1 |1 | Regulatory authority and Immunization programs: a joint work for patient safety Global Vaccine Safety Group Department of Essential Medicines and Health Products

2 |2 | Unsafe vaccine can have serious consequences Safety crises derail immunization programs Real incidents: –Tuberculosis following oral BCG. –Polio following IPV. –Swine flu campaign and GBS. Real safety issues: –Programme errors. –Anaphylaxis. –VAPP. –Disseminated BCG disease. Rumours, poor science and over-reaction: –Pertussis vaccine coverage in the UK. –MS and hepatitis B vaccine in France. –OPV and chronic diseases in Nigeria. –Thiomersal and neuro-developmental disorders. –Pentavalent vaccine in Asian countries.

3 |3 | Resurgence of polio in Nigeria

4 |4 | Pentavalent vaccines in Asian countries Pentavalent DTwP-HepB-Hib vaccine introduced in >170 countries to date. In several Asian countries, serious AEFI in the first week after introduction raised concerns and in 2 countries led to a suspension of vaccine use for more than one year. Investigations did not identify any causal relationship between vaccine use and serious AEFI.

5 |5 | AEFI of particular interest for pandemic flu vaccination campaigns The Lancet 2009;374: Epub 31 October 2009.

6 |6 | Number of coincidences following pandemic influenza vaccination

7 |7 | New vaccines Coming soon: new IPV and IPV combos, malaria, dengue, Japanese encephalitis, typhoid conjugate, new TB vaccine, etc…

8 |8 | Way forward Strong methodologies to address concerns: –Harmonized tools. –Methodological excellence. –Adjusted to local circumstances. –Information exchange (including industry). International collaborations: –Multicenter studies. –Training curriculums. –Laboratory access. Expert scientific advice: –Local, regional and global committees. –Networks for technical support.

9 |9 |

10 | Blueprint vision and goals VISION Effective vaccine pharmacovigilance systems are established in all countries  To assist low- and middle-income countries to have at least minimal capacity for vaccine safety activities;  To enhance capacity for vaccine safety assessment in countries that: introduce newly developed vaccines, introduce vaccines in settings with novel characteristics or both manufacture and use prequalified vaccines;  To establish a global vaccine safety support structure. 3 main goals

11 | Advisory body to WHO/IVB. Response to vaccine safety issues of potential global importance: −promptly, efficiently, with scientific rigor. Broad expertise. Independence. Decisions and recommendations based on best available evidence. Global Advisory Committee on Vaccine Safety (GACVS) Reports and statements:

12 | 12 Building blocks are in place  Consensus on need for improved PV among stakeholders  Health care providers and researchers  Regulators and public health authorities  Industry  Donors  Roadmaps/reports/strategies  USAID Safety of Medicines in Sub-Saharan Africa  WHO Global Vaccine Safety Blueprint  CIOMS/WHO Working Group on PV and Vaccine PV

13 | 13 Building blocks are in place  Surveillance capacity globally - UMC  Networks and collaboration including regulators  WHO-coordinated International Collaborative H1N1 Influenza Vaccine Safety  Case only methods suitable for countries without population-based data systems  Promising new efforts in multiple fora (APEC, PAHO)  Donors increasingly cognizant of the need, identifying approaches (BMGF: Safety Surveillance Working Group)  Common nomenclature and reporting data standards  “Joint Initiative” - ICH/ISO/HL7/CEN and others – the end is in sight  MedDRA, SNOMED, Brighton Collaboration: mature nomenclatures/terminologies but adaptable

14 | Conclusions Ensuring the safest possible use of vaccines should be the standard for all immunization programs. Proactive communication should be the norm: –Know risks and benefits of vaccines are presented. –Systems for continuous monitoring of safety are described. –Local stakeholders ensure first line communication. –Risk management plans are part of vaccine safety strategies. Expertise available among many stakeholders, but insufficient information exchange.

15 | Global Vaccine Safety website Global Vaccine Safety website