Preparing for COVID-19 vaccine roll-out through simulation exercises
Authors: Frederik A Copper, Cindy Chiu de Vázquez, Allan Bell, Landry Ndriko Mayigane, Liviu Vedrasco, Stella Chungong
Journal: The Lancet Global Health (2021)

As the COVID-19 pandemic reached over 97 million cases and exceeded 2 million deaths globally only 1 year after its emergence,1WHOWHO Coronavirus Disease (COVID-19) Dashboard.https://covid19.who.int/Date accessed: January 25, 2021Google Scholar several candidate vaccines have shown promising efficacy and safety profiles, with some already approved for emergency use and rolled out globally.2Cavaleri M Enzmann H Straus S Cooke E The European Medicines Agency's EU conditional marketing authorisations for COVID-19 vaccines.Lancet. 2021; 397: 355-357Summary Full Text Full Text PDF PubMed Scopus (66) Google Scholar At this juncture, it is critical that the national deployment and vaccination plans are carefully crafted as recommended in the WHO guidance on developing a national deployment and vaccination plans for COVID-19 vaccines.3WHOGuidance on developing a national deployment and vaccination plan for COVID-19 vaccines.https://www.who.int/publications/i/item/WHO-2019-nCoV-Vaccine_deployment-2020.1Date: 2020Date accessed: December 21, 2020Google Scholar Countries need to be ready to carry out unprecedented mass vaccination, including having procedures in place for national regulatory agencies to approve vaccines for emergency use; coordination systems between national regulatory agencies and import control entities; communication strategies to address rumours and misinformation to combat vaccine hesitancy; systems for the monitoring and management of adverse events following immunisation; and logistics and delivery systems for maintaining cold chains. To ensure countries have the best chance of a successful COVID-19 vaccine deployment, WHO with COVAX4WHOCOVAX: the vaccines pillar of the access to COVID-19 tools (ACT) Accelerator Structure and Principles.https://www.who.int/publications/m/item/covax-the-vaccines-pillar-of-the-access-to-covid-19-tools-(act)-acceleratorDate: 2020Date accessed: December 21, 2020Google Scholar partners including UNICEF have developed two COVID-19 vaccine-specific tabletop exercise simulation packages to test planning assumptions before national vaccine roll-out.5WHOCoronavirus disease (COVID-19) training: simulation exercise.https://www.who.int/emergencies/diseases/novel-coronavirus-2019/training/simulation-exerciseDate accessed: December 21, 2020Google Scholar The first exercise focuses on regulatory and safety issues so that countries can test their regulatory frameworks and systems for granting the emergency approval of vaccines or exploring how they might rely on WHO's prequalification and emergency use listing, as well as procedures and oversight for monitoring vaccine safety after it is deployed. The participants could be from national regulatory agencies, medical standards and regulations agencies, and departments for monitoring the safety of new vaccines post-introduction. The second tabletop exercise focuses on strategy, supply chain, and communications to help countries identify the target populations and test vaccination strategies, manage supply chains, and prepare communication plans to promote vaccine acceptance and uptake. The participants could be decision-makers, logisticians, warehouse managers, freight services personnel, communication specialists, vaccinators, health promotion and behaviour change specialists, and community leaders. For both exercises, the participants will represent their actual roles and respond as if in a real situation. The two vaccine tabletop exercises developed should be customised to mimic the country context as realistically as possible.6WHOWHO simulation exercise manual.https://www.who.int/ihr/publications/WHO-WHE-CPI-2017.10/en/Date: 2017Date accessed: December 21, 2020Google Scholar To begin, the facilitators will first introduce the exercise and the specific purpose, scope, and objectives. As the simulated scenario evolves over the course of the exercise, open-ended questions and problem statements will be used to provoke constructive discussion of what actions participants might take in line with the national deployment and vaccination plans. At the end of the exercise, a debrief will be done to identify strengths and bottlenecks and propose recommendations, which should be developed into an action plan to enhance the existing vaccine deployment plan. To complement these national vaccine-specific tabletop exercises, the exercises should also be done at the global and regional levels. These global and regional simulations will have a different purpose, scope, and objectives and could involve other stakeholders. However, they are important to ensure that vaccines are delivered correctly and are disseminated as planned. These targeted exercises will help support the coordination of global vaccine procurement and distribution managed by the wider international community. In addition to testing the system before vaccination launch, for new vaccines, WHO also recommends a post-introduction evaluation to be done 6–12 months after their introduction.7WHONew Vaccine post-introduction evaluation (PIE) tool.https://www.who.int/immunization/monitoring_surveillance/resources/PIE_tool/en/Date: 2010Date accessed: December 21, 2020Google Scholar Given COVID-19 vaccines have been developed and approved in an expedited manner with mass vaccination planned or already underway, continual review of vaccine deployment is vital as various vaccines are rolled out. Therefore, WHO has collaborated with the group responsible for the post-introduction evaluation of new vaccines within the COVAX working group to develop the vaccination component for the country COVID-19 intra-action review.8WHOGuidance for conducting a country COVID-19 intra-action review (IAR).https://www.who.int/publications/i/item/WHO-2019-nCoV-Country_IAR-2020.1Date: 2020Date accessed: December 21, 2020Google Scholar, 9Mayigane LN de Vázquez CC Vente C et al.The necessity for intra-action reviews during the COVID-19 pandemic.Lancet Glob Health. 2020; 8: e1451-e1452Summary Full Text Full Text PDF PubMed Scopus (16) Google Scholar Frequent review of this component can allow the close monitoring of vaccine roll-out and prompt actions to address obstacles encountered. The findings from these intra-action reviews can then feed into the post-introduction evaluation.7WHONew Vaccine post-introduction evaluation (PIE) tool.https://www.who.int/immunization/monitoring_surveillance/resources/PIE_tool/en/Date: 2010Date accessed: December 21, 2020Google Scholar As the pandemic evolves, it is key that countries take a comprehensive approach to test and fine-tune their national deployment and vaccination plans before vaccine deployment using tabletop exercise at all levels, conduct regular intra-action reviews during vaccine roll-out, especially with variants emerging that might reduce vaccine efficacy, before the post-introduction evaluation. This recommendation is in line with the sixth meeting of the Emergency Committee under the International Health Regulations of Jan 14, 2021, which recommended state parties to "Prepare for COVID-19 vaccine introduction and post-introduction evaluation using the guidance, tools, and trainings for national/subnational focal points and health workers developed by the Access to COVID-19 Tools (ACT) Accelerator's Country Readiness and Delivery workstream".10WHOStatement on the sixth meeting of the International Health Regulations (2005) Emergency Committee regarding the coronavirus disease (COVID-19) pandemic.https://www.who.int/news/item/15-01-2021-statement-on-the-sixth-meeting-of-the-international-health-regulations-(2005)-emergency-committee-regarding-the-coronavirus-disease-(covid-19)-pandemicDate: 2021Date accessed: January 18, 2021Google Scholar Both vaccine-specific tabletop exercises and intra-action review adopt a whole-of-society approach that involves different sectors of the government, private and public sectors, community organisations, and academia to conduct studies to understand vaccine hesitancy and how to promote positive behaviour change. Hence, being one of the biggest vaccination endeavours in history, everyone needs to be on board. By working together, being prepared, and staying one step ahead, we can prevail in the fight against COVID-19. We declare no competing interests. We thank Mike Ryan, Executive Director, WHO Health Emergencies Programme (WHE); and Jaouad Mahjour, Assistant Director-General, Emergency Preparedness, WHE, for their leadership and guidance; Denis Charles, Candice Vente, and Hilary Kagume Njenge from the Country Simulation Exercises and Reviews Unit, WHE, for their critical contribution to developing and implementing this work. We also extend our gratitude to Ann Moen, Diana Chang Blanc, Shoshanna Goldin, Alireza Khadem Broojerdi, Jenny Walldorf, Jhilmil Bahl, and other colleagues from the COVAX Country Readiness and Delivery workstream who contributed to developing the vaccine SimEx packages and IAR trigger questions for the vaccine pillar.