Comirnaty LP.8.1 (Sars-Cov-2 Spike Protein (Mrna) Lp.8.1)

Complete patient guide for uses, dosage, side effects, and safety information

Prescription Required

Quick Facts

Generic Name
SARS-CoV-2 spike protein (mRNA) LP.8.1
Drug Class
mRNA vaccine
Used For
Prevention of COVID-19 disease
How Taken
Injection into muscle of upper arm or thigh

What Is Comirnaty LP.8.1 Used For?

Comirnaty LP.8.1 is an mRNA vaccine designed to protect against COVID-19 disease caused by the SARS-CoV-2 virus.

Primary Uses

This vaccine prevents coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in adults, infants and children from 6 months of age and older.

How It Works

Comirnaty LP.8.1 works by triggering your immune system to produce antibodies and blood cells that work against the virus, to protect against COVID-19 disease.

Important: You may not be protected against COVID-19 disease until at least seven days after the last dose of your primary vaccination schedule. It is very important you complete your primary vaccination.

How to Take Comirnaty LP.8.1

Comirnaty LP.8.1 is given as an injection into the muscle of your upper arm or thigh by a doctor, nurse or pharmacist.

Dosage Instructions

For children and adults 5 years of age and older: You will receive one dose followed by a second dose at least 21 days later as the primary vaccination. For infants and children 6 months to less than 5 years of age: A third dose will be given at least 8 weeks after the second dose as part of the primary vaccination. Additional dose(s) may be given at least 3 months after the previous dose for people 5 years of age and older.

What If You Miss a Dose?

If you miss the second dose, ask your doctor for advice. If you receive one dose of Comirnaty LP.8.1, you should continue to receive the same vaccine to complete the primary vaccination schedule.

Important: A doctor, nurse or pharmacist will observe you for at least 15 minutes after being given the vaccine.

Available Tablet Strengths

Yellow cap vial (6 months to less than 5 years)
Yellow cap vial (6 months to less than 5 years) Tablet Yellow, Vial • 0.3 mL dose, 3 doses per vial
Light Blue cap vial (5 to less than 12 years)
Light Blue cap vial (5 to less than 12 years) Tablet Light blue, Vial • 0.3 mL dose, 1 dose per vial
Dark Blue cap vial (5 to less than 12 years)
Dark Blue cap vial (5 to less than 12 years) Tablet Dark blue, Vial • 0.3 mL dose, 6 doses per vial
Dark Grey cap vial (12 years and older)
Dark Grey cap vial (12 years and older) Tablet Dark grey, Vial • 0.3 mL dose, 6 doses per vial
Prefilled Syringe (12 years and older)
Prefilled Syringe (12 years and older) Tablet Clear glass, Syringe • 0.3 mL dose, 1 dose per syringe

Side Effects

Like all medications, this medicine can cause side effects. Most are mild and temporary, but some require medical attention.

Common Side Effects

These side effects occur relatively frequently and usually don’t require emergency care:

  • Pain, swelling, or tenderness at injection site
  • Tiredness
  • Headache
  • Muscle pain
  • Chills
  • Joint pain
  • Fever
  • Irritability (in 6 months to less than 2 years of age)
  • Redness at injection site
  • Nausea

Seek immediate medical attention if you experience:

  • Severe allergic reaction
  • Allergic reactions such as rash, itching, hives or swelling of the face
  • Inflammation of the heart muscle (myocarditis) or inflammation of the lining outside the heart (pericarditis) which can result in chest pain, breathlessness and/or palpitations
  • Temporary one-sided facial drooping

Important Warnings

There are important safety considerations and warnings you should know before receiving this vaccine.

Who Should Not Take Comirnaty LP.8.1

You should not receive this vaccine if you are allergic to the active ingredient (SARS-CoV-2 spike protein (mRNA) LP.8.1) or any of the ingredients listed. Comirnaty LP.8.1 should not be given to infants under 6 months of age.

Medical Conditions to Discuss

Check with your doctor if you have: had a severe allergic reaction or breathing problems after any other vaccine or after being given any other COMIRNATY COVID-19 vaccine in the past; fainted following any needle injection; a severe illness or infection with high fever; a weakened immune system or are on a medicine that affects your immune system; a bleeding disorder, bruise easily or are on a blood thinning medicine.

Pregnancy and Breastfeeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before you receive this vaccine.

Heart Inflammation Risk: Very rare cases of myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of the lining outside the heart) have been reported. Be alert to signs such as breathlessness, palpitations and chest pain, and seek immediate medical attention if these occur.

Drug Interactions

Tell your doctor or pharmacist about all medicines you are taking and any vaccines you have recently received.

  • Any other medicines, including prescription and over-the-counter medications
  • Vitamins or supplements bought without prescription
  • Any recently received vaccines

Alcohol & Driving

Be careful with activities that require alertness until you know how the vaccine affects you.

Driving and Operating Machinery

Be careful before you drive, cycle or use any machines or tools until you know how Comirnaty LP.8.1 affects you. Some of the side effects may temporarily affect your ability to drive, cycle or use machines.

Storage

A doctor, nurse or pharmacist will prepare the injection for you before you are given it and will dispose of any unused vaccine. You do not need to store this vaccine yourself.

Overdose Information

Since this vaccine is given by a healthcare professional in a medical setting, overdose is unlikely. If you have concerns about the vaccine dose you received, contact your healthcare provider.

Frequently Asked Questions

You may not be protected against COVID-19 disease until at least seven days after the last dose of your primary vaccination schedule. Complete protection requires finishing the full vaccination series.

Tell your doctor or pharmacist if you have recently received any other vaccine. Your healthcare provider will advise you on the appropriate timing for different vaccines.

Most side effects are minor and temporary. However, seek immediate medical attention if you experience severe allergic reactions, chest pain, breathlessness, palpitations, or temporary facial drooping.

If you are pregnant, breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before you receive this vaccine.

For ages 5 and older: two doses at least 21 days apart for primary vaccination. For ages 6 months to less than 5 years: three doses (third dose at least 8 weeks after the second). Additional doses may be given at least 3 months after primary vaccination.

You will be observed for at least 15 minutes after vaccination. Be alert for signs of heart inflammation such as chest pain, breathlessness, or palpitations, and seek immediate medical attention if these occur.

Be careful before you drive, cycle, or use machines until you know how the vaccine affects you. Some side effects may temporarily affect your ability to perform these activities safely.

Important Disclaimer

This information is intended for general educational purposes only and should not be considered medical advice. Always consult your healthcare provider or pharmacist before starting, stopping, or changing any medication.

If you think you may have a medical emergency, call your doctor or emergency services immediately.