FAQs 6 months - 4 years

The following questions and answers have been developed by the National Immunisation Office.

Which COVID-19 vaccine is recommended for children aged 6 months to 4 years?

Comirnaty® XBB.1.5 3 micrograms (0.2ml)

Spikevax 25 micrograms (0.25ml) has been licensed in other countries for children aged 6 months to 5 years but it is not being marketed in Ireland.

Why is the COVID-19 vaccine offered to children aged 6 months to 4 years?

A primary course of COVID-19 vaccination is recommended for those aged 6 months to 4 years with underlying conditions that place them at higher risk of severe COVID-19. The presence of an underlying condition (as listed in the table below) significantly increase the risk of hospitalisation and severe disease.

However, COVID-19 vaccination is being offered to all children aged 6 months to 4 years because of:

the protection provided against severe COVID-19 infection and Multisystem Inflammatory Syndrome in Children (MIS-C, further details below) and their late consequences
the enhanced protection vaccination gives to those who have had COVID-19 infection
the modest protection for immunocompromised and other household contacts who are too young to be vaccinated
the safety profile of the vaccines
similar vaccine immunogenicity to that in older children and adolescents.

Multisystem Inflammatory Syndrome in Children (MIS-C) is a rare but serious hyperinflammatory syndrome related to prior SARS-CoV-2 infection, in which different organs can become inflamed. The incidence of MIS-C is about 100/100,000 in those under 21 years of age, with a median age of 9 years old, and 75% of cases with no underlying medical condition. Most children recover with appropriate treatment.

See NIAC Immunisation Guidelines for Ireland Table 5a.2 for conditions or treatments associated with very high or high risk of severe COVID-19 disease.

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What is the dose of Comirnaty® X BB.1.5 for children aged 6 months to 4 years?

The dose of Comirnaty® for children aged 6 months to 4 years is 3 micrograms (0.2ml).

The primary course for all children in this age group (including children with immune compromise) is two doses for those with no prior history of SARS-CoV-2 infection. A four week interval is recommended between dose one and dose two. In exceptional circumstances a 3 week interval may be used.

A single dose is recommended for those with a prior history of SARS-CoV-2 infection.

A prior history of COVID-19 infection can be confirmed by an of: positive PCR, antigen test or clinical diagnosis.

What should I do if the interval between doses is shorter than recommended?

If the second dose is given more than four days before the minimum interval this is not considered a valid dose. A further dose should be given at least 4 weeks after the invalid dose.

Where should the vaccine be injected?

The vaccine must be delivered intramuscularly (IM injection). For infants aged 6 months to 11 months, the recommended injection site is the anterolateral aspect of the thigh. For children aged 1 year to 4 years of age, either the deltoid muscle or the anterolateral aspect of the thigh can be used (depending on muscle mass) as the injection site.

Can other vaccines be co-administered with the COVID-19 vaccine in children aged 6 months to 4 years?

No, in this age group there must be at least a 2 week interval between the administration of the COVID-19 vaccine and any other vaccines. No interaction studies in young children have been performed on coadministration of Comirnaty® with childhood vaccines. Priority should be given to other routine childhood immunisations. Until there is more evidence it is prudent to separate COVID-19 vaccination in children aged 6 months-4 years from other vaccines for a period of 14 days.

As a precaution, if a child has recently received the monkeypox vaccine (Imvanex or Jynneos), they need to wait 4 weeks before they get their COVID-19 vaccine because of the unknown risk of myocarditis.

What are the most common adverse reactions seen in children aged 6 months to 4 years following the primary course of COVID-19 vaccination?

The most frequent adverse reactions in those that received any primary course dose included:

in infants 6-23 months of age, irritability (> 60%), drowsiness (> 40%), decreased appetite (>30%), tenderness at the injection site (> 20%), injection site redness and fever (> 10%)
in children 2-4 years of age, pain at injection site and fatigue (> 40%), injection site redness and fever (> 10%).

A higher rate of pyrexia was seen after administration of the second dose.

This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions to the HPRA.

In the US, over one million children aged 6 months-5 years have received at least one dose of either Comirnaty® or Spikevax®. The CDC reviewed adverse events and the most commonly reported symptoms were irritability or crying, sleepiness, loss of appetite and fever. Almost all (98%) reports were for non-serious events. Of the serious events reported, two were likely attributable to the vaccination, one febrile convulsion and one anaphylaxis associated with a dosing error. No cases of myocarditis were reported.

Is a third dose or booster dose recommended for children aged 6 months to 4 years?

There are currently no indications for a third dose or booster doses in any age group. The primary course of 2 doses of Comirnaty® Omicron XBB.1.5 10 micrograms (0.2ml) (or one dose if a prior history of COVID-19 infection) is the only recommendation for COVID-19 vaccination for children aged 6 months to 4 years.

What are the contraindications and precautions with this vaccine?

Contraindications

Anaphylaxis following a previous dose of the vaccine or any of its constituents (including polyethylene glycol (PEG) and trometamol).

Appropriate support should be available in case of anaphylaxis or fainting after vaccine administration. Precautions should be in place to minimise injury from fainting.

Precautions

Acute severe illness; defer until recovery.
Previous history of myocarditis or pericarditis after any COVID-19 vaccine - seek specialist advice.
Vaccination should be postponed in children with a previous history of MIS-C, until clinical recovery or until 90 days or more since diagnosis, whichever is the longer.

What are the considerations for a child planned to begin immunosuppressing therapy?

Children with planned immunosuppressing therapy should ideally complete vaccination two weeks before treatment. The recommended minimum interval may be used. Specialists should consider the child’s risk and likelihood of disease exposure, and provide advice based on knowledge and understanding of their immune status and likely immune response to vaccination.

What are the considerations for a child who is immunocompromised?

If the child is already immunocompromised (either due to disease or treatment), they may be vaccinated if they have no contraindications. Vaccine efficacy may be lower in immunocompromised individuals.

Which Comirnaty® vaccine dose should a child receive if they are currently 4 years of age, but will turn 5 years old before they can receive a second dose?

The dose of Comirnaty® depends on the age at the time of the vaccination e.g., a 4-year-old child should receive the first dose of Comirnaty® Omicron XBB.1.5 30 micrograms and if they have turned 5 years of age at the time of a subsequent dose, the dose given should be Comirnaty® Omicron XBB.1.5 10 micrograms for those aged 5-11 years.

Therefore, if a child becomes five years of age before completion of the recommended course, the schedule should be completed with the age appropriate dose, Comirnaty® Omicron XBB.1.5 10 micrograms for those aged 5-11 years.

How can I ensure that the right formulation of Comirnaty® is given to the appropriate age group?

The following checks are routinely recommended before COVID-19 vaccination:

Is this a primary course and what dose number is it?
What is the age of the person?
What is the recommended vaccine for this age-group?
What is the recommended dose?
What is the recommended interval since the last dose?
Has the person had COVID-19 infection? What is the recommended interval since laboratory-confirmed COVID-19 infection?

In addition, NIAC recommends consideration should be given to establishing separate child friendly vaccination clinics for children. This would minimise distress in young children and reduce likelihood of vaccine error by avoiding having the adult and paediatric formulations of COVID-19 vaccines at the same venue. However, as the dose and vaccines for 6 months to 4 year olds and for 5 to 11 year olds are different, caution must still be exercised to ensure the child is receiving the correct vaccine and vaccine dose for their age group.