Challenges

The technological complexity involved in producing high-quality vaccines has led to a decrease in their production around the world, which is now limited to a few manufacturers, putting developing countries in a vulnerable position with regard to production shortages. In the case of influenza vaccine, the situation is aggravated due to the need for seasonal vaccines and in the case of pandemics.

The main challenge in implementing this initiative is to establish strategic cooperation among the institutions involved in the production and regulation of the influenza vaccine, as well as building the capacity of the human resources needed to perform all the critical processes, ensuring quality, safety and effectiveness of locally produced vaccines.

Toward a Solution

To address this challenge, the Pan American Health Organization/World Health Organization (PAHO/WHO) is supporting an initiative that seeks to establish inter- country cooperation by transferring vaccine technology and strengthening the national regulatory authority so as to guarantee access to vaccines of proven quality, safety and efficacy in Nicaragua. In addition, this project will allow other elements of the health sector, such as the immunization programme, the social security system and the academy, to develop knowledge and practices to respond to the challenges of vaccine production as part of the country’s development.

This project to produce biological and immunobiological products involves technology transfer from the Russian Federation to a production plant in Nicaragua. It is coordinated by PAHO/WHO to strengthen capacities in the area of vaccine regulation and other technologies for health, which will have a positive impact on the health of the people of Nicaragua and other countries of the region.

The project involves establishing a technical advisory committee, including health professionals and institutions necessary to carry out the planning, production, regulation, use and distribution of the vaccine and particularly, the training of human resources. The committee includes the following members: PAHO/WHO (which coordinates the committee); the Nicaraguan Social Security Institute (INSS); the Ministry of Health (MINSA)- Pharmacy Directorate; the Nicaraguan regulatory authority (NRA); the National Autonomous University of Nicaragua (UNAN); the Cuban regulatory authority (CECMED); the Scientific Institute of Vaccines and Serums of St. Petersburg (IICVSSPb), Federal Agency for Medicines and Biologicals from the Ministry of Health of the Russian Federation; the Mechnikov Biotechnology Institute in Managua; and the Russian regulatory authority.

An institutional development plan was prepared to strengthen the regulatory authority in Nicaragua and includes specific actions. Implementation of a quality management system within the NRA, with capacity- building for the staff of the NRA and UNAN, among others, will ensure the availability of human resources who can sustain the project over the long term.

PAHO has supported the project, particularly in coordinating and supporting NRA evaluation, and has assisted with self-evaluation to identify weaknesses and strengthen regulatory functions. It has also sponsored: capacity-building for the NRA in regulatory matters with experts from various countries, particularly Cuba and Chile; and, training on good practices, including manufacturing, clinical, inspections, sanitary licencing and laboratory practices, as well as lot releases. Forty- one professionals have been trained to date, including 17 from the NRA and their institutions, such as UNAN and national medicines manufacturers.

There are significant advances with the NRA following a better understanding of its strategic role in the the project. The NRA is fully engaged in all the activities that PAHO/WHO has facilitated for the implementation of the institutional development plan.

PAHO/WHO have also developed and supported the following: exchanges with universities to include regulatory issues in the curriculum for pharmacists and other health professionals involved in the project to ensure its sustainability; the allocation of human resources for capacity-building; NRA implementation of a quality management system; and, coordination and monitoring of progress in implementing the 2018 operational plan, which includes all of the actions leading up to the launch of the Mechnikov manufacturing plant this year.

The initiative is innovative because it considers synergies among national regulatory authorities. It is replicable because it can be implemented in any country interested in achieving self-sufficiency in terms of access to influenza and other vaccines and biologicals.

This good practice can be replicated in other developing countries, with the understanding that its replicability requires the support and partnership of a government willing to engage in technology transfer in vaccine and health technologies development. This would result in local development and production, with the support and experience of international organizations such as PAHO/WHO.