Comirnaty 30 micrograms Injection

COMIRNATY is a vaccine used for preventing COVID-19 caused by SARS-CoV-2 virus. COMIRNATY 30 micrograms/dose concentrate for dispersion for injection is given to adults and adolescents from 12 years of age and older.

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 does not contain the virus to produce immunity, it cannot give you COVID-19.

COMIRNATY should not be administered to you:

• if you are hypersensitive (allergic) to COVID-19 mRNA vaccine (nucleoside modified) or any of the other ingredients of COMIRNATY (listed in section 6).

Warnings and precautions

Tell your doctor or health care provider before you are given the vaccine:

• if you have ever had a severe allergic reaction or breathing problems after any other vaccine injection or after you were given COMIRNATY in the past
• if you are feeling nervous about the vaccination process or have ever fainted following any needle injection
• if you have a severe illness or infection with high fever. However, you can have your vaccination if you have a mild fever or upper airway infection like a cold
• if you have a bleeding problem, you bruise easily or you use a medicine to prevent blood-clots
• if you have a weakened immune system, because of a disease such as HIV infection or a medicine such as corticosteroid that affects your 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 (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. The risk of myocarditis and pericarditis seems lower in children ages 5 to 11 years compared with ages 12 to 17 years. 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.

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

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

Children

COMIRNATY READY TO USE ADULT VACCINE 30 micrograms/dose dispersion for injection is not recommended for children aged under 12 years. There is a paediatric presentation available for children 5 to 11 years of age (i.e. 5 to less than 12 years of age). For details, please refer to the patient information leaflet for COMIRNATY DILUTE TO USE PAEDIATRIC VACCINE 10 micrograms/dose concentrate for dispersion for injection. COMIRNATY is not recommended for infants under 6 months of age.

Other medicines and COMIRNATY

Always tell your health care provider if you are taking any other medicine. (This includes all complementary or traditional medicines.)

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, please consult your doctor, pharmacist or other health care provider for advice before you receive this vaccine.

You will not be expected to give yourself COMIRNATY. It will be given to you by a person who is qualified to do so. COMIRNATY is given after dilution as an injection of 0,3 mL into a muscle of your upper arm. You 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 you are immunocompromised, you may receive a third dose of COMIRNATY at least 28 days after the second dose. A booster dose of COMIRNATY may be given at least 3 months after the most recent dose of a COVID-19 vaccine in individuals 12 years of age and older. Please check with your healthcare provider regarding eligibility for and timing of the booster dose.

If you have the impression that the effect of COMIRNATY is too strong or too weak, tell your doctor or pharmacist.

If you receive more COMIRNATY than you should Since a health care provider will administer COMIRNATY, he/she will control the dosage. However, in the event of overdosage your doctor will manage the overdosage.

If you forget to receive COMIRNATY Since a health care provider will administer COMIRNATY, it is unlikely that the dose will be missed.

COMIRNATY can have side effects. Not all side effects reported for COMIRNATY are included in this leaflet. Should your general health worsen or if you experience any untoward effects while taking COMIRNATY, 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

Some of these side effects were slightly more frequent in adolescents 12 to 15 years than in adults.

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

Other side effects

• heavy menstrual bleeding (most cases appeared to be non-serious and temporary in nature)

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)
• dizziness
• 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 cosmetic injections)

Reporting of side effects If you get 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.

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. Unopened vials may be stored and transported at -25 °C to -15 °C for a single period of up to 2 weeks and can be returned to -90 °C to -60 °C; not exceeding the printed expiry date (EXP).

Store in the original package in order to protect from light.

• When stored frozen at -90 °C to -60 °C, 195-vial packs of the vaccine can be thawed at 2 °C to 8 °C for 3 hours or individual vials can be thawed at room temperature (up to 30 °C) for 30 minutes.

Transfers of frozen vials stored at ultra-low temperature (< -60 °C)

• Closed-lid vial trays containing 195 vials removed from ultra-low temperature frozen storage (< -60 °C) may be at temperatures up to 25 °C for up to 5 minutes.
• Open-lid vial trays, or vial trays containing less than 195 vials, removed from ultra-low temperature frozen storage (< -60 °C) may be at temperatures up to 25 °C for up to 3 minutes.
• After vial trays are returned to frozen storage following temperature exposure up to 25 °C, they must remain in frozen storage for at least 2 hours before they can be removed again.

Transfers of frozen vials stored at -25 °C to -15 °C

• Closed-lid vial trays containing 195 vials removed from frozen storage (-25 °C to -15 °C) may be at temperatures up to 25 °C for up to 3 minutes.
• Open-lid vial trays, or vial trays containing less than 195 vials, removed from frozen storage (-25 °C to -15 °C) may be at temperatures up to 25 °C for up to 1 minute.

Once a vial is removed from the vial tray, it should be thawed for use.

• After thawing, the vaccine should be diluted and used immediately. However, in-use stability data have demonstrated that once removed from freezer, the undiluted vaccine can be stored for up to 1 month at 2 °C to 8 °C; not exceeding the printed expiry date (EXP). Within the 1-month shelf-life at 2 °C to 8 °C, up to 48 hours may be used for transportation.
• Prior to use, the unopened vaccine can be stored for up to 2 hours at temperatures up to 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 6 hours. Discard any unused vaccine.
• Once removed from the freezer and diluted, the vials should be marked with the date and time. Once thawed, the vaccine cannot be re-frozen.
• Do not use this vaccine if you notice particulates in the dilution or discolouration.
• Return all unused medicine to your pharmacist.
• Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).