Vaccine Specific Information

3. Janssen
It is a recombinant, replication-incompetent adenovirus serotype 26 vector encoding a full-length and stabilized SARS-CoV-2 spike protein. It is recommended for people who are 18 years age and above.

Characteristics:

Preservative-free, multi-dose suspension for injection.
One vial (2.5 mL) contains 5 doses of vaccine.
A single dose schedule.
It is given intramuscular; the preferred site is deltoid muscle.

Administration:

Thaw vaccine at room temperature up to 25 °C; individual vials take about 1 hour to thaw and a carton of 10 vials takes about 2 hours to thaw, or
Thaw vaccine in refrigerator at +2 to +8 °C, individual vials take about 2 hours to thaw and a carton of 10 vials takes about 12 hours to thaw.
Once thawed, the vaccine is ready to use, do not dilute it.
Swirl the vial gently in an upright position for 10 seconds, do not shake.
Inspect the vial visually to make sure that the liquid is colorless to slightly yellow, and clear to very opalescent suspension.

Handling:

The vaccine is provided to countries at -20°C with a shelf life of 24 months in a multi-dose vial containing 5 doses (0.5ml each).
It can be stored at +2°C to +8°C for 3 months.
Once thawed the vaccine should not be re-frozen.
The vials should be protected from light.
After the first dose has been withdrawn, the vial should be held between at +2°C to +8°C for not longer than 6 hours, discard after six hours of opening or at the end of the session.
Thawed unopened vaccine vial in refrigerator at +2 to +8 °C: once removed from the freezer, for a single period of up to 3 months.
The expiry date must be updated when the vaccine is removed from the freezer and before it is stored in the refrigerator.
If a 3-month period is within expiry date, cross out the expiry date on the outer carton to mark as not valid and write down the new expiry date which would be 3 months from the date you removed the vaccine from the freezer.
If a 3-month period is longer than the original expiry date printed on the outer carton, respect the original expiry date.

Adverse events following immunization:

Most adverse events occurred 1 to 2 days following vaccination.
The events were mild to moderate in severity and usually resolved within 1 to 2 days.
Observed events were generally milder and less frequently reported in older adults (≥60 years) than in younger adults.
Very common AEFIs: injection site pain, headache, fatigue and myalgia.
Common AEFIs: fever, fatigue, myalgia and arthralgia.
Rare AEFI: Guillain Barre syndrome.

Contraindication:

A history of anaphylaxis to any component of the vaccine

Precautions:

Assess each person for a very rare syndrome of blood clotting described as thrombosis with thrombocytopenia syndrome.
Patients who are taking blood thinner, the benefit and risk has to be discussed with the patient.