VPPAG contribution to the establishment of the Target Product Profile for the Pneumococcal Advance Market Commitment
An Advance Market Commitment (AMC) is a new approach to public health funding designed to stimulate the development and manufacture of vaccines for use in developing countries. Donors commit money to guarantee the price of vaccines once they have been developed, thus creating the potential for a viable future market. Pneumococcal vaccines have been chosen to pilot the first AMC and donors have committed US$1.5B for this purpose. The AMC is expected to become operative around mid 2009.
In late 2006 the Strategic Advisory Group of Experts (SAGE) to WHO recommended that WHO take responsibility to provide recommendations to SAGE on a Target Product Profile (TPP) for vaccines to be eligible for funding under the Pneumococcal AMC.
Following the SAGE recommendation, the Vaccine Presentation and Packaging Advisory Group was established by GAVI early 2007 to ‘make recommendations for possible presentations of pneumococcal and rotavirus vaccines for procurement by developing countries through the GAVI Fund’. Part of the mandate was to inform the design of the target product profile (TPP) of the AMC for pneumococcal vaccine.
Based on a review of some of the vaccine formulation and presentation issues relating to pneumococcal conjugate vaccines VPPAG recommended the following:
· A ready-to-use liquid vaccine (ie, does not require preparation by vaccinator)
· If in multi-dose vials vaccines should be formulated to allow use of opened vials at subsequent session (ie, with preservative added)
· Use of Vaccine Vial Monitors (VVM), and ideally a VVM30
· If freeze sensitive, allow use of shake test or other indicator of freezing
· Maximum storage volume to be based on Guidelines on the international packaging and shipping of vaccines (WHO/IVB/05.23.) with maximum: 4.0, 6.5, 13.0, and 15.0 cm³ for 10-, 5-, 2-, 1-dose vials, respectively. [Note: the WHO guidelines do not currently state these as maxima for all vaccines; VPPAG derived these suggested maxima for PCV from the ones specified for similar vaccines, and they could apply to all injectable liquid vaccines in future recommendations]
· Pre-filled glass syringes are unsuitable due to large per-dose volumes, whereas non-reusable compact pre-filled devices may be useful in some settings
· Secondary packaging should be designed so that primary vaccine containers are closely nested together to reduce the packed volume
· A minimum shelf life of 36-months is preferred
VPPAG did not make a recommendation for the optimal number of doses per vial for pneumococcal vaccines, because this depends on data on price-per-dose; cold chain costs; and wastage data. However, initial analysis suggested that multi-dose vials are viable require very low wastage to be very low (and paradoxically it may be easier to achieve the required wastage levels with a 10-dose than a 2-dose, vial but that is open to interpretation - see report); hence the recommendation for formulation to allow usage in subsequent sessions.
VPPAG presented the recommendation to the Pneumococcal TPP expert committee for consideration and discussion at a meeting in September 2007.
In December 2008 the Independent Assessment Committee of the AMC officially endorsed the TPP, making it the definitive guidelines for determining the characteristics of AMC-eligible pneumococcal conjugate vaccines. The essential - minimally acceptable - product criteria are listed in the TPP Master Table, whereas both essential and desirable attributes for new pneumococcal vaccines are described in the document Part II: Target Product Profile (TPP) for the AMC for pneumococcal vaccines, Supplementary information. The minimally acceptable product criteria related to the presentation and packaging attributes for AMC eligibility are:
More information on essential product criteria not related to presentation and packaging is available in the documents referred to above.
WER. Meeting of the immunization Strategic Advisory Group of Experts, November 2006 – conclusions and recommendations, pp1-15. 12 January 2007. vol 82, 1/2.
VPPAG TOR’s established by GAVI (early 2007):
VPPAG document prepared by Andrew Garnet contracted through PATH
Vaccine Presentation for Pneumococcal Vaccines
WHO consultation for the development of a target product profile for pneumococcal vaccines
A report from PATH on behalf of the GAVI Alliance and the Vaccine Presentation and Packaging Advisory Group
TPP Master Table: http://www.vaccineamc.org/files/TTP_Master_Table.pdf