Schedule 

Primary course 

A single dose of Comirnaty 30mcg XBB.1.5 is used as a primary course from 12 years of age.  

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Incomplete primary course

Anyone over the age of 12 years needing to complete a primary course after an incomplete course of original Comirnaty 3mcg, 10mcg or 30mcg, Nuvaxovid or other overseas COVID-19 vaccines can have a single Comirnaty 30mcg XBB.1.5 from three months after their most recent dose.  

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Three-dose primary course for immunocompromise 

People who have a medical condition or are receiving therapies that affect the function of their immune system are at increased risk from severe COVID-19 illness. Vaccination is highly recommended, but depending on the type and the level of immunocompromise they may not produce as good a protective response as a healthy person. This means that they are less well protected by the vaccine, or their protection wanes to below protective levels faster. Extra doses of Comirnaty can help to overcome this reduced response. 

For information for vaccination of immunocompromised people and third primary dose requirements click here.

A three-dose primary course of Comirnaty 30mcg XBB.1.5 is recommended for those with severe immunocompromise, at eight-week intervals. A prescription is required for any Comirnaty 30mcg XBB.1.5 dose given with less than three months spacing between a previous one.

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Additional dose eligibility and spacing

A single additional dose is recommended for individuals aged 16 years and over, after completing the primary course. This is given at least six months after previous COVID‑19 vaccination or COVID‑19 infection.  

Additional doses of Comirnaty 30mcg XBB.1.5 continue to be recommended from six months after last COVID-19 vaccination for those aged 12 and over who are eligible because of a higher risk of severe infection. Additional doses also continue to be available for healthy people aged 30 and over.  

The interval recommended from prior COVID-19 infection or vaccination is six months, as we know that protection against severe disease persists for up to at least six months. Having a dose earlier has limited benefit. Note, the eligibility criteria have not changed.  

As a reminder, additional COVID-19 doses are available for those: 

• aged 12-29 and at higher risk of severe illness from COVID-19
• pregnant
• aged 30 and over. 

Clinical discretion 

Clinical discretion can be applied when considering vaccination given less than six months after COVID-19 infection or previous dose. A shorter spacing of at least three months may be appropriate for those considered at high risk of severe disease from COVID-19 re-infection. Spacing of at least six months is preferred.  

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Storage and preparation 

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

Comirnaty 30mcg XBB.1.5 grey cap preparation: 

• Does not require dilution. 
• It is recommended that vaccines are prepared as needed, selecting the correct length of needle, and administered as soon as possible after drawing up into a syringe.  
• Partially used vials must be stored in separate containers with a completed vaccine label, recording time of opening, and date and time of expiry.  Maximum storage time for vaccine in an open vial is 12 hours from first puncture and six hours when drawn into a syringe, both can be stored at 2°C to 30°C.
• Do not need to come to room temperature before administration. 
• Please see Comirnaty_XBB.1.5_Vaccine preparation guide for more detailed instructions.

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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 completing the primary course. 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.  

Additional doses are also recommended for people who have had COVID-19 previously if they meet the eligibility criteria.  Allow a gap of six months between infection and an additional dose. Having a dose earlier has limited benefit.    

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Pregnancy 

Pregnant people are encouraged to have the Comirnaty vaccine at any stage of pregnancy or while breastfeeding. 

Having COVID-19 infection when pregnant can cause the pregnant person to become very unwell. The vaccine protects from severe COVID-19 infection and can also provide temporary protection for newborns via passive transfer of antibodies through the placenta and breastmilk. 

There is no evidence that the vaccine is associated with an increased risk of miscarriage during pregnancy.  

The Comirnaty vaccine does not contain a live virus or any ingredients that are harmful to pregnant people or their babies.

Anyone with questions or concerns about receiving Comirnaty vaccine in pregnancy is advised to discuss these with their health professional. Everyone has a right to make an informed decision about receiving the vaccine. The linked resources below are designed to help support health professionals with these discussions along with our factsheet Vaccination in pregnancy and when breastfeeding for health professionals.

Other consumer facing resources that may support conversation include: Unite against COVID-19 and Immunise.health.nz.

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Fertility 

There is currently no evidence that any vaccines, including Comirnaty, cause fertility problems (problems trying to get pregnant) in women or men. Refer to our factsheet Comirnaty and fertility for more specific information on this.

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Frail and elderly people 

There are no safety concerns around giving COVID-19 vaccine to older and frail adults.  

In general, it is recommended that all eligible adults, including the frail and elderly with comorbidities, are offered vaccination against COVID-19 if there are no contraindications to its administration. As with all clinical interventions, there needs to be an individual risk/benefit appraisal and shared decision making between clients, whānau, surrogate decision makers and clinicians on the individual and collective benefits and risk of COVID-19 vaccination. For frail elderly people with a prognosis of a short number of weeks (including those in terminal decline or on an end-of-life care pathway), the individual risk/benefit appraisal will be particularly important. 

A single dose of COVID-19 vaccine substantially reduced (over 70 percent) the risk of COVID-19-related hospitalisation in elderly, frail patients with extensive co-existing conditions in the UK. By 2 weeks after the second dose, effectiveness against symptomatic COVID-19 in adults aged over 70 years was 85-93 percent. This is important, as increasing age is a risk factor for severe COVID-19. 

Following early reports of deaths of frail, elderly adults in residential care facilities after COVID-19 vaccination, independent reviews by both the CDC and the WHO concluded that the mortality rate in this population is typically high, and a substantial number of deaths will occur coincidentally following vaccination.  

When vaccinating an elderly person who has an intercurrent or comorbid condition, it is wise to ensure they are stabilised or as well as possible before they have the vaccine. Following vaccination, ensure good hydration and careful management of potential systemic adverse events, such as fever. It is advisable for them to be with someone else for 24 hours after receipt of the vaccine to help manage such adverse events.

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Spacing with other vaccines 

National immunisation schedule vaccines: all can be given at the same time as the Comirnaty 30mcg XBB.1.5 grey cap vaccine, preferably in a different limb. 

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

Mpox (Jynneos) vaccine: consider spacing mpox and Comirnaty vaccine by 28 days for individuals at increased risk of myocarditis and/or pericarditis following a Comirnaty dose (males aged 16 to 40 years) in an abundance of caution. 

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Individuals with thrombocytopenia and coagulation disorders 

• The vaccine can be given intramuscularly (IM) to individuals with stabilised thrombocytopenia, bleeding disorders and anticoagulant therapy. The risk of a haematoma should be included as part of the informed consent process. 
• A fine needle should be used for the vaccination followed by firm pressure for at least two minutes. Press (do not rub) injection site until bleeding stops. 
• If there is doubt regarding the level of anticoagulation control, please consult a clinician. 

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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.

Clinical trial data and real-world data from vaccination programmes using Comirnaty indicate a good safety profile. As it does not contain live virus, it is suitable for use in those with compromised immune systems and older adults.

Safety has been and continues to be closely monitored globally. There are no medical conditions or medications that are contraindicated for Comirnaty (except those given below).

‍Comirnaty 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 an 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. 
• Vaccination should be deferred, and specialist immunisation advice should be sought for those who have experienced myocarditis, myopericarditis or pericarditis following a previous dose of Comirnaty. 
• Those with a history of pericarditis or myocarditis, unrelated to Comirnaty, may have the vaccination if the condition is completely resolved, (ie, no symptoms for at least three months and no evidence of ongoing heart inflammation).  

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. 

The symptoms following Comirnaty are similar to those after 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 a day or two after vaccination. These are more commonly reported after the second dose and in younger adults. This is an expected response not experienced by everyone. Active follow up of those who received the vaccine in New Zealand showed the expected range of side effects. For more information see Post Vaccine Symptom Check – Adult Survey (medsafe.govt.nz). 

A rare risk of myocarditis or pericarditis following vaccination with Comirnaty, particularly seen in young males aged 12-30 years and following the second dose, has been identified. Most cases are mild, but many require hospital assessment and occur within a week of vaccination. It is important to inform consumers to be alert to signs of chest discomfort, shortness of breath or palpitations/fluttering of heart, and to seek medical help. More information on myocarditis and/or pericarditis can be found here.

Immunisation stress related responses 

Other adverse events reported following vaccination can be associated with stress or anxiety responses to being injected. These symptoms can include dizziness, fainting and a rapid heartbeat. These usually occur during or immediately after vaccination. More information specifically on stress related responses can be found here and more general information on adverse events following immunisation here. 

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.

The monovalent Comirnaty 30mcg XBB.1.5 vaccine stimulates strong antibody responses against current variants of the Omicron XBB-lineage and the BA.2.86 variant in people who have previously received earlier vaccines.    

Receipt of the Comirnaty 30mcg XBB.1.5 can provide additional protection beyond that received by prior doses or infection and restore protection after waning.

As the monovalent XBB.1.5 vaccines were only recently introduced vaccine effectiveness estimates are still very limited, but available data suggests they provide some enhanced protection compared to bivalent variant-containing vaccines and monovalent index virus (original) vaccines. An American study found Comirnaty 30mcg XBB.1.5 vaccine provided 54% increased protection against symptomatic SARS-CoV-2 infection (including JN.1 variants) compared with no receipt of updated vaccine in adults over 18 years of age.  In a study from Denmark, it was associated with a 76·1% reduced risk of COVID-19 hospitalisation in the short term in a population vaccinated with a booster dose during the previous season.  

The main benefit of vaccination is to reduce the risk of severe COVID-19 infection including hospitalisation and death. Additional doses have the greatest additional benefit in those who have a higher risk of severe infection – older people, those with other health conditions (including pregnant people), Māori and Pacific peoples and those living with deprivation. We also know protection against severe infection declines with time - hence the need for additional doses.

For further information on efficacy data for Comirnaty 30mcg XBB.1.5 grey cap formulation, refer to the Immunisation Handbook (section 5.4.3).