Independent Assessment Committee

The Independent Assessment Committee (IAC) was created as an impartial oversight body of the AMC. The IAC is responsible for determining whether a candidate vaccine meets the minimally acceptable profile (the “Target Product Profile”) in terms of vaccine serotypes, target population/target age group, dosage schedule, route of administration and product formulation. The Target Product Profile is designed to ensure that AMC vaccines meet developing country needs.

In its monitoring role, the IAC appraises information and endorses annual progress reports. In addition, the IAC establishes when and if an adjustment of the pre-set long-term price of vaccines is necessary. Finally, the IAC has a dispute resolution function.

Membership

The IAC Selection and Oversight Panel, a group of international experts, is charged with the task of selecting and appointing IAC members as well as with reviewing claims of potential or declared conflicts of interest involving IAC members.

The composition of the IAC, in terms of required areas of expertise, was decided upon by the AMC stakeholders during the design phase. The IAC membership reflects a balance of significant expertise in the following areas: public health, health economics, vaccine business development, vaccine industry economics, contract law, public-private finance and clinical performance and delivery systems.

As per the IAC Bylaws, the IAC Selection and Oversight Panel was asked to select the IAC Chairperson and Vice Chairperson. The selection was decided on 6th July 2009 and announced to all IAC members on 14th July 2009. Claire Broome and Soonman Kwon were selected as the Chairperson and Vice Chairperson respectively of the Independent Assessment Committee (IAC).

Pfizer Inc.

2010 Application

On 15 January 2010, Pfizer Inc. submitted an application for Advance Market Commitment (AMC) Eligibility to the AMC Secretariat for the pneumococcal vaccine Prevenar 13 single dose presentation vaccine. In accordance with the AMC legal agreements, copies of this application were sent to the Independent Assessment Committee.

An AMC Eligibility Determination Meeting was scheduled within 30 business days when the candidate vaccine met WHO prequalification to review such application. Pfizer’s Prevenar 13 single dose received WHO prequalification on 19 August 2010.

An AMC Eligibility Determination Meeting was scheduled on 23 August 2010 to review the application and determine if the candidate product met the AMC Target Product Profile (TPP).

2016 Application

On 20 May 2016, Pfizer Inc. submitted an application for AMC Eligibility to the AMC Secretariat for the pneumococcal vaccine Prevenar 13 4 dose presentation. In accordance with the AMC legal agreements, copies of this application were sent to the Independent Assessment Committee.

Pfizer’s Prevenar 13 4 dose presentation received WHO prequalification on 14 July 2016.

An AMC Eligibility Determination Meeting was scheduled on 9 August 2016 to review the application and determine if the candidate product met the AMC Target Product Profile (TPP).

GlaxoSmithKline

2010 Application

On 9 March 2010, GlaxoSmithKline (GSK) Biologicals submitted an application for AMC Eligibility to the AMC Secretariat for the Synflorix 2 dose presentation vaccine. In accordance with the AMC legal agreements, copies of this application were sent to the Independent Assessment Committee. GSK's Synflorix 2 dose presentation vaccine received WHO prequalification on 19 March 2010.

An AMC Eligibility Determination Meeting was scheduled on 16 April 2010 to review such application and determine if the candidate product meets the AMC Target Product Profile (TPP).

2017 Application

On 19 July 2017, GSK Biologicals submitted an application for AMC Eligibility to the AMC Secretariat for the Synflorix 4 dose presentation vaccine. In accordance with the AMC legal agreements, copies of this application were sent to the Independent Assessment Committee. GSK's Synflorix 4 dose presentation vaccine received WHO prequalification on 16 October 2017.

An AMC Eligibility Determination Meeting was scheduled on 17 October 2017 to review such application and determine if the candidate product meets the AMC Target Product Profile (TPP).

17 October 2017: AMC ELIGIBILITY DETERMINATION MEETING

An Advance Market Commitment (AMC) eligibility determination meeting was held on 17 October 2017 to review GSK’s application for AMC Eligibility of the Synflorix 10 4-dose vial presentation. The Independent Assessment Committee (IAC) members unanimously determined that this 4-dose vial presentation meets all of the TPP criteria and that the candidate vaccine is therefore eligible for purchase pursuant to the terms and conditions of the AMC for Pneumococcal disease.

9 AUGUST 2016: AMC ELIGIBILITY DETERMINATION MEETING

An Advance Market Commitment (AMC) eligibility determination meeting was held on 9 August 2016 to review Pfizer’s application for AMC Eligibility of the Prevenar 13 4-dose vial presentation. The Independent Assessment Committee (IAC) members unanimously determined that this 4-dose vial presentation meets all of the TPP criteria and that the candidate vaccine is therefore eligible for purchase pursuant to the terms and conditions of the AMC for Pneumococcal disease.

23 August 2010: AMC eligibility determination meeting

An Advance Market Commitment (AMC) eligibility determination meeting was held on 23 August 2010 to review Pfizer’s application for AMC Eligibility. The Independent Assessment Committee (IAC) members unanimously determined that Prevenar 13 meets all of the TPP criteria and that the candidate vaccine is therefore eligible for purchase pursuant to the terms and conditions of the AMC for Pneumococcal disease.

16 April 2010: AMC eligibility determination meeting

An AMC eligibility determination meeting was held on 16th April 2010 to review GSK's application for AMC eligibility.

The IAC members unanimously determined that GSK Synflorix 2 dose presentation vaccine meets all of the Target Product Profiles (TPP) criteria and that the candidate vaccine is therefore eligible for purchase pursuant to the terms and conditions of the AMC for pneumococcal disease.

July and August 2009: induction calls

Following the signature of the legal agreements in June, the AMC Secretariat organised two induction calls on 14 July 2009 and on 10 August 2009 for IAC members to ensure that the committee was clear on its roles and responsibilities and related procedures as well as on the functioning of the AMC programme.

November and December 2008: endorsement of the Target Product Profile

In addition, the IAC first met by teleconference on 3 November 2008 to review and deliberate about the pneumococcal AMC Target Product Profile (TPP).

The IAC met again on 11 December 2008 to endorse the TPP.