Introducing a new vaccine is a large-scale endeavor that can face many challenges, resulting in introduction delays and inefficiencies. The development of national task teams and tools, such as prelaunch trackers, for the introduction of new vaccines (hereafter, “new vaccine introductions” [NVIs]) can help countries implement robust project management systems, front-load critical preparatory activities, and ensure continuous communication around vaccine supply and financing. In addition, implementing postlaunch assessments to take rapid corrective action accelerates the uptake of the new vaccines. NVIs can provide an opportunity to strengthen routine immunization, through strengthening program management systems or by reinforcing local immunization managers’ abilities, among others. This article highlights key lessons learned during the introduction of inactivated poliovirus vaccine in 3 countries that would make future NVIs more successful. The article concludes by considering how the Immunization Systems Management Group of the Global Polio Eradication Initiative has been useful to the NVI process and how such global structures could be further enhanced.

Understanding post-launch demand for new vaccines can help countries maximize the benefits of immunization programmes. In particular, low- and middle-income countries (LMICs) should ensure adequate resource planning with regards to stock consumption and service delivery for new vaccines, whereas global suppliers must produce enough vaccines to meet demand. If a country underestimates the number of children seeking vaccination, a stock-out of commodities will create missed opportunities for saving lives. We describe the post-launch demand for the first dose of pneumococcal conjugate vaccine (PCV1) in Ethiopia and Malawi and the first dose of rotavirus vaccine (Rota1) in Malawi, with focus on the new birth cohort and the ‘backlog cohort’, comprised of older children who are still eligible for vaccination at the time of launch. PCV1 and Rota1 uptake were compared with the demand for the first dose of pentavalent vaccine (Penta1), a routine immunization that targets the same age group and immunization schedule. In the first year, the total demand for PCV1 was 37% greater than that of Penta1 in Ethiopia and 59% greater in Malawi. In the first 6 months, the demand of Rota1 was only 5.9% greater than Penta1 demand in Malawi. Over the first three post-introduction months, 70.7% of PCV1 demand in Ethiopia and 71.5% of demand in Malawi came from children in the backlog cohort, whereas only 28.0% of Rota1 demand in Malawi was from the backlog cohort. The composition of demand was impacted by time elapsed since vaccine introduction and age restrictions. Evidence suggests that countries’ plans should account for the impact of backlog demand, especially in the first 3 months post-introduction. LMICs should request for higher stock volumes when compared with routine needs, plan social mobilization activities to reach the backlog cohort and allocate human resources and cold chain capacity to accommodate high demand following vaccine introduction.

The cost of vaccines includes the costs of discovery, development, regulatory clearance, production, and marketing. Research and development impose high risks and require advance investments to test many candidates that ultimately fail. After a candidate is successful, regulatory approvals also require investments. Most vaccines show increasing returns to scale so that the unit cost goes down as production increases. However, the long time-lag from the start to completion of a batch of vaccines implies that lower costs are possible when the size of an order is predictable. Prices are often set by companies that compare their products to other products for sale in a given country. Occasionally, prices are influenced by value-based pricing and what is known about a country’s willingness to pay to achieve a health outcome. Vaccine supply in the 2010–2020 era was dominated by four multinational corporations accounting for 80% of global vaccine revenues. A growing number of vaccine companies in emerging markets, organized into the Developing Countries Vaccine Manufacturers Network, provide lower-priced traditional vaccines to the global market. Vaccine markets are not very competitive and most vaccines are produced by only a small number of suppliers. Vaccine procurement is also highly concentrated because pooled procurement by UNICEF Supply Division and PAHO Revolving Fund accounts for a large allotment of vaccine sales each year. Gavi plays an outsized role in subsidizing procurement for Gavi-eligible countries. COVID-19 vaccines have led to new innovations in vaccine markets with COVAX offering pooled procurement for a large number of vaccines.