Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Pharmacy Guide
Patient leaflets and SmPCs, drug interaction checker, official dosages and NHS pharmacy opening hours — all in one place.
Comirnaty JN.1 3 micrograms/dose concentrate for dispersion for injection - 3-dose vial
⚠ This medicine appears to have been discontinued
The electronic medicines compendium (emc) no longer publishes a Summary of Product Characteristics for this product, which usually means it is no longer marketed in the UK. The patient leaflet below is kept for reference, but the product may not be available.
If you were prescribed this medicine, other products containing Bretovameran may still be available. Do not stop your treatment — ask your pharmacist or GP what to use instead.
What it is and what it is used for
for
Comirnaty JN.1 is a vaccine used for preventing COVID-19 caused by SARS-CoV-2. Comirnaty JN.1 3 micrograms/dose concentrate for dispersion for injection, 3-dose vial is given to infants and children from 6 months to 4 years of age. The vaccine causes the immune system (the body's natural defences) to produce antibodies and blood cells that work against the virus, so giving protection against COVID-19. As Comirnaty JN.1 does not contain the virus to produce immunity, it cannot give your child COVID- 19. The use of this vaccine should be in accordance with official recommendations. 2.
What you need to know before your child receives Comirnaty JN.1
Comirnaty JN.1 should not be given • if your child is allergic to the active substance or any of the other ingredients of this medicine (listed in section 6) Warnings and precautions Talk to your child's doctor, pharmacist or nurse before your child is given the vaccine if your child: • has ever had a severe allergic reaction or breathing problems after any other vaccine injection or after having been given this vaccine in the past. • is feeling nervous about the vaccination process or has ever fainted following any needle injection.
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• • •
has a severe illness or infection with high fever. However, your child can have the vaccination if he/she has a mild fever or upper airway infection like a cold. has a bleeding problem, bruises easily or uses a medicine to prevent blood-clots. has a weakened immune system, because of a disease such as HIV infection or a medicine such as corticosteroid that affects the immune system.
There is an increased risk of myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of the lining outside the heart) after vaccination with Comirnaty (see section 4). 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. The risk of myocarditis and pericarditis seems lower in children ages 5 to 11 years compared with ages 12 to 17 years. Most cases of myocarditis and pericarditis recover. Some cases required intensive care support and fatal cases have been seen. Following vaccination, you should be alert to signs of myocarditis and pericarditis, such as breathlessness, palpitations and chest pain, and seek immediate medical attention should these occur. As with any vaccine, Comirnaty JN.1 may not fully protect all those who receive it and it is not known how long your child will be protected. The efficacy of Comirnaty may be lower in people who are immunocompromised. If your child is immunocompromised, he/she may receive additional doses of Comirnaty. In these cases, your child should continue to maintain physical precautions to help prevent COVID-19. In addition, your child's close contacts should be vaccinated as appropriate. Discuss appropriate individual recommendations with your child's doctor. Children Comirnaty JN.1 3 micrograms/dose concentrate for dispersion for injection, 3-dose vial is not recommended for children aged 5 years to 11 years. There are paediatric formulations available for children 5 to 11 years of age. For details, please refer to the Package Leaflet for other formulations. The vaccine is not recommended for infants aged under 6 months. Other medicines and Comirnaty JN.1 Tell your child's doctor or pharmacist if your child is using, has recently used or might use any other medicines or has recently received any other vaccine. Pregnancy and breast-feeding Comirnaty JN.1 3 micrograms/dose concentrate for dispersion for injection, 3-dose vial is not intended for individuals older than 5 years of age. For details for use in individuals older than 5 years of age, please refer to the Package Leaflet for those formulations. Driving and using machines Some of the effects of vaccination mentioned in section 4 (Possible side effects) may temporarily affect your child's ability to use machines or undertake activities such as cycling. Wait until these effects have worn off before resuming activities that require your child's full attention. 3.
How to take it
If your infant is from 6 months to less than 12 months of age, he/she will be given Comirnaty JN.1 with a yellow cap after dilution as an injection of 0.3 mL into a muscle of the thigh. If your infant or child is 1 year of age or older, he/she will be given Comirnaty JN.1 with a yellow cap after dilution as an injection of 0.3 mL into a muscle of the thigh or into a muscle of the upper arm. 2
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If your child has not completed a COVID-19 primary vaccination course or has not been infected by COVID-19 in the past, your child will receive a maximum of 3 injections (the total number of doses required as primary course). It is recommended to receive the second dose 3 weeks after the first dose followed by a third dose at least 8 weeks after the second dose to complete the primary course. If your child has previously completed a COVID-19 primary vaccination course or has had COVID-19, your child will receive 1 injection. If your child was previously vaccinated with a COVID-19 vaccine, your child should not receive a dose of Comirnaty JN.1 until at least 3 months after the most recent dose. If your child turns 5 years old between their doses in the primary course, he/she should complete the primary course at the same 3 micrograms dose level. If your child is immunocompromised, he/she may receive additional doses of Comirnaty JN.1. Interchangeability Your child may receive any previous or current Comirnaty vaccine for the primary course. Your child should not receive more than the total number of doses needed as primary course. Your child should only be administered the primary course once. If you have any further questions on the use of Comirnaty JN.1, ask your child's doctor, pharmacist or nurse. 4.
Possible side effects
Like all vaccines, Comirnaty JN.1 can cause side effects, although not everybody gets them. Very common side effects: may affect more than 1 in 10 people • irritability (6 months to less than 2 years) • injection site: pain/tenderness, swelling • tiredness, headache • drowsiness (6 months to less than 2 years) • muscle pain, joint pain • chills, fever • diarrhoea Common side effects: may affect up to 1 in 10 people • nausea • vomiting ('very common' in pregnant women 18 years of age and older and in immunocompromised individuals 2 to 18 years of age) • injection site redness ('very common' in 6 months to 11 years and in immunocompromised individuals 2 years of age and older) • enlarged lymph nodes (more frequently observed after a booster dose) Uncommon side effects: may affect up to 1 in 100 people • feeling unwell, feeling weak or lack of energy/sleepy • arm pain • insomnia • injection site itching • allergic reactions such as rash ('common' for 6 months to less than 2 years) or itching • decreased appetite ('very common' for 6 months to less than 2 years) • dizziness • excessive sweating, night sweats 3
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Rare side effects: may affect up to 1 in 1 000 people • temporary one sided facial drooping • allergic reactions such as hives or swelling of the face Very rare side effects: may affect up to 1 in 10 000 people • inflammation of the heart muscle (myocarditis) or inflammation of the lining outside the heart (pericarditis) which can result in breathlessness, palpitations or chest pain Not known (cannot be estimated from the available data) • severe allergic reaction • extensive swelling of the vaccinated limb • swelling of the face (swelling of the face may occur in patients who have had facial dermatological fillers) • a skin reaction that causes red spots or patches on the skin, that may look like a target or "bulls-eye" with a dark red centre surrounded by paler red rings (erythema multiforme) • unusual feeling in the skin, such as tingling or a crawling feeling (paraesthesia) • decreased feeling or sensitivity, especially in the skin (hypoaesthesia) • heavy menstrual bleeding (most cases appeared to be non-serious and temporary in nature) Reporting of side effects If your child gets any side effects, talk to your child's doctor, pharmacist or nurse. This includes any
Possible side effects
not listed in this leaflet. You can also report side effects directly via a Yellow card. Reporting forms and information can be found at https://coronavirus-yellowcard.mhra.gov.uk/ or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine. 5.
How to store it
Comirnaty JN.1
Keep this medicine out of the sight and reach of children. The following information about storage, expiry and use and handling is intended for healthcare professionals. Do not use this medicine after the expiry date which is stated on the carton and label after EXP. The expiry date refers to the last day of that month. Store in freezer at -90 °C to -60 °C. Store in the original package in order to protect from light. The vaccine will be received frozen at -90 °C to -60 °C. Frozen vaccine can be stored either at -90 °C to -60 °C or 2 °C to 8 °C upon receipt. When stored frozen at -90 °C to -60 °C, 10-vial packs of the vaccine can be thawed at 2 °C to 8 °C for 2 hours or individual vials can be thawed at room temperature (up to 30 °C) for 30 minutes. Thawed (previously frozen) vials: Once removed from the freezer, the unopened vial may be stored and transported refrigerated at 2 °C to 8 °C for up to 10 weeks; not exceeding the printed expiry date (EXP). The outer carton should be marked with the new expiry date at 2 °C to 8 °C. Once thawed, the vaccine cannot be re-frozen. Prior to use, the unopened vials can be stored for up to 12 hours at temperatures between 8 °C and 30 °C. Thawed vials can be handled in room light conditions. 4
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After dilution, store the vaccine at 2 °C to 30 °C and use within 12 hours, which includes up to 6 hours transportation time. Discard any unused vaccine. Do not use this vaccine if you notice particulates in the dilution or discolouration. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment. 6.
Contents of the pack and other information
What Comirnaty JN.1 contains • The active substance of COVID-19 mRNA Vaccine (nucleoside modified) is called bretovameran. After dilution, the vial with a yellow cap contains 3 doses of 0.3 mL with 3 micrograms bretovameran each. • The other ingredients are: − ((4-hydroxybutyl)azanediyl)bis(hexane-6,1-diyl)bis(2-hexyldecanoate) (ALC-0315) − 2-[(polyethylene glycol)-2000]-N,N-ditetradecylacetamide (ALC-0159) − 1,2-Distearoyl-sn-glycero-3-phosphocholine (DSPC) − cholesterol − trometamol − trometamol hydrochloride − sucrose − water for injections What Comirnaty JN.1 looks like and contents of the pack The vaccine is a clear to slightly opalescent dispersion (pH: 6.9 – 7.9) provided in a multidose vial of 3 doses in a 2 mL clear vial (type I glass), with a rubber stopper and a yellow flip-off plastic cap with aluminium seal. Pack size: 10 vials Marketing Authorisation Holder BioNTech Manufacturing GmbH An der Goldgrube 12 55131 Mainz Germany Phone: +49 6131 9084-0 Fax: +49 6131 9084-2121 [email protected] Manufacturers BioNTech Manufacturing GmbH An der Goldgrube 12 55131 Mainz Germany BioNTech Manufacturing GmbH Kupferbergterrasse 17 – 19 55116 Mainz Germany
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Pfizer Manufacturing Belgium NV Rijksweg 12 Puurs-Sint-Amands, 2870 Belgium For any information about this medicine, please contact: Medical Information, Pfizer Ltd, Walton Oaks, Dorking Road, Tadworth, Surrey, KT20 7NS. Telephone 01304 616161. This leaflet was last revised in 04/2026. Ref: bCY (JN.1) 3 mcg Conc MDV 3 dose 7_0 ———————————————————————————————————————–The following information is intended for healthcare professionals only: If the child has not completed a COVID-19 primary vaccination course or does not have a history of prior SARS-CoV-2 infection, administer Comirnaty JN.1 with a yellow cap intramuscularly after dilution as a primary course of maximum 3 doses (the total number of doses required as primary course); the second dose administered 3 weeks after the first dose followed by a third dose at least 8 weeks after the second dose to complete the primary course. If the child has completed a COVID-19 primary vaccination course or has a history of prior SARS-CoV-2 infection, administer Comirnaty JN.1 with a yellow cap intramuscularly after dilution a single dose of 0.3 mL. If the individual was previously vaccinated with a COVID-19 vaccine, the individual should receive a dose of Comirnaty JN.1 at least 3 months after the most recent dose. Additional doses may be given to individuals who are severely immunocompromised. 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. Handling instructions prior to use Comirnaty JN.1 should be prepared by a healthcare professional using aseptic technique to ensure the sterility of the prepared dispersion. • Verify that the vial has a yellow plastic cap and the product name is Comirnaty JN.1 3 micrograms/dose concentrate for dispersion for injection, 3-dose vial (infants and children 6 months to 4 years). • If the vial has another product name on the label or a different cap colour, please make reference to the Summary of Product Characteristics for that formulation. • If the vial is stored frozen it must be thawed prior to use. Frozen vials should be transferred to an environment of 2 °C to 8 °C to thaw; a 10-vial pack may take 2 hours to thaw. Ensure vials are completely thawed prior to use. • Upon moving vials to 2 °C to 8 °C storage, update the expiry date on the carton. • Unopened vials can be stored for up to 10 weeks at 2 °C to 8 °C; not exceeding the printed expiry date (EXP). • Alternatively, individual frozen vials may be thawed for 30 minutes at temperatures up to 30 °C. • Prior to use, the unopened vial can be stored for up to 12 hours at temperatures up to 30 °C. Thawed vials can be handled in room light conditions. Dilution for a vial with a yellow cap • Allow the thawed vial to come to room temperature and gently invert it 10 times prior to dilution. Do not shake. • Prior to dilution, the thawed dispersion may contain white to off-white opaque amorphous particles.
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• • • • • • •
The thawed vaccine must be diluted in its original vial with 1.1 mL sodium chloride 9 mg/mL (0.9%) solution for injection, using a 21 gauge or narrower needle and aseptic techniques. Equalise vial pressure before removing the needle from the vial stopper by withdrawing 1.1 mL air into the empty diluent syringe. Gently invert the diluted dispersion 10 times. Do not shake. The diluted vaccine should present as a clear to slightly opalescent dispersion with no particulates visible. Do not use the diluted vaccine if particulates or discolouration are present. The diluted vials should be marked with the appropriate discard date and time. After dilution, store at 2 oC to 30 oC and use within 12 hours. Do not freeze or shake the diluted dispersion. If refrigerated, allow the diluted dispersion to come to room temperature prior to use.
Preparation of 0.3 mL doses using a vial with a yellow cap • After dilution, the vial contains 1.58 mL from which 3 doses of 0.3 mL can be extracted. • Using aseptic technique, cleanse the vial stopper with a single use antiseptic swab. • Withdraw 0.3 mL of Comirnaty JN.1 for infants and children aged 6 months to 4 years. Standard syringes and/or needles can be used in order to extract 3 doses from a single vial. • 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. • Discard any unused vaccine within 12 hours after dilution. Disposal Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
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Frequently asked questions about Comirnaty JN.1 3 micrograms/dose concentrate for dispersion for injection – 3-dose vial
How do I take Comirnaty JN.1 3 micrograms/dose concentrate for dispersion for injection – 3-dose vial?
Comirnaty JN.1 3 micrograms/dose concentrate for dispersion for injection – 3-dose vial comes as injection containing 3mcg. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
What is the active substance in Comirnaty JN.1 3 micrograms/dose concentrate for dispersion for injection – 3-dose vial?
The active substance in Comirnaty JN.1 3 micrograms/dose concentrate for dispersion for injection – 3-dose vial is bretovameran.
Where does this information come from?
This leaflet reproduces the patient information leaflet approved for Comirnaty JN.1 3 micrograms/dose concentrate for dispersion for injection – 3-dose vial, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Can I get Comirnaty JN.1 3 micrograms/dose concentrate for dispersion for injection – 3-dose vial without a prescription?
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
About this leaflet
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
- Source: electronic medicines compendium (emc), Datapharm
- Active substance: bretovameran
- Official document: view the original leaflet on emc →
⚕For healthcare professionals — Summary of Product Characteristics (SmPC)Full SmPC: dosage, interactions, contraindications, warnings+
4.1. Therapeutic indications
Comirnaty JN.1 3 micrograms/dose concentrate for dispersion for injection, 3-dose vial is indicated for active immunisation to prevent COVID-19 caused by SARS-CoV-2, in infants and children aged 6 months to 4 years.
The use of this vaccine should be in accordance with official recommendations.
4.2. Posology and method of administration
Posology
Infants and children 6 months to 4 years of age without history of completion of a COVID-19 primary course or prior SARS-CoV-2 infection
Comirnaty JN.1 3 micrograms/dose concentrate for dispersion for injection is administered intramuscularly after dilution as a primary course of 3 doses. It is recommended to administer the second dose 3 weeks after the first dose followed by a third dose administered at least 8 weeks after the second dose (see sections 4.4 and 5.1).
If a child turns 5 years old between their doses in the primary course, he/she should complete the primary course at the same 3 micrograms dose level.
Infants and children 6 months to 4 years of age with history of completion of a COVID-19 primary course or prior SARS‑CoV-2 infection
Comirnaty JN.1 3 micrograms/dose concentrate for dispersion for injection is administered intramuscularly after dilution as a single dose for infants and children 6 months to 4 years of age.
For individuals who have previously been vaccinated with a COVID-19 vaccine, Comirnaty JN.1 should be administered at least 3 months after the most recent dose of a COVID-19 vaccine.
Severely immunocompromised individuals
Additional doses may be administered to individuals who are severely immunocompromised in accordance with national recommendations (see section 4.4).
Interchangeability
The Comirnaty JN.1 3 micrograms/dose primary course may consist of any previous or current Comirnaty vaccine but not exceeding the total number of doses required as primary course. The primary course should only be administered once.
The interchangeability of Comirnaty with COVID-19 vaccines from other manufacturers has not been established.
Paediatric population
There are paediatric formulations available for children 5 to 11 years of age. For details, please refer to the Summary of Product Characteristics for other formulations.
The safety and efficacy of the vaccine in infants aged less than 6 months have not yet been established.
Method of administration
Comirnaty JN.1 3 micrograms/dose concentrate for dispersion for injection, 3-dose vial should be administered intramuscularly after dilution (see section 6.6).
After dilution, vials with a yellow cap of Comirnaty JN.1 contain 3 doses of 0.3 mL of vaccine. Standard syringes and needles can be used to extract 3 doses 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.
In infants from 6 to less than 12 months of age, the recommended injection site is the anterolateral aspect of the thigh. In individuals 1 to 4 years of age, the recommended injection site is the anterolateral aspect of the thigh or the deltoid muscle.
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. No further dose of the vaccine should be given to those who have experienced anaphylaxis after a prior dose of Comirnaty.
Myocarditis and pericarditis
There is an increased risk of myocarditis and pericarditis following vaccination with Comirnaty. 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 (see section 4.8). 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
Safety and immunogenicity have been assessed in a limited number of immunocompromised individuals, including those receiving immunosuppressant therapy (see sections 4.8 and 5.1). The efficacy of Comirnaty JN.1 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 Comirnaty JN.1 may not protect all vaccine recipients. Individuals may not be fully protected until 7 days after their vaccination.
4.5. Interaction with other medicinal products and other forms of interaction
No interaction studies have been performed.
Concomitant administration of Comirnaty JN.1 with other vaccines has not been studied.
4.6. Fertility, pregnancy and lactation
Comirnaty JN.1 3 micrograms/dose concentrate for dispersion for injection, 3-dose vial is not intended for individuals older than 5 years of age.
For details for use in individuals older than 5 years of age, please refer to the Summary of Product Characteristics for those formulations.
4.7. Effects on ability to drive and use machines
Comirnaty JN.1 has no or negligible influence on the ability to drive, cycle, and use machines. However, some of the effects mentioned under section 4.8 may temporarily affect the ability to drive, cycle, or use machines.
4.8. Undesirable effects
Summary of safety profile
The safety of Comirnaty JN.1 is inferred from safety data of the prior Comirnaty vaccines.
Initially approved Comirnaty vaccine
Infants 6 to 23 months of age – after 3 doses
In an analysis of Study 3 (Phase 2/3), 2 176 infants (1 458 initially approved Comirnaty 3 mcg and 718 placebo) were 6 to 23 months of age. Based on data in the blinded placebo-controlled follow-up period up to the cut‑off date of 28 February 2023, 720 infants 6 to 23 months of age who received a 3‑dose primary course (483 Comirnaty 3 mcg and 237 placebo) have been followed for a median of 1.7 months after the third dose.
The most frequent adverse reactions in infants 6 to 23 months of age that received any primary course dose included irritability (> 60%), drowsiness (> 40%), decreased appetite (> 30%), tenderness at the injection site (> 20%), injection site redness and fever (> 10%).
Children 2 to 4 years of age – after 3 doses
In an analysis of Study 3 (Phase 2/3), 3 541 children (2 368 Comirnaty 3 mcg and 1 173 placebo) were 2 to 4 years of age. Based on data in the blinded placebo-controlled follow-up period up to the cut‑off date of 28 February 2023, 1 268 children 2 to 4 years of age who received a 3‑dose primary course (863 Comirnaty 3 mcg and 405 placebo) have been followed a median of 2.2 months after the third dose.
The most frequent adverse reactions in children 2 to 4 years of age that received any primary course dose included pain at injection site and fatigue (> 40%), injection site redness and fever (> 10%).
Children 5 to 11 years of age (i.e. 5 to less than 12 years of age) – after 2 doses
In Study 3, a total of 3 109 children 5 to 11 years of age received at least 1 dose of the initially approved Comirnaty vaccine and a total of 1 538 children 5 to 11 years of age received placebo. At the time of the analysis of Study 3 Phase 2/3 with data up to the cut-off date of 20 May 2022, 2 206 (1 481 Comirnaty 10 mcg and 725 placebo) children have been followed for ≥ 4 months after the second dose in the placebo‑controlled blinded follow-up period. The safety evaluation in Study 3 is ongoing.
The overall safety profile of Comirnaty in participants 5 to 11 years of age was similar to that seen in participants 16 years of age and older. The most frequent adverse reactions in children 5 to 11 years of age that received 2 doses were injection site pain (> 80%), fatigue (> 50%), headache (> 30%), injection site redness and swelling (≥ 20%), myalgia, chills and diarrhoea (> 10%).
Children 5 to 11 years of age (i.e. 5 to less than 12 years of age) – after booster dose
In a subset from Study 3, a total of 2 408 children 5 to 11 years of age received a booster dose of Comirnaty 10 mcg at least 5 months (range of 5.3 to 19.4 months) after completing the primary series. The analysis of the Study 3 Phase 2/3 subset is based on data up to the cut-off date of 28 February 2023 (median follow-up time of 6.4 months).
The overall safety profile for the booster dose was similar to that seen after the primary course. The most frequent adverse reactions in children 5 to 11 years of age after the booster dose were injection site pain (> 60%), fatigue (> 30%), headache (> 20%), myalgia, chills, injection site redness and swelling (> 10%).
Adolescents 12 to 15 years of age – after 2 doses
In an analysis of long-term safety follow-up in Study 2, 2 260 adolescents (1 131 Comirnaty and 1 129 placebo) were 12 to 15 years of age. Of these, 1 559 adolescents (786 Comirnaty and 773 placebo) have been followed for ≥ 4 months after the second dose.
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. The most frequent adverse reactions in adolescents 12 to 15 years of age that received 2 doses were injection site pain (> 90%), fatigue and headache (> 70%), myalgia and chills (> 40%), arthralgia and pyrexia (> 20%).
Participants 16 years of age and older – after 2 doses
In Study 2, a total of 22 026 participants 16 years of age or older received at least 1 dose of Comirnaty 30 mcg and a total of 22 021 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 with a data cut-off of 13 March 2021 for the placebo-controlled blinded follow-up period up to the participants' unblinding dates, a total of 25 651 (58.2%) participants (13 031 Comirnaty and 12 620 placebo) 16 years of age and older were followed up for ≥ 4 months after the second dose. This included a total of 15 111 (7 704 Comirnaty and 7 407 placebo) participants 16 to 55 years of age and a total of 10 540 (5 327 Comirnaty and 5 213 placebo) participants 56 years of age and older.
The most frequent adverse reactions in participants 16 years of age and older that received 2 doses were injection site pain (> 80%), fatigue (> 60%), headache (> 50%), myalgia (> 40%), 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.
Participants 12 years of age and older – after booster dose
A subset from Study 2 Phase 2/3 participants of 306 adults 18 to 55 years of age who completed the original Comirnaty 2-dose course, received a booster dose of Comirnaty approximately 6 months (range of 4.8 to 8.0 months) after receiving Dose 2. Overall, participants who received a booster dose, had a median follow-up time of 8.3 months (range 1.1 to 8.5 months) and 301 participants had been followed for ≥ 6 months after the booster dose to the cut-off date (22 November 2021).
The overall safety profile for the booster dose was similar to that seen after 2 doses. The most frequent adverse reactions in participants 18 to 55 years of age were injection site pain (> 80%), fatigue (> 60%), headache (> 40%), myalgia (> 30%), chills and arthralgia (> 20%).
In Study 4, a placebo-controlled booster study, participants 16 years of age and older recruited from Study 2 received a booster dose of Comirnaty (5 081 participants), or placebo (5 044 participants) at least 6 months after the second dose of Comirnaty. Overall, participants who received a booster dose, had a median follow-up time of 2.8 months (range 0.3 to 7.5 months) after the booster dose in the blinded placebo-controlled follow-up period to the cut-off date (8 February 2022). Of these, 1 281 participants (895 Comirnaty and 386 placebo) have been followed for ≥ 4 months after the booster dose of Comirnaty. No new adverse reactions of Comirnaty were identified.
A subset from Study 2 Phase 2/3 participants of 825 adolescents 12 to 15 years of age who completed the original Comirnaty 2-dose course, received a booster dose of Comirnaty approximately 11.2 months (range of 6.3 to 20.1 months) after receiving Dose 2. Overall, participants who received a booster dose, had a median follow-up time of 9.5 months (range 1.5 to 10.7 months) based on data up to the cut-off date (3 November 2022). No new adverse reactions of Comirnaty were identified.
Booster dose following primary vaccination with another authorised COVID-19 vaccine
In 5 independent studies on the use of a Comirnaty booster dose in individuals who had completed primary vaccination with another authorised COVID-19 vaccine (heterologous booster dose), no new safety issues were identified.
Omicron-adapted Comirnaty
Infants 6 to 23 months of age – after the booster (fourth dose)
In 2 groups from Study 6 (Phase 3, Groups 2 and 3), 160 participants (Group 2: 92, Group 3: 68) 6 to 23 months of age who had completed 3 doses of Comirnaty, received a booster (fourth dose) of Comirnaty Original/Omicron BA.4-5 (1.5/1.5 mcg) 2.1 to 8.6 months after receiving Dose 3 for Group 2 and 3.8 to 12.5 months after receiving Dose 3 for Group 3. Participants who received a booster (fourth dose) of Comirnaty Original/Omicron BA.4-5 had a median follow-up time of 4.4 months for Group 2 and had a median follow-up time of 6.4 months for Group 3.
The overall safety profile for the Comirnaty Original/Omicron BA.4-5 booster (fourth dose) was similar to that seen after 3 doses. The most frequent adverse reaction in participants 6 to 23 months of age was irritability (> 30%), decreased appetite (> 20%), drowsiness, tenderness at the injection site and fever (> 10%).
Children 2 to 4 years of age – after the booster (fourth dose)
In 2 groups from Study 6 (Phase 3, Groups 2 and 3), 1 207 participants (Group 2: 218, Group 3: 989) 2 to 4 years of age who had completed 3 doses of Comirnaty, received a booster (fourth dose) of Comirnaty Original/Omicron BA.4-5 (1.5/1.5 mcg) 2.1 to 8.6 months after receiving Dose 3 for Group 2 and 2.8 to 17.5 months after receiving Dose 3 for Group 3. Participants who received a booster (fourth dose) of Comirnaty Original/Omicron BA.4-5 had a median follow-up time of 4.6 months for Group 2 and had a median follow-up time of 6.3 months for Group 3.
The overall safety profile for the Comirnaty Original/Omicron BA.4-5 booster (fourth dose) was similar to that seen after 3 doses. The most frequent adverse reactions in participants 2 to 4 years of age were injection site pain (> 30%) and fatigue (> 20%).
Children 5 to 11 years of age (i.e. 5 to less than 12 years of age) – after the booster (fourth dose)
In a subset from Study 6 (Phase 3), 113 participants 5 to 11 years of age who had completed 3 doses of Comirnaty, received a booster (fourth dose) of Comirnaty Original/Omicron BA.4-5 (5/5 mcg) 2.6 to 8.5 months after receiving Dose 3. Participants who received a booster (fourth dose) of Comirnaty Original/Omicron BA.4-5 had a median follow-up time of 6.3 months.
The overall safety profile for the Comirnaty Original/Omicron BA.4-5 booster (fourth dose) was similar to that seen after 3 doses. The most frequent adverse reactions in participants 5 to 11 years of age were injection site pain (> 60%), fatigue (> 40%), headache (> 20%), and myalgia (> 10%).
Participants 12 years of age and older – after a booster dose of Comirnaty Original/Omicron BA.4-5 (fourth dose)
In a subset from Study 5 (Phase 2/3), 107 participants 12 to 17 years of age, 313 participants 18 to 55 years of age and 306 participants 56 years of age and older who had completed 3 doses of Comirnaty, received a booster (fourth dose) of Comirnaty Original/Omicron BA.4-5 (15/15 mcg) 5.4 to 16.9 months after receiving Dose 3. Participants who received a booster (fourth dose) of Comirnaty Original/Omicron BA.4-5 had a median follow-up time of at least 1.5 months.
The overall safety profile for the Comirnaty Original/Omicron BA.4-5 booster (fourth dose) was similar to that seen after 3 doses. The most frequent adverse reactions in participants 12 years of age and older were injection site pain (> 60%), fatigue (> 50%), headache (> 40%), myalgia (> 20%), chills (> 10%), and arthralgia (> 10%).
Participants 12 years of age and older – after a booster dose of Comirnaty Omicron XBB.1.5 (fourth dose or more)
In a subset from Study 13 (Phase 2/3), 412 participants 12 years of age and older, who had received at least 3 doses of an authorised mRNA COVID-19 vaccine, received a booster (fourth dose or more) of Comirnaty Omicron XBB.1.5 2.0 to 24.1 months after receiving Dose 3. Participants who received a booster (fourth dose or more) of Comirnaty XBB.1.5 had a median follow-up time of 6.3 months.
The safety profile of Comirnaty Omicron XBB.1.5 was similar to the overall Comirnaty safety profile.
Participants 12 years of age and older – after a single dose of Comirnaty Omicron XBB.1.5
In a subset from Study 13 (Phase 2/3), 311 participants 12 years of age and older who were considered to be baseline SARS-CoV-2 positive and COVID-19 vaccine-naïve, received 1 dose of Comirnaty Omicron XBB.1.5. Participants had a median follow-up time of 6.4 months.
The safety profile of Comirnaty Omicron XBB.1.5 was similar to the overall Comirnaty safety profile. The most frequent adverse reactions in participants were injection site pain (> 50%), fatigue (> 30%), headache (> 20%), myalgia, diarrhoea, arthralgia, chills and injection site swelling (> 10%).
Participants 12 years of age and older – after a single dose of Comirnaty Omicron JN.1
In a subset from Study 13 (Phase 2/3), 216 participants 12 years of age and older received 1 dose of Comirnaty Omicron JN.1 and had a median follow-up time of 6.3 months.
The safety profile of Comirnaty Omicron JN.1 was similar to the overall Comirnaty safety profile. The most frequent adverse reactions in participants were injection site pain (> 60%), fatigue (>30%), headache (>20%), myalgia, chills and injection site swelling (>10%).
Participants 18 years of age and older – after a single dose of Comirnaty Omicron KP.2
In a subset from Study 13 (Phase 2/3), 102 participants 18 years of age and older received 1 dose of Comirnaty Omicron KP.2 and had a median follow-up time of 6.3 months.
The safety profile of Comirnaty Omicron KP.2 was similar to the overall Comirnaty safety profile. The most frequent adverse reactions in participants were injection site pain (> 50%), fatigue (>40%), headache and myalgia (>20%).
Tabulated list of adverse reactions from clinical studies of Comirnaty and Comirnaty Original/Omicron BA.4-5 and post‑authorisation experience of Comirnaty in individuals 6 months of age and older
Adverse reactions observed during clinical studies and post-authorisation experience 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 2. Adverse reactions from Comirnaty and Comirnaty Original/Omicron BA.4-5 clinical trials and Comirnaty post‑authorisation experience in individuals 6 months of age and older
System Organ Class
Frequency
Adverse reactions
Blood and lymphatic system disorders
Common
Lymphadenopathya
Immune system disorders
Uncommon
Hypersensitivity reactions (e.g. rashi, pruritus, urticariab, angioedemab)
Not known
Anaphylaxis
Metabolism and nutrition disorders
Uncommon
Decreased appetitej
Psychiatric disorders
Very common
Irritabilityk
Uncommon
Insomnia
Nervous system disorders
Very common
Headache; drowsinessk
Uncommon
Dizzinessd; lethargy
Rare
Acute peripheral facial paralysisc
Not known
Paraesthesiad; hypoaesthesiad
Cardiac disorders
Very rare
Myocarditisd; pericarditisd
Gastrointestinal disorders
Very common
Diarrhoead
Common
Nausea; vomitingd,m
Skin and subcutaneous tissue disorder
Uncommon
Hyperhidrosis; night sweats
Not known
Erythema multiformed
Musculoskeletal and connective tissue disorders
Very common
Arthralgia; myalgia
Uncommon
Pain in extremitye
Reproductive system and breast disorders
Not known
Heavy menstrual bleedingl
General disorders and administration site conditions
Very common
Injection site pain; injection site tendernessk; fatigue; chills; pyrexiaf; injection site swelling
Common
Injection site rednessh
Uncommon
Asthenia; malaise; injection site pruritus
Not known
Extensive swelling of vaccinated limbd; facial swellingg
a. In participants 5 years of age and older, a higher frequency of lymphadenopathy was reported after a booster (≤ 2.8%) dose than after primary (≤ 0.9%) doses of the vaccine.
b. The frequency category for urticaria (participants 5 years and older) and angioedema (participants 6 months and older) was rare.
c. 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.
d. Adverse reaction determined post‑authorisation.
e. Refers to vaccinated arm.
f. A higher frequency of pyrexia was observed after the second dose compared to the first dose.
g. Facial swelling in vaccine recipients with a history of injection of dermatological fillers has been reported in the post‑marketing phase.
h. Injection site redness occurred at a higher frequency (very common) in participants 6 months to 11 years of age and in immunocompromised participants 2 years of age and older.
i. The frequency category for rash was common in participants 6 to 23 months of age.
j. The frequency category for decreased appetite was very common in participants 6 to 23 months of age.
k. Irritability, injection site tenderness, and drowsiness pertain to participants 6 to 23 months of age.
l. Most cases appeared to be non-serious and temporary in nature.
m. The frequency category for vomiting was very common in pregnant women 18 years of age and older and in immunocompromised participants 2 to 18 years of age.
Special populations
Infants born to pregnant participants – after 2 doses of Comirnaty
Study C4591015 (Study 9), a Phase 2/3, placebo-controlled study, evaluated a total of 346 pregnant participants who received Comirnaty (n = 173) or placebo (n = 173). Infants (Comirnaty n = 167 or placebo n = 168) were evaluated up to 6 months. No safety concerns were identified that were attributable to maternal vaccination with Comirnaty.
Immunocompromised participants (adults and children)
In study C4591024 (Study 10), a total of 124 immunocompromised participants 2 years of age and older received Comirnaty (see section 5.1).
Description of selected adverse reactions
Myocarditis and pericarditis
The increased risk of myocarditis after vaccination with Comirnaty is highest in younger males (see section 4.4).
Two large European pharmacoepidemiological studies have estimated the excess risk in younger males following the second dose of Comirnaty. One study showed that in a period of 7 days after the second dose there were about 0.265 (95% CI: 0.255 - 0.275) extra cases of myocarditis in 12-29 year old males per 10 000 compared to unexposed persons. In another study, in a period of 28 days after the second dose there were 0.56 (95% CI: 0.37 - 0.74) extra cases of myocarditis in 16-24 year old males per 10 000 compared to unexposed persons.
Limited data indicate that the risk of myocarditis and pericarditis after vaccination with Comirnaty in children aged 5 to 11 years seems lower than in ages 12 to 17 years.
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 a Yellow card. Reporting forms and information can be found at https://coronavirus-yellowcard.mhra.gov.uk/ or search for MHRA Yellow Card in the Google Play or Apple App Store.
Alternatively, adverse events of concern in association with Comirnaty can be reported to Pfizer Medical Information on 01304 616161 or via www.pfizersafetyreporting.com.
Please do not report the same adverse event(s) to both systems as all reports will be shared between Pfizer and MHRA (in an anonymized form) and dual reporting will create unnecessary duplicates.
4.9. Overdose
There have been reports of higher than recommended doses of Comirnaty in clinical trials and post-authorisation experience. In general, adverse events reported with overdoses have been similar to the known adverse reaction profile of Comirnaty.
In the event of overdose, monitoring of vital functions and possible symptomatic treatment is recommended.
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