Primary course

A single dose of Comirnaty 30mcg LP.8.1 is used as a primary course from 12 years of age.

Incomplete primary course

Anyone aged 12 years or over, 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 LP.8.1 from six months after their most recent dose.  

Two-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 more quickly. Extra doses of Comirnaty can help to overcome this reduced response. 

A two-dose primary course of Comirnaty 30mcg is recommended for those with severe immunocompromise who are unvaccinated, at 8-week intervals.

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‍Additional dose eligibility and spacing

A single additional dose of Comirnaty 30mcg is available for those aged 16 to 29 years (minimum 6 months from previous dose.) No further doses are funded for this age group unless they have underlying medical conditions.

Additional doses of Comirnaty 30mcg continue to be recommended once or twice yearly for those aged 12 and over who are eligible because of a higher risk of severe infection and for anyone aged ≥75 years and older or with severe immunocompromise. They continue to be available for healthy people aged 30 and over if requested.

For more details on recommended groups, spacing and eligibility, see Table 5.2 and Table 5.3 from the Immunisation Handbook or alternatively IMAC factsheets - recommendation guidelines for additional doses for severely immunocompromised people and for those with a higher risk of severe infection (excluding severely immunocompromised).

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.

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Clinical discretion 

Clinical discretion can be applied when considering vaccination given less than six months after a 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.

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.

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Storage and preparation 

The vaccine should be received and stored at +2°C to +8°C. Do not freeze.

Monitor temperature as per cold chain policy. If temperature varies from +2°C to +8°C, follow cold chain breach process.

Click here for more information on cold chain processes.

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Comirnaty 30mcg preparation: 

• Does not require dilution. Do not shake.

• It is recommended that vaccines are prepared as needed, selecting the correct length of needle.  

• Does not need to come to room temperature before administration. 

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Special considerations 

Vaccination following SARS-CoV-2  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  or positive COVID-19 test  before having a vaccine dose. This is because the virus infection boosts your immunity in a similar way that the vaccine does.  Having a dose earlier has limited benefit.    

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

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Pregnancy 

Comirnaty 30mcg is recommendedfor anyone who is pregnant who has never receiveda COVID-19 vaccine or had COVID-19 infection. An additional doseis particularly recommended for those with high-risk pregnancies that increase their risk of severe COVID-19.

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. 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 LP.8.1 vaccine, preferably in a different limb. 

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

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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 JN.1 vaccine stimulates antibody responses against JN.1-derived variants, including JN.1 subvariants, KP3 and XEC.

The updated vaccines continue to provide protection against hospitalisation and death. For example, in Scandinavia, a dose of the XBB.1.5 vaccine in adults aged ≥65 years was 58% and 75% effective at reducing hospital admissions and deaths, respectively, for at least 24 weeks during 1 October 2023 and 21 April 2024. The level of protection was the same regardless of number of doses of previous COVID-19 vaccines or ages 65-74 vs ≥75 years.

It is expected Comirnaty 30mcg JN.1 will provide similar protection.

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 JN.1 grey cap formulation, refer to the Immunisation Handbook (section 5.4.3).