Coronavac Suspension

CORONAVAC is indicated for active immunisation to prevent COVID-19 caused by SARS-CoV-2 in individuals 3 to 59 years of age.

CORONAVAC should not be administered to you

• If you are hypersensitive (allergic) to inactivated SARS-CoV-2 virus or any of the other ingredients of CORONAVAC (listed in section 6).

Warnings and precautions

Tell your doctor or health care provider before being given the injection

• If you had an allergic reaction to the first dose of CORONAVAC.
• If you feel anxious or stressed before receiving the injection.
• If you suffer from acute illness, acute infection with fever.
• If you suffer from a mental illness or disease (such as Guillain-Barré syndrome).
• If you have impaired immune function (such as HIV) or receiving immunosuppressant therapy.
• If you suffer from thrombocytopenia or any coagulation disorder (such as haemophilia) as the intramuscular injection of CORONAVAC may cause bleeding or bruising.
• No warning and precaution for use is specific to the paediatric population.

Other medicines and CORONAVAC

Always tell your health care provider if you are taking any other medicine. (This includes all complementary or traditional medicines.) No interaction studies have been performed both in adults and in the paediatric and adolescent population. Concomitant administration of CORONAVAC with other vaccines has not been studied.

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 receiving CORONAVAC. Safety in pregnancy and breastfeeding has not been established.

Driving and using machines

CORONAVAC has no or negligible influence on the ability to drive and use machines. However, some of the side effects mentioned under possible side effects include dizziness and drowsiness which may temporarily affect your ability to drive or use machines.

You will not be expected to give yourself CORONAVAC. It will be given to you by a person who is qualified to do so. CORONAVAC is for intramuscular use only. CORONAVAC should be administered by intramuscular injection in the deltoid muscle of the upper arm.

Usual dose for people aged 18 to 59 years

CORONAVAC is administered as a course of two doses of 0,5 ml each. Dose 1 at the start date. Dose 2 14 to 28 days after first dose. If the second dose is inadvertently administered earlier than 2 weeks after the first, the dose does not need to be repeated. If the second dose is inadvertently delayed beyond 4 weeks, it should be given at the earliest possible opportunity.

It is recommended that all vaccinated individuals receive two doses. According to the current recommendation, the same product should be used for both doses.

People living with HIV/AIDS

The efficacy, safety and immunogenicity of the vaccine has only been evaluated in a limited number of individuals living with HIV/AIDS in China and Brazil. The vaccine was safe in these populations, but the efficacy of the vaccine may be lower.

Paediatric population and adolescents aged 3 to 17 years

The dosage and administration interval for the paediatric and adolescent population is the same as for the individuals aged 18-59 years.

If you receive more CORONAVAC than you should

Since a health care provider will administer CORONAVAC, he/ she will control the dosage. However, in the event of overdosage your doctor will manage the overdosage.

If you missed a dose of CORONAVAC

Since a health care provider will administer CORONAVAC, it is unlikely that the dose will be missed.

CORONAVAC can have side effects. Not all side effects reported for CORONAVAC are included in this leaflet. Should your general health worsen or if you experience any untoward effects while receiving CORONAVAC, please consult your health care provider for advice.

Adults 18 to 59 years of age

If any of the following happens, stop receiving CORONAVAC and tell your doctor immediately or go to the casualty department at your nearest hospital

• swelling of the hands, feet, ankles, face, lips and mouth or throat, which may cause difficulty in swallowing or breathing,
• rash or itching,
• fainting.

These are all very serious side effects. If you have them, you may have had a serious reaction to CORONAVAC. You may need urgent medical attention or hospitalisation.

The following side effects have been reported in clinical trials of CORONAVAC

Very common side effects

• headache
• tiredness
• pain at the site of the injection

Common side effects

• loss of appetite
• blocked nose
• runny nose
• cough
• sore throat
• nausea
• diarrhoea
• stomach pain
• itching
• muscle pain
• joint pain
• feeling of coldness
• swelling, itching, warmth, reddening of the skin or hardening of the skin at the injection site

Uncommon side effects

• allergic reaction
• trembling
• dizziness
• drowsiness
• reddening of the face
• vomiting
• abnormal skin and lining of the mouth
• fever
• water retention

Rare side effects

• eyelid swelling
• eye congestion
• hot flushes
• nosebleed
• constipation
• bloating
• muscle spasms
• reduced ability to smell
• hearing loss

nausea, vomiting, headache, confusion, drowsiness, unsteady walk, weakness in the arms and legs, numbness, trouble with vision, fever

sudden weakness in the facial muscles

brain bleeding

Guillian Barré syndrome (muscle weakness, tingling in the hands and feet, decreased reflexes in the arms and legs)

small, raised areas of bleeding underneath the skin

swelling of the larynx

purple spotted skin rash, stomach pain, upset stomach, inflammation in the joints, swelling and pain

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

Paediatric population and adolescents aged 3 to 17 years

The following side effects have been reported in clinical trials of CORONAVAC

Very common side effects

• pain at the site of the injection

Common side effects

• loss of appetite
• headache
• cough
• runny nose
• pain at the part of the throat at the back of the mouth
• nausea
• swelling at the site of the injection

Uncommon side effects

• fever
• an infection in one or more of the lymph nodes
• hypersensitivity
• dizziness
• inflammation of the eyelid
• pain of the larynx
• inflammation of the pharynx
• upper respiratory tract infection
• chest discomfort
• diarrhoea
• vomiting
• stomach pain
• upper stomach pain
• swelling of the stomach
• pimple or swelling of the skin
• raised, itchy skin rash
• acne
• rash
• reddening of the skin
• itchy skin
• muscle pain
• itching at the site of the injection
• reddening at the site of the injection

Store all medicines out of reach of children.

• Store in a refrigerator (2 - 8 ºC).
• Store in the original package in order to protect from light.
• Do not freeze.
• After first opening, the vaccine should be used immediately.
• Do not use after the expiry date stated on the label / carton.
• Do not dispose of unused medicine in drains or sewerage systems (e.g. toilets).