Regional Malaria Vaccine Decision-Making Framework

The Malaria Vaccine Decision-Making Framework (DMF) is a strategic planning tool to help decision-makers weigh multiple considerations and fill information gaps while planning for a future malaria vaccine.

The framework aims to facilitate more effective cooperation between governments and partners at national, regional, and global levels, so that a decision can be made on a malaria vaccine within one to three years of licensure.

In order to make a decision about introducing a malaria vaccine, decision-makers require information to support their planning processes.

The DMF's first page shows the various types of data that will support this planning.

Across the top of the page, the DMF shows these categories of data.

Decision-makers will require different information over time.

Their data needs will depend on how many years remain until the vaccine is licensed, or how many years ago it was released.

The DMF shows these time periods from the top to the bottom of the page.

Decision-makers will require information about their own countries in order to plan.

For example, they will need to know the malaria disease burden carried by different population groups and geographic areas.

The DMF presents this national data in purple boxes, arranged by point in time and by category.

Decision-makers will also require information that is not specific to their country, such as data on the vaccine's cost and efficacy (which should become available during Phase 3 clinical trials).

The DMF presents this global data in green boxes, also arranged by time period and by category.

Some of the information items will be critical for decision-making—these data are written in red text.

Other information items are not critical, but would be good to have—these data are written in black text.

For a malaria vaccine to reach the people who need it, policy-makers will require the local and global data described on the DMF's first page.

However, simply having this knowledge will not be enough. To get the vaccine out, many groups and people will have to act on that knowledge to support successful introduction of a vaccine.

The DMF's second page shows the processes required to support the possible introduction of a malaria vaccine.

Some of the processes will take place on a global level, while others will take place in individual countries.

Different processes will be required over time—depending on how many years remain until the vaccine is licensed, or how many years ago it was released.

Similar to the data needs framework, the process needs framework shows these time periods from the top to the bottom of the page.

National level processes appear in purple boxes, arranged by time period.

For example, a country will need to incorporate the malaria vaccine into its national budgeting procedures at the time that it decides to introduce the vaccine.

Global level processes appear in green boxes, also arranged by time period.

For example, pharmaceutical manufacturers will need to integrate the countries' requirements for indications, safety, efficacy, specificity, and other vaccine characteristics into their product development plans five years before licensure and prior to Phase 3 clinical trials.

Some of the processes will be critical for vaccine introduction—they are written in red text.

Other processes are not critical, but will ideally be completed—they are written in black text.