Is there a difference between the two Comirnaty (Pfizer) COVID-19 vaccines?
What are the most recent Australian Technical Advisory Group on Immunisation (ATAGI) recommendations in regard to the Comirnaty (Pfizer) 5 to <12 years of age formulation vaccine?
Is there any additional training required before administering the Comirnaty (Pfizer) 5 to <12 years of age formulation vaccine?
Can children who have had SARS-CoV-2 receive a COVID-19 vaccine?
Can children receive one of the other available COVID-19 vaccines?
Can the current adult/adolescent formulation (purple cap) be used to vaccinate children aged 5 to less than 12 years of age?
Why can't I use the existing formulation, just at a lower dose?
What should I do if the vaccine remaining in the vial cannot provide a full dose of 0.2mL?
What if the multidose vial is frozen?
How long can unopened vials be stored at +2 to +8°C?
Can I thaw individual vials of the Comirnaty (Pfizer) 5 to <12 years of age formulation vaccine (orange cap)?
What is the volume of diluent for the Comirnaty (Pfizer) 5 to <12 years of age formulation vaccine (orange cap)?
What should I do if the vial contains particles, or the vaccine is discolored?
How should I manage multiple vaccine brands and formulations?
What should I do if I inadvertently administer the incorrect dose or vaccine?
What is the recommended dosing schedule for people aged 5 to <12 years of age?
Which vaccine formulation should a person receive as their second dose if they turn 12 years after their first dose of vaccination?
What is the preferred anatomical site for IM vaccination of people aged 5 to <12 years of age?
How do I correctly identify the deltoid muscle in a child?
How do I position a child for a vaccination?
What are the side effects of Comirnaty Vaccine?
What should I do if a child refuses a vaccination that a parent or guardian has given consent for?
How effective is Comirnaty (Pfizer) vaccine for children aged 5 to <12 years of age and how long will the protection from the vaccine last?
What are the contraindications to receiving the Comirnaty (Pfizer) 5 to <12 years of age formulation vaccine?
What is myocarditis and pericarditis and does the Comirnaty (Pfizer) vaccine cause these conditions?
Comirnaty, also called BNT162b2 or tozinameran, is a COVID-19 vaccine developed by Pfizer and BioNTech. It is an mRNA vaccine that contains the genetic code for an important part of the COVID-19 virus called the 'spike protein'. After getting the injection, the body reads the genetic code and makes copies of the spike protein. The immune system then detects these spike proteins and learns how to recognise and fight against COVID-19. The genetic code is quickly broken down and cleared away by the body.
Yes. The Comirnaty (Pfizer) 5 to <12 years of age formulation vaccine is a different formulation to the Comirnaty (Pfizer) adult/adolescent formulation vaccine.
The formulation for people 5 to <12 years of age has an orange cap and the dose is 10 micrograms in 0.2mL, while the formulation for people 12 years and over has a purple cap and contains 30 micrograms in 0.3mL. The required diluent is also a different volume. These two vaccines must always be managed as separate vaccines. Lower doses of the adult/adolescent formulation MUST NOT be administered to people aged 5 to <12 years of age.
Please refer to the TGA Product Information (PI) for the most up to date information.
All health professionals involved in administering COVID-19 vaccines must have completed the Australian Government training on COVID-19 vaccines including the relevant modules for each vaccine they intend to administer. A specific module for the Comirnaty (Pfizer) 5 to <12 years of age formulation vaccine is now available.
The module provides information on the handling, storage and administration requirements for this vaccine.
Children who have previously had SARS-CoV-2 infection can receive Comirnaty (Pfizer) 5 to <12 years of age formulation vaccine. Past infection reduces the risk of reinfection for at least 6 months. However, a two-dose primary schedule is recommended in previously infected people and is safe and well tolerated. People with SARS-CoV-2 infection can be vaccinated as soon as they have recovered from their acute illness or can defer vaccination for up to six months after onset of the SARS-CoV-2 infection. People who have received an anti-SARS-CoV-2 monoclonal antibody or convalescent plasma should defer future doses of COVID-19 vaccine for at least 90 days.
No. The Comirnaty (Pfizer) 5 to <12 years of age formulation vaccine is the only vaccine that has been provisionally approved by the Therapeutic Goods Administration (TGA) for use in children aged 5 to <12 years of age.
No. A lower dose of the adult/adolescent formulation MUST NOT be administered to people aged 5 to <12 years of age. The Comirnaty (Pfizer) 5 to <12 years of age formulation vaccine is the only vaccine that has been provisionally approved by the Therapeutic Goods Administration (TGA) for use in children aged 5 to <12 years of age.
The use of the current adult/adolescent formulation (purple cap) would result in an injection volume considered too small for effective delivery of the required dose. The Comirnaty (Pfizer) 5 to <12 years of age formulation vaccine (orange cap) is the only vaccine that has been provisionally approved for use in children aged 5 to <12 years of age by the Therapeutic Goods Administration (TGA). This approval is based on the results of clinical trials demonstrating that the vaccine is highly effective and that most side effects are mild and short-lived.
The remaining excess volume and the vial should be discarded. Do NOT pool excess vaccine from multiple vials.
The multidose vial must be thawed prior to use. Frozen vials should be transferred to an environment of +2°C to +8°C to thaw; a 10 vial pack may take 4 hours to thaw. Additional information is available in the Therapeutic Goods Administration approved Product Information.
Unopened vials can be stored for up to 10 weeks at +20C to +8OC. Additional information is available in the Therapeutic Goods Administration approved Product Information.
Individual frozen vials may be thawed for 30 minutes at temperatures up to +300C for immediate use. Additional information is available in the Therapeutic Goods Administration approved Product Information.
Thawed vaccine must be diluted in its original vial with 1.3mL of sodium chloride 9 mg/L (0.9%) solution (normal saline). Gently invert the diluted suspension 10 times. DO NOT shake. The diluted vaccine should present as a white to off-white suspension. Note the volume for the Comirnaty (Pfizer) 5 to <12 years of age formulation is different to the adolescent/adult formulation.
Do NOT use the vial. Quarantine it in a refrigerator at +2°C to 8°C, clearly labelled "Do not use". Contact the Commonwealth Vaccine Operations Centre (VOC) for advice or on 1800 318 208.
The vaccines should be stored separately to avoid errors and incorrect administration. If they must be stored together in the same fridge/freezer they must be stored in separate areas and be clearly labelled. Vaccines must never be in the same clinical area at the same time including the preparation area when drawing up. Further advice is available on the NSW Health webpage: Process for managing multiple COVID-19 vaccines at the same site.
Advice must be sought from the Commonwealth Vaccine Operations Centre (VOC) for advice or on 1800 318 208.
Clinical advice is also available from the NSW Immunisation Specialist Immunisation Service via email at: SCHN-NSWISS@health.nsw.gov.au. Ensure that you include your name and contact details.
ATAGI recommends a dose interval of 8 weeks apart for children aged 5 to 11 years. ATAGI recommends a longer interval than the manufacturer’s recommended schedule of 2 doses, 3 weeks apart which is described in the product information.
ATAGI has made this recommendation as a longer dosing interval may increase how effective the vaccine is, as well as a potentially increasing the duration of protection. An 8-week interval is recommended by other countries such as Canada.
There is also a population-based study in Canada of people aged 12 years and older, which has shown that the risk of conditions like myocarditis (inflammation of the heart muscle) and pericarditis (inflammation of the outer lining of the heart) might be decreased with a longer interval between the first and second dose.
ATAGI recommends that children who turn 12 years after their first dose should receive the Comirnaty (Pfizer) adolescent/adult formulation COVID-19 vaccine to complete their primary vaccine course.
The preferred anatomical site for intramuscular vaccination of children aged 5 to <12 years of age is the deltoid muscle.
Locate the shoulder tip (acromion) and the muscle insertion at the middle of the humerus (deltoid tuberosity). Draw an imaginary line inverted triangle below the shoulder tip, using the identified anatomical markers. The deltoid site for injection is halfway between the acromion and the deltoid tuberosity, in the middle of the muscle. More information is available on the Australian Government Immunisation Handbook website.
The preferred position will be dependent on a number of factors including the child's age and comfort with vaccination.
Straddle position – sit facing the carer, with child straddling both of the carer's legs. The child's arms should be folded in front, and the carer should hug the child's body to their chest. More information is available on the Australian Government Immunisation Handbook website.
Solo sitting position for deltoid injections:
Common side effects after Comirnaty (Pfizer) vaccine include:
Less common and uncommon side effects after Comirnaty (Pfizer) vaccine include:
Rare side effects that have been reported after Comirnaty (Pfizer) vaccine are:
A patient factsheet is available and can be downloaded.
If a child or adolescent refuses a vaccination that a parent or guardian has given consent for, you should respect the child's or adolescent's wishes, and inform the parent or guardian. More information is available on the Australian Government Immunisation Handbook website.
In phase 2/3 clinical trials, Comirnaty (Pfizer) demonstrated a strong antibody response in children aged 5 to 11 years of age when using a two-dose schedule, given 3 weeks apart. The antibody response in participants given the 5 to <12 years of age (lower) dose, were comparable to those recorded in a study of 16 to 25 year olds.
More information on how effective the vaccine is in a real-world setting and the duration of protection for children aged 5 to 11 years will be available over the coming months.
Contraindications:
Precautions:People with the conditions below should be referred to a medical practitioner for assessment of suitability to be vaccinated.
Parents or guardians with any concerns regarding vaccination should be referred to a medical practitioner for additional advice.
Myocarditis is inflammation of the heart muscle. Pericarditis is inflammation of the outer lining of the heart. Myopericarditis is where these two conditions occur together. There are many conditions that can cause myocarditis and pericarditis, and these include autoimmune conditions, viral and bacterial infection, certain cancers and certain medications. People who get COVID-19 can develop myocarditis and pericarditis.
Myocarditis and pericarditis have been seen in people who have had mRNA COVID-19 vaccines (including the Pfizer vaccine) overseas. Cases have been reported more commonly in males aged <30 years, mostly after the second dose of vaccine and typically within the first few days of COVID-19 vaccination. The exact rate is not yet known but it is rare. Most cases have been mild and respond to simple measures such as pain relief. The WHO's Global Advisory Committee on Vaccine Safety and ATAGI continue to recommend that the benefits of mRNA COVID-19 vaccine strongly outweigh the risk of myocarditis or pericarditis.
Cases of myocarditis and pericarditis after vaccination have also been reported in Australia. The TGA is monitoring these cases. Both these conditions occur relatively commonly in the general population, and not all cases that are reported after vaccination will be caused by the vaccine (that is, some may occur coincidentally).
