Table 2.

Factors to consider in site selection and capacity planning.

Factor	Rationale	Recommendations
Containment requirements	The additional regulatory requirements for recombinant viral vector and live viral vaccines can lead to challenges and delays in manufacturing, testing, and distribution58.	If possible, regulators could determine whether these classifications will be needed according to appropriate risk/benefit calculations. Developers can then identify facilities that can adhere to relevant standards.
Manufacturer’s expertise	There is wide variety of experience and expertise across manufacturers. Many DCVMs have significant experience navigating the WHO PQ process, the WHO programmatic utilization recommendation process, and GAVI/UNICEF procurement procedures59,60. However, several DCVMs have limited experience with novel vaccines. By contrast, many multinational corporations (MNCs) have significant experience developing and manufacturing novel vaccines, but may not be as familiar with WHO PQ, WHO programmatic recommendations, GAVI/UNICEF procurement practices, or with developing packaging appropriate for use in LMICs. Small biotechnology companies are unlikely to have significant experience operating outside of their home country.	For each manufacturer, it is important to plan for the right expertise and technical assistance so that appropriate packaging images are developed, the submission is not incomplete or rate-limiting, analytic processes are established, and procurement procedures are initiated and followed at the right time61,62. Other possible areas of assistance include developing new analytical methods for characterization and release, identification and classification of impurities, setting clinically justified specifications, and scaling up to supply global markets.
Multiple, differentiated Backups	Given the high attrition rates inherent in vaccine development, there must be multiple backup plans that optimize for the availability of quality supply upon regulatory approval, programmatic recommendation, and procurement.	Such backup plans require substantial at-risk funding, and the manufacturer will likely need to consider trade-offs in planning and manufacturing for other products, and what level of capacity could be redirected or repurposed if needed22,25,63
Inspection planning	Regulatory facility inspections can be challenging to schedule. This issue has been compounded by travel restrictions imposed by COVID-19.	Ideally, a facility could partake in prospective manufacturing inspections for vaccines being developed in response to a PHEIC, where certain parts of the inspection could be conducted virtually, and/or where reliance on a previous PQ or ML4 inspection may suffice under the EUL conditions. For nOPV2, BPOM (Indonesian Food and Drug Authority) assisted with facility inspections typically done by WHO when travel was not possible. The best approach should be discussed early with the WHO PQ unit.
Technology transfer	Vaccine technology transfer requires extensive time and resources64. The process includes extensive documentation, asset transfers and training, as well as significant negotiations around intellectual property, liability, and data ownership.	Tech transfer of any vaccine must be planned for as early as possible in the development process, and procurers and implementers need to plan for volumes based on realistic timelines for product availability.
Competent NRA	Under EUL, the facility where the EUL is located may need to assume responsibility for lot-release testing	If the local NRA is unable or unwilling to do this, an alternative will need to be identified.