stemming the SARS-CoV-2 pandemic. Audience
interaction with these industry leaders will be supplemented with a panel discussion that includes global
regulators, who are currently evaluating these vaccines and hold special interests in vaccine control
strategies.

Along with technical questions from participants, some topics that might expand the discussion towards
industry and regulatory coordination will include:

• Given the immediate need for a safe and effective vaccine, what do companies and regulators
perceive as the greatest technical hurdles to rapid development and adequate control of a vaccine?
• What are the special considerations, if any, associated with the development of a vaccine targeted
towards a pandemic pathogen?
• The interactions between companies and regulators, among regulators, and among companies
might differ for a pandemic development program versus a routine vaccine development program.
What technical expectations and practices, if any, should be different to help progress a pandemic
vaccine towards successful introduction to populations in need?