A tale of two pandemics: improvements in regulatory performance between the 2009 influenza A(H1N1) pandemic to the COVID-19 pandemic - World Health Organization

When a pandemic strikes, national regulatory authorities (NRAs) are responsible for ensuring that people have timely access to quality medicines, vaccines and diagnostics. A critical part of this role lies in providing timely marketing authorization (MA) to avoid delays in access to and uptake of products.

 In 2009, during the influenza A(H1N1) pandemic, 96 countries were eligible to receive vaccines through the WHO deployment initiative, but only 75 received vaccines. The remaining 21 (22%) did not ultimately provide MA or accept pandemic products because of liability and legal issues, poor regulatory readiness or limited operational capacity to deploy.

After the pandemic, WHO conducted a gaps and needs assessment and selected 10 of the 21 countries for regulatory strengthening through the PIP PC. An additional 38 countries with limited regulatory capacities were also identified for PIP PC support. Since then, WHO has used a multi-pronged approach to strengthen regulatory readiness for an influenza pandemic in these countries, including issuing policy and technical guidance, benchmarking NRA performance and capacity-building to fill gaps, delivering planning workshops and mentoring NRA staff.

 In 2016, as part of its efforts to facilitate accelerated approval, WHO published guidance on MA options for countries that don't produce vaccines (full review, fast-track review, reliance and recognition). WHO worked with countries and regional bodies to build their understanding of what these options are, identify country needs and help NRAs choose an approach that works for them.

Ten years after the 2009 influenza pandemic, the world is now experiencing another respiratory disease pandemic: COVID-19. Have WHO's investments improved regulatory processes?

The answer is an undeniable 'yes': By 30 June 2021, 47 out of the 48 PIP PC recipient countries had authorized one or more COVID-19 vaccines (one country did not seek COVID-19 vaccines for non-technical reasons). For the 45 countries with data, 87% provided timely MA within 15 days of emergency use listing by WHO.  Nine of the ten countries that did not receive pandemic influenza vaccines during the 2009 pandemic have authorized one or more COVID-19 vaccines, with eight doing so in a timely fashion.

There is little doubt that WHO technical support, enabled in part by the PIP PC, contributed to the improved performance of NRAs during the COVID-19 pandemic. More lessons are being learnt from COVID-19 that will help countries and partners continuously improve their regulatory capacities for future emergencies including an influenza pandemic and the PIP PC will continue to support regulatory strengthening to prepare for the next pandemic.