No 10 - 2019
Vaccination with Pentavac in the childhood vaccination programme
Vaccination with Pentavac in the childhood vaccination programme
As announced in EPI-NEWS 3/19, the Pentavac vaccine must be used as a new primary vaccine in the childhood vaccination programme as from March 2019. Pentavac is equivalent to the previously used primary vaccine DiTeKiPol/Hib from AJ Vaccines A/S (previously an SSI vaccine).
Children who initiate the childhood vaccination programme as from 18 March 2019 must be immunised using the new vaccine that provides protection against the usual conditions (diphtheria, tetanus, whooping cough, polio and Haemophilus influenzae type b infection). The vaccine is provided by the pharmaceutical firm Sanofi Pasteur.
The above-mentioned change does not cause any changes in the vaccination times. In line with the DiTeKiPol/Hib vaccine, Pentavac is given at 3, 5 and 12 months of age.
Children who initiate vaccination with Pentavac under the childhood vaccination programme
Children who have not yet initiated the childhood vaccination programme are vaccinated with Pentavac at three months of age and continue the primary vaccination programme with this vaccine.
Children who have initiated vaccination with the DiTeKiPol/Hib vaccine from AJ Vaccines A/S
Whenever possible, children who have initiated vaccination with the DiTeKiPol/Hib vaccine from AJ Vaccines A/S should also conclude their vaccination series with this vaccine. We expect that the SSI will be able to provide primary vaccines from AJ Vaccines A/S to conclude vaccination of these children. Only if vaccines from AJ Vaccines A/S are not available at the time of vaccination, either decentrally or centrally, shall the child conclude vaccination by receiving the third dose as Pentavac.
There is no change in the normally used settlement code, which remains:
1. 2. and 3. Pentavac = 8341
Monitoring of the coverage of the vaccination programme is based on the statutory notification of vaccinations to the Danish Vaccination Register (DVR) through www.fmk-online.dk or via integration of the DVR into the electronic health record system used.
About the primary vaccine Pentavac
The primary vaccine Pentavac is produced by Sanofi Pasteur and approved by the European Medicines Agency (EMA). By 2016, more than 160 million doses of Pentavac had been administered worldwide. The vaccine is, among others, used in the childhood vaccination programmes of Sweden, Finland and Island. The vaccine is approved for administration in a 3-, 5- and 12-month primary programme and can be given concurrently with Prevenar13. When Pentavac and Prevenar13 are administered concurrently, they should be given in opposite extremities.
The primary vaccine Pentavac protects against five conditions: diphtheria, tetanus, whooping cough, polio and Haemophilus influenzae type b infection. The antigens are adsorbed on 0.30 mg aluminum hydroxide. The Hib-component is conjugated to tetanus protein. The vaccine’s five antigens are identical to five of the six antigens used in the Hexyon vaccine from the same manufacturer (Sanofi Pasteur), and which were used for a limited period of time in Denmark in 2016-2017, EPI-NEWS 5/16 and 13/17.
As the primary vaccine from AJ Vaccines A/S, Pentavac is provided as a conjugated Haemophilus influenzae type b vaccine in powder form (vial) and suspension of combined diphtheria, tetanus, acellular pertussis and inactivated polio vaccine, adsorbed, in a loaded syringe to be mixed before injection. The boxes contain 10 vaccines and 20 syringes. If the needle is not mounted on the injection syringe, it is screwed tightly onto the syringe by turning it 45 degrees. Pentavac is given by intramuscular injection. The vaccine is injected immediately after mixing the freeze-dried substance with the suspension.
In the normal vaccination programme, at 3, 5 and 12 months the minimum interval between the first and second dose is two months (as opposed to one month for the previously used vaccine) and the minimum interval between the second and third dose is six months.
As previously, following primary vaccination with three doses, a DTaP-IPV booster is given at five years of age (from the autumn of 2019 the Tetravac vaccine will be used).
The pattern of adverse reactions for Pentavac does not differ markedly from that of the primary vaccine from AJ Vaccines. Very common (≥ 1/10) adverse reactions include loss of appetite, vomiting, crying, irritability, drowsiness, fever ≥ 38 degrees Celsius, local swelling, pain and erythema at the injection site. Common (≥ 1/100 to <1/10) adverse reactions include diarrhoea, induration at the injection site and sleeplessness.
In the clinical studies leading up to the approval of Pentavac, adverse reactions were seen more frequently within 48 hours following vaccination. After the two initial primary vaccinations, the frequency of reactions at the injection site tends to increase when the third primary dose is given. For information about more rarely observed adverse reactions and special warnings and precautions concerning the use of the vaccine, please refer to its summary of product characteristics which is available for download at the SSI website.
The package leaflet for Pentavac is included in the box along with the vaccine, and may - as from late March 2019 - also be downloaded from www.indlaegsseddel.dk.
Reporting of adverse reactions - enhanced duty of notification
As the vaccine has not previously been used in the Danish childhood vaccination programme, the Danish Medicines Agency has decided that Pentavac is subject to enhanced duty of notification for one year following its introduction into the childhood vaccination programme. Enhanced duty of notification means that doctors are required to report all presumed adverse events in persons they are treating.
Serious adverse reactions are to be reported to the Danish Medicines Agency no later than 15 days after the doctor has become aware of the possible adverse reaction, and they can be reported through www.meldenbivirkning.dk.
Ordering and supply
Pentavac may be ordered via:
SSI item number 100116 Pentavac, 10x1 dose
The vaccine may be ordered using Form 6 at or by contacting the SSI Order Office (Ordremodtagelsen) email@example.com or by phone 3268 3111. The vaccines used to initiate the vaccination course are provided as from Week 10 on the standard supply day.
(P. H. Andersen, L.K. Knudsen, P. Valentiner-Branth, Department of Infectious Disease Epidemiology and Prevention, B. Neale, Supply)
6 March 2019