Contraindications and Factsheet for COVID-19 Vaccines

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

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

DR. MANOHAR AGNANI, IAS
Additional Secretary

Dear All,

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

In this regard, a comparative fact-sheet 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 contradistinctions 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.

with kind regards

Enclosure : As above

Yours sincerely,

(Dr. Manohar Agnani)

To,

Additional Chief Secretary/Principal Secretary/Secretary, Health & Family Welfare

All States/UTs

Copy to:

1. Mission Director, NHM, All States/UTs

2. State Immunization Officers, All States/UTs

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

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 RT­PCR 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