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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 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 is being rolled out 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. See the Ministry of Health COVID-19: Getting a vaccine webpage for more information.

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

Responses to the 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)

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

References

Medsafe. New Zealand data sheet: Comirnaty [Internet]. Wellington: New Zealand Medicines and Medical Devices Safety Authority; 2021 [updated 2021 February 3; cited 2021 March 9]. Available from: https://www.medsafe.govt.nz/profs/Datasheet/c/comirnatyinj.pdf

Ministry of Health. Immunisation handbook [Internet]. Wellington: Ministry of Health; 2020 [updated 2021 March 1; cited 2021 March 9]. Available from: https://www.health.govt.nz/publication/immunisation-handbook-2020

Ministry of Health. COVID-19: Vaccines. Wellington: Ministry of Health; 2021 [updated 2021 February 19; cited 2021 March 9] https://www.health.govt.nz/our-work/diseases-and-conditions/covid-19-novel-coronavirus/covid-19-vaccines

Ministry of Health. COVID-19: Getting a vaccine. Wellington: Ministry of Health; 2021 [updated 2021 March 09; cited 2021 March 9] https://www.health.govt.nz/our-work/diseases-and-conditions/covid-19-novel-coronavirus/covid-19-vaccines/covid-19-getting-vaccine

Polack FP, Thomas SJ, Kitchin N, Absalon J, Gurtman A, Lockhart S, et al. Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine. N Engl J Med. 2020;383(27):2603-15.

Dagan N, Barda N, Kepten E, Miron O, Perchik S, Katz MA, et al. BNT162b2 mRNA Covid-19 Vaccine in a Nationwide Mass Vaccination Setting. New England Journal of Medicine. 2021.

In Depth

Other brands: none available in New Zealand

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 is being rolled out according to priority groups, starting with those at high risk of exposure to SARS-CoV-2 and patients with COVID-19 and their household contacts, and then those at high risk of severe disease will be immunised. [link to other info] COVID-19 vaccines will not be available for purchase for those who wish to receive vaccination earlier than the Ministry of Health strategy. [link https://www.health.govt.nz/our-work/diseases-and-conditions/covid-19-novel-coronavirus/covid-19-vaccines/covid-19-getting-vaccine]

Currently, Comirnaty™ is approved for use from age of 16 years. Approval for use in younger age groups is awaiting clinical trial outcomes.

Storage and preparation

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.

Thawing: the multidose vials can be thawed at +2 to +8 °C. At this temperature, they can be stored for up to 5 days (120 hours). 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.

Administration

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 16 years, two doses are given 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

Pregnancy is a precaution for Comrinaty™. Pregnant women at risk of exposure to SARS-CoV-2 can be vaccinated with informed consent. To date, clinical studies have not investigated the mRNA vaccine in pregnancy – a phase II/III clinical trial is underway in the US and several registries are actively monitoring women and their infants following vaccination in pregnancy. Based on how the vaccine works, it is unlikely to pose a specific risk when given to pregnant women. Increased risk of severe COVID-19 disease in pregnancy and adverse fetal outcomes have been documented.

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

    Preliminary 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. 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 20-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.

      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.

       

       

      Last updated: Apr 2021