Covid Suspension

COVID - 19 Vaccine Janssen is a vaccine used for preventing COVID - 19 caused by the SARS - CoV - 2 virus. COVID - 19 Vaccine Janssen is given to adults aged 18 years and older. The vaccine causes the immune system (the body’s natural defences) to produce antibodies and specialised white blood cells that work against the virus, so giving protection against COVID - 19. None of the ingredients in this vaccine can cause COVID - 19.

Do not have the vaccine if

• You are allergic to the active substance or any of the other ingredients of this vaccine (listed in section 6).
• You have had a blood clot occurring at the same time as having low levels of blood platelets (thrombosis with thrombocytopenia syndrome, TTS) after receiving any COVID - 19 vaccine.
• You have a previous diagnosis of capillary leak syndrome, (a condition causing fluid leakage from small blood vessels).

Warnings and precautions

Talk to your doctor, pharmacist or nurse before you are given COVID - 19 Vaccine Janssen if:

• you have ever had a severe allergic reaction after injection of any other vaccine,
• you have ever fainted following any needle injection,
• you have a severe infection with a high temperature (over 38°C). However, you can have your vaccination if you have a mild fever or upper airway infection like a cold,
• you have a problem with bleeding or bruising, or if you are taking an anticoagulant medicine (to prevent blood clots),
• your immune system does not work properly (immunodeficiency) or you are taking medicines that weaken the immune system (such as high-dose corticosteroids, immunosuppressants or cancer medicines),
• you have risk factors for blood clots in your veins (venous thromboembolism (VTE)).

As with any vaccine, vaccination with COVID - 19 Vaccine Janssen may not fully protect all those who receive it. It is not known how long you will be protected.

Your doctor, pharmacist or nurse will inject the vaccine into the muscle - usually in the upper arm.

How much vaccine will you receive

A single-dose primary vaccination (0.5 mL) of COVID - 19 Vaccine Janssen is injected. A booster dose (second dose) of COVID - 19 Vaccine Janssen may be given at least 2 months after the primary vaccination in individuals 18 years of age and older. Higher immune responses are observed with an interval up to 6 months between primary vaccination and the booster dose. COVID - 19 Vaccine Janssen may be administered as a single booster dose to eligible individuals 18 years of age and older who have completed primary vaccination with an mRNA COVID - 19 vaccine, an adenoviral vector-based COVID - 19 vaccine. The dosing interval for the booster dose is the same as that authorised for a booster dose of the vaccine used for primary vaccination.

After the injection your doctor, pharmacist or nurse will watch over you for around 15 minutes to monitor for signs of an allergic reaction.

Like all vaccines, COVID - 19 Vaccine Janssen can cause side effects, although not everybody gets them. Most of the side effects occur in the 1 or 2 days of getting the vaccination. Get medical attention immediately if within 3 weeks of vaccination you get any of the following symptoms:

• experience severe or persistent headaches, blurred vision, mental status changes or seizures (fits);
• develop shortness of breath, chest pain, leg swelling, leg pain or persistent abdominal pain;
• notice unusual skin bruising or pinpoint round spots beyond the site of vaccination.

Get urgent medical attention if you get symptoms of a severe allergic reaction. Such reactions may include a combination of any of the following symptoms:

• feeling faint or light-headed
• changes in your heartbeat
• shortness of breath
• wheezing
• swelling of your lips, face, or throat
• hives or rash
• nausea or vomiting
• stomach pain

The following side effects can happen with this vaccine.

Very common:

may affect more than 1 in 10 people

• headache
• nausea
• muscle aches
• pain where the injection is given
• feeling very tired

Common:

may affect up to 1 in 10 people

• redness where the injection is given
• swelling where the injection is given
• chills
• fever

Uncommon:

may affect up to 1 in 100 people

• rash
• joint pain
• muscle weakness
• arm or leg pain
• feeling weak
• feeling generally unwell
• cough
• sneezing
• sore throat
• back pain
• tremor
• diarrhoea
• vomiting
• dizziness

Rare:

may affect up to 1 in 1000 people

• allergic reaction
• hives
• excessive sweating
• swollen lymph nodes (lymphadenopathy)
• unusual feeling in the skin, such as tingling or crawling feeling (paraesthesia)
• decreased feeling or sensitivity, especially in the skin (hypoaesthesia)
• persistent ringing in the ears (tinnitus)
• blood clots in veins (venous thromboembolism (VTE))
• drooping eyelid and/or sagging muscles usually on one side of the face (“facial palsy” or “Bell’s palsy”), which is usually temporary

Very Rare:

may affect up to 1 in 10000 people

• blood clots often in unusual locations (e.g., brain, liver, bowel, spleen) in combination with low level of blood platelets
• serious nerve inflammation, which may cause paralysis and difficulty breathing (Guillain - Barré syndrome (GBS))

Unknown

(cannot be estimated from the available data)

• severe allergic reaction
• capillary leak syndrome (a condition causing fluid leakage from small blood vessels)
• low levels of blood platelets (immune thrombocytopenia) that can be associated with bleeding (see section 2, ‘Blood Disorders’)
• inflammation of the spinal cord
• inflammation of small blood vessels (small vessel vasculitis) with skin rash or small red or purple, flat, round, spots under the skin’s surface or bruising

Tell your doctor, pharmacist or nurse if you have any side effects that bother you or do not go away.

Reporting of side effects

If you get side effects, talk to your doctor or 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 COVID - 19 Vaccine Janssen.

Keep this vaccine out of the sight and reach of children. Store vial in the original carton to protect from light. Your doctor, pharmacist or nurse is responsible for storing this vaccine and disposing of any unused product correctly. Store and transport frozen at - 25 °C to - 15 °C. The expiry date for storage at - 25 °C to - 15 °C is printed on the vial and outer carton after “EXP”. The vaccine comes ready to use once thawed. The vaccine may be supplied frozen at - 25 °C to - 15 °C or thawed at 2 °C to 8 °C. When stored frozen at - 25 °C to - 15 °C, the vaccine can be thawed either at 2 °C to 8 °C or at room temperature:

• at 2 °C to 8 °C: a carton of 10 or 20 vials will take approximately 13 hours to thaw, and a single vial will take approximately 2 hours to thaw.
• at room temperature (maximally 25 °C): a carton of 10 or 20 vials will take approximately 4 hours to thaw, and a single vial will take approximately 1 hour to thaw.

Do not re-freeze vaccine once thawed. The vaccine can also be stored in a refrigerator or transported at 2 °C to 8 °C for a single period of up to 11 months, not exceeding the original expiry date (EXP). Upon moving the product to 2 °C to 8 °C storage, the updated expiry date must be written on the outer carton and the vaccine should be used or discarded by the updated expiry date. The original expiry date should be crossed out. The vaccine can also be transported at 2 °C to 8 °C as long as the appropriate storage conditions (temperature, time) are applied.