Assured Emergency Supply OPtions (AESOP) - for FMD vaccines - Update on progress of the financial feasibility study and initiative to establish ...

Assured Emergency Supply OPtions (AESOP)
           - for FMD vaccines

Update on progress of the financial feasibility study and initiative to establish long term
                                agreements on supply

                       EuFMD Session of the ExCom, March 2018

• Recent meetings where the issues raised:
The current issues                            • EuFMD GS42, TAIEX Workshop under
                                                Maltese Presidency (June 2017)
1.Heavy reliance on the EU-VB in a crisis     • REMESA JPC item on vaccine banks–July
2.European neighbourhood – dynamic risk         2017
situation
                                              • OIE Vaccine Banks Think Tank – November
3.National VBs turnover is slow in relation
to change in priority antigens                  2017 (AESOP examined as a model)
4.Alternative or additional system not in     • AESOP presented to International Strategic
place to assure delivery                        Reserves teleconference (Feb 2018)
5.Funds not the principal issue – we need a
system
6.Suitable antigens ARE an issue

Antigen banks, virtual banks and assured stock options
(OIE Think-Tank, November 2017, examined these)

    Differences -in ownership and availability

    1. Purchase of antigen reserves - owned by purchaser but held
       by producer, formulated on demand. Fixed costs paid even if
       not used.
    2. Virtual bank; no fixed costs, as antigens remain owned by
       producer. Price agreed for formulated products. “”ideal”” for
       buyer but risks for supplier if forecasts of future sales
       volumes do not materialise.
    3. Assured stock options (AESOP): producers contracted to hold
       reserves (fixed costs likely); antigens remain owned by
       producer, until formulated vaccine procured by contract
       owner or “”released”” to 3rd party.

Assured emergency supply options
(AESOP) for FMD vaccine – how it may
work
                                                                              Safety stock
    Vaccine producers always carry safety levels of      Production
•                                                                                                  Sales
    stock to deal with demand and level of re-supply
    from production cycles
•   Under AESOP, these are contracted to carry                             Option Stock
    higher safety levels of stock (Antigen OR vaccine)
    as “”option stock””
•   The Option Stock antigens remain property of
    the producer
•   The holder of the contract has the option to buy
    the stock
•   The system separates the cost of “”holding the                    Option stock can be called
    stock”” from the vaccine cost (per dose supplied)                  upon by option owner

                                                                        If called upon, supplier
                                                                         must replenish option
                                                                      stock within agreed period
                                                                          (probably 3 months)

FAO Call – for Expression of interest to enter into Long Term Supply Arrangements

•   Launched by FAO In December 2017
•   10 respondents, of which 6 were vaccine producers (1= regional agent of vaccine producer)
•   Covering
     – AESOP (antigen storage, 5-10 day formulation)
     – and normal procurement of formulated vaccines (90 day delivery)
•   Skype/phone consultations with 6 held in January 2018
•   Confirmed interest to bid
•   Attractive model - of contracts to hold additional stock
•   Next stage: call for tender likely to be launched in April 2018

Consultations with producers - January 2018

 All expressed high interest in the system, considering it an improvement
 Lead-in times: varied; from 30 days to one year to establish 1 million doses of antigens of interest
 Replenishment: from 1 month to 6 months, most agreed 3 months or less. One indicated that contracted
  arrangements will assist them to ensure plants are not diverted from FMD production.
 Scales of arrangements: for several large producers (200-400 million MV doses per year), system might work OK
  with up to 30 million doses of antigen as an ""option"".
 Likely problem is niche antigens, not part of routine high volume production and supply
 Changing antigens held under the contract every year was agreeable although some risks if the producer could
  not resell that antigen (niche issue)
 Most expressed willingness to supply DIRECT to 3rd party (direct financial route) if FAO/EuFMD releases the
  stock option. Some were concerned with issues affecting financial transfer (e.g. Governments in some
  countries)

Quality issues: what system?

•   pre-qualification of suppliers
•   post-delivery inspections
•   Mixed?

•   The idea to have routine, post-delivery inspection of immunogenicity is proposed; allows system of suspending
    contracts if failure to explain the inadequate immunogenicity
•   All suppliers were willing to participate in a system in which post-vaccinal sera are collected by a standard
    protocol (21 days). Some insist on specific Ref Centres that are independent (not tied to vaccine producer).
•   This system is easier to introduce than a GMP based, pre-qualification system
•   It also enables a wider set of suppliers and data to be gathered from routine preventive vaccination programmes
    to give confidence to titres expected in other formulations (higher potency).

Options – and what to expect from the tender process

•   Tender will call for storage/supply of priority antigens (circa 10, from WRL recommendation)
•   Bids can be for any number of the antigens of interest.
•   Invitation to bid (ITB) route: 80% price, 20% on other non-mandatory criteria
•   Each bid must meet Mandatory criteria: - critical GO/no GO areas for quality
     – Tech spec have been drafted
     – Under consideration: for Post-vaccination immunogenicity: requirement to provide homologous viruses to elected
       OIE/FAO Reference Centres to enable routine small scale immunogenicity studies on delivered vaccines

•   Other criteria:
     – Under consideration for scoring :
          • Shorter replenishment times (restocking from 0 to 100% of agreed level)
          • Added value that supplier can offer multiple antigens

Price considerations - bids should indicate

    – price per quantity of antigens held, different scales
    – Cost per formulated MV vaccine, in offered adjuvants, emergency basis (5 days)
    – Cost per indicate formulated vaccine, MV /multivalent, standard basis (90 days)

Expected results

•   At least
     – one valid bid for the AESOP supply (but - may be restricted in antigens offered)
     – and multiple for the preventive vaccine supply
•   major range in cost per 1m antigen doses stored
•   Expect multiple suppliers needed to cover 10 antigens
•   Some difficulty to meet the mandatory requirements for AESOP quality
•   Decisions then needed:
     – On AESOP cost effectiveness (storage vs outright purchase)

•   Relating to vaccine quality uncertainties:
          •    Can have different suppliers for emergency and preventive programmes (90 days delivery)
          •    Build up evidence for immunogenicity studies - preventive programme purchases
          •    Later rounds of AESOP contracting may consider this evidence (immunogenicity sufficient for emergencies?)
•   AESOP: once costs identified, open consultation with interested parties (EC, member states, QUADS countries, others)
•   Preventive programmes: the LTAs would become the standard procurement route (FAO)

How AESOP could go forward: Pilot Phase

•   EuFMD has an emergency reserve fund, for vaccine purchase
•   After the tender bids evaluated:
     – Decision (EC/Secretariat) on awarding of the contracts (cost and service /coverage)
     – Contracts awarded – annual extension if cover antigens required

•   If/When suppliers cannot cover the range required – additional tenders invited
•   EuFMD/FAO responsibility to maintain the Framework Contracts with suppliers

Assured emergency supply options (AESOP)
    •   Should assure the availability of stock
    •   may be less cost than buying the physical vaccine stock
    •   and open the possibility of “assurance ”” - a guarantee to others of availability

Progress – towards 2019 and beyond – a new system from 2020 ?

1. An additional “”vaccine bank”” mechanism, mainly as an “’assurance option””
2. Addition - Not replacement – for conventional bank contracts
3. Potentially, EuFMD MS could opt-in to become AESOP owners (”assured supply options”), using the established
   EuFMD Multi-Donor Trust Funds (MTF).
4. Potential for the EuFMD General Sessions to become “”share-holders”” meetings for the AESOP (direction,
   agreement on “”premium”” costs, and cost-sharing).
5. We are on track to present the system, and cost of AESOP, by April 2019 to MS and others.
6. Potentially the system is a model for other emergency supplies as well.