FAQs for health professionals (children aged 5-11)

Comirnaty (10 micrograms/dose concentrate) for children aged 5-11

 

Which COVID-19 vaccine is approved for children aged 5-11?

For children aged 5 to 11 years Comirnaty (10 micrograms/dose concentrate) is currently the only vaccine approved and licensed by the EMA for this age group. The EMA recommended extending the indication for Comirnaty to include use in children aged 5 to 11 years of age on 25th of November 2021.

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

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

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, the consequences that can follow infection e.g. multisystem inflammatory syndrome in children (MIS-C), long COVID, psycho-social and developmental impacts.

What is the dose of Comirnaty 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 dose volume, and the vaccine dose is different to that for ≥12 years (0.3mls and 30 micrograms per dose).

What volume of 0.9% saline should be used to dilute a 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. Note that the dilution volume and the discard time is different.

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If more than ten 0.2ml doses can be safely and accurately withdrawn from a diluted vial, they can be used as valid doses.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

What is the recommended Interval between doses?

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

The recommended interval is 21 days.

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 between 19 and 20 days after the first dose, it is a valid dose.

The minimum interval is 19 days. If the second dose is given before 19 days, this is not considered a valid dose. A third dose should be given 21 days after the second (invalid) dose.

**Note this is a different minimum interval compared to that for those aged ≥12 years**

When is an additional dose recommended for children aged 5-11?

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.

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

A booster dose for children aged 5-11 is recommended only for children with immunocompromise associated with a sub optimal response to vaccines at the time of their primary vaccination course. They should receive the booster dose at least 4 months after their additional dose (total 4 doses of vaccine). In exceptional circumstances a 3 month interval may be used. 

Is a booster dose is also recommended for children who have become immunocompromised 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.

What if a child becomes immunocompromised after their primary vaccination course? Do they need an additional dose 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 month after completion of their primary course.

Which Comirnaty 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® 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.

Which Comirnaty® 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®, they should receive the 30 microgram Comirnaty® dose.

Which Comirnaty® vaccine dose should a child receive if they are immunocompromised and 11 years of age when receiving their additional dose, but will turn 12 years old before they can receive the 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.

Can other vaccines be co‐administered with Comirnaty 10 mcg/dose vaccine in children aged 5-11? 

Yes. NIAC now recommend that Comirnaty® 10mcg/dose may be given at the same time or at any interval as other vaccines (live and non-live) including influenza vaccine. The only exception to this is children who have received monkeypox vaccine. In this instance, there should be a 4 week interval between monkeypox vaccine and a subsequent COVID-19 vaccine.

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.

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 four weeks after diagnosis or onset of symptoms, or four weeks from the first PCR positive specimen in those who are asymptomatic.

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

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. In exceptional circumstances a 3 month interval may be used.

What if a child with immunocompromised 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.

What are contraindications to vaccination with a Comirnaty® (10 micrograms/dose concentrate)?

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).

Myocarditis after a previous dose of Comirnaty®.

What are precautions to vaccination with a Comirnaty® Vaccine?

Acute severe febrile illness; defer until recovery

Pericarditis after a previous dose of Comirnaty® (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.

What if only the diluent of Comirnaty® is administered?

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.

What if an over-diluted 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. 

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.

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.

What if a 10mcg dose of children’s Comirnaty is inadvertently given to a person aged 12 and over? 

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:

Person aged 12-17 years

Error

Action

Given lower 1st dose

Do not repeat. Give correct second dose

Given lower 2nd dose

Do not repeat

Given lower 1st and 2nd dose

Give correct dose 21 days after incorrect second dose

Given lower booster  dose

Do not repeat

Person aged 18 years and older

Error

Action

Given lower 1st dose

Give correct dose immediately (no minimum interval) and correct second dose 21 days later

Given lower 2nd dose

Give correct dose immediately (no minimum interval)

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

Comirnaty® vaccine for children aged 5-11 years (orange cap) contains 10 micrograms of mRNA vaccine in each dose. The vaccine for people aged 12 years and older contains 30 micrograms in each 0.3ml dose. Can I use 0.1 mls of the purple cap vaccine to vaccinate a child who is aged 5-11 years?

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.

What if a 30mcg dose of Comirnaty® if given in error to a child aged 5-11?

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.

How can you ensure 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, 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.

 

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

 

This page was updated on 20 September 2022