Changes to the Primary Childhood Immunisation Programme and advice about administration of liquid infant paracetamol

November 2016
The PSI and HSE National Immunisation Office (NIO) highlight the following important information to all pharmacists about administration of liquid infant paracetamol after Meningococcal B vaccination.

Meningococcal B (MenB) vaccine and rotavirus oral vaccine have been added to the Primary Childhood Immunisation Programme for all babies born on or after 1 October 2016.

This means that from December 2016 babies will start to receive the MenB vaccine at their 2, 4 and 12 month vaccination visits, and rotavirus oral vaccine at their 2 and 4 month vaccination visits.

Summary of Key Points

When MenB vaccine is given with the other Primary Childhood Immunisation vaccines at 2 and 4 months there is a higher risk that the baby will develop a fever.
For this reason, the Immunisation Guidelines for Ireland recommend that babies at their 2 and 4 month vaccination visits receive 3 doses of liquid infant paracetamol. The first dose (2.5ml/60mg) should be given at or just after the vaccine is given. Dose 2 should be given 4-6 hours after dose 1, and dose 3 should be given a further 4-6 hours after dose 2.
This information differs from the information in the package leaflet for liquid infant paracetamol which states that babies aged 2-3 months should not be given more than 2 doses of paracetamol.
Ibuprofen is NOT recommended.
Paracetamol does NOT need to be routinely given at the 12 month MenB vaccine.
With the exception of MenB vaccine, the Immunisation Guidelines for Ireland do not recommend the routine use of paracetamol for pain and fever after vaccinations.
Pharmacists should actively inform all parents and caregivers whose babies will receive the MenB vaccine of the new recommendations for paracetamol following vaccination, and that these differ from the package leaflet in liquid paracetamol products.

Information you should know

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What are the Changes to the Primary Childhood Immunisation Programme?

Meningococcal B (MenB) and rotavirus oral vaccines are being introduced to the Primary Childhood Immunisation Programme (PCIP) for all babies born on or after October 1st 2016. The addition of these vaccines will result in changes to the vaccines given at each of the five GP visits for all babies born on or after October 1st 2016. These babies will start to receive their vaccines from 1st December. You can read more about these changes on the HSE website.
What additional risk is there when MenB vaccine is given?

When MenB vaccine is given with the other primary childhood immunisation vaccines at the 2 and 4 month visits there is a higher risk that the baby will develop a fever. Fever after MenB vaccine typically rises over the first 6 hours and peaks at this point. It then reduces until 24 hours, when most fevers will be gone.
What is the pharmacist’s role in providing advice to parents and caregivers?

Pharmacists play a key role in the supply of medicines in the community and are ideally placed to advise parents and caregivers on the appropriate use of antipyretics after vaccination. The following recommendations regarding the administration of paracetamol should be actively communicated to all parents and caregivers whose babies will be receiving the MenB vaccine.
The advice for parents whose babies will not receive the MenB vaccine (i.e. those born before 1 October 2016) has not changed; the Immunisation Guidelines for Ireland do NOT recommend the routine use of paracetamol for pain and fever after vaccinations.
What are the new recommendations regarding administration of paracetamol following MenB vaccination?

The Immunisation Guidelines for Ireland recommend that babies are given liquid infant paracetamol to reduce this fever at the time of, or just after, their 2 and 4 month MenB vaccinations. It is important that babies are not given paracetamol prior to vaccination, as the GP or practice nurse will need to assess that the baby is well to receive the immunisations. Ibuprofen is NOT recommended.
Paracetamol will not stop babies developing a fever however it reduces the rate of fever by approximately 50%. Therefore parents should be informed their baby might still get a fever, despite giving them paracetamol but it is likely that this fever will be lower and shorter lived.
Paracetamol does NOT need to be routinely given at the 12 month MenB vaccine, as a baby's risk of fever after the vaccine at this age is no different from the risk of fever after any other routine childhood vaccines.
At what dose, and how often, should liquid infant paracetamol be given?
The Immunisation Guidelines for Ireland recommend that babies at their 2 and 4 month visits receive 3 doses of liquid infant paracetamol after each visit.
- Dose 1 should be given at vaccination or just after the vaccine is given.
- Dose 2 should be given 4-6 hours after dose 1.
- Dose 3 should be given a further 4-6 hours after dose 2.
One dose = 2.5mls (60mg)
Babies less than 4kg (8lb 8oz) at the time of vaccination should be given paracetamol at a dosage of 15mg/kg.
How does this differ from the information in the Package Leaflet for liquid infant paracetamol?

The package leaflet states that babies aged 2-3 months should not be given more than 2 doses of paracetamol. As stated in the meningococcal chapter of the Immunisation Guidelines for Ireland, where advice differs from the PIL or Summary of Product Characteristics (SmPC) the recommendations based on current expert advice from the National Immunisation Advisory Committee (NIAC) should be followed.
What if fever continues or a baby is unwell following vaccination?

If the fever continues after the 3 doses of liquid infant paracetamol have been given and the baby is otherwise well an additional dose of paracetamol may be given 4-6 hours after dose 3 i.e. a total of 4 doses of paracetamol in the 24 hours after vaccination. The baby should be referred to their GP for medical review if they are unwell at any stage or have a fever at other times.
What is the advice about antipyretics and other Primary Childhood Immunisation vaccines?

With the exception of MenB vaccine, the Immunisation Guidelines for Ireland do not recommend the routine use of paracetamol for pain and fever after vaccinations. Fever which occurs after vaccination is generally benign and self-limiting; it rarely rises above 39⁰C. Antipyretic drugs do not prevent febrile convulsions in at risk children. However, either paracetamol or ibuprofen may be considered for treatment of fever >39⁰C, for a significant reaction at the site of vaccination or if the baby is distressed.
Where can I find further information?

For more information please contact your local immunisation office, local public health department or the NIO and see www.immunisation.ie.

Information and Resources

The Immunisation Guidelines for Ireland are published by the National Immunisation Advisory Committee (NIAC) and are available on the HSE immunisation website.
Information is given to parents/guardians of children receiving vaccinations and each of those leaflets set out the common reactions expected after vaccine in the different age groups and provide advice on the use of paracetamol and ibuprofen. Click to view each of the leaflets: primary childhood vaccination leaflet ¦ primary school vaccination leaflet ¦ secondary school vaccination leaflet
The HSE health promotion website includes useful posters and leaflets about vaccinations, including a summary poster about paracetamol administration at the time of the MenB vaccination. It is recommended that you print this so it is available for easy reference by all pharmacy staff members.