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FACT SHEETS OF INDIAN COVID-19 VACCINES

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FACTSHEETS OF INDIAN COVID-19 VACCINES

Precautions and Contraindications for COVID-19 Vaccination
1. Authorized Age Group: Under the EUA, COVID-19 vaccination is indicated only for 18 years and above.
2. Co-administration of vaccines: If required, COVID-19 vaccine and other vaccines should be separated by an interval of at least 14 days
3. Interchangeability of COVID-19 Vaccines is not permitted: Second dose should also be of the same COVID-19 vaccine which was administered as the first dose.

Contraindication
1. Persons with history of:
• Anaphylactic or allergic reaction to a previous dose of COVID-19 vaccine
• Immediate or delayed-onset anaphylaxis or allergic reaction to vaccines or injectable therapies, pharmaceutical products, food-items etc.
2. Pregnancy & Lactation:
• Pregnant & Lactating women have not been part of any COVID-19 vaccine clinical trial so far. Therefore, women who are pregnant or not sure of their pregnancy; and lactating women should not receive COVID-19 vaccine at this time

Provisional / temporary contraindications: In these conditions, COVID vaccination is to be deferred for 4-8 weeks after recovery
1. Persons having active symptoms of SARS-CoV-2 infection.
2. SARS-COV-2 patients who have been given anti-SARS-CoV-2 monoclonal antibodies or convalescent plasma
3. Acutely unwell and hospitalized (with or without intensive care) patients due to any illness Special precautions: Vaccine should be administered with caution in persons with history of any bleeding or coagulation disorder (e.g., clotting factor deficiency, coagulopathy or platelet disorder).

Following conditions are not contraindicated for COVID vaccines
• Persons with a past history of SARS-CoV-2 infection (sero-positivity) and or RT- PCR positive illness
• History of chronic diseases and morbidities (cardiac, neurological, pulmonary, metabolic, renal, malignancies)
• Immuno-deficiency, HIV, patients on immune-suppression due to any condition (the response to the COVID 19 vaccines may be less in these individuals) Other Important Issues to consider
• Vaccine specific contraindications may apply as the new information becomes available


COVISHIELD

Type of Vaccine: Recombinant COVID-19 vaccine based on Viral Vector Technology
No. of doses in each vial : 10
Shelf life : 6 months
Expiry date available on vial : Yes
Vaccine Vial Monitor (VVM) : Not Available
Route : Intramuscular (IM) Injectable
Physical Appearance of : Clear to slightly opaque, colourless
Vaccine : to slightly brown
Dose : 0.5 ml each dose
Course : 2-doses
Schedule : 4-weeks apart
Vaccination during Pregnancy : Not recommended
Vaccination < 18 years of age : Not recommended
Vaccination to Lactating mother : Not recommended
Storage and transportation : +2°C to +8°C at all levels
Cold chain storage space in secondary packaging : 2.109 cm3
Shake test : Not applicable
Open Vial Policy : Not applicable
Freeze Sensitive : Yes
Discard the vaccine vial, if found: ‘frozen’ or ‘frozen and thawed’
Discard the vial, if : Solution is discoloured or visible particles are observed, Some mild AEFI may occur like, injection site tenderness, injection
AEFI : site pain, headache, fatigue, myalgia, malaise, pyrexia, chills and arthralgia, nausea
AEFI : Paracetamol may be used to provide
Other: symptomatic relief from post­vaccination adverse reactions Very rare events of demyelinating disorders have been reported following vaccination with this Vaccine without the causal relationship establishment As with other intramuscular injections, COVISHIELD should be given with caution to individuals with thrombocytopenia

COVAXIN

Type of Vaccine : Whole-Virion Inactivated Corona Virus Vaccine
No. of doses in each vial : 20
Shelf life : 6 months
Expiry date available on vial : Yes
Vaccine Vial Monitor (VVM) : not available
Route : Intramuscular (IM) Injectable
Physical Appearance of Vaccine : Whitish translucent
Dose : 0.5 ml each dose
Course : 2-doses
Schedule : 4-weeks apart
Vaccination during Pregnancy : Not recommended
Vaccination < 18 years of age : Not recommended
Vaccination to Lactating mother : Not recommended
Storage and transportation : +2°C to +8°C at all levels
Cold chain storage space in secondary packaging: 1.7187 cm3
Shake test : Not applicable
Open Vial Policy : Not applicable
Freeze Sensitive : Yes
Discard the vaccine vial, if found: ‘frozen’ or ‘frozen and thawed’
Discard the vial, if : Presence of particulate matter or other coloration Some mild AEFIs may occur like injection site pain, headache, fatigue, fever, body
AEFI : ache, abdominal pain, nausea and vomiting, dizziness-giddiness, tremor, sweating, cold, cough and injection site swelling
Any other instruction : Shake well, before use Use of Chloroquine and Corticosteroids may impair antibody response.


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Packaging details

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