Comirnaty Dilute To Use Paediatric Vaccine 10 micrograms

COMIRNATY DILUTE TO USE PAEDIATRIC VACCINE is a vaccine used for preventing COVID-19 caused by SARS-CoV-2. COMIRNATY DILUTE TO USE PAEDIATRIC VACCINE 10 micrograms/dose concentrate for dispersion for injection is given to children from 5 to 11 years of age. The vaccine causes the immune system (the body’s natural defences) to produce antibodies and blood cells that work against the virus, so giving protection against COVID-19. As COMIRNATY DILUTE TO USE PAEDIATRIC VACCINE does not contain the virus to produce immunity, it cannot give your child COVID-19.

COMIRNATY DILUTE TO USE PAEDIATRIC VACCINE should not be administered:

• if your child is hypersensitive (allergic) to COVID - 19 mRNA vaccine (nucleoside modified) or any of the other ingredients of COMIRNATY DILUTE TO USE PAEDIATRIC VACCINE (listed in section 6).

Warnings and precautions

Tell your doctor or health care provider before your child is given the vaccine if your child:

• has ever had a severe allergic reaction or breathing problems after any other vaccine injection or after having been given COMIRNATY DILUTE TO USE PAEDIATRIC VACCINE in the past
• is feeling nervous about the vaccination process or have ever fainted following any needle injection
• has a severe illness or infection with high fever. However, your child can have the vaccination if he/she have a mild fever or upper airway infection like a cold
• has a bleeding problem, bruises easily or uses a medicine to prevent blood-clots
• has a weakened immune system, because of a disease such as HIV infection or a medicine such as corticosteroid that affects your child’s 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 DILUTE TO USE PAEDIATRIC VACCINE (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. 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.

COMIRNATY DILUTE TO USE PAEDIATRIC VACCINE may not fully protect all those who receive it and it is not known how long your child will be protected. Your child may receive a third dose of COMIRNATY DILUTE TO USE PAEDIATRIC VACCINE. The efficacy of COMIRNATY DILUTE TO USE PAEDIATRIC VACCINE, even after a third dose, may be lower in people who are immunocompromised. In these cases, you/your child should continue to maintain physical precautions to help prevent COVID-19. In addition, your/your child’s close contacts should be vaccinated as appropriate. Discuss appropriate individual recommendations with your health care provider.

Due the evolution of SARS CoV2 variants in South Africa, vaccinated patients are advised to report any COVID or suspected COVID to their doctor to enable collection of virus samples for analysis.

Children

COMIRNATY DILUTE TO USE PAEDIATRIC VACCINE is not recommended for children aged under 5 years.

Other medicines and COMIRNATY DILUTE TO USE PAEDIATRIC VACCINE

Always tell your health care provider if your child is taking, has recently taken, might take any other medicine or has recently received any other vaccine. (This includes all complementary or traditional medicines.)

Pregnancy and breastfeeding

If your child is pregnant or breastfeeding, think your child may be pregnant, please consult your doctor, pharmacist or other health care provider for advice before your child receives this vaccine. COMIRNATY DILUTE TO USE PAEDIATRIC VACCINE can be used during pregnancy. A large amount of information from pregnant women vaccinated with COMIRNATY DILUTE TO USE PAEDIATRIC 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 DILUTE TO USE PAEDIATRIC VACCINE can be given during breastfeeding.

You or your child will not be expected to administer COMIRNATY DILUTE TO USE PAEDIATRIC VACCINE. It will be given to you by a person who is qualified to do so. COMIRNATY DILUTE TO USE PAEDIATRIC VACCINE is given after dilution as an injection of 0,2 mL into a muscle of your upper arm. Your child will receive 2 injections. It is recommended to receive the second dose of the same vaccine 3 weeks after the first dose to complete the vaccination course. If your child is immunocompromised, he or she may receive a third dose of COMIRNATY DILUTE TO USE PAEDIATRIC VACCINE at least 28 days after the second dose. If you have the impression that the effect of COMIRNATY DILUTE TO USE PAEDIATRIC VACCINE on your child is too strong or too weak, tell your doctor or pharmacist.

If your child receives more COMIRNATY DILUTE TO USE PAEDIATRIC VACCINE than he/she should Since a health care provider will administer COMIRNATY DILUTE TO USE PAEDIATRIC VACCINE, he/she will control the dosage. However, in the event of overdosage your doctor will manage the overdosage.

If your child forgets to receive COMIRNATY DILUTE TO USE PAEDIATRIC VACCINE Since a health care provider will administer COMIRNATY DILUTE TO USE PAEDIATRIC VACCINE, it is unlikely that the dose will be missed.

COMIRNATY DILUTE TO USE PAEDIATRIC VACCINE can have side effects. Not all side effects reported for COMIRNATY DILUTE TO USE PAEDIATRIC VACCINE are included in this leaflet. Should your child’s general health worsen or if he/she experiences any untoward effects while taking COMIRNATY DILUTE TO USE PAEDIATRIC VACCINE, please consult your health care provider for advice.

Adverse effects reported in clinical trials. Tell your doctor if you notice any of the following:

Frequent side effects

• headache
• nausea
• joint pain
• muscle pain
• injection site pain
• tiredness
• chills
• fever
• injection site swelling
• injection site redness

Less frequent side effects

• enlarged lymph nodes (more frequently observed after the booster dose)
• allergic reactions such as rash or itching, hives or swelling of the face
• decreased appetite
• difficulty sleeping
• feeling weak or lack of energy/sleepy
• excessive sweating
• night sweats
• arm pain
• feeling unwell
• injection site itching
• temporary one-sided facial drooping
• severe allergic reaction

If you notice any side effects not mentioned in this leaflet, please inform your doctor or pharmacist.

Post - marketing side effects

• unusual feeling in the skin, such as tingling or a crawling feeling (paraesthesia)
• decreased feeling or sensitivity, especially in the skin (hypoaesthesia)
• inflammation of the heart muscle (myocarditis) or inflammation of the lining outside the heart (pericarditis) which can result in breathlessness, palpitations or chest pain
• diarrhoea
• vomiting
• a skin reaction that causes red spots or patches on the skin, that may look like a target or “bulls-eye” with a dark red center surrounded by paler red rings (erythema multiforme)
• extensive swelling of the vaccinated limb
• swelling of the face (swelling of the face may occur if you have had facial dermatological fillers)

Reporting of side effects If your child gets side effects, talk to your doctor, pharmacist or nurse. You can also report side effects to SAHPRA via the “6.04 Adverse Drug Reaction Reporting Form”, found online under SAHPRA’s publications:

https://www.sahpra.org.za/Publications/Index/8. By reporting side effects, you can help provide more information on the safety of COMIRNATY DILUTE TO USE PAEDIATRIC VACCINE.

Store all medicines out of reach of children. The following information about storage, expiry and use and handling is intended for health care providers.

• Do not use this medicine after the expiry date which is stated on the carton and label after EXP. The expiry date refers to the last day of that month.
• Store in freezer at -90 °C to -60 °C.
• Store in the original package in order to protect from light.
• The vaccine may be received frozen at -90 °C to -60 °. Frozen vaccine can be stored either at -90 °C to -60 °C or 2 °C to 8 °C upon receipt.
• When stored frozen at -90 °C to -60 °C, 10-vial packs of the vaccine can be thawed at 2 °C to 8 °C for 4 hours or individual vials can be thawed at room temperature (up to 30 °C) for 30 minutes.
• Once removed from the freezer, the unopened vial may be stored refrigerated at 2 °C to 8 °C for up to 10 weeks; not exceeding the printed expiry date (EXP). The outer carton should be marked with the new discard date at 2 °C to 8 °C. Once thawed, the vaccine cannot be re-frozen.
• Prior to use, the unopened vials can be stored for up to 12 hours at temperatures between 8 °C and 30 °C.
• Thawed vials can be handled in room light conditions.
• After dilution, store and transport the vaccine at 2 °C to 30 °C and use within 12 hours which includes up to 6 hours transportation time. Discard any unused vaccine.
• Do not use this vaccine if you notice particulates in the dilution or discolouration.
• Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).