No 49 - 2013

Temporary change in the childhood vaccination programme

As from 15 January 2014, two vaccines in the Danish childhood vaccination programme are temporarily changed. This implies that for a period of time the basic vaccine against diphtheria, tetanus, pertussis, polio and Haemophilus influenzae B infection (DTaP-IPV/Hib) administered at 3, 5 and 12 months of age will also include hepatitis B vaccination. Furthermore, the booster vaccination given at 5 years of age against diphtheria, tetanus, pertussis and polio will now be given as two vaccines rather than one as is currently the case.

Statens Serum Institut has experienced technical production issues relating to the polio vaccine (Pol) that forms part of two of the vaccines under the Danish childhood vaccination programme. After putting out a tender, it has been established that no other producers are able to provide the needed quantity of equivalent vaccines.

The Danish Health and Medicines Authority has therefore recommended to the Danish Ministry of Health that the childhood vaccination programme be changed temporarily by introducing another available vaccine to the basic vaccination that may easily be included in the childhood vaccination programme. This vaccine also protects against hepatitis B.

Today, the Danish programme does not include hepatitis B vaccination as the risk of infection among Danish children is, in general, limited. In many Central and Southern European countries, hepatitis B forms part of the national programmes as also recommended globally by the WHO. Denmark instead chose a strategy focusing on vaccination of risk groups, e.g. children to mothers with hepatitis B.

The change of provider will therefore affect both the basic DTaP-IPV/Hib vaccine, administered to children at 3, 5 and 12 months of age, and the DTaP-IPV booster vaccine given to children at 5 years of age. The vaccines protect against diphtheria, tetanus, pertussis, polio and Haemophilus influenzae B infection. It is anticipated that Statens Serum Institut will start providing the two vaccines again as from the autumn of 2014.

Consequences of the changes

Dispensing of the vaccines produced at Statens Serum Institut is expected to end in the beginning of 2014.

Specifically, this means that: 

• All children who receive their basic DTaP-IPV/Hib vaccination after 15 January 2014 will be given the "Infanrix hexa" vaccine which protects against DTaP-IPV/Hib and hepatitis B. The vaccine is produced by GlaxoSmithKline and is approved by the European Medicines Agency (EMA). As previously, the vaccine will be given as a single injection at 3, 5 and 12 months of age.
• Children who are vaccinated with the DTaP-IPV/Hib from Statens Serum Institut before 15 January 2014 will conclude their vaccination using this vaccine to the extent possible. A limited number of children may, however, conclude their vaccination with "Infanrix hexa". These children will be offered a separate vaccination that concludes their hepatitis B vaccination so as to afford them with the choice of full protection against this condition. 
•  All children who are to receive the DTaP-IPV booster vaccine at 5 years of age will receive a DTaP-IPV vaccine produced by Statens Serum Institut and a vaccine protecting against polio produced by either Statens Serum Institut or Sanofi Pasteur. These children will therefore receive two injections rather than one as is presently the case.

Danish physicians will be informed about the specifics of the changes in an upcoming issue of EPI-NEWS.
(Danish Health and Medicines Authority and Statens Serum Institut)

Link to previous issues of EPI-NEWS

4 December 2013