4.1 Therapeutic indications
Comirnaty is indicated for active immunisation to prevent COVID-19 caused by SARS-CoV-2 virus, in individuals 12 years of age and older.
The use of this vaccine should be in accordance with official recommendations.
4.2 Posology and method of administration
Posology
Individuals 12 years of age and older
Comirnaty is administered intramuscularly after dilution as a course of 2 doses (0.3 mL each). It is recommended to administer the second dose 3 weeks after the first dose (see sections 4.4 and 5.1).
There are no data available on the interchangeability of Comirnaty with other COVID-19 vaccines to complete the vaccination course. Individuals who have received 1 dose of Comirnaty should receive a second dose of Comirnaty to complete the vaccination course.
Paediatric population
The safety and efficacy of Comirnaty in paediatric participants aged less than 12 years have not yet been established. Limited data are available.
Elderly population
No dosage adjustment is required in elderly individuals ≥ 65 years of age.
Method of administration
Comirnaty should be administered intramuscularly after dilution (see section 6.6).
After dilution, vials of Comirnaty contain six doses of 0.3 mL of vaccine. In order to extract six 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.
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.
For precautions to be taken before administering the vaccine, see section 4.4.
For instructions regarding thawing, handling and disposal of the vaccine, see section 6.6.
4.3 Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
4.4 Special warnings and precautions for use
Traceability
In order to improve the traceability of biological medicinal products, the name and the batch number
of the administered product should be clearly recorded.
General recommendations
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. A second dose of the vaccine should not be given to those who have experienced anaphylaxis to the first dose of Comirnaty.
Anxiety-related reactions
Anxiety-related reactions, including vasovagal reactions (syncope), hyperventilation or stress‐related reactions may occur in association with vaccination as a psychogenic response to the needle injection. 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, safety and immunogenicity of the vaccine has not been assessed in immunocompromised individuals, including those receiving immunosuppressant therapy. The efficacy of Comirnaty may be lower in immunosuppressed 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 Comirnaty may not protect all vaccine recipients. Individuals may not be fully protected until 7 days after their second dose of vaccine.
Excipients
This vaccine contains less than 1 mmol potassium (39 mg) per dose, that is to say essentially ‘potassium free’.
This vaccine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially ‘sodium free’.
4.5 Interaction with other medicinal products and other forms of interaction
No interaction studies have been performed.
Concomitant administration of Comirnaty with other vaccines has not been studied.
4.6 Fertility, pregnancy and lactation
Pregnancy
There is limited experience with use of Comirnaty in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryo/foetal development, parturition or post-natal development (see section 5.3). Administration of Comirnaty in pregnancy should only be considered when the potential benefits outweigh any potential risks for the mother and foetus.
Breast-feeding
It is unknown whether Comirnaty is excreted in human milk.
Fertility
Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity (see section 5.3)
4.7 Effects on ability to drive and use machines
Comirnaty has no or negligible influence on the ability to drive and use machines. However, some of the effects mentioned under section 4.8 may temporarily affect the ability to drive or use machines.
4.8 Undesirable effects
Summary of safety profile
The safety of Comirnaty was evaluated in participants 12 years of age and older in 2 clinical studies that included 22,875 participants (comprised of 21,744 participants 16 years of age and older and 1,131 adolescents 12 to 15 years of age) that have received at least one dose of Comirnaty.
The overall safety profile of Comirnaty in adolescents 12 to 15 years of age was similar to that seen in participants 16 years of age and older.
Participants 16 years of age and older
In Study 2, a total of 21,720 participants 16 years of age or older received at least 1 dose of Comirnaty and a total of 21,728 participants 16 years of age or older received placebo (including 138 and 145 adolescents 16 and 17 years of age in the vaccine and placebo groups, respectively). A total of 20,519 participants 16 years of age or older received 2 doses of Comirnaty.
At the time of the analysis of Study 2, a total of 19,067 (9,531 Comirnaty and 9,536 placebo) participants 16 years of age or older were evaluated for safety for at least 2 months after the second dose of Comirnaty. This included a total of 10,727 (5,350 Comirnaty and 5,377 placebo) participants 16 to 55 years of age and a total of 8,340 (4,181 Comirnaty and 4,159 placebo) participants 56 years and older.
The most frequent adverse reactions in participants 16 years of age and older were injection site pain (> 80%), fatigue (> 60%), headache (> 50%), myalgia and chills (> 30%), arthralgia (> 20%), pyrexia and injection site swelling (> 10%) and were usually mild or moderate in intensity and resolved within a few days after vaccination. A slightly lower frequency of reactogenicity events was associated with greater age.
The safety profile in 545 participants 16 years of age and older receiving Comirnaty, that were seropositive for SARS-CoV-2 at baseline, was similar to that seen in the general population.
Adolescents 12 to 15 years of age
In an analysis of Study 2, based on data up to the cutoff date of 13 March 2021, 2,260 adolescents (1,131 Comirnaty and 1,129 placebo) were 12 to 15 years of age. Of these, 1,308 adolescents (660 Comirnaty and 648 placebo) have been followed for at least 2 months after the second dose of Comirnaty. The safety evaluation in Study 2 is ongoing.
The most frequent adverse reactions in adolescents 12 to 15 years of age were injection site pain (> 90%), fatigue and headache (> 70%), myalgia and chills (> 40%), arthralgia and pyrexia (> 20%).
Tabulated list of adverse reactions from clinical studies and postauthorisation experience in individuals 12 years of age and older
Adverse reactions observed during clinical studies are listed below according to the following frequency categories:
Very common (≥ 1/10),
Common (≥ 1/100 to < 1/10),
Uncommon (≥ 1/1,000 to < 1/100),
Rare (≥ 1/10,000 to < 1/1,000),
Very rare (< 1/10,000),
Not known (cannot be estimated from the available data).
Table 1: Adverse reactions from Comirnaty clinical trials and post authorisation experience in individuals 12 years of age and olderSystem Organ Class | Very common
(≥ 1/10) | Common
(≥ 1/100 to < 1/10) | Uncommon
(≥ 1/1,000 to < 1/100) | Rare
(≥ 1/10,000 to < 1/1,000) | Not known (cannot be estimated from the available data) |
|---|
Blood and lymphatic system disorders | | | Lymphadenopathy | | |
Immune system disorders | | | Hypersensitivity reactions (e.g. rash, pruritus, urticaria,a angioedemaa ) | | Anaphylaxis |
Psychiatric disorders | | | Insomnia | | |
Nervous system disorders | Headache | | | Acute peripheral facial paralysisb | |
Gastrointestinal disorders | Diarrhoeac | Nausea; Vomitingc | | | |
Musculoskeletal and connective tissue disorders | Arthralgia; Myalgia | | Pain in extremityd | | |
General disorders and administration site conditions | Injection site pain; Fatigue; Chills; Pyrexiae; Injection site swelling | Injection site redness | Malaise; injection site pruritus | | |
a. The frequency category for urticaria and angioedema was Rare.
b. Through the clinical trial safety follow-up period to 14 November 2020, acute peripheral facial paralysis (or palsy) was reported by four participants in the COVID-19 mRNA Vaccine group. Onset was Day 37 after Dose 1 (participant did not receive Dose 2) and Days 3, 9, and 48 after Dose 2. No cases of acute peripheral facial paralysis (or palsy) were reported in the placebo group.
c. Adverse reaction determined post authorisation.
d. Refers to vaccinated arm.
e. A higher frequency of pyrexia was observed after the second dose |
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in www.signalement-sante.gouv.fr and include batch/Lot number if available.
4.9 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 Comirnaty. 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.
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