Your Daily Vaccine Update

Lessons about National Regulatory Agencies and Covid-19 vaccines

The recent paper, "A scoping review of authorisation pathway for COVID-19 vaccines among selected countries," by Suphap, Luksameesate, Nerapusee, and Anantachoti (2025) provides a comprehensive overview of how various countries expedited COVID-19 vaccine approvals during the pandemic. This review discusses the important role of accelerated regulatory mechanisms and international collaboration in rapidly deploying vaccines to combat the pandemic. The study underscores the importance of documenting these diverse pathways to inform future pandemic preparedness efforts.

The researchers conducted a scoping review, analyzing 24 regulatory pathways across 20 countries. These pathways were broadly categorized into Emergency Use Authorization (EUA), Conditional Marketing Authorization (CMA), and Temporary Authorization (TA). A significant finding was that 12 new pathways were established by 11 countries, demonstrating the adaptive nature of regulatory bodies in response to the unprecedented demand for rapid vaccine approval. Common requirements for vaccine approval included Good Manufacturing Practice (GMP), benefit-risk evaluations, and the demonstration of unmet medical need.

The review identified several supporting strategies that facilitated and accelerated the approval process. These included "rolling submission" (allowing manufacturers to submit data incrementally) and "pre-submission meetings" (enabling early engagement between regulators and developers).

A key insight for low- and middle-income countries (LMICs) is the preference for the "reliance" strategy. This approach involves National Regulatory Authorities (NRAs) heavily weighting the assessment reports and approval decisions of recognized reference countries, significantly reducing local review times.

In contrast, high-income countries often engaged in direct regulatory networking. The study noted that review times for the first COVID-19 vaccines ranged from 10 to 84 days, a remarkable acceleration (3 to 27 times faster) compared to standard review processes. This rapid pace was largely attributed to international collaboration.

This agility in vaccine authorization pathways, particularly the reliance strategy adopted by many LMICs, aligns with the arguments my colleagues at Baylor and I made in "Global regulatory reforms to promote equitable vaccine access in the next pandemic" by Mahoney, Peter Hotez, and Maria Elena Bottazzi (2023). Our paper argues that the global response to the COVID-19 pandemic revealed significant inequities in vaccine access, stemming from over-reliance on high-income country (HIC) manufacturers, vaccine nationalism, and inadequate support for LMIC national regulatory authorities. It advocates for strengthening selected LMIC regulatory systems to become Stringent Regulatory Authorities (SRAs) and re-prioritizing the WHO Prequalification (PQ) system to ensure early vaccine availability in LMICs, especially during pandemics.

The "reliance" strategy observed in the scoping review serves as a practical example of how LMICs can leverage external regulatory expertise to expedite access, thereby addressing some of the challenges highlighted by Mahoney, Hotez, and Bottazzi.
The findings from both papers emphasize a critical need for robust and adaptable regulatory frameworks that prioritize global equity and access, particularly for LMICs. While expedited pathways were successful in fast-tracking COVID-19 vaccines, the ongoing challenge is to institutionalize these collaborative and reliance-based approaches to ensure that future pandemic responses are more equitable and efficient for all nations.

The COVID-19 pandemic, despite its devastation, has indeed stimulated global preparedness, providing valuable lessons for enhancing regulatory systems and fostering international cooperation in vaccine development and deployment.

Citations:
• Suphap, S., Luksameesate, P., Nerapusee, O., & Anantachoti, P. (2025). A scoping review of authorisation pathway for COVID-19 vaccines among selected countries. Journal of Pharmaceutical Policy and Practice, 18(1), 2520861. https://doi.org/10.1080/20523211.2025.2520861
• Mahoney, R., Hotez, P. J., & Bottazzi, M. E. (2023). Global regulatory reforms to promote equitable vaccine access in the next pandemic. PLOS Global Public Health, 3(2), e0001550. https://doi.org/10.1371/journal.pgph.0001550

Both articles are open access.

Richard Mahoney
Adjunct Professor
National School of Tropical Medicine
Baylor College of Medicine

I used Google Gemini to draft this post. I edited the draft and verified the statements.