Accelerating the Rollout of COVID-19 Vaccines: A How-to Guide for National Regulatory Authorities in Low- and Middle-Income Countries

National regulatory authorities (NRAs) in low- and middle-income countries (LMICs) are critical in safeguarding the quality, safety, and effectiveness of future COVID-19 vaccines. The actions NRAs take now will not only enable a sustainable and quality-assured supply of vaccines to fight the pandemic but will also help preserve public trust. There are a number of steps that NRAs can take to expedite the review, approval, and ultimately, the availability of COVID-19 vaccines while working to ensure the continued safety, efficacy, and quality of these vaccines. The introduction of COVID-19 vaccines provides a critical opportunity to strengthen quality assurance and safety regulations that will help address the current pandemic and prepare for future public health crises.

This paper proposes immediate actions that NRAs in resource-limited settings can take now to prepare to accelerate COVID-19 vaccine introduction and minimize delays in scale-up. The paper recommends practical approaches to consider while responding to the ongoing pandemic.

These actions may help reduce the years-long delays seen in previous efforts to scale up new medical products in LMICs. A similar delay in access to future COVID-19 vaccines would not only jeopardize health in LMICs but would also imperil progress against the pandemic response globally.