How to accelerate the supply of vaccines to all populations worldwide? Part I: Initial industry lessons learned and practical overarching proposals leveraging the COVID-19 situation

Chemistry Manufacturing and Controls Development, Industry Reflections on Manufacture, and Supply of Pandemic Therapies and Vaccines

“…These reflections and recommendations are intended to stimulate ongoing discussion among stakeholders (including industry, regulators, and patient groups) on measures that could facilitate public health responses in future pandemics, and that could also be valuable in non-pandemic situations. The recommendations and discussion points proposed within, augment and expand on the vaccine-specific recommendations proposed by McGoldrick et al ( 17 , 18 )…”

“…These reflections and recommendations are intended to stimulate ongoing discussion among stakeholders (including industry, regulators, and patient groups) on measures that could facilitate public health responses in future pandemics, and that could also be valuable in non-pandemic situations. The recommendations and discussion points proposed within, augment and expand on the vaccine-specific recommendations proposed by McGoldrick et al (17,18) One of the most challenging issues faced by companies introducing innovative medicines for use in the COVID-19 pandemic was having to engage each authority and their respective governmental distribution organizations to negotiate regulatory criteria for authorization and distribution in each market. Companies found that differences in expectations between different regions could not be managed during parallel, simultaneous submissions due to resource constraints.…”

Regulatory Cooperation in Vaccines in Asia-Pacific Region

“…Yet again among efforts to increase regulatory agility by increasing collaboration among regulatory and once more under COVAX, was the establishment of Support Work to Advance Teams (SWAT) comprising groups of experts dedicated to "resolving technical issues and challenges common across all COVID-19 vaccine development projects" (McGoldrik, Gastineau, Wilkinson et al 2022, p. 1217. For example a…”

Trade Therapy: Deepening Cooperation to Strengthen Pandemic Defenses

“…COVAX established a 10-nation Regulatory Advisory Group to provide feedback and guidance on COVID-19 vaccine development and activities. Numerous groups of experts were created to resolve technical issues pertaining to COVID-19 vaccine development projects (McGoldrick et al 2022). These examples of cooperation, both formal and informal, complement the work of the primary multilateral agency charged with safeguarding global health: WHO.…”

“…Greater harmonization and alignment with international standards such as those of the ICH can strengthen supply chains. Sovereignty is not a compelling reason for opposing work toward global reliance regimes, since this has been achieved in other sectors such as civil aviation (McGoldrick et al 2022; see also Hoekman and Sabel 2019).…”