Vaccine investment strategy

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Gavi’s vaccine investment strategy determines which vaccines are made available to countries through our vaccine support programmes.

Every five years, Gavi takes stock of available and expected vaccines to develop a new vaccine investment strategy (VIS). The VIS sets new priorities for our vaccine support programmes through in-depth analysis and extensive consultations.

Gavi is currently developing a new VIS for its 2021-2025 strategic period. The new VIS, which will be finalised in 2018, follows three phases:

  • Phase one prepares the ground for the VIS by developing a decision-making process and analytical plan, identifying and categorising vaccine candidates, and setting out a first set of evaluation criteria.
  • Phase two shortlists vaccine candidates for use in routine immunisation programmes, sets criteria for evaluating vaccine investments in epidemic preparedness and response, and identifies an approach for inactivated polio vaccine (IPV) support beyond 2020.
  • Phase three: in the final phase, recommendations for new vaccine investments will be developed for the November 2018 Gavi Board meeting.

VACCINE CANDIDATES

In April 2017, WHO conducted a landscape analysis, which identified candidate vaccines for consideration in Gavi’s 2018 VIS. The inclusion criteria included public health relevance to low- and middle-income countries and expected licensure by 2023.

The vaccines under consideration in the 2018 VIS fit into one of the following three categories:

  1. Vaccine investments for endemic disease prevention through routine immunisation
  2. Vaccine investments for epidemic preparedness and response
  3. IPV support post-2020

For each vaccine, Gavi will identify and review the latest evidence against a set of evaluation criteria. Partners and external stakeholders are essential in helping to build our evidence base.

*Not for investment decisions in 2018 as Gavi pilots are still ongoing. Treated as comparator in VIS 2018. 

EVALUATION OF VACCINES FOR ENDEMIC DISEASES

In November 2017, the Gavi Board approved a set of criteria to be used for evaluating the first category of vaccines (for endemic disease prevention).

Evaluation criteria for vaccines for endemic disease prevention through routine immunisation 

Data sources used in the evaluation included consultations with in-country stakeholders, peer-reviewed literature, expert and partner input, health impact modelling and analytics developed for the VIS process.

Based on the analysis of each vaccine against the criteria included in the Board-approved evaluation framework, in June 2018, the Gavi Board shortlisted six vaccine candidates for endemic disease prevention for further consideration and investment case development:          

  • multivalent meningococcal conjugate vaccine;
  • hepatitis B birth dose;
  • oral cholera vaccine for preventative immunisation;
  • diphtheria-tetanus-pertussis (DTP)-containing boosters;
  • respiratory syncytial virus (RSV) vaccine; and
  • rabies post-exposure prophylaxis.

During this phase, dengue, hepatitis A and maternal Influenza vaccines were deprioritised from the original list. More information on the rationale for shortlisting and deprioritisation can be found in the June 2018 report to the Gavi Board.

Gavi is currently reaching out to stakeholders, including in-country partners, vaccine Alliance constituencies and disease experts, to develop investment cases for each of the six shortlisted vaccines. A final decision as to which of these vaccines Gavi will support in its next strategic period will be taken at the next Board meeting in November 2018.

Evaluation of vaccines for epidemic preparedness and response

In June 2018, the Gavi Board approved the evaluation framework and approach for vaccines for epidemic preparedness and response. This builds on the developed approach for evaluating vaccines for endemic disease prevention but also includes criteria that are unique to epidemic risk reduction. Recognising that many diseases may be categorised as having both epidemic and endemic characteristics, assessment against one or the other framework will be determined by the public health goal and the type of investment (ie planned preventive immunisation, such as routine immunisation, versus a stockpile or similar intervention).

This framework for epidemic preparedness and response is intended to structure the assessment and decision-making process around four critical questions.

  1. Disease risk and burden: is the epidemic potential of the disease sufficient to prioritise a stockpile or similar investment?
  2. Vaccine impact and feasibility: would the vaccine be feasible to use and impactful as part of epidemic preparedness and response?
  3. Fit for Gavi and partners: what is Gavi’s comparative advantage and how can Gavi’s expertise contribute to the funding and delivery of this vaccine?
  4. Financial implications: what is the appropriate scale of the stockpile (or related intervention) and what would be the financial implications of an investment? 

Evaluation criteria for vaccines for epidemic preparedness and response 

Gavi will work with WHO to identify candidate vaccines to be considered for Gavi support. Once preliminary safety and immunogenicity data is available for these candidate vaccines (usually in phase 2a/b), a “living assessment” will be developed. This assessment will include preliminary information on disease risk and burden, vaccine impact and feasibility and whether the vaccine is fit for Gavi. A full investment case for Gavi Board decision will be triggered by one of the following: a clear timeframe and pathway to licensure, a WHO recommendation or an urgent public health need (e.g. disease epidemic). Recommendations on investment could be taken to the Board for decision both as part of the VIS or as a standalone investment case.

Based on the approach outlined above, Gavi is currently assessing the landscape of interventions regarding pandemic influenza preparedness in order to identify any potential opportunities for the Vaccine Alliance to engage. An update and any recommendations arising from this analysis will be presented to the Board in November 2018.

Evaluation of IPV support post-2020

Gavi’s investment in IPV beyond 2020 is also being considered as part of the VIS. However, unlike other vaccines evaluated as part of the VIS, a tailored assessment approach and consultation process are conducted to assess IPV. This is because the current VIS evaluation criteria such as lives saved and value for money do not adequately capture IPV’s unique role in mitigating the re-emergence of poliovirus. 

Support is being considered in order to strike a balance between the risk of IPV programme discontinuation and the principles of country ownership, as per Gavi’s eligibility and transition and co-financing policies. A full investment case will be brought to the Gavi Board in November 2018 can be found in the June 2018 report to the Gavi Board.

Please note that the contents of this page reflect decisions taken at the June 2018 Board meeting.

For further information about the VIS process, please contact VIS@gavi.org.

HISTORY OF VIS

Want more information about the Vaccine Investment Strategy in 2013 or 2008, click here.

>4 million

The Vaccine Alliance’s support for vaccines contributed to averting more than 4 million future deaths between 2011 and 2015.

Gavi, the Vaccine Alliance/Bill & Melinda Gates Foundation 2016

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