Schedule 

Comirnaty 10mcg orange cap vaccine is a two-dose schedule for tamariki between 5–11 years. It is recommended that the two doses are 8 weeks apart (with a minimum of 21 days apart for quicker protection eg, for those with significant medical issues such as immunosuppression).  

Those who start with a Comirnaty 10mcg orange cap vaccine and turn 12 years before completing the course, should have a Comirnaty 30mcg grey cap vaccine for any subsequent primary doses. 

A third primary dose for severely immunocompromised children aged 5-11 years can be given 8 weeks after their second primary dose. Comirnaty 10mcg orange cap vaccine is used. This requires a prescription and written consent. For further detail see the Immunisation Handbook 2020 Chapter 5 (section 5.5.8). 

Children in this age group are not eligible for first booster or additional booster doses. 

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 orange 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.
‍

[key-master]

[comirnaty-10mcg]

Storage and preparation 

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

Dilution  

• Comirnaty 10mcg orange cap vaccine comes as a concentrate and requires dilution. It needs to come to room temperature prior to dilution. 
• Each vial is diluted with 1.3ml sodium chloride 0.9% prior to drawing up 0.2ml individual syringe doses for consumers.   
• Each multidose vial contains 10 doses of 0.2ml after dilution. 

Comirnaty 10mcg orange cap vaccine is stable at +2°C to +30°C for 2 hours prior to adding diluent and 12 hours from adding diluent (6 hours in a syringe). It is best practice to return the opened vials to cold chain, making sure they are appropriately labelled with their expiry date and time. Allow this formulation to come to room temperature before administering.  

‍

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.  

The interval recommended from prior infection or vaccination was increased from 3 months to 6 months because we know that protection against severe disease persists for up to at least 6 months. Having a dose earlier has limited benefit.   

Spacing with other vaccines 

‍National immunisation schedule vaccines: all can be given at the same time as the Comirnaty 10mcg, 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.

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. 

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.

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).

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

‍