COVID-19 Vaccine Covishield (ChAdOx1 nCoV-19 [Recombinant])

Registered indications:

• Active immunisation for the prevention of coronavirus disease 2019 (COVID-19) 

Contraindications

• Hypersensitivity to the active ingredient or any of its excipients

Cautions

• Pregnancy
• Breastfeeding
• Renal impairment
• Hepatic impairment
• Concurrent illness
  - Acute severe febrile illness
• Thrombocytopenia or any coagulation disorder
• Immunocompromised individuals
  - Patients on immunosuppressant therapy
• Interchanging with other COVID-19 vaccines
• Coadministration with anticoagulation therapy
• Coadministration with other vaccines
• May impair ability to drive and operate machinery

Forms avail. in SA and covered in this monograph: inj

Active immunisation for the prevention of coronavirus disease 2019 (COVID-19) 

• IM: 1st dose: 0.5ml; 2nd dose: 0.5ml, given at 4-6 weeks after the 1st dose

There is data available for administration of the second dose up to 12 weeks after the first dose from the overseas studies 

COVID-19 Vaccine Covishield (ChAdOx1 nCoV-19 [Recombinant]) is for intramuscular (IM) injection only, preferably in the deltoid muscle 

It is recommended that individuals who receive the first dose complete the vaccination course with COVID-19 Vaccine Covishield (ChAdOx1 nCoV-19 [Recombinant]) 

There is limited information available regarding the current scheduling status of the COVID-19 Vaccine Covishield (ChAdOx1 nCoV-19 [Recombinant]) in South Africa

Not established for use in children below 18 years 

Pregnancy

• Caution
• There is a limited experience with the use of COVID-19 Vaccine Covishield (ChAdOx1 nCoV-19 [Recombinant]) in pregnant women
• Preliminary animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryofetal development, parturition or postnatal development; definitive animal studies have not been completed yet. The full relevance of animal studies to human risk with vaccines for COVID-19 remains to be established
• Administration of COVID-19 Vaccine Covishield (ChAdOx1 nCoV-19 [Recombinant]) in pregnancy should only be considered when the potential benefits outweigh any potential risks for the mother and foetus

Breastfeeding

• Caution; no information available 
• It is unknown whether COVID-19 Vaccine Covishield (ChAdOx1 nCoV-19 [Recombinant]) is excreted in human milk

Fertility

• Preliminary animal studies do not indicate direct or indirect harmful effects with respect to fertility

Renal Impairment

• Caution; no information available

Hepatic Impairment

• Caution; no information available

Elderly

• No dose adjustment recommended 
  Efficacy and safety data are currently limited in individuals ≥65 years of age. No dosage adjustment is required in elderly individuals ≥65 years of age

Drugs in Sport

• Permitted - No warnings

Central Nervous System Disorders

• Headache
• Dizziness
• Fatigue

Gastrointestinal Disorders

• Nausea and vomiting
• Abdominal pain

Endocrine and Metabolic Disorders

• Decreased appetite

Musculoskeletal Disorders

• Myalgia
• Arthralgia

Skin and Subcutaneous Tissue Disorders

• Hyperhidrosis
• Pruritis
• Rash
• Injection site
  - Tenderness
  - Pain
  - Warmth
  - Pruritus
  - Swelling
  - Bruising
  - Induration
  - Haematoma
  - Redness
  - Itch

Immune, Blood and Lymphatic System Disorders

• Lymphadenopathy
• Fever
• Chills
• Influenza-like illness
• Neuroinflammatory disorders

No information available

None routine

Additional observations

• Hypersensitivity reactions, such as anaphylactic events (following administration)

Administration directions

• COVID-19 Vaccine Covishield (ChAdOx1 nCoV-19 [Recombinant]) is a colourless to slightly brown, clear to slightly opaque solution. The vaccine should be inspected visually prior to administration and discarded if particulate matter or differences in the described appearance are observed
• The vaccine does not contain any preservative. Aseptic technique should be used for withdrawing the dose for administration
• To facilitate the traceability of the vaccine, the name and the batch number of the administered product must be recorded for each recipient
• COVID-19 Vaccine Covishield (ChAdOx1 nCoV-19 [Recombinant]) contains genetically modified organisms (GMOs)
• In the absence of compatibility studies, this vaccine must not be mixed with other medicinal products

Use and disposal

• Once opened, multi-dose vials should be used as soon as practically possible and within 6 hours when kept between +2ºC and +25ºC
• Any unused vaccine or waste material should be disposed of in accordance with local requirements. Spills should be disinfected with an appropriate antiviral disinfectant (e.g. Hydrogen peroxide-based disinfectants)

Interchangeability

• No data are available on the use of COVID-19 Vaccine Covishield (ChAdOx1 nCoV-19 [Recombinant]) in persons that have previously received partial vaccine series with another COVID-19 vaccine

A monovalent vaccine composed of a single recombinant, replication-deficient chimpanzee adenovirus (ChAdOx1) vector encoding the S glycoprotein of SARS-CoV-2. Following administration, the S glycoprotein of SARS-CoV-2 is expressed locally stimulating neutralising antibody and cellular immune responses. 

Injection (per 0.5ml) 5×10¹⁰ virus particles*

• Covishield (Serum Institute of India)

Injection (per 1.0ml) 2×5×10¹⁰ virus particles

• Covishield (Serum Institute of India)

Injection (per 2.5ml) 5×5×10¹⁰ virus particles

• Covishield (Serum Institute of India)

Injection (per 5.0ml) 10×5×10¹⁰ virus particles

• Covishield (Serum Institute of India)

Injection (per 10.0ml) 20×5×10¹⁰ virus particles

• Covishield (Serum Institute of India)

*5×10¹⁰ vp = 1 dose

There is limited information regarding the available formulations in South Africa