COVID-19 Vaccine Janssen (AD26.COV2-S [Recombinant])

Registered South African indications:

• Active immunisation to prevent coronavirus disease-2019 (COVID-19) caused by SARS-CoV-2

Contraindications

Registered contraindications in South Africa & other jurisdictions

• Hypersensitivity to the active ingredient or any of its excipients
• History of confirmed thrombosis with thrombocytopenia syndrome (TTS) following vaccination with any COVID-19 vaccine
• Individuals who have previously experienced episodes of capillary leak syndrome (CLS)

Cautions

• Pregnancy
• Breastfeeding
• Renal impairment
• Hepatic impairment
• Acute severe febrile illness or acute infection (See additional prescribing points)
• Thrombocytopenia
• Coagulation disorders, such as haemophilia
• Immunocompromised or immunosuppressed patients
• Coadministration with immunosuppressant therapy
• Coadministration with anticoagulant therapy
• Coadministration with other vaccines (See additional prescribing points)
• May impair ability to drive or operate machinery

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

South African registered indications and dosages

The use of this vaccine should be in accordance with official recommendations

Active immunisation to prevent coronavirus disease-2019 (COVID-19) caused by SARS-CoV-2

Primary vaccination

• IM: 0.5ml, as a single dose

Booster dose (2nd dose)

• IM: 0.5ml, admin. at least 2 months after primary vaccination; Higher immune responses are observed with an interval up to 6 months between primary vaccination and the booster dose

A booster dose of the COVID-19 vaccine Janssen (0.5ml) may be administered in individuals 18 years of age and older as a heterologous booster dose following completion of primary vaccination with an mRNA COVID-19 vaccine, an adenoviral vector-based COVID-19 vaccine or an inactivated whole-virion COVID-19 vaccine. The dosing interval for the heterologous booster dose is the same as that authorised for a booster dose of the vaccine used for primary vaccination

Not established for use in children below 18 years

Pregnancy

• Caution
• There is limited experience with the use of the COVID-19 Vaccine Janssen (AD26.COV2-S [Recombinant]) in pregnant women
• Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryo/foetal development, parturition or postnatal development
• Administration in pregnancy should only be considered when the potential benefits outweigh any potential risks to the mother and foetus

Breastfeeding

• Caution; no information available
• It is unknown whether the COVID-19 Vaccine Janssen (AD26.COV2-S [Recombinant]) is excreted in human milk
• No effects on the breastfed child are anticipated considering results from animal and human studies with Ad26-based vaccines showing limited dissemination of this non-replicating vector following IM injection. In addition, the possible risk associated with antibodies induced in the breastfeeding mother by the vaccine is considered negligible

Fertility

• Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity. No data are available on fertility in humans following the use of the COVID-19 Vaccine Janssen (AD26.COV2-S [Recombinant])
• A reproductive toxicity study in animals did not reveal any evidence of impaired female fertility. A conventional (repeat-dose) toxicity study did not reveal any effects on male sex organs that would impair male fertility

• Caution; no information available

• Caution; no information available

• No dose adjustment recommended

Central Nervous System Disorders

• Headache
• Tremor
• Fatigue

Respiratory Disorders

• Cough
• Sneezing
• Oropharyngeal pain

Gastrointestinal Disorders

• Nausea

Musculoskeletal Disorders

• Myalgia
• Arthralgia
• Muscular weakness
• Pain in extremities
• Back pain

Skin and Subcutaneous Tissue Disorders

• Urticaria
• Rash
• Hyperhidrosis

Immune, Blood and Lymphatic System Disorders

• Hypersensitivity
• Anaphylaxis
• Fever
• Chills

Others

• Injection site pain
• Injection site erythema
• Injection site swelling

None known

None routine

Additional observations

• Signs and symptoms of anaphylaxis (for ≥15mins after administration)
• Signs and symptoms of anxiety-related reactions, including vasovagal reactions (syncope), hyperventilation or stress‐related reactions

The COVID-19 Vaccine Janssen (AD26.COV2-S [Recombinant]) is a monovalent vaccine composed of a recombinant, replication-incompetent human adenovirus type 26 vector that encodes a SARS-CoV-2 Spike (S) protein in a stabilised conformation. The S protein on the surface of the coronavirus binds to the ACE2 receptor of a host cell allowing the virus to infect the cell. Vaccination with the COVID-19 Vaccine Janssen (AD26.COV2-S [Recombinant]) leads to humoral and cellular immune responses directed against the S protein and in particular the production of neutralising and other functional S antibodies which may block ACE2 receptor binding to the S protein, contributing to protection against COVID-19.

Injection (per 0.5ml) >8.92 log10 infectious units (Inf.U) (per single dose)

• COVID-19 Vaccine Janssen (Janssen Pharmaceutica)

There is limited information regarding the available formulations in South Africa