Table 3.

Presentation features that may change post-initial EUL.

Feature	Recommendation
Stability	• Initiate stability studies for a multitude of dose-per-vial presentations up-front.
	• Because stability studies necessarily require a certain duration, manufacturers may need to negotiate a process for registering with a limited stability claim that is modified as studies of longer duration are completed65.
Preservatives	• Need to make decisions about whether to include studies on preservatives.
	• Since not enough time to assess different preservatives is a limitation, initiate discussions with WHO PQ and relevant regulatory authorities on the use of preservative-free, multi-dose vials.
Setting specifications and labelling requirements	• While countries understandably want to set their own specifications and accommodate multiple languages, heterogeneous requirements can result in delays of product availability at the country level.
	• For EUL-approved vaccines that need to be implemented globally, the idea is to harmonize labelling and packaging requirements21.
	• Use of QR codes for package labeling, summary of product characteristics/package insert, and patient information leaflet should be discussed with regulators to see if these could be used under emergency circumstances.
Storage/transit infrastructure requirements	• Due to time constraints in process development and optimization, product presentations may have substantial shortcomings in deliverability (e.g. require ultra-cold chain).
	• Trade-offs need to be understood by procurers and delivery-focused groups to help inform where technical solutions and local infrastructure can enable delivery vs. those features that would constitute a no-go66.
	• Decisions on presentation should be taken jointly with procurers and delivery-focused stakeholders to ensure feasibility in the field.
	• Can have a plan and process to incorporate different presentation options later without having to re-submit for extensive regulatory review21.
Preliminary data generation	• To raise awareness within the field for implementing a novel vaccine, consider using early doses for field studies to establish the effectiveness and early safety data.
	• CMC needs to work closely with implementers to understand implementation options and to solicit early feedback on any component of the presentation that could be modified to aid roll-out and uptake.