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Coronavirus disease-2019 (COVID-19) is caused by the SARS-CoV-2 virus. Like other coronaviruses, it has characteristic crown-like protein spikes on the surface which it uses to infect the cells in our airways. The mRNA COVID-19 vaccine, Comirnaty, provides your body with the instructions to make the SARS-CoV-2 spike protein. The spike protein is presented to the cells in the lymph nodes and induces a strong immune response.
Everyone in Aotearoa New Zealand over the age of 12 years can receive two doses of the monovalent Comirnaty 30mcg grey cap [primary] vaccine, whether they are eligible for funded health and disability services or not.
First boosters and additional booster doses are also available using the bivalent Comirnaty 15/15mcg grey cap vaccine. See the Manatū Hauora Ministry of Health COVID-19 vaccines webpage and the Immunisation Handbook for more information.
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, the Ministry of Health, provides operational and policy guidance for COVID-19. Relevant information for health professionals can be found here.
These formulations are multi-dose vials and do not require dilution.
These vaccines are latex-free, and the stopper is a synthetic bromobutyl rubber with a grey plastic flip-off cap with an aluminium seal.
Comirnaty 10mcg orange cap is available for 5- to 11-year-olds.
Comirnaty 3mcg maroon cap is available for eligible infants and children aged from 6months to 4 years.
Also available for adolescents and adults aged from 12 years is a recombinant protein-based vaccine, Nuvaxovid (Novavax).
Vaxzevria (AstraZeneca) andCOVID-19 vaccine Janssen are also licensed but are not currently available in NZ.
All individuals from the age of 12 years are recommended to receive a primary course of two doses of Comirnaty 30mcg grey cap given eight weeks apart. In situations where the longer interval is not possible (eg. prior to planned immunosuppression, required for urgent international travel, or at very high risk from exposure to SARS-CoV-2), give the second dose a minimum of 21 days after first.
Full immunity from the primary course develops from around seven days after the second dose. For booster and additional doses, see the Immunisation Handbook section 5.5.10.
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.
Comirnaty 15/15mcg vaccine is used for first boosters and additional booster doses for those aged 16 years and over who have completed their primary course and are eligible for booster/additional booster doses, and for those eligible aged 12-15 years when prescribed.
The first booster and additional booster doses are especially recommended for:
Additional booster doses are available for those who meet the following criteria:
Those at highest risk of disease are most likely to have received their last additional dose almost 6 months ago, in April 2023. Click here for guidance on who is most likely to benefit from a further dose of COVID-19 vaccine in late 2023.
Some people aged 16 to 29 can have an additional booster dose. This includes:
Healthy children under 16 years old are not eligible for booster doses. Children have a good immune response and are much less likely to get severe infection or need to go to hospital if they get COVID-19.
Young people aged 12 to 15 who have a medical condition that increases the risk of severe illness from COVID-19 can get an additional booster dose on prescription.
If your workplace is using effective infection control measures, you are more likely to be infected with SARS CoV-2 outside of the workplace. Numerous studies support this.
Continue to protect yourself, your patients, and your colleagues by staying home if symptomatic or infected, wearing well-fitting masks and following testing protocols.
The first booster dose remains the most important protection against severe COVID-19 infection.
An additional booster is not expected to provide that much additional benefit to healthy individuals but is recommended for those at risk of severe illness from COVID-19 infection. Any protection against infection is limited and brief with the current variants, however, protection against severe infection is good.
Clinical discretion can be applied to spacing rules, following a documented informed consent discussion, either for clinical reasons or to allow equitable access to vaccination. With discretion, spacing could be reduced to a minimum of 5 months between primary and booster, 4 months between booster doses, and from 3 months after illness. Vaccine outside this spacing requires a prescription and written consent.
The interval recommended from prior infection or vaccination increased from 3 months to 6 months because we know that protection against severe infection persists for up to at least 6 months. Having a dose earlier has limited benefit.
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 and 15/15mcg grey cap preparations:
If syringes are not all being drawn up at once, return the open vial to the fridge making sure it is appropriately labelled with its expiry date and time. Note, returning unused vials of vaccine to the fridge is best practice, since the vaccine can be used directly from fridge.
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 booster doses are also recommended for people who have had COVID-19 previously. Allow a gap of 6 months between infection and an additional booster dose. The interval recommended from prior infection or vaccination has 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.
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 factsheets Vaccination in pregnancy for health professionals and Vaccination in pregnancy for consumers.
Other consumer facing resources that may support conversation include: Unite against COVID-19 and Immunise.health.nz.
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.
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.
National immunisation schedule vaccines: all can be given at the same time as the Comirnaty 30mcg or 15/15mcg grey cap vaccines, 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.
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:
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.
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.
Because current Omicron variants are immune evasive the vaccine currently only provides brief and partial protection against infection (50 to 60 percent initially, and wanes to 0 by 6 months). The main benefit of vaccination is to reduce the risk of severe COVID-19 infection including hospitalisation and death. Booster 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 booster doses.
Receipt of the Comirnaty 15/15mcg grey cap vaccine can provide additional protection beyond that received by prior doses or infection and restore protection after waning.
Studies in the US have demonstrated an increase in effectiveness of booster doses against hospitalisation and improved neutralising antibody activity when Comirnaty 15/15mcg grey cap vaccine is given compared monovalent doses only. This is especially relevant in those who have received two to four Comirnaty doses.
For further information on efficacy data for Comirnaty 30mcg and 15/15mcg grey cap formulations, refer to the Immunisation Handbook (section 5.4.3).
