Measles Containing Vaccines UNICEF Supply Division Industry Consultation Meeting 25-26 January 2012
Content Measles monovalent vaccine: Programme Updates and Procurement Overview Measles and Rubella vaccine: Programme Updates and Procurement Overview Measles, Mumps and Rubella vaccine: Programme Updates and Procurement Overview Tender strategic issues: Products and Quantities, Invitees, Tender Period, Timelines
Measles Monovalent vaccine
Estimated measles deaths 78% Reduction in Measles Mortality from 2000 to 2008 1,000,000 800,000 600,000 400,000 200,000-2000 2001 2002 2003 2004 2005 2006 2007 2008 * High-low lines indicate uncertainty bounds - Measles Initiative celebrated its Tenth Anniversary in 2011, 1 billion children immunized (as of July 2011) - Burden of Measles in 2000: 40 million cases and at least 500,000 deaths - In 2011, reported measles cases down by two-third globally, 13 million cases - Global mortality goal is set to reach 95% reduction in 2015 compared to 2000 Source: WHO/IVB measles deaths estimates, October 2009 Source: PD and WHO presentation at the Annual Measles meeting, Washington 2011
Measles and Rubella Elimination Goals by WHO Region, August 2011 Americas, Europe, E. Mediterranean, W. Pacific, Africa have measles elimination goals Americas and Europe have rubella elimination goals 2015 2015 2000 2010 2015 2012 2020 SEAR: 95% Measles Mortality Reduction by 2015
All Measles containing vaccine Procurement through UNICEF Historic and forecasted demand
Measles: Outlook Demand drivers: Continued routine uptake - 2 doses as per SAGE recommendation. In 2012, 9 countries introducing 2 nd dose; Bangladesh 2 nd dose given in MR. Sustained follow-up campaigns, intervals based on 1 st dose coverage, with intervals of 2-3 years until 2019 and possibly beyond. Review of use of 5-dose vial in routine will be completed before the tender. Offers for this presentation will be requested. Continued monovalent measles vaccine supply needed in the future.
Increase in number of emergencies and outbreaks in the recent years requires adequate response, including supplies Major outbreaks and emergencies in 2010-2011: Pakistan flooding, Haiti outbreaks in Central and West Africa and Central Asia, Horn of Africa humanitarian crisis. In 2010 18.2 Mds and in 2011 16.5 Mds of measles vaccine were shipped for emergency and outbreak response. Going forward, we will request 1-2 Mds at any given time to be available within 72 hours for emergency and outbreak response.
Measles procurement through UNICEF Historic & forecasted demand
Measles and Rubella (MR) vaccine
MR vaccine SAGE Recommendation April 2011: using Rubella vaccine to prevent the occurrence of congenital rubella infection, including CRS (congenital rubella syndrome) WHO Position Paper on Rubella revision July 2011: introduction criteria revised to at least 80% in either routine or campaigns November 2011: GAVI Board approved opening a new support window for Rubella: Countries can apply to GAVI for financing a catch up campaign using MR from 2012. Countries to procure MR for routine immunisation after the catch up campaign. Programme anticipates that countries will have regular follow up campaigns as required.
MR introduction GAVI opened a window for 52 eligible countries that have not yet introduced Rubella, financing catch up campaigns from 2013 onward. Countries should achieve and maintain immunization coverage of 80% or greater with Rubella containing vaccine delivered through routine immunization and/or regular campaigns. Introduction will start with a catch up campaign. Target population: 1 to 15 year olds. Routine immunization schedule: 1 st dose = 9-12 months of age (in same vaccine as measles and possibly mumps). As a condition for GAVI support, countries are to commit to pay for vaccines in their routine immunization programmes.
MR Procurement through UNICEF Historic and forecasted demand (High demand/unconstrained SCENARIO)
MR Procurement through UNICEF Historic and forecasted demand (Low demand SCENARIO)
MR: Outlook Currently 1 manufacturer producing pre-qualified vaccine. MR to be tendered together with Measles vaccine. Increase in demand from 2012 and expected to accelerate. Expect stabilized demand over the next 5-6 years after: All countries carry out catch up campaigns, starting in 2013. Countries introduced MR into their routine. Sustained follow-up campaigns with intervals of 2-3 years. Introduction is to be implemented in partnership with the industry feedback on feasibility is requested.
Measles Mumps Rubella (MMR) Vaccine
MMR Procurement through UNICEF - Overview and demand forecast
MMR: Outlook Demand has been low in the past with the slight trend to increase. Countries have strong strain preferences; sometimes preference are influenced based on price and availability. Increase in demand in 2009 is driven by Philippines - introduced MMR.
Strategic Tender Issues
Overview of Measles vaccine supply market - 4 manufacturers with WHO pre-qualified vaccines.
Overview of MR vaccine supply market - Need for additional manufacturers to enter the market to ensure vaccine security and meet the demand
Measles Containing vaccine Tender Objectives Tender to address the current market situation and support market shaping objectives: Strengthening Vaccine Security ensuring a sustained and uninterrupted supply of affordable vaccines as a support of the objectives of the Global Measles and Rubella Elimination Programme.
Tender duration: 2013 and beyond Tender period: considering 3 + years Allow for modification and review the progress of Rubella introduction over the next 3 years of the programme. Allow for manufacturers to offer substantial quantities recognizing the uncertainties of MR introduction and transition from Measles vaccine Requesting manufacturers to provide feedback
Products and quantities Products to be tendered for: Measles and MR in 10 and 5 dose presentations MMR with various mumps strains Offers for alternative presentations are welcome Demand scenarios for specific vaccine will be provided
Tender process: timelines Industry Consultation meeting: 25-27 January Feedback from manufacturers: mid February Issuance of tender: mid March (5/6 weeks response time) Closing of tender: mid May 2012 Opening of tender: mid May 2012 May-June: Initial commercial review and identification of issues for clarification Technical review of proposals by WHO, and follow-up with manufacturers for missing information, clarification of offers and technical requirements. Clarification calls and meetings with manufacturers Internal review and finalization of recommendations and approvals End June: Awards issued (6 months before required deliveries)
UNICEF VACCINES Thank You