16 Jan, 2021 8:37a.m.

COVID-19 vaccination precautions contraindications

covid-19-vaccination-precautions-contraindications

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 has 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: The second dose should also be of the same COVID-19 vaccine which was administered as the first dose.

Contraindication

  1. Persons with a 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 colouration
AEFI Some mild AEFIs may occur like injection site tenderness, 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
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
Tertiary 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





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