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Monday, January 18, 2021

 COVID-19 VACCINATION PRECAUTIONS CONTRAINDICATIONS AND SCHEDULED: DIFFERENCE OF COVID-19 VACCINES



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

IndicatorCOVISHIELDCOVAXIN
Type of VaccineRecombinant COVID-19 vaccine based on Viral Vector TechnologyWhole-Virion Inactivated Corona Virus Vaccine
No. of doses in each vial1020
Shelf life6 months6 months
Expiry date available on vialYesYes
Vaccine Vial Monitor (VVM) Not Availablenot available
RouteIntramuscular (IM) Injectable Intramuscular (IM) Injectable
Physical Appearance of VaccineClear to slightly opaque, colourless to slightly brownWhitish translucent
Dose0.5 ml each dose0.5 ml each dose
Course 2-doses2-doses
Schedule4-weeks apart4-weeks apart
Vaccination during Pregnancy Not recommendedNot recommended
Vaccination < 18 years of ageNot recommendedNot recommended
Vaccination to Lactating motherNot recommendedNot 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 packaging2.109 cm31.7187 cm3
Shake test Not applicableNot applicable
Open Vial PolicyNot applicableNot applicable
Freeze SensitiveYesYes
Discard the vaccine vial, if found‘frozen’ or ‘frozen and thawed’‘frozen’ or ‘frozen and thawed’
Discard the vial, ifSolution is discoloured or visible particles are observedPresence of particulate matter or other coloration
AEFISome mild AEFIs may occur like injection site tendenrness, injection site pain, headache, fatigue, myalgia, malaise, pyrexia, chills and arthralgia, nauseaSome 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
AEFIsite 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 detailsDosesDimensionTotal Volume
COVISHIELDCOVAXINCOVISHIELDCOVAXINCOVISHIELDCOVAXIN
Primary

10

10

21.09 cm334.37 cm3
Secondary500320L-18.5 cm, W-9.5 cm, H- 6cmL-10 cm, W- 10cm, H-5.5 cm1053 cm3550 cm3
Teritiary3,0007680L-31 cm, W-19 cm, H- 13.3 cmL-41 cm, W-20 cm, H- 18cm7833 cm314760 cm3
Quaternary (A)*12,000Not ApplicableL-57.9 cm, W-46.4 cm, H- 37 cmNot Applicable99402 cm3Not Applicable
Quaternary (B)12,000Not ApplicableL-60 cm, W-48 cm, H- 41 cmNot Applicable1,18,080 cm3Not Applicable


Source: MoHFW

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