Visit our COVID-19 website for more information

covid.immune.org.nz

Visit our COVID-19 website for more information

covid.immune.org.nz

Visit our influenza website for more information

influenza.org.nz

Overview

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 node and induces a strong immune response.

Everyone in New Zealand is eligible to receive this vaccine, whether they are eligible to funded health and disability services or not. Anyone aged from 12 years can access two doses of COVID-19 vaccine Comirnaty 30 mcg. Children aged from 5 years can access two doses of the paediatric formulation of Comirnaty 10mcg. First and second booster doses are also available. See the Ministry of Health COVID-19 vaccines webpage and the Immunisation Handbook for more information.

Also available for adolescents and adults aged from 12 years is a recombinant protein based vaccine, Nuvaxovid (from Novavax).

As part of the primary schedule, a third dose of Comirnaty is recommended for people aged from 5 years, who are severely immunocompromised. For more information on Comirnaty third primary dose, and second booster doses, click here.

For more information about COVID-19 vaccines and the COVID-19 vaccination education programme see our dedicated COVID-19 education website.

Responses to vaccine

Comirnaty (COVID-19)
Common reponses
  • Pain at injection site
  • Headache
  • Fatigue
  • Muscle aches
  • Chills
  • Fever
  • Joint aches
  • Nausea
Rare responses
  • Lymphadenopathy (swollen lymph nodes)
  • Myocarditis (rarely in young men after second dose)
  • Pericarditis

In Depth

Other brands:

COVID-19 Vaccine Nuvaxovid (Novavax) is available in New Zealand.

Vaxzevria (AstraZeneca) and COVID-19 vaccine Janssen are also licensed but are not currently available in NZ.

There are two formulations of Comirnaty:

  • 30 mcg of mRNA per dose (with purple cap) for use from age of 12 years
  • 10 mcg mRNA per dose (with orange cap) for use in children age from 5 years to 11 years.

Approval for use in younger age groups is awaiting clinical trial outcomes.

Storage and preparation

For details on storage and preparation of these vaccines please refer to the most current advice found here on the covid.immune.org.nz website.

Comirnaty requires ultra-cold storage (at -90°C to -60°C) to prevent degradation. Frozen vials are transported in containers containing dry-ice and then transferred to designated ultra-cold freezer facilities.

Adult formulation for ages from 12 years - Comirnaty 30mcg (Purple top)

  • Thawing: the multi-dose vials can be thawed at +2°C to +8 °C. At this temperature, unopened vials can be stored for up to 31 days. Protect from light.
  • Each vial contains 0.45ml of vaccine and requires dilution with 1.8 ml of 0.9% NaCl (saline). These are multi-dose vials.
  • Once diluted, the vaccine must be discarded after 6 hours. Do not refreeze.

Paediatric formulation for ages 5-11 years - Comirnaty 10mcg (Orange top)

  • Thawing: the multi-dose vials can be thawed at +2°C to +8 °C. At this temperature, unopened vials can be stored for up to 10 weeks. Protect from light.
  • Each vial contains 0.45ml of vaccine and requires dilution with 1.8 ml of 0.9% NaCl (saline). These are multi-dose vials.
  • Once diluted, the vaccine must be discarded after 12 hours in vial or 6 hours drawn up in syringe. Do not refreeze.

Administration

Adult formulation for ages from 12 years - Comirnaty 30mcg (Purple top)

  • These vials have a purple cap.
  • Each vial contains 0.45ml of vaccine and requires dilution with 1.8 ml of 0.9% NaCl (saline). These are multi-dose vials. Each diluted vial contains up to six doses.
  • Each 0.3 ml dose is administered by intramuscular injection into the deltoid muscle.
  • From age of 12 years, two doses are recommended to be given 8 weeks apart (minimum at least 21 days apart).
  • Certain individuals with immunocompromise are recommended to receive a third primary dose, given at least 8 weeks after the second dose (see the latest version of the Immunisation Handbook for details).
  • A first booster dose can given to those aged 16 and 17 years at a least six months, after the primary course. Those who are aged 18 years or older can received a first booster dose at least three months after the primary course.
  • A second booster is recommended for those over 16 years at increased risk of severe illness from COVID-19, a minimum of 6 months after a first booster. This 6 month gap allows the immune response to mature to provide optimal and sustained protection. Eligibility criteria can be found here.

Paediatric formulation for ages 5-11 years - Comirnaty 10mcg (Orange top)

  • These vials have an orange cap.
  • Each vial contains 1.3ml of vaccine and requires dilution with 1.3ml of 0.9% NaCl (saline). These are multi-dose vials. Each diluted vial contains up to ten doses.
  • Each 0.2 ml dose is administered by intramuscular injection into the deltoid muscle.
  • From age of 5 to 11 years, two doses are recommended to be given at least eight weeks apart; if required sooner due to high risk of severe disease, give at least 21 days apart.

Special considerations

Comirnaty is latex-free. The vial stopper is made with synthetic rubber (bromobutyl), not natural rubber latex.

Pregnancy

Pregnant people are encouraged to have Comirnaty at any stage of pregnancy. COVID-19 in pregnancy can be very severe and can require intensive care and preterm delivery of the baby (see IMAC COVID-19 website for further information).

Individuals with thrombocytopenia and coagulation disorders

  • The vaccine can be given intramuscularly (IM) to individuals with stabilized 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.

Vaccine Safety

Clinical trial data and real-world data from vaccination programmes using this vaccine 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. There are no medical conditions or medications that are contraindicated for Comirnaty (except those given below). Safety is being closely monitored globally.

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.
  • Vaccination should be deferred and specialist immunisation advice should be sought for those who have experienced myocarditis, myopericarditis or pericarditis.

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 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. These are more commonly reported after the second dose and in younger adults. This is an expected response not experienced by everyone.

A rare risk of myocarditis or pericarditis following vaccination with Comirnaty, particularly seen in young males age 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.

For further information see our COVID-19 education website.

Vaccine Effectiveness

Preliminary data from pivotal phase III clinical trial from age 16 years (included just under 44,000 vaccinated and unvaccinated placebo controls) and from Israeli vaccination programme (included around 1.2 million vaccinated and unvaccinated individuals age from 16 years) show that this vaccine is highly effective at preventing COVID-19.


Two-doses of mRNA-COVID vaccine
(Comirnaty) given 21 days apart

Clinical trial efficacy compared
with placebo control

Real-life effectiveness with
unvaccinated individuals

VE %

95% CI

VE %

95% CI
Documented infection 92 88-95
Symptomatic COVID-19 95 90-98 94 87-98
Hospitalised COVID-19 87 55-100
Severe disease 95 90-98 92 75-100
Death 92 88-95

Further data is continually being reported and a range of clinical trials are ongoing in special groups, including pregnant women, immunocompromised and children.

Initial data indicates that effectiveness against infection with the Omicron variant and mild COVID-19 symptoms is lower than seen with previous variants but vaccination continues to be highly protective against severe disease, hospitalisation and death.

References

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