MI4A Vaccine Purchase Data for Countries This Note Is Intended to Guide Countries in Their Use of the MI4A Vaccine Purchase Data
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MI4A Vaccine Purchase Data for Countries This note is intended to guide countries in their use of the MI4A vaccine purchase data. What data is available? new vaccine introductions, but also for product switches – and to understand the status of product The WHO vaccine market intelligence database registrations. Fifty-six Member States responded compiles vaccine purchase (product, price and to these new questions. procurement) data as reported by countries via the WHO/UNICEF Joint Reporting Form (JRF) over the This information is essential to WHO’s efforts to period of 2013–2018. While country names are not improve global market forecasts and inform displayed, data is publicly available on the MI4A suppliers’ and global policy-makers’ investment website and provides information by country decisions. WHO encourages all countries to characteristics (e.g. region, income group…) by report information on new introduction plans and vaccine and by year of purchase, along with price planned product changes as well as to respond to per dose (USD), procurement mechanism and questions related to registration. annual volumes. 1 The number of countries reporting vaccine How can my country use this data? purchase data through the JRF continues to Countries can use the vaccine purchase data in increase year after year, with 182 Member States several different ways, such as to: (93%) reporting some vaccine procurement information in 2019 – including 158 (81%) fully • Understand how the price of vaccines in their reporting on vaccine purchase data. Price reporting immunization schedule relate to other this year marks a 3% increase from last year and products on the market, or compare the more than triple the reporting from 2016. prices paid by other countries in similar conditions (e.g. income, funding/procurement Most importantly, full reporting from non-Gavi group, contract conditions) – for example: how self-procuring countries who tend to have less much does seasonal flu vaccine cost in access to market information increased by 12% countries similar to mine? compared to last year. Six countries also reported price for the first time this year. • Identify other vaccines available from a given manufacturer – for example, what products The largest proportion of non-reporting countries are in the portfolio of a manufacturer of are high-income countries, with 20% having never interest for my country? reported any market information. The majority of these countries are in the European region. • Understand other available products and presentations for each vaccine – for example, WHO encourages all countries to share vaccine which BCG vaccine products are on the purchase data. This will allow for a complete market? global market view, identifying risks to vaccine access without underrepresenting certain market • Develop budget estimates to inform new segments. vaccine introduction product choices, planning and budgeting New questions were included in the 2019 JRF to support efforts on prospective data collection and have better visibility on countries’ future plans – for 1 Also refer to the guidance note on How to interpret the data: factors to consider when comparing vaccine price https://www.who.int/immunization/programmes_systems/procurement/mi4a/platform/module2/factors_to_consider.pdf?ua=1 WORKING DOCUMENT - MI4A Vaccine Purchase Data Note [December 2019] | 1 The 2018 data, provided in Section D for easy BCG VACCINES: reference, is organized by vaccine, listing all As of 2019, available global supply is more than reported manufacturers and vial sizes. Prices are twice the global demand, and this situation is likely indicated by procurement mechanism, income to continue in the future. BCG vaccine is produced group and WHO region. Reference to UNICEF price by over 20 manufacturers, which ensures a large information is included in Section B; PAHO supplier base. However, there are still risks that Revolving Fund prices are reported in Section C. could lead to national stock-outs in the event of Building on the list of products reported as production issues from individual manufacturers. purchased by countries, WHO is also leveraging This is due to: other publicly available intelligence to publish a (i) the concentration of a large share of global more complete list of vaccine products available for supply in two manufacturers that are regulated procurement – including non-prequalified- by the same NRA, which, coupled with an vaccines.2 This list is included in Section A. unstable manufacturing process, can The Vaccine Purchase data set (including past contribute to unexpected and sudden reduction years’ data) can also be downloaded in Excel in availability; and format from http://who.int/immunization/MI4A (ii) many countries having only one product Moving forward, understanding and monitoring the registered. impact of market information use in countries will Vaccine product registration is an important factor be an area of focus for WHO and its partners. This affecting access to vaccines. Registering more will be an important step to better adapt the than one product will help countries to avoid information and related support provided to stock-outs in the case of market exit or supply countries – particularly for self-procuring MICs. shortage from the preferred manufacturer. WHO encourages countries to share their Investments have been made to streamline experience on data use at [email protected]. WHO regulatory procedures, encourage the use of can also respond to any request or questions at this reliance and mutual recognition among National address. Regulatory Authorities, set up regional regulatory networks, enhance the use of the Collaborative Key messages to countries Procedure for Accelerated Registration of The data shared by countries allows MI4A to Prequalified Products, and develop guidelines on complete global analysis, providing key insights to procedures for post-approval changes. Dialogue understand availability and affordability issues. A between manufacturers, countries and WHO on Global Vaccine Market Report is published how to resolve registration challenges and related annually, offering global insights on vaccine matters is ongoing. Ultimately, it is up to countries’ markets.3 MI4A also develops vaccine-specific leadership to bring about change. Global Market Studies. Some important vaccine-specific messages are found below – particularly for self-procuring middle-income countries. 2 The list of vaccine products provides an overview of vaccine products available organized by vaccine type, manufacturer and commercial name. See Section A and Excel format available on the WHO website: https://www.who.int/immunization/programmes_systems/procurement/mi4a/platform/module1/en/ 3 The most recent version of the Global Vaccine Market Report is available at: https://www.who.int/immunization/programmes_systems/procurement/mi4a/platform/module2/en/ WORKING DOCUMENT - MI4A Vaccine Purchase Data Note [December 2019] | 2 DIPHTHERIA AND TETANUS (D&T)– Replacement of TT with Td vaccine for dual CONTAINING VACCINES: protection Sufficient vaccine supply is available for all In June 2018, WHO and UNICEF issued a joint countries to introduce the recommended life communiqué urging countries to replace course of six doses of D&T–containing vaccines and tetanus toxoid (TT) vaccine with tetanus- to replace TT vaccine with Td. However, supply of diphtheria (Td) vaccine – in light of the growing acellular pertussis (aP)–containing vaccines number of diphtheria outbreaks.* remains limited. It is sufficient to support demand from countries where the product is already in use, As of January 2020, UNICEF will no longer fund but introduction in additional countries may lead to TT vaccine, nor provide procurement services availability issues and require, under all for supply of TT vaccine. UNICEF will continue circumstances, 12 to 18 months advance notice to to support Td vaccine only, in support of the suppliers or procurement agency. This maternal immunization programmes. constraint – and WHO recommendations on WHO confirms sufficient supply is available to pertussis4 – should be taken into account before meet increased global demand for Td vaccines considering switching from whole-cell pertussis and highlights minimal price differentials (wP)–containing products. between TT and Td vaccines. Supply for whole-cell (wP)–containing vaccines For countries self-procuring TT vaccine, it is remains sufficient to absorb any production issues expected that this vaccine will remain available or sudden increases in demand. Some vaccine on the global market. However, as a result of combinations (DTwP-HepB, DTwP-Hib, TdaP-IPV, decreased demand through UNICEF and Td-IPV) are used in a very limited number of market evolution toward production of Td countries and may be at risk of discontinuation vaccine, the cost and delivery lead-time of TT from the manufacturers. Countries procuring those vaccine may increase. Those countries who combinations should make themselves aware of have not yet planned this replacement are potential product alternatives. strongly encouraged to do so as soon as possible. HPV VACCINES:5 To streamline the logistics and reduce the Supply is currently insufficient to meet demand. number of different products needed for According to the latest analysis, constraints are various age groups, WHO has also reviewed the expected to last until at least 2023/24, possibly evidence supporting the use of Td vaccine in leading to challenges for countries to