No 3 - 2016

New temporary childhood vaccination programme

Since 2013, Statens Serum Institut has been affected by production issues relating to vaccine production. In 2014, this made it necessary to introduce a temporary childhood vaccination programme in Denmark, EPI-NEWS 50/13 and 3/14. This temporary vaccination programme formally ended at the end of 2015, EPI-NEWS 47/15.

In 2015, apart from a short period during the autumn, EPI-NEWS 41/15, the SSI has been capable of providing the primary and booster vaccines used in the childhood vaccination programme. Nevertheless, production issues have continued into 2015, and it has not been possible to build stocks of the desired magnitude. Currently, the vaccine dTap-IPV Booster (product name: diTekiPol Booster) is on back order, and we foresee that the primary vaccine DTaP-IPV/Act-Hib (product name: DiTeKiPol/Act-Hib) will go on back order in the course of Week 4. Therefore, the outlook for 2016 is that it may not be possible to provide the necessary vaccines and to establish a stock sufficiently large to ensure a stable supply.

On this backdrop and by appointment with the Danish Health Authority and the Danish Ministry of Health, it was decided to introduce a new temporary childhood vaccination programme which is expected to remain in force for one year. Currently, it is not possible to obtain a pentavalent vaccine corresponding to the SSI's primary vaccine DTaP-IPV/Act-Hib. The hexavalent vaccine used in the first temporary vaccination programme (Infanrix hexa^®) is also unavailable, but an equivalent hexavalent vaccine, Hexyon^®, will be used. Hexyon^® is produced by Sanofi Pasteur and was approved by the European Medicines Agency (EMA). We expect that this vaccine will be available as from the beginning of Week 6.

Children who initiate their vaccination as from the point in time when Hexyon^® is supplied shall therefore receive this vaccine. In addition to protecting against the same conditions as the SSI’s vaccine DTaP-IPV/Act-Hib, Hexyon^® also provides protection against hepatitis B. The aim is to procure sufficient of Hexyon^® to allow all children who initiate a Hexyon^® vaccination schedule also to conclude vaccination using this vaccine.

When the SSI’s primary vaccine DTaP-IPV/Act-Hib goes on back order, any remaining vaccines in local storage with physicians shall be prioritised to ensure that vaccination of 3-month-old infants can be initiated as scheduled. If a practice depletes its stock of this vaccine during the period from Week 4 to Week 6, it may try to borrow vaccines from a neighbouring practice, for example, so that children may initiate their vaccination under the childhood vaccination programme.

Children who have already initiated their course of the vaccination programme and who have received one or two DTaP-IPV/Act-Hib vaccines shall also conclude their vaccination with this vaccine, if possible. We expect that the SSI will be able to provide primary vaccines to conclude vaccination of these children. Only if SSI-vaccines are not available at the time of the vaccination, either decentrally or centrally, shall the child conclude vaccination with Hexyon^®. We expect that this issue will only affect a limited number of children.

Like in the first temporary vaccination programme, these children will be offered to conclude their vaccination with a hepatitis B mono vaccine (Engerix B Pæd^®). We expect that the SSI will once again be able to provide the DiTeKiPol/Act-Hib (DTaP-IPV/Act-Hib) vaccines needed to conclude other vaccination as from mid-February 2016. Furthermore, the SSI expects to be able to provide DTaP-IPV Booster for use as booster vaccination in 5-year-olds as from Week 5.

Notification of any administered childhood vaccines to the Danish Vaccination Register (DVR) has been a statutory requirement as from 15 November 2015, EPI-NEWS 45/15. However, as all physicians do not yet notify via the DVR, it is also necessary to introduce temporary settlement codes to ensure that Hexyon^® may be distinguished from the standard SSI-vaccine.

In a future issue of EPI-NEWS, we will share more detailed information on vaccination under the new temporary vaccination programme and about the Hexyon^® vaccine.
(P.H. Andersen, Department of Infectious Disease Epidemiology)

Link to previous issues of EPI-NEWS

21 January 2016