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The vaccine global market is currently growing at a rate of 16.52%. Nowadays the vaccine manufacturing industry is limited in the sense that not all vaccine manufacturers have the capacity to execute all the steps necessary to produce a successful product. The biological variation inherent to vaccine manufacturing and the initial investment required to bring a vaccine to the market are some of the factors that discourage vaccine manufacturing initiatives. Given the current global context in vaccine innovation and production, and the increasing participation of vaccine manufacturers from developing countries in global markets, this paper aims to review vaccine manufacturing capacity in Latin American and Caribbean (LAC) countries with specific focus on trends in national or public sector manufacturing, presenting current challenges and future opportunities for the sector in meeting national and regional (LAC) needs. Despite the overall low vaccine manufacturing capacity reported within the LAC region within this paper, it is considered that the relatively high and concentrated capacity that exists within a number of countries, combined with political commitment of all countries within the Region, can provide the necessary platform for the continued development of capacity in vaccine development and manufacture within LAC.

National immunization programs have had a significant impact on the reduction of morbidity and mortality caused by common vaccine-preventable childhood diseases and remain a key component of countries' primary health care strategies. Key strategies include development and improvement of national surveillance capabilities, improvement in the delivery of vaccination programs, use of quality vaccines in immunization programs, and provision of an adequate and logistic infrastructure. A great number of new and combined vaccines are becoming available, bringing to the forefront the debate of how to introduce them in a sustainable way in immunization programs in the Americas. The arrival of these vaccines requires the total reformulation of the cold chain systems. Countries in the Americas have led the world in conquering infectious diseases that can be prevented through vaccination. In 1971, the Western Hemisphere was the first region in the world to achieve the goal of smallpox eradication. In 1991, the Americas were officially declared the first region to be free of indigenous transmission of wild poliovirus. These breakthroughs obtained in immunization have stimulated countries to promote new initiatives aimed at the control and eradication of other vaccine-preventable diseases and to introduce new vaccines of public health importance in routine schedules. In the twenty-first century, vaccines will remain the most cost-effective means of preventing diseases and avoiding expensive treatment costs.

Hib conjugate vaccines are widely used in the industrialized world, but are just now beginning to be introduced into other countries. To identify factors facilitating rapid global introduction, we evaluated the decision-making process, mode of introduction, effectiveness, and impact on the immunization program of Hib conjugate vaccine introduction in four non- industrialized countries through site visits and use of a standardized questionnaire. The key promoters of Hib introduction were the pediatric community and ministries of health. Local surveillance and severity data were critical in the decision to adopt Hib vaccine. Assistance with surveillance, introduction guidelines, educational material, tenders, and funding is needed to accelerate wider adoption.