Comirnaty Original/Omicron BA.4-5 (Tozinameran And Famtozinameran)
Complete patient guide for uses, dosage, side effects, and safety information
Prescription RequiredQuick Facts
What Is Comirnaty Original/Omicron BA.4-5 Used For?
Comirnaty Original/Omicron BA.4-5 is a vaccine designed to protect you against COVID-19 disease caused by the SARS-CoV-2 virus. It can be given to people 6 months of age and older.
Primary Uses
This vaccine prevents coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 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: This vaccine has provisional approval in Australia and continues to be monitored for safety and effectiveness.
How to Take Comirnaty Original/Omicron BA.4-5
This vaccine will be given as an injection into the muscle of your upper arm 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. If you are immunocompromised, you may receive a third dose at least 28 days after the second dose. Additional doses may be given at least 3 months after the previous dose.
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 for proper protection.
Important: You may not be protected against COVID-19 until at least seven days after your last primary vaccination dose. Complete the full vaccination schedule for best protection.
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
- redness at injection site
- nausea
- irritability (in 6 months to less than 2 years of age)
- decreased appetite (in 6 months to less than 2 years of age)
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)
- 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 before receiving this vaccine. Make sure to discuss your medical history with your healthcare provider.
Who Should Not Take Comirnaty Original/Omicron BA.4-5
You should not receive this vaccine if you are allergic to tozinameran, famtozinameran, or any other ingredients in the vaccine. This vaccine should not be given to children 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 doses; fainting after 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, breast-feeding, think you may be pregnant, or are 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 and seek immediate medical attention if these occur.
Drug Interactions
Tell your doctor or pharmacist about all medicines you are taking, including prescription drugs, vitamins, and supplements you buy without a prescription.
Vaccine Timing: Different injectable vaccines should be given at different injection sites (e.g., one vaccine in each arm) when given together.
- seasonal flu (influenza) vaccine – may be given at the same time for individuals 12 years and older
- other vaccines – tell your doctor if you have recently received any other vaccine
Alcohol & Driving
Be careful with activities that require alertness until you know how the vaccine affects you.
Alcohol
No specific alcohol warnings mentioned in the source material.
Driving and Operating Machinery
Be careful before you drive or use any machines or tools until you know how the vaccine affects you. Some side effects may temporarily affect your ability to drive or use machines.
Temperature Regulation
You may develop a temporary, stress-related response including dizziness, fainting, sweating, increased heart rate and/or anxiety during the injection process.
Storage
A doctor, nurse or pharmacist will prepare the injection for you before administration and will dispose of any unused vaccine. You do not need to store this vaccine yourself.
Overdose Information
This vaccine is administered by healthcare professionals in controlled doses, so overdose is not applicable. If you have concerns about your vaccination, 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.
This vaccine may be given at the same time as the seasonal flu vaccine for individuals 12 years and older. Different injectable vaccines should be given at different injection sites.
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 receiving this vaccine.
If you miss the second dose, ask your doctor for advice. It’s very important to complete your primary vaccination schedule for proper protection.
The vaccine can be given to individuals 6 months of age and older, including elderly patients. Discuss any medical conditions with your healthcare provider before vaccination.
Additional doses may be given at least 3 months after the primary vaccination or previous dose, depending on your individual circumstances.
Watch for signs of heart inflammation such as chest pain, breathlessness, and palpitations, and seek immediate medical attention if these occur. You’ll be observed for at least 15 minutes after vaccination.
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.