§ Mr. BellinghamTo ask the Secretary of State for Health whether the second tranche of smallpox vaccines to be ordered by his Department are to undergo clinical trials; whether any of the manufacturers bidding for the contract have offered to supply vaccines that have undergone clinical trials; and if he will make a statement. [108000]
§ Mr. HuttonThe procurement procedure for selecting the successful company or companies for supply of the second tranche of smallpox vaccine is still in progress. We will require the production of our new smallpox vaccine to follow the European Union Committee 623W for Proprietary Medicinal Products guidance, which includes recommendations for a clinical development programme.
§ Mr. BellinghamTo ask the Secretary of State for Health whether IDT was invited to submit a bid for the second tranche of smallpox vaccines to be procured by his Department; why no direct invitation was made to IDT to submit a bid for the first tranche; and if he will make a statement on the relative merits and demerits of(a) the Lister strain and (b) the New York Board of Health strain of smallpox vaccine. [108001]
§ Mr. HuttonThe second tranche of smallpox vaccines is being procured by way of a competitive tendering procedure. A notice was placed in the Official Journal of the European Communities in October 2002, seeking expressions of interest from any company wishing to tender for the contract. No company was approached on an individual basis and invited to bid.
Impfstoffwerke Dessau Tornav Gmbh (IDT) was not approached during the first smallpox vaccine procurement process. It was known from the outset that IDT were a sub-contracting partner of Bavarian Nordic, with whom PowderJect had an exclusive agreement to act as their suppliers for smallpox vaccine.
In selecting the strain for the new smallpox vaccine, the Department of Health sought advice from a specially convened expert subgroup of the Joint Committee on Vaccination and Immunisation (JCVI). Experts considered that there was no difference in efficacy between vaccines based upon the Lister strain and those based upon the New York City Board of Health (NYCBH) vaccinia strain as both were known to have been effective in the past.
The JCVI sub-group also concluded that there is a greater body of evidence to demonstrate the efficacy of the Lister strain vaccines against the more severe form of smallpox "variola major" in the past than there is for the NYCBH based vaccines. The view was taken that using a different strain for our new vaccine than that chosen by the United States offered the greatest safeguard in the event of difficulties arising with the production of either new vaccine.