Comirnaty LP.8.1 30 micrograms/dose dispersion for injection in pre-filled syringe

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor, pharmacist or nurse.
• If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

1. What Comirnaty LP.8.1 is and what it is used for
2. What you need to know before you receive Comirnaty LP.8.1
3. How Comirnaty LP.8.1 is given
4. Possible side effects
5. How to store Comirnaty LP.8.1
6. Contents of the pack and other information

• if you are allergic to the active substance or any of the other ingredients of this medicine (listed in section 6)

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.
• 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 LP.8.1 may not fully protect all those who receive it and it is not known how long you will be protected.

The efficacy of Comirnaty LP.8.1 may be lower in people who are immunocompromised. If you are immunocompromised, you may receive additional doses of Comirnaty LP.8.1. 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.

Comirnaty LP.8.1 30 micrograms/dose dispersion for injection in pre-filled syringe 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.

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 LP.8.1 may be given at the same time as a flu vaccine.

In adults 18 years of age and older, Comirnaty LP.8.1 may be given at the same time as a pneumococcal conjugated vaccine (PCV).

In adults 18 years of age and older, Comirnaty LP.8.1 may be given at the same time as a respiratory syncytial virus (RSV) vaccine.

In older adults 65 years of age and older, Comirnaty LP.8.1 may be given at the same time as a high dose flu and an RSV vaccine.

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 LP.8.1 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 during the first trimester is limited, no change to the risk for miscarriage has been seen. Comirnaty LP.8.1 can be used during pregnancy.

No data are available yet regarding the use of Comirnaty LP.8.1 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 LP.8.1 can be used while breast-feeding.

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.

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.

The active substance of COVID-19 mRNA Vaccine (nucleoside modified) is called mRNA encoding LP.8.1. Each pre-filled syringe contains 1 dose of 0.3 mL with 30 micrograms mRNA encoding LP.8.1 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

The vaccine is a white to off-white dispersion (pH: 6.9 - 7.9) provided in a pre-filled syringe (type I glass syringe) with plunger stopper (synthetic bromobutyl rubber) and a tip cap (synthetic bromobutyl rubber) without needle.

Pack sizes:

1 pre-filled syringe

10 pre-filled syringes

Not all pack sizes may be marketed.

For any information about this medicine, please contact: Medical Information,