How do we get the vaccine presentations that we need?

1. How do we get the vaccine presentations that we need? Presentation to TechNet Meeting, 30 Nov – 2 Dec 2010 Dr. Rudi Eggers WHO/EPI

2. WHO Pre-qualification of vaccines "…to ensure that vaccines used in national immunization services in different countries are safe and effective for the target population at the recommended schedules and that they meet particular operational specifications for packaging and presentation."

3. VPPAG gPPP • August 2009 • Global Preferred Product Profile

4. Programmatic suitability - historically • Has been a component of pre-qualification since inception • Decisions based as far as possible on precedent • Consultation with programme components in WHO and in countries • Made on a case-by-case basis • Decided to include in the revision of the pre-qualification system currently under way

5. New approach • Define the vaccine characteristics that are problematic for the programmatic suitability better, and communicate these clearly to developers and manufacturers • Judge the programmatic suitability against the problematic and preferred characteristics in a process that is transparent and reproducible • Clearly state the preferred characteristics to guid future vaccine development • Maintain "human judgement" in cases that require closer scrutiny for reasons of public health need

6. Recent examples of vaccines that have had programmatic challenges during pre-qualification • Pre-filled syringes • Large cold chain volume, not auto disabled, difficulty in disposing of material • Unpreserved liquid multi-dose vials • Unknown risks of health workers potentially keeping these opened vials for future sessions (in line with their training) • Oral vaccines • In packaging that may be confused with pre-filled devices an erroneously injected • Multi-component vaccines • Different components of the vaccine differ in heat stability resulting on difficulty in assigning VVMs

7. Examples

8. Revision - introductory comments • Currently… • Applies to future screenings of prequalification applications • Do not apply to vaccines which are already WHO prequalified, to renewal of prequalification, or to vaccines that are under review for prequalification at the time of initial publication of this document. • WHO recognizes that programmatic suitability characteristics can vary by WHO region and expects that this variation will be expressed in the procurement and tendering process.

9. Vaccine characteristics that will affect pre-qualification • Mandatory • Compliance is compulsory • Failure to meet this characteristic will prevent the vaccine to be further considered for pre-qualification • Critical • Compliance is also compulsory • However, deviations in vaccine characteristics will be reviewed by the Programmatic Suitability for WHO Prequalification (PSPQ) Standing Committee • Under special circumstances exceptions can be granted to vaccines that deviate from the critical characteristics. • Decision can only be taken by the PQ Secretariat and will include consideration of recommendations from the PSPQ Standing Committee and consideration of topics such as public health need and access to vaccines.

10. Programmatic Suitability for Prequalification (PSPQ) Standing Committee • Is an independent advisory committee to the WHO Prequalification (PQ) Secretariat made up of experts with immunization program and policy experience. • Is aligned to IPAC a one of the IPAC Standing Committees • During their review, discussion and recommendation-making, the PSPQ Standing Committee may engage in confidential discussion with manufacturers and additional technical experts. They may also recommend validation by research of the acceptability of non-compliant characteristics. • The maximum allowed time for review by the PSPQ Standing Committee is 3 months.

15. Vaccine characteristicsthat are unique • Unique (characteristics not otherwise specified) • Are reviewed by the PSPQ Standing Committee • May be pre-qualified if considered by the PQ Secretariat on the advice of the PSPQ Standing Committee

16. Who makes the final decision? PQ decision-making These rules give guidance, the decision to pre-qualify or not lies entirely with the PQ team and IVB director (as before) Maintain "human judgement" in cases that require closer scrutiny for reasons of public health need

17. Vaccine characteristicsthat are preferred (but do not affect PQ) • Preferred • Are intended to indicate what WHO and national immunization programmes would want in a best case scenario and expect in the future • Are meant to guide vaccine manufacturers during the development of the new vaccine formulations • A vaccine not complying to preferred characteristics would not be prevented to be further reviewed for pre-qualification • However with time, a preferred characteristic may in future revisions be deemed to become critical

18. Preferred Vaccine Characteristics - 1

19. Preferred Vaccine Characteristics - 2

20. Proposed Preferred Vaccine Characteristics - 3

21. Thank you