3rd Global Meeting on Implementing New and Under-utilized Vaccines, 16-18 June 2009
Workgroup 2. Coordination between National Regulatory Authorities and National Immunization Technical Advisory Groups and/or Immunization Managers
National Immunization Technical Advisory Groups (NITAGs) guide and enable policy makers and programme managers to make evidence-based immunization related policy decisions, using a comprehensive and integrated approach, serving as a neutral forum and providing credibility. NITAGs provide advice on optimal policies and formulate strategies, monitor the national immunization programme by collecting important data, and support the latest scientific development in the area of vaccines and vaccine preventable diseases.
National Regulatory Authorities (NRAs) ensure that vaccines released for use are effectively evaluated and meet international standards for safety, efficacy and quality. NRAs also define scientific documentation and criteria for licensing, and continually oversee the quality of vaccines by releasing each lot intended for use in the country.
In several countries, there is inadequate coordination between NITAGs and NRAs, although this coordination is critical for in-country collaboration.
Main Topics of Discussion
- Many countries do not have functional NITAGs and/or NRAs.
- Where both organs do exist, exchange of information between NITAGs and NRAs is often insufficient
- Vaccines, in particular OPV, Pneumococcal, BCG and Rotavirus vaccines, are sometimes not used as indicated in the market authorization
- Some NRAs consider that once they have made a decision on vaccine introduction, they no longer have a role to play in the next steps
- The respective roles of the NRAs and NITAGs are not clear to all actors
- Appropriate timing for inputs from the NITAG during the licensing evaluation process is vital
- Further strengthen, standardize and coordinate NRAs and NITAGs by improving the dissemination of existing guidelines on their respective roles and responsibilities.
- Promote formal discussions between existing NITAGs and NRAs to prepare recommendations on the coordination level and methodology.
- Consider the appropriateness of formalizing the use of sub-regional ITAGs to support NITAGs without undermining national sovereignty.
- Be aware of the need for balance between the involvement of NITAGs in NRAs and protecting the independence of the NRAs.
- Explore further utilization of NRAs and NITAGs to support immunization managers during risk communication with public; to advocate for surveillance; and make recommendations for both private and public delivery of vaccines.