A framework agreement is offered for the purchase of whooping cough vaccine for vaccination of pregnant women in the Danish vaccination programme.

The vaccine must be approved for use in vaccination of pregnant women against whooping cough and documentation of this must appear in the current edition of the Summary of Product Charasteristics (SPC). At the time of submission of an offer, the vaccine offered must have a marketing authorisation valid for Denmark.

Additional requirements for the vaccine appear in the tender material.

A framework agreement with 1 supplier is offered for the purchase of whooping cough vaccine, cf. section II.1.4.

The vaccine is to be used for vaccination of pregnant women in the Danish vaccination programme, cf. Appendix 1 to the framework contract.

It is estimated that the need for procurement of vaccines under the contract is generally 50,000 – 70,000 doses annually, based on the estimated consumption and the current Danish vaccination programme.

The purpose of the framework agreement is to ensure that the SSI can make the necessary purchases of the covered vaccines for the Danish market in accordance with the expected need for such vaccines during the framework agreement of up to 4 years. The purchase under the agreement depends on the decisions taken for the public vaccination programme and on the vaccination coverage in the cohorts concerned. If the Danish vaccination programme is changed, purchases may be made under the framework contract, provided that the vaccine in question is approved for such use by the competent approval authorities. However, the SSI may choose instead to offer the purchase of vaccines, either as a replacement for or as a supplement to the concluded framework agreement, if it is considered most appropriate.

In view of this, and in view of the fact that the total need for vaccines may thus vary significantly, the SSI may purchase up to 300,000 doses of vaccines under the framework agreement during its term, cf. Appendix 2 to the framework contract.