FAQs for health professionals (children aged 5-11)

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

Which COVID-19 vaccines are available in Ireland for children aged 5-11?

There are currently two COVID-19 vaccines available in Ireland for vaccination of children aged 5 to 11 years, Comirnaty® Original/Omicron BA.4-5 10 micrograms (0.2ml) and Comirnaty® Omicron XBB.1.5 10 micrograms (0.2ml).

  • Comirnaty® Original/Omicron BA.4-5 10 micrograms (0.2ml)
    • o for primary course vaccination
    • o may be used for booster vaccination if Comirnaty® Omicron XBB.1.5 for children aged 5-11 years is not available
  • Comirnaty® Omicron XBB.1.5 10 micrograms (0.2ml)
    • o for booster vaccination only
    • o Comirnaty® Omicron XBB.1.5 is the preferred vaccine for booster vaccination, however if this vaccine is unavailable then Comirnaty ® Original/Omicron BA.4-5 for children aged 5-11 years may be used as an alternate for booster vaccination 

Of note: The National Immunisation Advisory Committee (NIAC) recommends the preferential use of new Comirnaty® Omicron XBB adapted monovalent vaccines for booster doses when they become available in Ireland. In the interim, bivalent Comirnaty® Original/Omicron BA.4-5 mRNA COVID-19 vaccines should continue to be used.

**Note the vaccines for children aged 5-11 are different vaccine formulations to the one used in children aged 6 months to 4 years (Comirnaty® 3 micrograms/dose concentrate).**

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Why is the COVID-19 vaccine recommended for children aged 5-11? 

A primary course of COVID-19 vaccination is recommended by the NIAC for children aged 5 to 11 years who:

  • live with underlying conditions
  • living with a younger child with complex medical needs
  • living with a person who is immunocompromised

COVID-19 vaccination should be offered to all other children aged 5-11 years because of the favourable risk benefit profile of the vaccine, to protect them from severe disease and the consequences that can follow infection e.g., multisystem inflammatory syndrome in children (MIS-C), long COVID, psychosocial and developmental impacts.

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Can a child aged 5-11 receive Comirnaty® Original/Omicron BA.4-5 10 micrograms (0.2ml) vaccine for a primary course?

Comirnaty Original/Omicron BA.4-5 10 micrograms vaccine for primary courses may be used in CVCs for those aged 5-11 years.

If a child aged 5-11 years received ‘Comirnaty Original 10 micrograms for those aged 5-11 years’ for their first dose of the primary course, then they may receive ‘Comirnaty® Original/Omicron BA.4-5 10 micrograms for those aged 5-11 years’ for the second dose of their primary course of vaccination.

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What is the dose of Comirnaty® Original/Omicron BA.4-5 10 micrograms for children aged 5-11 years?

The dose of vaccine for those aged 5 to 11 years is 0.2 ml intramuscularly (IM) into the deltoid muscle. Each dose contains 10 micrograms.

Note that the vaccine dose is different to the dose of Comirnaty Original/Omicron BA.4-5 bivalent vaccine for those ≥12 years (0.3ml and 30 micrograms per dose).

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What volume of 0.9% saline should be used to dilute a Comirnaty® Original/Omicron BA.4-5  10 micrograms vaccine vial?

The vaccine requires dilution with 1.3ml of 0.9% sodium chloride. After dilution, the vaccine should be kept at +2°C to +30°C and used within 12 hours.

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How many doses of 0.2mls are in a diluted vial of the Comirnaty®Original/Omicron BA.4-5 10 micrograms for children aged 5-11 years vaccine?

If more than ten 0.2ml doses can be safely and accurately withdrawn from a diluted vial, they can be used as valid doses.

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What is the recommended interval between doses of the Comirnaty®Original/Omicron BA.4-5 10 micrograms for children aged 5-11 years vaccine when used for a primary course?

The vaccination course consists of two doses. From April 2023 the NIAC recommends the interval between the two doses is 8 weeks.  A minimum interval of 3 weeks may be used if there is urgency to achieve protection.

The day that the first dose of vaccine is given is day 0.

If the interval between doses is longer than 8 weeks, the second dose should be given as soon as possible. The course does not need to be restarted.

If the second dose is given more than 4 days before the minimum interval (i.e., before 17 days), this is not considered a valid dose. A third dose should be given at least 8 weeks after the second (invalid) dose.

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When is an extended primary vaccination series recommended for children aged 5-11?

NIAC have recommended that children aged 5 to 11 years with immunocompromise associated with a suboptimal response to vaccination at the time of vaccination should be given an extended primary vaccination series. This extended primary series includes an additional or third dose of Comirnaty Original/Omicron BA.4-5 10 micrograms (0.2ml) given after the second dose to complete the primary series. The recommended intervals between the 3 doses of the extended primary series for immunocompromised children aged 5-11 years is:

  • 3 vaccine doses with a 4 week interval between dose one and two, and an 8 week interval between dose two and three.

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What is the dose of Comirnaty® Omicron XBB.1.5 10 micrograms for children aged 5-11?

The dose of this vaccine for those aged 5 to 11 years is 0.2 ml intramuscularly (IM) into the deltoid muscle. Each dose contains 10 micrograms.

Note that the vaccine dose is different to the dose of Comirnaty® Omicron XBB.1.5 vaccine for those ≥12 years (0.3ml and 30 micrograms per dose).

Of note: Comirnaty® Omicron XBB.1.5 10 micrograms (0.2ml) should be used for booster vaccination only.

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Is a first booster dose recommended for children aged 5-11?

A first booster dose of Comirnaty® Omicron XBB.1.5 10 micrograms (0.2ml) for children aged 5-11 years [or Comirnaty® Original/Omicron BA.4-5 10 micrograms (0.2ml) for children aged 5-11 years if Comirnaty® Omicron XBB.1.5 10 micrograms (0.2ml) is unavailable] is recommended for all those aged 5-11 years with immunocompromise associated with a suboptimal response to vaccines who have completed an extended primary vaccination series (3 doses). They should receive the booster vaccine dose at least 4 months after their additional dose (also known as the third dose of the extended primary series) or confirmed SARS-CoV-2 infection. In exceptional circumstances a 3 month interval may be used (e.g., in a person scheduled to commence chemotherapy). 

A booster dose is also recommended for children who have developed severe immunocompromise following their primary vaccination course. They should receive the booster dose at least 4 months after the last dose of vaccine (total 3 vaccine doses). In exceptional circumstances a 3 month interval may be used.

An autumn booster dose is recommended for those aged 5-11 years:

  • with immunocompromise associated with a suboptimal response to vaccination
  • those with medical conditions associated with a higher risk of COVID-19 hospitalisation, severe disease or death

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What if a child becomes immunocompromised after their primary vaccination course? Do they need an additional dose (also known as the third dose of the extended primary series) as well as a booster those?

These children do not need an additional dose, as they are expected to have mounted a normal immune response to the primary vaccination course. They are recommended a booster dose at least 4 months after completion of their primary course.

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Which Comirnaty Original/Omicron BA.4-5 bivalent vaccine dose should a child receive if they are 11 years of age, but will turn 12 years old before they can receive a second dose?

The dose of Comirnaty Original/Omicron BA.4-5 bivalent vaccine depends on the age of the child at the time of vaccination. An 11 year old child who receives the first dose of 10 micrograms Comirnaty® Original/Omicron BA.4-5 bivalent vaccine for those aged 5-11 years, and who then becomes 12 years of age, should receive a dose of the Comirnaty® Original/Omicron BA.4-5 30 micrograms (0.3ml) vaccine for those aged 12 years and older, as their second dose of the primary course.

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Which Comirnaty® Original/Omicron BA.4-5 bivalent vaccine dose should a child receive if they are immunocompromised and 11 years of age when receiving their 1st and 2nd dose, but will turn 12 years old before they can receive an additional/third dose?

If the child has turned 12 at the time they are due the additional/3rd dose of Comirnaty®Original/Omicron BA.4-5, they should receive the Comirnaty® Original/Omicron BA.4-5 30 micrograms (0.3ml) vaccine dose for those aged 12 years and older.

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Can other vaccines be co‐administered with Comirnaty® Original/Omicron BA.4-5 10 micrograms vaccine in children aged 5-11 years? 

Yes. NIAC now recommend that Comirnaty® Original/Omicron BA.4-5 10 micrograms (0.2ml) bivalent vaccine may be given to children aged 5-11 at the same time or at any interval as other vaccines (live and non-live) including influenza vaccine. Co-administered vaccines should be given in different arms. The only exception to this is children who have received mpox (formerly known as monkeypox) vaccine. In this instance, there should be at least a 4 week interval between mpox vaccine and a subsequent COVID-19 vaccine.

This is different to the advice for children aged 6 months to 4 years, where it is currently advised not to co-administer the Comirnaty® 3mcg/dose with any other vaccine – please see the FAQs for children aged 6 months to 4 years for more details.

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Should unvaccinated children aged 5-11 who have had COVID‐19 infection be offered the COVID‐19 vaccine?

Vaccination should be deferred until clinical recovery from COVID-19 infection and for at least four weeks after diagnosis or onset of symptoms, or four weeks from the first PCR positive specimen in those who are asymptomatic. 

Those with persistent symptoms post COVID-19 may be vaccinated unless there is evidence of recent clinical deterioration. 

Serological testing prior to vaccination is not recommended.

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What if a child aged 5-11 is diagnosed with COVID‐19 infection after a first dose of vaccine?

Vaccination with the second dose should be deferred until clinical recovery from COVID‐19 and at least 8 weeks after diagnosis or onset of symptoms, or 8 weeks from the first PCR positive specimen in those who are asymptomatic.

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What if a child with immunocompromise aged 5-11 is diagnosed with breakthrough COVID‐19 infection after their second dose of vaccine?

If a child aged 5-11 years who is immunocompromised has SARS-CoV-2 infection more than seven days after their second vaccine dose, a third dose of the primary series is not required. They should proceed to their first booster dose as per Table 5a.1 of the NIAC Immunisation Guidelines for Ireland. For those with infection within seven days of their second dose they should complete the extended primary series after an interval of 4-8 weeks.

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What if a child with immunocompromise aged 5-11 is diagnosed with breakthrough COVID‐19 infection after their additional dose of vaccine?

If a child is immunocompromised and has had a laboratory-confirmed breakthrough infection following their additional vaccine dose, the booster dose should be delayed for at least 4 months. In exceptional circumstances a 3 month interval may be used.

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What are contraindications to vaccination with the below vaccines for children aged 5-11 years?

- Comirnaty® Original/Omicron BA.4-5 10 micrograms (0.2ml) vaccine                                               

- Comirnaty® Omicron XBB.1.5 10 micrograms (0.2ml) vaccine

- Anaphylaxis after an mRNA vaccine

- Anaphylaxis following a previous dose of the vaccine or following any of its constituents including polyethylene glycol (PEG) and Trometamol (found in gadolinium- containing contrast dyes).

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What are precautions to vaccination with the below vaccines for children aged 5-11 years?              

- Comirnaty® Original/Omicron BA.4-5 10 micrograms (0.2ml) vaccine

- Comirnaty® Omicron XBB.1.5 10 micrograms (0.2ml) vaccine

Acute severe illness; defer until recovery

Previous history of myocarditis or pericarditis after any COVID-19 vaccine – seek specialist advice (i.e., consult with a Cardiologist).

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.

Allow at least a 4 week interval between mpox vaccine and subsequent COVID-19 vaccine.

If vaccination is advised for a child with prior history of mastocytosis, observe for 30 minutes after vaccination.

For full list of contraindications and precautions see Chapter 5a of the NIAC Immunisation Guidelines for Ireland, Table 5a.3: Contraindications and precautions to mRNA COVID-19 vaccines.

For more information see Frequently Asked Questions about COVID-19 vaccines for children with pre-existing allergic conditions.

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What if only the diluent of Comirnaty® Original/Omicron BA.4-5 10 micrograms is administered?

The diluent for Comirnaty® Original/Omicron BA.4-5 10 micrograms bivalent vaccine (Pfizer BioNTech) is sodium chloride, which is salt and purified water so no adverse reactions would be expected.

This should be explained to their parent/guardian and a correctly diluted dose of the vaccine should be given as soon as possible. This should be reported to HPRA if this is associated with an adverse event and an incident report form completed.

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What if an over-diluted Comirnaty Original/Omicron BA.4-5 vaccine is administered?

In this case, the person will not have received a sufficient dose of vaccine for protection. 

This should be explained to the parent or guardian and a correctly diluted dose of the vaccine should be given as soon as possible (i.e. no minimal interval). This should be reported to HPRA if this is associated with an adverse event and an incident report form completed. 

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What if an under-diluted vaccine or the whole multi‐dose vial of vaccine is administered instead of the recommended dose?

In clinical trials where a small number of children were given higher doses of a similar vaccine was not associated with serious adverse events during the observation period but most local reactions were mild to moderate and short lived.

If the error was made with the first dose, the child is given their second dose of vaccine according to the recommended schedule. The parents should also be informed of the very rare adverse event of myocarditis and pericarditis, the symptoms to be aware of, and to seek medical attention if they develop.

This vaccine error should be reported to HPRA if associated with an adverse event and an incident report form completed.

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How can you ensure the right formulation of Comirnaty® Original/Omicron BA.4-5 bivalent vaccine or Comirnaty® Omicron XBB.1.5 vaccine is given to the appropriate age group?

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

  • Is this a primary course, an additional dose for a person who is immunocompromised or a booster dose? 
  • 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 aged 5 - 11 years. This would minimise distress in young children and reduce likelihood of vaccine error by avoiding having the adult and paediatric formulations of Comirnaty® Original/Omicron BA.4-5 bivalent vaccine and Comirnaty® Omicron XBB.1.5 vaccine at the same venue.

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Visit the COVID-19 Frequently Asked Questions for Health Professionals webpage for more information

 

This page was updated on 12 September 2023