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 30 micrograms/dose dispersion for injection
⚠ 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 30 micrograms/dose dispersion for injection is given to adults and adolescents from 12 years of age and older. 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 you COVID-19. The use of this vaccine should be in accordance with official recommendations. 2.
What you need to know before you take it
e Comirnaty JN.1
Comirnaty JN.1 should not be given • if you are allergic to the active substance or any of the other ingredients of this medicine (listed in section 6) Warnings and precautions Talk to your doctor, pharmacist or nurse before you are given the vaccine if: • you have ever had a severe allergic reaction or breathing problems after any other vaccine injection or after you were given this vaccine in the past. • you are feeling nervous about the vaccination process or have ever fainted following any needle injection. • you have a severe illness or infection with high fever. However, you can have your vaccination if you have a mild fever or upper airway infection like a cold. 1
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you have a bleeding problem, you bruise easily or you use a medicine to prevent blood-clots. you have a weakened immune system, because of a disease such as HIV infection or a medicine such as corticosteroid that affects your 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 you will be protected. The efficacy of Comirnaty JN.1 may be lower in people who are immunocompromised. If you are immunocompromised, you may receive additional doses of Comirnaty JN.1. In these cases, you should continue to maintain physical precautions to help prevent COVID-19. In addition, your close contacts should be vaccinated as appropriate. Discuss appropriate individual recommendations with your doctor. Children Comirnaty JN.1 30 micrograms/dose dispersion for injection is not recommended for children aged under 12 years. There are paediatric formulations available for infants aged 6 months and above and children below 12 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 doctor or pharmacist if you are using, have recently used or might use any other medicines or have recently received any other vaccine. Comirnaty JN.1 may be given at the same time as a flu vaccine. In adults 18 years of age and older, Comirnaty JN.1 may be given at the same time as a pneumococcal conjugated vaccine (PCV). In adults 18 years of age and older, Comirnaty JN.1 may be given at the same time as a respiratory syncytial virus (RSV) vaccine. In older adults 65 years of age and older, Comirnaty JN.1 may be given at the same time as a high dose flu and an RSV vaccine. Pregnancy and breast-feeding If you are pregnant or think you may be pregnant, tell your doctor, nurse or pharmacist before you receive this vaccine. No data are available yet regarding the use of Comirnaty JN.1 during pregnancy. However, a large amount of information from pregnant women vaccinated with the initially approved Comirnaty vaccine during the second and third trimester have not shown negative effects on the pregnancy or the newborn baby. While information on effects on pregnancy or the newborn baby after vaccination
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during the first trimester is limited, no change to the risk for miscarriage has been seen. Comirnaty JN.1 can be used during pregnancy. No data are available yet regarding the use of Comirnaty JN.1 during breast-feeding. However, no effects on the breastfed newborn/infant are anticipated. Data from women who were breast-feeding after vaccination with the initially approved Comirnaty vaccine have not shown a risk for adverse effects in breastfed newborns/infants. Comirnaty JN.1 can be used while breast-feeding. Driving and using machines Some of the effects of vaccination mentioned in section 4 (Possible side effects) may temporarily affect your ability to drive or use machines. Wait until these effects have worn off before you drive or use machines. 3.
How to take it
Comirnaty JN.1 is given as an injection of 0.3 mL into a muscle of your upper arm. You will receive 1 injection, regardless whether you have received a COVID-19 vaccine before. If you were previously vaccinated with a COVID-19 vaccine, you should not receive a dose of Comirnaty JN.1 until at least 3 months after the most recent dose. If you are immunocompromised, you may receive additional doses of Comirnaty JN.1. If you have any further questions on the use of Comirnaty JN.1, ask your 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 • injection site: pain, swelling • tiredness, headache • muscle pain, joint pain • chills, fever • diarrhoea Some of these side effects were slightly more frequent in adolescents 12 to 15 years than in adults. 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 12 to 18 years of age) • injection site redness ('very common' in immunocompromised individuals 12 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 or itching • decreased appetite 3
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dizziness excessive sweating, night sweats
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 you get any side effects, talk to your 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. Multidose vials: 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 6 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. 4
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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. Opened vials: After first puncture, 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 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. A multidose vial contains 6 doses of 0.3 mL with 30 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 white to off-white dispersion (pH: 6.9 – 7.9) provided in a multidose vial of 6 doses in a 2 mL clear vial (type I glass), with a rubber stopper and a grey 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 5
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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) 30 mcg MDV 8_0 ———————————————————————————————————————–The following information is intended for healthcare professionals only: Administer Comirnaty JN.1 intramuscularly as a single dose of 0.3 mL regardless of prior COVID-19 vaccination status. 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. 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 for frozen vials 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 grey plastic cap and the product name is Comirnaty JN.1 30 micrograms/dose dispersion for injection (12 years and older). • If the vial has another product name on the label, 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. Ensure vials are completely thawed prior to use. 10-vial pack of multidose vials may take 6 hours to thaw. • 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. Preparation of 0.3 mL doses • Gently mix by inverting vials 10 times prior to use. Do not shake. • Prior to mixing, the thawed dispersion may contain white to off-white opaque amorphous particles. • After mixing, the vaccine should present as a white to off-white dispersion with no particulates visible. Do not use the vaccine if particulates or discolouration are present. • Check whether the vial is a multidose vial and follow the applicable handling instructions below: Multidose vials contain 6 doses of 0.3 mL each. Using aseptic technique, cleanse the vial stopper with a single use antiseptic swab. Withdraw 0.3 mL of Comirnaty JN.1. 6
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Low dead-volume syringes and/or needles should be used in order to extract 6 doses from a single vial. 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. 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. Record the appropriate date/time on the vial. Discard any unused vaccine 12 hours after first puncture.
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 30 micrograms/dose dispersion for injection
How do I take Comirnaty JN.1 30 micrograms/dose dispersion for injection?
Comirnaty JN.1 30 micrograms/dose dispersion for injection comes as injection containing 30mcg. 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 30 micrograms/dose dispersion for injection?
The active substance in Comirnaty JN.1 30 micrograms/dose dispersion for injection is bretovameran.
Are there equivalent medicines to Comirnaty JN.1 30 micrograms/dose dispersion for injection?
Medicines with the same active substance, strength and form include: Comirnaty JN.1 30 micrograms/dose dispersion for injection in pre-filled syringe. They are interchangeable only if your prescriber or pharmacist says so.
Where does this information come from?
This leaflet reproduces the patient information leaflet approved for Comirnaty JN.1 30 micrograms/dose dispersion for injection, 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 30 micrograms/dose dispersion for injection 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 30 micrograms/dose dispersion for injection is indicated for active immunisation to prevent COVID-19 caused by SARS-CoV-2, 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 JN.1 30 micrograms/dose dispersion for injection is administered intramuscularly as a single dose of 0.3 mL for individuals 12 years of age and older regardless of prior COVID-19 vaccination status (see sections 4.4 and 5.1).
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).
Paediatric population
There are paediatric formulations available for infants aged 6 months and above and children below 12 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.
Elderly population
No dose adjustment is required in elderly individuals 65 years of age and older.
Method of administration
Comirnaty JN.1 30 micrograms/dose dispersion for injection should be administered intramuscularly (see section 6.6). Do not dilute prior to use.
The preferred site is the deltoid muscle of the upper arm.
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.
Multidose vials of Comirnaty JN.1 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.
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
Comirnaty JN.1 30 micrograms/dose dispersion for injection may be administered concomitantly with seasonal influenza vaccine.
In individuals 18 years of age and older, Comirnaty JN.1 may be administered concomitantly with a pneumococcal conjugate vaccine (PCV).
In individuals 18 years of age and older, Comirnaty JN.1 may be administered concomitantly with an unadjuvanted recombinant protein respiratory syncytial virus (RSV) vaccine.
In individuals 65 years of age and older, Comirnaty JN.1 may be administered concomitantly with an unadjuvanted recombinant protein RSV vaccine and a high dose influenza vaccine.
Different injectable vaccines should be administered at different injection sites.
4.6. Fertility, pregnancy and lactation
Pregnancy
No data are available yet regarding the use of Comirnaty JN.1 during pregnancy.
However, there are limited clinical study data (less than 300 pregnancy outcomes) from the use of Comirnaty in pregnant participants. A large amount of observational data from pregnant women vaccinated with the initially approved Comirnaty vaccine 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 (see section 5.3). Based on data available with other vaccine variants, Comirnaty JN.1 can be used during pregnancy.
Breast-feeding
No data are available yet regarding the use of Comirnaty JN.1 during breast‑feeding.
However, no effects on the breastfed newborn/infant are anticipated since the systemic exposure of breast‑feeding woman to the vaccine is negligible. Observational data from women who were breast‑feeding after vaccination with the initially approved Comirnaty vaccine have not shown a risk for adverse effects in breastfed newborns/infants. Comirnaty JN.1 can be used during breast‑feeding.
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 JN.1 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 JN.1 is inferred from safety data of the prior Comirnaty vaccines.
Initially approved Comirnaty vaccine
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 10 mcg 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 the initially approved Comirnaty vaccine 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.
Participants 12 years of age and older – after subsequent booster doses
The safety of a booster dose of Comirnaty in participants 12 years of age and older is inferred from safety data from studies of a booster dose of Comirnaty in participants 18 years of age and older.
A subset of 325 adults 18 to ≤ 55 years of age who had completed 3 doses of Comirnaty, received a booster (fourth dose) of Comirnaty 90 to 180 days after receiving Dose 3. Participants who received a booster (fourth dose) of Comirnaty had a median follow-up time of 1.4 months up to a data cut-off date of 11 March 2022. The most frequent adverse reactions in these participants were injection site pain (> 70%), fatigue (> 60%), headache (> 40%), myalgia and chills (> 20%), and arthralgia (> 10%).
In a subset from Study 4 (Phase 3), 305 adults > 55 years of age who had completed 3 doses of Comirnaty, received a booster (fourth dose) of Comirnaty 5 to 12 months after receiving Dose 3. Participants who received a booster (fourth dose) of Comirnaty had a median follow-up time of at least 1.7 months up to a data cut-off date of 16 May 2022. The overall safety profile for the Comirnaty booster (fourth dose) was similar to that seen after the Comirnaty booster (third dose). The most frequent adverse reactions in participants > 55 years of age were injection site pain (> 60%), fatigue (> 40%), headache (> 20%), myalgia and chills (> 10%).
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
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 12 years 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 postauthorisation experience in individuals 12 years 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. rash, pruritus, urticariab, angioedemab)
Not known
Anaphylaxis
Metabolism and nutrition disorders
Uncommon
Decreased appetite
Psychiatric disorders
Uncommon
Insomnia
Nervous system disorders
Very common
Headache
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,j
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 bleedingi
General disorders and administration site conditions
Very common
Injection site pain; 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 and angioedema 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 children 5 to 11 years of age and in immunocompromised participants 5 years of age and older.
i. Most cases appeared to be non-serious and temporary in nature.
j. The frequency category for vomiting was very common in pregnant women 18 years of age and older and in immunocompromised participants 5 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).
Safety with concomitant vaccine administration
Concomitant administration with seasonal influenza vaccine
In Study 8, a Phase 3 study, participants 18 through 64 years of age who received Comirnaty coadministered with seasonal inactivated influenza vaccine (SIIV), quadrivalent followed 1 month later by placebo, were compared to participants who received an inactivated influenza vaccine with placebo followed 1 month later by Comirnaty alone (n = 553 to 564 participants in each group).
Concomitant administration with pneumococcal conjugate vaccine
In Study 11 (B7471026), a Phase 3 study, participants 65 years of age and older who received a booster dose of Comirnaty coadministered with 20-valent pneumococcal conjugate vaccine (20vPNC) (n = 187) were compared to participants who received Comirnaty alone (n = 185).
Concomitant administration with an unadjuvanted recombinant protein RSV vaccine or with an unadjuvanted recombinant protein RSV vaccine and a high dose influenza vaccine
In Study 12 (C5481001), a Phase 1/2 study, participants 65 years of age and older who received Comirnaty Original/Omicron BA.4-5 and RSV vaccine coadministered in one arm plus high dose quadrivalent influenza vaccine (QIV) (n = 158) or placebo (n = 157) in the opposite arm were compared to participants who received the individual vaccines given with placebo.
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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