Schedule 

Primary course

Comirnaty 10mcg XBB.1.5 blue cap vaccine is a single-dose (0.3mL) schedule for tamariki between 5–11 years.

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Partially completed primary course

All children aged 5 to 11 years who have not completed a primary course of COVID-19 vaccination are eligible for a single dose of Comirnaty 10mcg XBB.1.5 vaccine.

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Three-dose course for severely immunocompromised

A three dose primary course is recommended for severely immunocompromised children aged 5-11 years using Comirnaty 10mcg XBB.1.5 vaccine. A primary course of 3 doses of Comirnaty 10mcg XBB.1.5 vaccine is recommended 8 weeks apart. This can be given at a minimum spacing of 3 weeks between the first and second dose; and 8 weeks between the second and third dose, if clinically indicated.

The exception to this rule is when a child has turned 12 years old and when 3 months or more has elapsed between a dose of the vaccine. In this case give Comirnaty 30mcg XBB.1.5 vaccine to complete the course. For further detail see the Immunisation Handbook 2020 Chapter 5 (section 5.5.8). 

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Additional doses

Healthy children in this age group are not eligible for additional doses. 

Children who are severely immunocompromised and at-risk of severe outcomes of COVID-19 infection are eligible for a single additional dose of Comirnaty 10mcg XBB.1.5 at least 6 months after completion of primary course.

Severe immunocompromise and those with complex and/or multiple health conditions who are at highest risk of severe disease if they were to catch COVID-19, are described in the Starship guidelines for COVID-19 in children (seestarship.org.nz/guidelines/covid-19-diesase-in-children/).

These are:

• On immunosuppressive treatment including chemotherapy, high-dose corticosteroids, biologics or DMARDS.

• Chronic or congenital airway/lung issues including bronchiectasis, cystic fibrosis, BiPAP for OSA.

• Complex congenital heart disease, acquired heart disease or congestive heart failure.

• Diabetes (insulin-dependent).

• Chronic kidney disease (GFR <15 ml/min/1.73m2).

• Severe neurodisability including severe neuromuscular conditions.

• Primary or acquired immunodeficiency.

• Haematologic malignancy and post-transplant (solid organ or HSCT in last 24 months).

• Complex genetic, metabolic and/or liver or multiple congenital anomalies, including Trisomy 21.

Be aware that eligible children who are undergoing the 3-dose Comirnaty 3mcg maroon cap (6 months to 4 years) vaccine schedule will progress to a Comirnaty 10mcg XBB.1.5 blue cap vaccine for subsequent dose(s) should they turn 5 years during their course. Click here for more information on the Comirnaty 3mcg maroon cap vaccine.

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‍Storage and preparation 

For details on storage and preparation of the Comirnaty 10mcg XBB.1.5 blue cap vaccine please refer to the most current advice in our vaccine preparation resources. Click here for more information on cold chain processes.

Comirnaty 10mcg XBB.1.5 blue cap vaccine should be stored at +2°C to +8°C and once punctured is stable at +2°C to +30°C for 12 hours (6 hours in a syringe). No dilution is required for this single dose vial, it is ready to use. Draw up a 0.3mL dose as per the vaccine preparation guidance.

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Special considerations 

Vaccination following COVID-19 infection 

People who are currently isolating or experiencing symptoms of COVID-19 should not be vaccinated until they have recovered from acute illness and met the criteria to stop isolating. 

It is recommended to wait at least 6 months after acute COVID-19 illness or positive COVID-19 test if asymptomatic before a further dose. This is because the virus infection boosts your immunity in a similar way that the vaccine does. Leaving a space allows time for a good response to the vaccine to occur. 

Hybrid immunity (a mixture of wild-type infection and vaccination) is highly effective at preventing further symptomatic infection and severe infection for a few months.  

Spacing with other vaccines 

‍National Immunisation Schedule vaccines: all can be given at the same time as the Comirnaty 10mcg XBB.1.5, preferably in a different limb. 

Influenza vaccine: can be given at the same time as all Comirnaty vaccines. 

Overseas COVID-19 vaccinations 

COVID-19 vaccinations given overseas can be added to an individual’s profile and count towards their schedule in Aotearoa New Zealand. Click here for more details.

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Before recommending Comirnaty 10mcg orange cap vaccination for tamariki, randomised clinical trials with 31,091 children aged 5-11 years old were undertaken and most adverse events were mild to moderate, and no serious safety concerns were identified. 

In October 2021 the US FDA gave Comirnaty 10mcg orange cap vaccine emergency authorisation to use in children ages 5-11 years old. Since that time there has been accumulating data on real world experience of using this vaccine in this age group. 

Based on safety data of over 8 million doses of Comirnaty 10mcg orange cap vaccine given in the US, there were no unexpected serious reports. Data on common local and systemic adverse events are emerging. The adverse event profile of Comirnaty 10mcg XBB.1.5 blue cap is expected to be similar to its earlier formulations and that is what experience to date suggests. Safety is being closely monitored globally. There are no medical conditions or medications that are contraindicated for Comirnaty (except those given below).  

Vaccine should not be given to: 

• Anyone with severe allergy (anaphylaxis) to a previous dose of this vaccine or a component of the vaccine. 
• Administration of Comirnaty should be postponed in individuals suffering and acute severe febrile illness (fever over 38°C) or who are systemically unwell. The presence of a minor infection is not a reason to delay immunisation. 

Ensure a 15-minute post-vaccination wait and clear post-vaccination advice is given. A definite history of any immediate allergic reaction to any other product is a precaution but not a contraindication to vaccination with Comirnaty. In this case, 30 minutes is recommended for observation post-vaccination. If Comirnaty is given with other NIS vaccines a 20-minute wait needs to be observed.  

The safety profile of Comirnaty is like that of other vaccines given in New Zealand. Some people experience mild to moderate discomfort at the injection-site and flu-like symptoms (such as headache, muscle and joint aches, fever) for just a day or two after vaccination. This is an expected response not experienced by everyone. 

Myocarditis has been reported but is significantly less common than older adolescents and young adults. The myocarditis incidence rate after dose 2 is 14 per 1 million doses among boys aged 5–11 years. It is very rare after dose 1, and in females.  

Post Vaccine Symptom Check Surveys were completed by over 24,000 parents or caregivers of children aged 5 to 11 years vaccinated in New Zealand. At least one adverse event/reaction to the vaccine was reported by 21 percent. More adverse events were reported after the second (22 percent) than first dose (18 percent). The proportion of tamariki for whom an adverse event was reported was similar for each ethnic group. 

The most frequently reported adverse events were injection site reaction, tiredness, headache and body pain.  

Comirnaty vaccines are being held to the same high safety standards as all vaccines and medications licensed for use in New Zealand. CARM monitors and analyses the database for the identification of new signals, or important patterns, clusters or unusual events or practices that could have significance for medicine safety and prescribing practices in New Zealand. Any adverse event experienced post-vaccination should be reported to CARM. Click here for more information on adverse events following immunisation, reporting and monitoring.

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In a trial, mRNA-CV (10mcg) showed efficacy of 90.7 percent (95 percent CI 67.7–98.3 percent) against symptomatic COVID-19 from seven days after dose two in 1,305 children aged 5–11 years (Walter et al).

A review of multiple studies showed that COVID-19 vaccination is associated with lower risks of SARS-CoV-2 infection, symptomatic COVID-19, hospitalisation, and multisystem inflammatory syndrome in children (Watanabe et al).

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Walter EB, Talaat KR, Sabharwal C, et al. Evaluation of the BNT162b2 COVID-19 vaccine in children 5 to 11 years of age. New England Journal of Medicine, 2021. 386(1): p. 35-46.

Watanabe A, KaniR,  Iwagami M et al. Assessment of Efficacy and Safety of mRNA COVID-19 Vaccines in Children Aged 5 to 11 Years A Systematic Review and Meta-analysis. JAMA Pediatr. doi:10.1001/jamapediatrics.2022.6243

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