Reference material

1 : National Immunization Schedule (NIS) for Infants and Children

Vaccine Age (When to give) Dose Route Site

For Infants
BCG At birth or within 1 0.05ml (0.1ml ≥ 1 Intra-dermal Left Upper Arm
year of age mth age)
Hepatitis B - Birth At birth or within 24 0.5 ml Intra-muscular Antero-lateral side
dose hours of mid-thigh
OPV-0 At birth or within the 2 drops Oral
first 15 days
OPV 1, 2 & 3 2 drops Oral
At 6 weeks, 10 weeks
Pentavalent 1, 2 & 14 weeks (OPV 0.5 ml Intra-muscular Antero-lateral side
&3 can be given till 5 of mid-thigh
Rotavirus years of age) 5 drops Oral
IPV Two fractional doses 0.1 ml Intra dermal Intra-dermal:
at 6 and 14 weeks of Right upper arm
age
Measles/ MR* 9 mths - 12mths (can 0.5 ml Sub-cutaneous Right upper Arm
be given till 5 years of
age)
JE - 1* 9 mths - 12mths 0.5 ml Sub-cutaneous Left upper Arm
For Children
OPV Booster 2 drops Oral
DPT booster-1 Intra-muscular Antero-lateral side
16-24 months 0.5 ml of mid-thigh
MCV Sub-cutaneous Right upper Arm
JE-2* Sub-cutaneous Left Upper Arm
DPT Booster-2 5-6 years Intra-muscular Upper Arm
TT 10 years & 16 years Intra-muscular Upper Arm
* JE Vaccine available in select endemic districts.
Pneumococcal vaccine is in the process of introduction
MR – Measles and Rubella combined vaccine is given in a few states

Ref: https://mohfw.gov.in/sites/default/files/245453521061489663873.pdf

http://vikaspedia.in/health/child-health/immunization#section-1

2: Common minor ADR to vaccines and their incidence

Vaccine Local adverse events Fever Irritability, malaise and

(pain, swelling, redness) (> 38°C) systemic symptoms
Pertussis (DTwP) up to 50% up to 50% up to 55%
BCG 90-95% - -
Tetanus ~ 10% ~ 10% ~ 25%
MCV ~10% 5-15% 5% (Rash)
Hepatitis B 5% 1-6% -
Hib 5-15% 2-10% -
OPV None Less than 1% Less than 1%
Ref: Adverse event following Immunization: Surveillance and Response Operational Guidelines, 2015.
Ministry of health and family welfare, Government of India.

3: Frequency and nature of serious vaccine reactions

Vaccine Reaction Onset interval Incidence

Pertussis Prolonged (>3 hours) crying and <1 /100
(DTwP) seizures
0-24 hours
Hypotonic, hyporesponsive 1 to 2 /1,000
episode (HHE)

MCV Febrile seizures 6-12 days 1 / 3,000

Thrombocytopenia 15-35 days 1 / 30,000

Anaphylaxis 0-1 hour 1 / 1,00,000

Rotavirus Intussusception 3-14 days 1 to 2 / 1,00,000

BCG Disseminated BCG infection 1-12 months 0.19 to 1.56/ 10,00,000
Oral Vaccine associated paralytic 4-30 days 2 to 4 / 10,00,000
poliomyelitis poliomyelitis
Ref: Adverse event following Immunization: Surveillance and Response Operational Guidelines, 2015.
Ministry of health and family welfare, Government of India.

4: Types of Immunisation errors with examples and adverse reactions

Immunization errors Examples Related reaction

Errors in vaccine/ diluent Exposure to excessive Systemic or local reactions
handling temperatures due to incorrect
transport, storage or handling of
the vaccine/ diluent.
Use of a vaccine after its expiry
date. Failure to vaccinate as a result of loss
of potency

Errors in vaccine Failure to adhere to a Anaphylaxis, disseminated infection

prescribing contraindication. with an attenuated live vaccine.

Failure to adhere to vaccine Systemic and/or local reactions,

indications or prescription (dose neurological, muscular, vascular or
or schedule). bony injury due to incorrect
injection site or technique.
Errors in administration Using an incorrect diluent or Failure to vaccinate due to incorrect
injection of a product other than diluent.
the intended vaccine. Reaction due to the inherent properties
of the incorrect diluent /product

Infection at the site of injection/ beyond

Incorrect sterile technique or the site of injection.
inappropriate procedure with a
multidose vial.
Ref: Adverse event following Immunization: Surveillance and Response Operational Guidelines, 2015.
Ministry of health and family welfare, Government of India.

5: Reasons for which vaccination should NOT be deferred or refused in a child

Do not defer or refuse vaccination in a child for any of these reasons

 allergy or asthma except if there is a known allergy to a specific vaccine component
 respiratory tract infections, diarrhoea with temperature below 38.5°C
  family history of adverse events following immunization, seizures
 on treatment with antibiotics
 known or suspected HIV infection with no signs and symptoms of AIDS
 child being breast fed
 chronic diseases of the heart, lung, kidney, or liver
 neurological conditions, such as cerebral palsy or Down’s Syndrome
 premature or low-birth weight
 recent or imminent surgery
 malnutrition and
 history of jaundice at birth.

Ref: World Health Organization (2015). Immunization in Practice: A Practical Guide for Health Staff,
2015 Update. World Health Organization.
 6. Sensitivity of vaccines to heat, light and freezing

Vaccine Exposure to heat/light Exposure to cold

Heat and light sensitive vaccines
OPV Sensitive to heat Not damaged by freezing
Measles/MR Sensitive to heat and light Not damaged by freezing
BCG, Rotavirus and JE Relatively heat stable, but Not damaged by freezing
sensitive to light
Freeze sensitive vaccines
Hep B/Pentavalent/PCV Relatively heat stable Freezes at -0.50C
(Should not be frozen)
IPV, DPT and TT Relatively heat stable Freezes at -30C
(Should not be frozen)
Sensitivity of vaccines in order of most sensitive to least sensitive
Vaccines sensitive to heat Vaccines sensitive to freezing
 BCG (after reconstitution) Most  HepB Most
 OPV, Rotavirus sensitive  PCV sensitive
 IPV  Pentavalent
 MR, Rotavirus  IPV
 JE  DPT
 DPT  TT
Least
 BCG (before reconstitution) sensitive
 TT
 Pentavalent, HepB,PCV
Least
sensitive
Most vaccines are stored at a temperature of +20C to +80C

Ref: Immunization Handbook for Medical Officers (2017). Ministry of Health and Family welfare,
Government of India.