Comirnaty Omicron XBB.1.5 (Raxtozinameran)

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

Prescription Required

Quick Facts

Generic Name

raxtozinameran

Drug Class

mRNA vaccine

Used For

Prevention of COVID-19 disease caused by SARS-CoV-2

How Taken

Injection into muscle of upper arm or thigh by healthcare professional

What Is Comirnaty Omicron XBB.1.5 Used For?

Comirnaty Omicron XBB.1.5 is an mRNA vaccine designed to protect against COVID-19 disease caused by the SARS-CoV-2 virus. It’s approved for use in adults, infants, and children from 6 months of age and older.

Primary Uses

Prevention of coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in people 6 months of age and older.

How It Works

This mRNA vaccine works by triggering your immune system to produce antibodies and blood cells that work against the virus to protect against COVID-19 disease.

Good to know: The vaccine may not fully protect all those who receive it, but completing your primary vaccination schedule is very important for protection.

How to Take Comirnaty Omicron XBB.1.5

This vaccine is given as an injection into the muscle of your upper arm or thigh by a doctor, nurse, or pharmacist. You will be observed for at least 15 minutes after receiving the vaccine.

Dosage Instructions

For children and adults 5 years and older: Two doses with the second dose given at least 21 days after the first. For infants and children 6 months to less than 5 years: Three doses total – a third dose given at least 8 weeks after the second dose. Additional doses may be given at least 3 months after the previous dose for people 5 years and older. Immunocompromised individuals may receive a third dose at least 28 days after the second dose as part of primary vaccination.

What If You Miss a Dose?

If you miss the second dose, ask your doctor for advice. It’s very important to complete your primary vaccination schedule as you may not be protected if you only receive one dose.

Important: You may not be protected against COVID-19 until at least seven days after the last dose of your primary vaccination schedule.

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, 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 several important warnings and precautions to be aware of before receiving this vaccine.

Who Should Not Take Comirnaty Omicron XBB.1.5

Do not receive this vaccine if you are allergic to raxtozinameran or any of the ingredients listed. The vaccine should not be given to infants under 6 months of age.

Medical Conditions to Discuss

Tell your doctor if you have had: severe allergic reactions or breathing problems after any vaccine or previous Comirnaty vaccines; fainting following needle injections; severe illness or infection with high fever; weakened immune system or take medicines affecting your immune system; bleeding disorders, bruise easily, or take blood thinning medicines.

Pregnancy and Breastfeeding

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

Heart Inflammation Risk: Very rare cases of myocarditis (heart muscle inflammation) and pericarditis (heart lining inflammation) have been reported, mostly within two weeks of vaccination, more often after the second dose, and more frequently in younger men. Watch for chest pain, breathlessness, and palpitations.

Drug Interactions

Tell your doctor or pharmacist about all medicines you are taking, including over-the-counter medicines, vitamins, and supplements.

Tell your doctor if you have recently received any other vaccine
May be given at the same time as seasonal flu vaccine for individuals 12 years and older (different injection sites required)
Inform healthcare provider of all medicines, vitamins, or supplements you are taking

Alcohol & Driving

Be careful before driving, cycling, or using machines or tools until you know how the vaccine affects you.

Alcohol

No specific alcohol warnings mentioned in the source material.

Driving and Operating Machinery

Some side effects may temporarily affect your ability to drive, cycle, or use machines. Be cautious until you know how the vaccine affects you.

Temperature Regulation

No specific temperature regulation warnings mentioned in the source material.

Storage

A doctor, nurse, or pharmacist will prepare the injection for you before administration and will dispose of any unused vaccine. No patient storage required.

Overdose Information

This vaccine is administered by healthcare professionals in controlled doses, so overdose is not applicable for patient self-administration.

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.

Yes, for individuals 12 years and older, this vaccine may be given at the same time as the seasonal flu vaccine, but different injection sites must be used (e.g., one vaccine in each arm).

Yes, the vaccine is approved for infants and children from 6 months of age and older. It should not be given to infants under 6 months of age.

You may not be protected if you only receive one dose, so it is very important that you complete your primary vaccination schedule. If you miss the second dose, ask your doctor for advice.

Yes, additional doses may be given at least 3 months after the previous dose for people 5 years of age and older.

You should be alert to signs of myocarditis and pericarditis, such as breathlessness, palpitations and chest pain, and seek immediate medical attention if these occur. You will be observed for at least 15 minutes after receiving the vaccine.