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Comirnaty

Common name:

mRNA COVID-19 vaccine, mRNA-CV

Protects against COVID-19 disease caused by SARS-CoV-2 virus

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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 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.

The early symptoms of COVID-19 appear like other respiratory viral infections, with fever, dry cough, sometimes sore throat and nasal congestion, and muscle aches. An unusual symptom, particuarly associated with earlier variants such as Delta variant, is the loss of taste and smell which is not associated with nasal congestion. For some people, this disease becomes much more severe, causing pneumonia, respiratory and organ failure and inflammation which requires hospitalisation and intensive care. The risk of severe disease and death increases with age and in those with chronic health conditions, such as diabetes, obesity and chronic respiratory disease and includes pregnancy. Health care workers exposed to patients with high viral loads are also at increased risk of severe disease if not adequately protected by personal protective equipment.

Everyone in New Zealand is eligible to receive this vaccine, whether they are eligible to funded health and disability services or not. The COVID-19 immunisation programme rollout began in February 2021 according to priority groups, starting with those at high risk of exposure to SARS-CoV-2 and patients with COVID-19, and then those at high risk of severe disease will be immunised. Since 1 September 2021, anyone aged from 12 years can access two doses of COVID-19 vaccine (Comirnaty 30 mcg mRNA per dose) and since January 2022, children aged from 5 years can access two doses of the paediatric formulation of Comirnaty (10mcg of mRNA per dose). A booster dose was also introduced in late 2021. See the Ministry of Health COVID-19 vaccines webpage for more information.

Also available for adults aged frm 18 years is a viral vector based COVID-19 Vaccine AstraZeneca (also known as Vaxzevria) and recombinant protein based vaccine, Nuvaxovid (from Novavax).

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 responses

  • 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)

 As with any medicine, very rarely a severe allergic reaction (anaphylaxis) can occur following immunisation.

 

 

References

In Depth

Other brands: COVID-19 Vaccine AstraZeneca (Vaxzevria), Nuvaxovid (Novavax) and COVID-19 vaccine Janssen is also licensed but not currently available.

Vaccine type: messenger RNA vaccine

Schedule and administration

Everyone in New Zealand is eligible to receive this vaccine, whether they are eligible to funded health and disability services or not. The COVID-19 immunisation programme was initially rolled out according to priority groups. It is now available to anyone aged from 5 years.[see Ministry of Health COVID-19 vaccine webpage]

There are two formulations of Comirnaty™. One provides 30 mcg of mRNA per dose (with purple top) that is approved for use from age of 12 years and the other is a paediatric formulation provides 10 mcg mRNA per dose (with orange cap) is approved 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 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)

  • Thawing: the multidose vials can be thawed at +2 to +8 °C. At this temperature, unopened vials can be stored for up to 31 days (1 month). Protect from light.
  • Each vial contains 0.45ml of vaccine and requires dilution with 1.8 ml of 0.9% NaCl (saline). These are multidose vials.
  • Once diluted, the vaccine must be discarded after 6 hours. Do not refreeze.

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

  • Thawing: the multidose vials can be thawed at +2 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 multidose 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)

  • 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 multidose 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 given 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 2020 for details)
  • A booster dose is given to those aged 18 years or over at least three months after the primary course.

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

  • These vials have an orange cap
  • Each vial contains 1.3ml of vaccine and requires dilution with 1.3 ml of 0.9% NaCl (saline). These are multidose 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 women/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.

    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 in 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.

      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.

      Last updated: Mar 2022