FAQs for health professionals (children aged 5-11)

For children aged 5 to 11 years, Comirnaty 10 micrograms (0.2ml)) and Comirnaty Original/Omicron BA.4-5 10 micrograms (0.2ml) are two vaccines approved and licensed by the EMA for this age group.  

**Note the vaccine for children aged 5-11 is a different vaccine formulation to the one used in children aged 6 months to 4 years (Comirnaty 3 micrograms/dose concentrate) and to the one used in persons aged 12 and over (Comirnaty 30 micrograms/dose concentrate).**

COVID-19 vaccines are strongly 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

For all children in this age group, the recommendation of NIAC is that the benefits of vaccination are greater than the risks from the vaccine.

This is because of the favourable benefit risk 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, psycho-social and developmental impacts.

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 for children aged 6 months to 4 years (0.2ml and 3 micrograms per dose) and to the dose for those ≥12 years (0.3ml and 30 micrograms per dose).

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. Note that the dilution volume and the discard time is different to other age groups.

If more than ten 0.2ml doses can be safely and accurately withdrawn from a diluted vial, they can be used as valid doses. There are a maximum of 12 doses in each vial.

The vaccination course consists of two doses. The recommended interval between doses is 21 days.

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

If the interval between doses is longer than 21 days, 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 21 days after the second (invalid) dose.

**Note this is a different interval compared to that for children aged 6 months to 4 years **

The dose of Comirnaty Original/Omicron BA.4-5 vaccine for those aged 5 to 11 years is 0.2 ml intramuscularly (IM) into the deltoid muscle. Each dose contains 10 micrograms.

NIAC have recommended that children aged 5 to 11 years who are severely immunocompromised at time of vaccination should be given a third dose of Comirnaty (10 micrograms/dose) at least 28 days after the second dose to complete the primary series in line with the licensed documentation.

A first booster dose of Comirnaty 10 micrograms (0.2ml) or Comirnaty Original/Omicron BA.4-5 10 micrograms (0.2ml) for children aged 5-11 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 course (3 doses). They should receive the booster vaccine dose at least 4 months after their additional dose 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.

For children aged 5-11 who are recommended to receive a booster COVID-19 vaccine dose, the adapted bivalent vaccine Comirnaty® Original/Omicron BA.4-5 10 micrograms for children aged 5-11 years is preferred, as this vaccine provides added protection against the BA.4 and BA.5 Omicron variants of COVID-19.

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 month after completion of their primary course.

The dose of Comirnaty® depends on the age of the child at the time of the vaccine, an 11 year old child who receives the first dose of 10 micrograms Comirnaty and who then becomes 12 years of age should receive a second dose of the 30 microgram Comirnaty as their second dose.

If the child has turned 12 at the time they are due the booster dose of Comirnaty®, they should receive an adapted 30 microgram Comirnaty® booster dose.

If the child has turned 12 at the time they are due the booster dose of Comirnaty®, they should receive the 30 microgram Comirnaty® dose.

Yes. NIAC now recommend that Comirnaty® 10mcg/dose 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 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.

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.

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

If a child is immunocompromised and has had a laboratory-confirmed breakthrough infection following their second vaccine dose, the additional dose should be delayed for at least 4 months.

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.

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).

Acute severe febrile 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.

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

The diluent for Comirnaty® (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.

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. 

In settings where doses may be prepared in advance, if thirteen doses have been obtained from a vial, each of the syringes must be examined by another person to identify the syringe with less than 0.2ml. If all syringes contain 0.2ml then more than 1.3ml must have been added and the vial has been over-diluted.

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.

In this case, the error should be explained to the parent or person (if aged 16 and over). The actions will dependent on the person’s age:

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

No. You cannot use the vaccine for people aged 12 years and older (purple cap) to vaccinate children aged 5-11 years. Although it might appear that 0.1ml of the purple cap formulation would be equivalent to a 10 microgram dose of the orange cap formulation, the correct concentration of mRNA vaccine cannot be guaranteed in such a small volume of vaccine.

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 and 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.

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 at the same venue.