DCVMN Perspective: Barriers and how developing countries manufacturers will be able to reach goal.

Transcription

1 DCVMN Perspective: Barriers and how developing countries manufacturers will be able to reach goal. Dr. Suresh Jadhav Executive Director Serum Institute of India Limited.

2 H1N1 Pandemic: What went well More than 20 monovalent pandemic influenza (H1N1) vaccines got licensed globally Vaccines were found generally safe Consensus on immunization policy recommendations. (WHO-SAGE) Vaccines were available slightly ahead of plan in developed world Extensive data sharing DCVMN: showed signs of progress in vaccine development. David wood (2010): Vaccines for H1N1.

3 H1N1 Vaccine and DCVMN manufacturers. (What went well) Year 2006: GAP intiative was planned and 5 DC manufacturers were approached for seasonal and H5N1 influenza vaccine production capacity building. Year 2008: Additional 6 DC manufacturers were shortlisted for capacity buidling. April 2009: Pandemic Threat of H1N1 was announced and these manufacturers were asked to ready H1N1 vaccine for global use. July 2010: DC Manufacturers showed potential to ready vaccine (nasal live attenuated vaccine) and injectable (inactivated) H1N1 vaccine for global use in a Years time. 3

4 Global access to H1N1 Vaccines What didn't work well Vaccine roll out to developing world was slow. Lack of Global advocacy Was there a ? Were DC s completely unaware of the pandemic threat. Or, a strategic failure Equity in deployment of vaccine was low Has this acquired a lower priority in line of already existing challenges of scarcities and shortages Else, lack of infrastructure in DCs in dealing with such situations Political will Immunization supply systems and manufacturing capacities Diaster management

5 Demand Global production less than predicted. Demand collapsed in 2010 Limitations in existing global survelliance systems -Close interactions with national and international disease survelliance agencies for global concerted responses: - Establishment of a permanent cell with help from national and international laboratories to monitor the spread of disease globally Ad hoc approach has limitiations. A global framework for future pandemics with suitable alarm systems will be crucial for prepardeness. Advocacy - Barriers to vaccinations need to be better understood and addressed - Role of electronic and print media for increasing the awareness about the disease and its prevention (positive as well as negative impacts. Sustaining and buidling vaccine capacities in DC s

6 H1N1 Vaccine Demand and DCs During H1N1, demand for Vaccine in DC s was noted to be dependent on: - Public awareness of their own - Information passed on from public health department - Panic - Political will Proportions of these factors varied from country to country in developing world. As a result, significant variations in uptake of vaccine was recorded.

7 Communications Lines of communication between public and private stakeholders were not adequate to meet pandemic threats Concept of diaster management needs to be in place, for setting up guiding principles for decision making at appropriate alarm levels. Need of separate contigency fund at country level for meeting any such health threats.

8 Communications Stakeholders especially from private sector should be suitably rewarded. Compensation does not necessarily mean financial. What was lacking: A coordinated approach between the decision makers at govt level, public health authorities, regulators, manufacturers, social organizations including NGOs.

9 DCVMN: Positive Developments Members showed potential and ability to undertake vaccine development Vaccine development was cost effective vis a vis western world costs. Local Govt support NRA showed signs of preparedness Fast track regulatory mechanisms

10 DCVMN Action Points- to reach goals Support global preparedness by establishing strong production capacities in developing world: - By leveraging newer production technologies for real time access to member countries. - Support members to develop production capacities at regional levels for better vaccine access in DCs. - Coordinate/undertake studies to establish effectiveness of newer technologies (VLP, newer adjuvants) Successfully addressing the supply scenario (vaccine administration) in future pandemics. Many organizations are working globally to develop apt strategies for addressing programmatic issues. - DCVMN would like to leverage such efforts in DCs.

11 DCVMN Action Points - to reach goals Develop synergies with international agencies such as WHO, BARDA, US. Developing effective and coordinated communication lines with public health authorities, decision makers at developing countries. Workforce development in influenza vaccine development. Sustaining vaccine production capacities in developing world Developing collaboration to address vaccine development challenges at local and regional levels. Play an important role in advocacy for increased uptake of seasonal influenza vaccine in developing world. Harmonization of regulatory requirements Coordinate research and development efforts for better vaccines, clinical trials, adjuvants.

12 Thank You