Precautions and Contraindications for COVID-19 Vaccination

Precautions and Contraindications for COVID-19 Vaccination – Comparative Sheet for different Covid-19 vaccines, under Indian Government supply: MoHFW

GOVERNMENT OF INDIA
MINISTRY OF HEALTH & FAMILY WELFARE
NIRMAN BHAVAN, NEW DELHI – 110011

DO No. T-22020/14/2020-Imm
Date: 14th January 2021

Dear All,

As you are aware that COVID-19 vaccine is scheduled for roll-out in the country on 16th January 2021 and the States/UTs have already received vaccines for the same.

In this regard, a comparative factsheet for both the vaccines that will be used during the introduction have been prepared which contains information on vaccine platform, physical specifications, dosage, cold chain storage requirements, contraindications and minor AEFIs. A detailed note on contraindications and special precautions has also been prepared and is enclosed.

You are requested to kindly disseminate the above mentioned documents to Programme Managers across all levels and through them to cold chain handlers and vaccinators for ready reference.

Enclosure: As above

Yours sincerely,

(Dr. Manohar Agnani)

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)
Vaccine specific contraindications may apply as the new information becomes available

Comparative Sheet for different Covid-19 vaccines, under Indian Government supply

Indicator	COVISHIELD	COVAXIN
Type of Vaccine	Recombinant COVID-19 vaccine based on Viral Vector Technology	Whole-Virion Inactivated Corona Virus Vaccine
No. of doses in each vial	10	20
Shelf life	6 months	6 months
Expiry date available on vial	Yes	Yes
Vaccine Vial Monitor (VVM)	Not Available	not available
Route	Intramuscular (IM) Injectable	Intramuscular (IM) Injectable
Physical Appearance of Vaccine	Clear to slightly opaque, colourless to slightly brown	Whitish translucent
Dose	0.5 ml each dose	0.5 ml each dose
Course	2-doses	2-doses
Schedule	4-weeks apart	4-weeks apart
Vaccination during Pregnancy	Not recommended	Not recommended
Vaccination < 18 years of age	Not recommended	Not recommended
Vaccination to Lactating mother	Not recommended	Not recommended
Storage and transportation	+2°C to +8°C at all levels	+2°C to +8°C at all levels
Cold chain storage space in secondary packaging	2.109 cm3	1.7187 cm3
Shake test	Not applicable	Not applicable
Open Vial Policy	Not applicable	Not applicable
Freeze Sensitive	Yes	Yes
Discard the vaccine vial, if found	‘frozen’ or ‘frozen and thawed’	‘frozen’ or ‘frozen and thawed’
Discard the vial, if	Solution is discoloured or visible particles are observed	Presence of particulate matter or other coloration
AEFI	Some mild AEFIs may occur like injection site tendenrness, injection site pain, headache, fatigue, myalgia, malaise, pyrexia, chills and arthralgia, nausea	Some mild may occur like injection site pain, headache, fatigue, fever, body ache, abdominal pain, nausea and vomiting, dizziness-giddiness, tremor, sweating, cold, cough and injection site swelling
AEFI	site pain, headache, fatigue, myalgia, malaise, pyrexia, chills and arthralgia, nausea
AEFI Other	Paracetamol may be used to provide symptomatic relief from post-vaccination 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
Any other instruction		Shake well, before use Use of Chloroquine and Corticosteroids may impair antibody response.

Packaging details —

Packaging details	Doses		Dimension		Total Volume
Packaging details	COVISHIELD	COVAXIN	COVISHIELD	COVAXIN	COVISHIELD	COVAXIN
Primary	10	10			21.09 cm3	34.37 cm3
Secondary	500	320	L-18.5 cm, W-9.5 cm, H- 6cm	L-10 cm, W- 10cm, H-5.5 cm	1053 cm3	550 cm3
Teritiary	3,000	7680	L-31 cm, W-19 cm, H- 13.3 cm	L-41 cm, W-20 cm, H- 18cm	7833 cm3	14760 cm3
Quaternary (A)*	12,000	Not Applicable	L-57.9 cm, W-46.4 cm, H- 37 cm	Not Applicable	99402 cm3	Not Applicable
Quaternary (B)	12,000	Not Applicable	L-60 cm, W-48 cm, H- 41 cm	Not Applicable	1,18,080 cm3	Not Applicable