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Vial 6 doses*30mcg/one diluted vial |
Related information
Dosage
Individuals 12 years of age and older
This medicinal product is administered intramuscularly as a course of 2 doses (0.3 mL each). It is recommended to administer the second dose 3 weeks after the first dose.
Interchangeability
The interchangeability of this drug with COVID-19 vaccines from other manufacturers to complete the course has not been established. Individuals who have received a dose of this product should continue to receive this product to complete the 2 dose course.
Doses of Comirnaty (supplied in a vial with a purple cap) and Comirnaty TRIS 30 (supplied in a vial with a grey cap) are considered interchangeable.
Paediatric population
There is a paediatric formulation available for individuals 5 to 11 years of age (i.e. 5 to less than 12 years of age). For details, please refer to Comirnaty TRIS 10 label.
The safety and efficacy of this drug in infants aged less than 5 years of age have not yet been established.
Elderly population
No dosage adjustment is required in elderly individuals ≥ 65 years of age.
Method of administration
This medicinal product should be administered intramuscularly. Do not dilute prior to use.
The preferred site is the deltoid muscle of the upper arm.
Do not inject the vaccine intravascularly, subcutaneously or intradermally.
The vaccine should not be mixed in the same syringe with any other vaccines or medicinal products.
Multidose vials
Multidose vials of this drug contain 6 doses of 0.3 mL of vaccine. In order to extract 6 doses from a single vial, low dead-volume syringes and/or needles should be used. The low dead-volume syringe and needle combination should have a dead volume of no more than 35 microlitres. If standard syringes and needles are used, there may not be sufficient volume to extract a sixth dose from a single vial. Irrespective of the type of syringe and needle:
• Each dose must contain 0.3 mL of vaccine.
• If the amount of vaccine remaining in the vial cannot provide a full dose of 0.3 mL, discard the vial and any excess volume.
• Do not pool excess vaccine from multiple vials.
Indications
Active immunisation to prevent COVID-19 caused by SARS-CoV-2, in individuals 12 years of age and older.
Contra-Indications
Hypersensitivity to the active substance or to any of the excipients.
Special Precautions
Hypersensitivity and anaphylaxis
Events of anaphylaxis have been reported. Appropriate medical treatment and supervision should always be readily available in case of an anaphylactic reaction following the administration of the vaccine.
Close observation for at least 15 minutes is recommended following vaccination. No further dose of the vaccine should be given to those who have experienced anaphylaxis after a prior dose of this drug.
Myocarditis and pericarditis
There is an increased risk of myocarditis and pericarditis following vaccination with this drug. These conditions can develop within just a few days after vaccination, and have primarily occurred within 14 days. They have been observed more often after the second vaccination, and more often in younger males. Available data indicate that most cases recover. Some cases required intensive care support and fatal cases have been observed.
Healthcare professionals should be alert to the signs and symptoms of myocarditis and pericarditis. Vaccinees (including parents or caregivers) should be instructed to seek immediate medical attention if they develop symptoms indicative of myocarditis or pericarditis such as (acute and persisting) chest pain, shortness of breath, or palpitations following vaccination.
Healthcare professionals should consult guidance and/or specialists to diagnose and treat this condition.
Anxiety-related reactions
Anxiety-related reactions, including vasovagal reactions (syncope), hyperventilation or stress‐related reactions (e.g. dizziness, palpitations, increases in heart rate, alterations in blood pressure, paraesthesia, hypoaesthesia and sweating) may occur in association with the vaccination process itself. Stress-related reactions are temporary and resolve on their own. Individuals should be advised to bring symptoms to the attention of the vaccination provider for evaluation. It is important that precautions are in place to avoid injury from fainting.
Concurrent illness
Vaccination should be postponed in individuals suffering from acute severe febrile illness or acute infection. The presence of a minor infection and/or low-grade fever should not delay vaccination.
Thrombocytopenia and coagulation disorders
As with other intramuscular injections, the vaccine should be given with caution in individuals receiving anticoagulant therapy or those with thrombocytopenia or any coagulation disorder (such as haemophilia) because bleeding or bruising may occur following an intramuscular administration in these individuals.
Immunocompromised individuals
The efficacy and safety of the vaccine has not been assessed in immunocompromised individuals, including those receiving immunosuppressant therapy. The efficacy may be lower in immunocompromised individuals.
Duration of protection
The duration of protection afforded by the vaccine is unknown as it is still being determined by ongoing clinical trials.
Limitations of vaccine effectiveness
As with any vaccine, vaccination with this drug may not protect all vaccine recipients. Individuals may not be fully protected until 7 days after their second dose of vaccine.
Side Effects
Very common: Headache, diarrhoea , arthralgia; myalgia, injection site pain, fatigue, chills, pyrexiae; injection site swelling.
Common: Nausea; vomiting, injection site redness, Lymphadenopathy.
See perescribing information for full details.
Drug interactions
No interaction studies have been performed.
Concomitant administration of this drug with other vaccines has not been studied.
Pregnancy and Lactation
Pregnancy
A large amount of observational data from pregnant women vaccinated with this drug during the second and third trimester have not shown an increase in adverse pregnancy outcomes. While data on pregnancy outcomes following vaccination during the first trimester are presently limited, no increased risk for miscarriage has been seen. Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryo/foetal development, parturition or post-natal development. This medicinal product can be used during pregnancy.
Breast-feeding
No effects on the breastfed newborn/infant are anticipated since the systemic exposure of breast-feeding woman to this drug is negligible. Observational data from women who were breast-feeding after vaccination have not shown a risk for adverse effects in breastfed newborns/infants. This medicinal product can be used during breast-feeding.
Fertility
Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity.
Overdose
Overdose data is available from 52 study participants included in the clinical trial that due to an error in dilution received 58 micrograms of this drug. The vaccine recipients did not report an increase in reactogenicity or adverse reactions.
In the event of overdose, monitoring of vital functions and possible symptomatic treatment is recommended.
Important notes
Store in a freezer at -90 °C to -60 °C.
Store in the original package in order to protect from light.
During storage, minimize exposure to room light, and avoid exposure to direct sunlight and ultraviolet light.
For storage conditions after thawing and first opening, see prescribing information.