Overview
Visit our COVID-19 website for more information
Young children often have mild or no symptoms of COVID-19 with a short duration of illness. The incidence of severe or fatal infection in children is significantly lower than in adults.
The use of Comirnaty 3mcg JN.1 yellow cap vaccine is limited to young children aged between 6 months and 4 years of age who are at highest risk of severe infection if they were to catch COVID-19, such as those with severe immunocompromise (see section 5.5.8) or with complex and/or multiple health conditions (see the Starship guidelines).
Click here for information on how mRNA vaccines, like Comirnaty, work and how they are developed. You can access the following video for a visual account of how the COVID-19 vaccines work, click here.
Manatū Hauora Ministry of Health provide operational and policy guidance for COVID-19. Relevant information for health professionals can be found here.
Responses to vaccine
Other formulations and brands
Comirnaty 10mcgJN.1 blue cap is available for 5 to 11 year olds.
Comirnaty 30mcg JN.1 grey cap is available those aged from 12 years.
The Pfizer vaccines are the only Medsafe-approved and funded vaccines available for use in Aotearoa New Zealand. Pharmac have previously funded a Novavax vaccine for COVID-19. However, in July 2024 Novavax decided to withdraw its application for approval of its latest vaccine. Therefore, the Novavax vaccine is currently unavailable in New Zealand.
Vaxzevria (AstraZeneca) and COVID-19 vaccine Janssen are also licensed but are not currently available in NZ.
Schedule and administration
Three doses of Comirnaty 3mcg JN.1 yellow cap vaccine are given to individuals aged 6 months to 4 years. It is recommended to administer dose two at least 21 days after dose one followed by dose three at least eight weeks after dose two.
Children who start their course aged under 5 years need three doses even if they turn 5 years part way through their course. For children who turn 5 years during their course it is recommended to complete the course using Comirnaty 3mcg JN.1 vaccine.
Additional dose
A further single Comirnaty 3mcg XBB.1.5JN.1 dose can be given from 6 months after previous COVID-19 infection or completed vaccine course.
Storage and preparation
For details on storage and preparation of the Comirnaty 3mcg JN.1 yellow 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 3mcg JN.1 yellow cap vaccine comes as a concentrate and requires dilution. It needs to come to room temperature prior to dilution.
- Each vial is diluted with 1.1mL normal saline 0.9% prior to drawing up 0.23mL individual syringe doses for consumers.
- Each multidose vial contains 3 doses of 0.3mL after dilution.
- Allow this formulation to come to room temperature before administering.
Special considerations
Vaccination following COVID-19 infection
Those who have had SARS-CoV-2 infection are advised to wait 6 months before any dose of COVID-19 vaccine. However, clinical discretion can be applied and there are no safety concerns with doses given earlier.
Spacing with other vaccines
National Immunisation Schedule vaccines: all can be given at the same time as the Comirnaty 3mcg JN.1 vaccine, 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.
Vaccine Safety
Experience of JN.1 Comirnaty vaccines in children is limited. Since there is no change in the formulation of the vaccine, except for the spike protein expressed by the mRNA, the responses to paediatric JN.1 Comirnaty vaccines are expected to be similar to the original formulations. Generally, fewer adverse events were reported in children than adults who received the original Comirnaty vaccine. Common responses were mostly mild to moderate. These included local injection-site pain and fewer reported fatigue, headache, muscle or joint pain, gastrointestinal symptoms and fever.
In clinical trials for Comirnaty 3mcg, the most frequent responses seen in infants aged 6–23 months were irritability, decreased appetite, injection-site tenderness and redness, and fever; and in children aged 2–4 years, injection-site pain and redness, fatigue and fever were most frequent.
Less common responses included lymphadenopathy, diarrhoea, vomiting and nausea. Consistent with the clinical trial, systemic reactions were more frequently reported to V-safe for infants (ages 6 months–2 years) than those aged 3–5 years.
The risk of myocarditis following vaccination is not thought to be greater in this age group than any other group, acknowledging that the background rate of myocarditis in infants (aged under 1 year) is higher than in older children ‒ unrelated to COVID-19 vaccination.
There is no current evidence of a safety concern for this vaccine in infants or young children, overall.
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.
Vaccine Effectiveness
Clinical trial data showed combined efficacy against confirmed symptomatic COVID-19 of 80.4 percent (14.1–96.7 percent) for ages 6 months to 4 years. This was reported during a period of Omicron prevalence in the US.
Due to a limited number of symptomatic COVID-19 cases in each group during the clinical trial, vaccine efficacy is difficult to predict due to wide confidence intervals. The antibody response after three doses was shown to be similar to that known to be effective in young adults.
References
Hause AM, Marquez P, Zhang B, et al. COVID-19 mRNA Vaccine Safety Among Children Aged 6 months-5 years - United States, June 18, 2022-August 21, 2022. MMWR: Morbidity and Mortality Weekly Report, 2022. 71(35): p. 1115-1120
