The National Immunisation Advisory Committee (NIAC), an expert committee of the Royal College of Physicians of Ireland (www.rcpi.ie), has recommended the introduction of vaccines to protect against meningococcal B (MenB) and rotavirus diseases so the HSE primary childhood immunisation schedule changed significantly for all babies born on, or after, October, 1 2016. 

The introduction of these two new vaccines means there will be a change in the vaccines given at each of the five visits in the childhood vaccination schedule. Payment for the new schedule is currently under negotiation. 

As GPs have such a pivotal role in achieving high vaccine uptake rates, it is important they are fully aware of the new vaccines and the schedule changes.

What will the changes be?

Table 1 summarises the changes that will be made to the immunisation schedule for babies born on or after October 1, 2016. Among these changes are:

• MenB vaccine (Bexsero GSK) at two, four and 12 months to protect against meningococcal B disease

• Rotavirus oral vaccine (Rotarix GSK) at two and four months to protect babies against rotaviral gastrointestinal disease.  

To allow for earlier protection of meningococcal B infection, changes include:

• MenC vaccine changes from four and 13 months to six and 13 months 

• PCV schedule changes from two, six and 12 months to two, six and 13 months.

To minimise the number of injections given at 13 months, the following change has been implemented:

• HiB/MenC combination vaccine (Menitorix GSK) will be used instead of separate vaccines.

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Why are the new vaccines recommended?

Ireland has the highest rate in Europe of invasive meningococcal disease. Since the successful introduction of the meningococcal C (MenC) vaccine in 2000, meningococcal group B disease is now the predominant cause of these infections. The highest rates of disease are seen in infancy, then early childhood, with a smaller peak in infections seen in adolescence. 

Meningococcal B disease is a much feared infection among parents and healthcare professional staff alike, owing to its rapid onset and the significant morbidity and mortality which can be associated with the infection. This disease is now vaccine preventable. 

Rotavirus

Rotavirus disease is a viral infection that causes diarrhoea and vomiting in babies and young children. While most babies and children will recover at home, some will become significantly dehydrated and require hospitalisation and treatment. 

Rotavirus is highly infectious and the most common cause of gastroenteritis in children in Ireland under the age of five years and it is considered that all children will have been infected with rotavirus infection by the age of five years. 

There are approximately 2,400 cases of rotavirus notified each year in the zero to four-year age group in Ireland, with most of these under one. Further, among the zero to four-year age group there is an average of 920 discharges from hospital each year, with the average length of stay in hospital being five days (data courtesy of the Health Protection Surveillance Centre). This is a significant burden of disease to young families and one that is now vaccine preventable.

Are the vaccines safe and effective?

Yes, all vaccines undergo rigorous safety checks before they are licensed for use and are continually monitored after licensure.

Both MenB and rotavirus vaccines are widely used internationally and have proven to be very safe and effective. The UK introduced MenB vaccine to their national immunisation programme in 2015 and no safety concerns have been identified. Rotavirus vaccines are used routinely in 12 EU countries, the US and Australia.

Both vaccines also have good efficacy profiles. MenB vaccine has been shown to be very effective at producing an immune response to the particular strains causing invasive meningococcal disease in Ireland. Research has suggested that up to 88% of meningococcal B strains should be protected by MenB vaccine. A European study on rotavirus vaccines identified a 65-84% reduction in hospitalisations from rotavirus infection with vaccine effectiveness estimated at between 82-94%. 

How will the vaccines be given?

The MenB vaccine is an injected vaccine which will be given to babies in their anterolateral thigh as per the other childhood vaccines. 

The rotavirus vaccine is an oral vaccine. This will come as a sugary solution, prepared in an oral syringe. This vaccine should be given first to babies, while they are more settled and it will help act as a pain reliever for the injected vaccines. The syringe should be placed in the baby’s mouth and aimed down one side and towards the back of the baby’s mouth. All the syringe contents should be given.

What are the key side-effects of the vaccines?

For the MenB vaccine the key side-effect is a higher rate of fever when given at the same time as the other childhood vaccines so NIAC has recommended that all babies should receive three doses of 2.5ml (60mg) of liquid infant paracetamol at or just after their MenB vaccines at two and four months and four to six hours later, respectively, for the second and third doses. This will reduce the severity of any fever and the risk of a baby developing a fever by approximately 50%.

Experience from the UK has shown that parents are happy to give their baby paracetamol and that they are unlikely to seek medical help if they are informed that a fever is likely over the first 24 hours after vaccination. Prophylactic paracetamol is not recommended when MenB vaccine is given at 12 months as the rate of fever is the same as for the other childhood vaccines. 

For rotavirus vaccine the key side-effect is the increased risk of intussusception (intestinal prolapse leading to obstruction). In Ireland, approximately one in 1,500 babies will develop this condition naturally, most commonly between the ages of five months and one year. 

Intussusception can occur at any time after rotavirus vaccine. It is estimated that for every 100,000 first doses of rotavirus vaccine given, there may be one or two extra cases of intussusception, ie. up to two cases per year in Ireland.

Babies with intussusception have pain similar to a severe colic, accompanied with bouts of crying. However, they generally become very pale during episodes, rather than flushed as they might with colic, and they may draw their legs up. 

The episodes become more frequent over a few hours and are associated with vomiting or blood in their stools. If this occurs then the baby needs to be urgently referred to hospital for investigation. The sooner a baby is identified and referred to hospital, the less likely they are to need an operative intervention. As the risk of intussusception increases with age, babies should not be given rotavirus vaccine at eight months and zero days or older.

Further side-effects of both vaccines are in line with common vaccine side-effects and information on these will be provided in the immunisation materials and available on the www.immunisation.ie website.

How will we support these changes?

We are aware that this new schedule requires significant changes for everyone and we will provide support to health- care professionals prior to the implementation. A resource package with full details of the schedule, vaccines, contraindications, side-effects and frequently asked questions will be sent to all GPs. A new range of materials will be available for parents and the national immunisation website www.immunisation.ie is being updated. Local public health departments and the National Immunisation Office are available to assist with any questions, queries and problems that you may encounter.

The new childhood immunisation schedule will provide enhanced protection to infants and young children against serious but vaccine preventable diseases and we look forward to working with GPs and supporting them in the successful implementation of this new programme.