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, 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.
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, few clinical studies 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. Recent data has shown no safety concerns after mRNA vaccines were given to over 35,000 pregnant women in the US. 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.
