by Kamel Senouci, AMP and Liliana Chocarro, Consultant
As a wider array of vaccines become available in developing countries, many national immunization programs are starting to rely on the professional advice of National Immunization Technical Advisory Groups (NITAGs)
to help them make critical decisions about new vaccine introduction, such as immunization schedules, target groups, and coverage improvement targets. These same programs count on national regulatory authorities (NRAs) to issue recommendations about vaccine quality, safety, and efficacy in licensed-use conditions. While few countries have established formal relationships between the two bodies, many are recognizing that a strong relationship can be beneficial and the lack of such a relationship can present serious challenges to immunization programs.
The lack of systematic and clear communication between NITAGs and NRAs was first recognized as a possible global issue at the 2008 New and Under Used Vaccine Implementation
meeting. This was confirmed at the 2010 Developing Country Vaccine Regulator’s Network (DCVRN) meeting when organizers invited NITAG members and NRA representatives from various countries to discuss the problem and potential solutions. The consultation was hosted by the World Health Organization (WHO) and the Supporting National Independent Immunization and Vaccine Advisory Committees (SIVAC)
Initiative, and a joint initiative implemented by the Agence de Médecine Préventive
and International Vaccine Institute
At the DCVRN meeting, participants noted a number of challenges resulting from a lack of communication between NITAGs and NRAs. Recently, for example, one country’s NRA made a regulatory recommendation to revaccinate children after finding a quality control problem in a Bacilles Calmette-Guérin vaccine. The country’s ministry of health requested a recommendation from the NITAG based on both an international literature review and local data. The NITAG recommended not revaccinating the children, as the doses received were sufficient. It further recommended an epidemiological study to compare immunogenicity among these children and controls. Both recommendations were rational; however, when the media got hold of the story, people became confused. In the end, the country’s ministry of health asked the NRA and NITAG to discuss their findings and come forward with a unified recommendation, which was done. Although the issue was resolved, the public may have lost a degree of confidence and trust in the immunization program as a result.
In other cases, NRAs and NITAGs have been unclear about each other’s responsibilities and the basis upon which recommendations are made (e.g., clinical trials versus public health considerations). This has led NITAGs to dismiss the recommendations of the NRA (and vice versa), ultimately leading to nonoptimal policy decisions at the programmatic level and confusion among health care workers. A common result of poor interaction between NITAGs and NRAs is an immunization program that vaccinates an age group for which the vaccine was not tested or authorized for use.
On the other hand, when communication between NRAs, NITAGs, and Ministries of Health is strong, immunization programs have seen clear benefits. For example, in Indonesia, the Ministry of Health, the National Agency of Drug and Food Control (NADFC), and the NITAG work together to ensure availability of vaccines of assured quality, safety, and efficacy for the exact use that the immunization program had in mind.
NADFC may seek scientific opinion from the NITAG during vaccine development (investigational process for new vaccines), during vaccine registration, as well as during post-marketing surveillance. During vaccine development, when a vaccine is going to be investigated under clinical trials, the NITAG is involved in NADFC review in clinical trial protocol, consultation on the result of good-clinical-practice inspection, and advice for immunization schedules for clinical trials and target population. As part of vaccine submission review during registration, NADFC may seek scientific advice from the NITAG before issuing a decision for marketing authorization. The NITAG may also look at pre-market evaluation on clinical data of new vaccines.
Seeking more examples of NRA/NITAG interactions that work, SIVAC and WHO have conducted surveys to identify different models of collaboration that currently exist between NITAGs and NRAs and to better understand the factors that lead to a successful (or unsuccessful) collaboration. WHO and SIVAC are also launching a pilot project with countries in the Eastern Mediterranean Region, most of which already have NITAGs and NRAs in place, to identify appropriate levels and modes of interaction that could result in an optimal decision-making process. In late October 2011, the countries will share their experiences and discuss how they can individually and collectively improve the collaboration between NRAs and NITAGs.
Because NRAs and NITAGs operate differently in different countries, there will be no one-size-fits-all approach to solving this problem. However, with better examples and case studies that demonstrate the benefits of and explain possible structural arrangements for collaboration, more countries may embark on their own efforts to strengthen the relationship between the two groups.
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