Vaccines and Immunization

Dr. Priyanka Devgun, Associate Professor.

Protection from preventable diseases, disabilities and deaths. Birth right of every child Most cost effective healthcare intervention Greek word mmune means to be protected .

Some definitions

Acquired immunity: protection offered by introduction of various antigens or antibodies The process by which this is obtained is known as immunization Active immunization: Specific antigens evoke the needed immune response Passive immunization: Antibodies are supplied readymade as immunoglobulin and sera.

Vaccination: Process of inoculating the vaccine or the antigen Immunization: Process of inducing immune response, humoral or cell mediated. Seroconversion: Change from antibody negative state to antibody positive state. Seroprotection: The state of protection (from disease) due to presence of humoral immunity or antibody detectable in serum

History

Jenner: Cowpox vaccine 1796 Pasteur: Rabies prophylaxis 1885 EPI: WHO 1974, India 1978 UIP: India 1985 Child vaccine initiative: with support from several international agencies 1991 Global programme on vaccines: WHO 1993 Global alliance for vaccine and immunization - 1999

Achievements
Small pox eradicated in 1977 EPI coverage of > 80% by 1990 Certification for polio eradication by 2005 Over 3 million lives saved globally, annually

Types of vaccines

Live bacteria- BCG, Ty 21 a Live virus OPV, MMR Killed bacteria Pertussis, S.typhi Killed virus IPV, Rabies, HAV Toxoid DT, TT Capsular polysaccharide HiB, Pneumo, Meningo Viral subunit - HBsAg Bacterial subunit Acellular pertussis

National Immunization Schedule

Age Birth 6 wks 10 wks 14wks 9 months 15-18 months 5 years 10 years 16 years Pregnant women Vaccine BCG, OPV 0 DPT 1, OPV 1, HBV-1 DPT 2, OPV 2, HBV-2 DPT 3. OPV 3, HBV-3 Measles , Vitamin A DPT 4, OPV 4 DPT TT TT 2 TT at 4 wks interval

IAP immunization schedule

Age Birth 1 year Birth, 6, 10, 14 wks, 16-18 mo, 5 yrs Birth, 6, 10, 14 wks, 16-18 mo, 5 yrs Birth., 6, 14 wks / 6, 10, 14 wks Birth, 6, 10, 14 wks, 16-18 mo 9 mo plus 15 months 2 years Vaccine BCG OPV DPT Hepatitis B HiB Conjugate Measles MMR Typhoid

10., 16 Pregnant women

TT / dT 2 doses of TT

Additional vaccines

Varicella above 1 yr Hepatitis A above 2 yr

Cold chain

The system of transporting, distributing and storing vaccines from the manufacturers right up to the point of use under refrigeration using any convenient method is referred to as cold chain
Vital link in immunization

If not maintained, vaccine efficacy will grossly suffer

Safe temp. zone mandatory to maintain potency

Safe zone for short term storage (1-2 months)is 2-8 deg C. For long term storage 20 degC is used only for BCG,OPV,Measles/MMR
The T series of vaccine(DPT,DT,TT),typhoid Vi,Hep B should not be frozen as once frozen the aluminium salts used as adjuvant will be desiccated and will act as irritantsterile abscess

NAME CONTENT PREPARATION INITIATION SCHEDULE BOOSTER DOSE ADMIN. EFFICACY

BCG-LAV (Danish bovine strain) BCG strain of bovine mycobacterium-3-10 million bac/dose Lyophilised At birth/first contact Single dose Nil 0.05 ml(newborn)0.1 ml(infants and children Intra dermal left deltoid 0-80%

C/I S/E

Immunodeficiency Axillary adenitis

NAME CONTENT

DPT-KILLED PERTUSIS+TOXOID DIPHTHERIA & TETANUS Diph tox 20 Lf,Tet tox 5 Lf.Pertusis 6 IU(40,000 million killed bacteria +ALPO4-3 m

PREPARATN INITIATION SCHEDULE BOOSTER DOSE ADMNSTRN EFFICACY C/I

S/E

Liquid 6 wks 3 doses 6,10,14 wks 15- 18 mo, 5 yrs 0.5 ml I/M lat thigh P80%D80%T100% Prog neuro dis,uncontrolled cry,convulsion, severe rxn for 1st dose
Fever, local induration, pains

NAME CONTENT PREPARATN INITIATION SCHEDULE BOOSTER DOSE ADMNSTRN EFFICACY

OPV-LAV SABIN, type 1-106(CCID 50),type-2-105(CCID 50),type-3- 105(CCID50 Liquid Birth Birth,6,10,14 wks 15- 18 mo,5 yrs 2 drops Oral 80-90%

C/I
S/E

Immuno defeciency,HIV
none

NAME CONTENT

HEPATITS B (HBSAG) Plasma derived/yeast derived r-DNA/CHO cells derived r-DNA

PREPARATN Liquid INITIATION Birth within 48 hrs6 wks SCHEDULE Birth,6,14 wks/0,1,6 months BOOSTER DOSE Nil 10 microgram,0.5 ml(<10 yrs), 1 ml(>10 yrs)

ADMNSTRN I/M deltoid EFFICACY 90% C/I S/E None Local pain,erythema

NAME CONTENT

MEASLES(LAV) 1000TCID50.Schwarz or Edmonston Zagreb strain 1000 TCID/CCID

PREPARATN Lyophilised INITIATION >9 mo SCHEDULE 1 dose at 9-12 mo.2nd doseafter 3 mo if 1st dose<9 mo BOOSTER DOSE ADMNSTRN EFFICACY C/I S/E Nil 0.5 ml S/C deltoid 95% Imm def,anaphylaxis,egg protein allergy Fever ,rash after a week

NAME CONTENT PREPARATN INITIATION SCHEDULE

MMR (LAV) Measles as above,Mumps5000 TCID of Urabe AM-9,Rubella 1000 TCID of Wistar RA/3M Lyophilised 15 mo Single dose

BOOSTER DOSE
ADMNSTRN

Nil 0.5ml
SC deltoid

EFFICACY
C/I S/E

95%
As in measles+pregnancy As in measles

NAME
CONTENT PREPARATN INITIATION SCHEDULE BOOSTER DOSE ADMNSTRN EFFICACY C/I S/E

MUMPS(LAV)
L-Zagreb/Jerry Lynn strain 5000TCID Lyophilised 15 mo with M&R or at 11 yrs Single dose Nil 0.5 ml SC deltoid 90-95% Imm def Fever

NAME CONTENT PREPARATN

H INFL B(CONJUGATE) PRPD/PRPT/HBOC H.Infl capsular oligosaccharide b Liquid/freeze dried

INITIATION SCHEDULE
BOOSTER DOSE ADMNSTRN EFFICACY C/I S/E

6 wks 6,10,14 wks/2,4,6 mo

After 1 yr 0.5 ml.10 mcg SC/IM-deltoid/ant lat thigh 90-100% None Local rxn,fever

NAME

TYPHOID(KILLED)

CONTENT
PREPARATN INITIATION SCHEDULE BOOSTER DOSE ADMNSTRN EFFICACY C/I S/E

S.typhi 1000 million killed/ml

Liquid 2 yrs 2 doses 4 wks apart Every 3 yrs 0.25 ml<10yrs,0.5 ml>10 yrs SC deltoid 57-75% None Local rxn,fever

NAME CONTENT

TYPHOID(Vi polysaccharide Vi capsular polysach S.typhi

PREPARATN INITIATION SCHEDULE

BOOSTER

Liquid >2 yrs Single dose

Every 3 yrs

DOSE ADMNSTRN EFFICACY C/I S/E

25-50 mcg(0.5 ml) I/M 70% None Fever,pain,induratn

NAME CONTENT

TYPHOID oral Ty 21a strAin(109 organisms)

PREPARATN INITIATION SCHEDULE

BOOSTER

Capsule >6yrs 3 doses on alternate days

Every 3 yrs

DOSE ADMNSTRN EFFICACY C/I S/E

1 capsule Oral 70% None Abdominal pain,vomiting, loose stools

NAME CONTENT PREPARATN INITIATION SCHEDULE BOOSTER DOSE ADMNSTRN

HEP-A (inactivated vaccine) HM 175 of HAV 720 ELU antigen/ml Liquid >2 yrs 2 doses 0, 6 mo Nil 0.5 ml IM antero lat thigh

EFFICACY C/I S/E

99% None Mild reaction

NAME CONTENT

PNEUMOCOCCAL Capsular poly saccharide

PREPARATN INITIATION SCHEDULE

BOOSTER DOSE ADMNSTRN EFFICACY C/I S/E

Lyophilised >2 yrs Single dose

Every 3-5 yrs 0.5 ml SC/IM over Ant. Lat thigh 85-90 % First trimester pregnancy none

NAME

VARICELLA VACCINE

CONTENT
PREPARATN INITIATION SCHEDULE BOOSTER DOSE ADMNSTRN

OKA strain of varicella zoster103(3 PFU)

Lyophilised >1 yr 1-12 yrs(single dose),>13 yrs 2 doses 1 mo apart Nil 0.5 ml SC deltoid

EFFICACY C/I S/E

95-100% None Varicella type rash after 1 wk with fever

NAME CONTENT
PREPARATN INITIATION

MENINGOCOCCAL A+C N.meningitidis groupA,C 50 mcg each

Lyophilised For use only in endemic areas during epidemics.>2 yrs

SCHEDULE
BOOSTER

Single dose
5 yrs

DOSE ADMNSTRN EFFICACY C/I S/E

0.5 ml SC/IM-deltoid/Ant lat thigh 90-100% None Local rxn, mild fever

NAME

JAPANESE ENCEPHALITIS(KILLED MONOVALENT) Mouse brain(Nakayama/NIH strain) or Baby hamster kidney(P-3) or Recombinant DNA vaccine

CONTENT

PREPARATN Freeze dried /liquid

INITIATION Same as meningo cocci SCHEDULE 2 doses 1-2 wks interval BOOSTER After 3-4 yrs DOSE 1 ml ADMNSTRN SC-deltoid/ant lat thigh EFFICACY C/I S/E 60-80%,100% after booster None Local swelling,fever,malaise

NAME
CONTENT PREPARATN INITIATION SCHEDULE BOOSTER DOSE

INFLUENZA VACCINE (INACTIVATEDSPLIT VIRION) 1.5 mcg hemaglutinin of each of the chosen strain as suspension
Liquid All ages Single dose Every year with current strain 0.5 ml

ADMNSTRN EFFICACY C/I S/E

SC/IM 80-90% Egg protein allergy Local reaction,fever

NAME CONTENT PREPARATN INITIATION SCHEDULE BOOSTER

DPT WC+HIB D &T toxoid PWC+capsular polysaccharide of Hib Lyophilised/liquid 6 wks 6,10,14 wks Nil

DOSE ADMNSTRN
EFFICACY C/I S/E

0.5 ml IM
90-100% None Mild fever,local induration

NAME CONTENT

DPT WC+HB COMBINATION D and T toxoid+PWC+ yeast derived r-DNA HBsAg Liquid 6 weeks 6,10,14 wks Nil 0.5 ml IM 90-100% Same as DPT

PREPARATN INITIATION SCHEDULE BOOSTER DOSE ADMNSTRN EFFICACY C/I

S/E

Fever,pain,local induration

NAME CONTENT

RABIES (TISSUE CULTURE)-INACTIVATED

1.

HDCV(virus grown in Human Diploid fibroblasts) 2. PCEC (Chick embryo cells) 3. Vero cell(vervet monkey kidney cell) PREPARATN Lyophilised INITIATION Any age-/after dog bite

SCHEDULE
BOOSTER DOSE ADMNSTRN EFFICACY C/I S/E

Pre expo:0.7,21 days.Post expo:0,3,7,14,28.Re expo0,7(<5 yrs), full course(>5 yrs) First after 1 year then every 3 yrs 0.5 ml/1ml depending on preparatn S/C deltoid/ ant lat thigh 90-100% None Local pain,rarely encephalopathy

BCG Vaccine

Attenuated M. Bovis developed in 1921 Protects against TB meningitis , Miliary T B Maternal antibodies do not interfere as CMI not transplacentally transferred Induces long term protection Supplied freeze dried and stored frozen or refrigerated Reconstituted vaccine to be used w/I 4-6 hrs Dose 0.05 ml(infants),0.1 ml(infants and children) Intra-dermal over left deltoid Local lesion due to bacterial multiplication which heals leaving a scar in 12 wks(repeat if no scar) C/I- Immune deficiency Side effect-Axillary adenitis

OPV

Live attenuated polio virus types1,2&3-developed by sabin ,1961 Temperature sensitive store frozen or refrigerated Can be given simultaneous with any other vaccine Multiple doses necessary to ensure vaccine virus take and response to all three types of viruses IAP recommends additional doses of opv as a part of pulse polio program every year till age of 5 yrs

Why PULSE POLIO?

On national immunisation days(NIDs) pulse doses of oral polio vaccine has to be administered as simultaneous feeding of vaccine to all susceptibles is neede to produce immunity, by preventing wild polio viruses from multiplying in the gut

It is mandatory to give all reccomended doses in NIDs so that no wild virus remains in circulation
OPV is contraindicated in immunodeficiency,HIV,active viral infections No side effects

IPV

Formaldehyde killed polio virus grown in monkey kidney or human diploid cell Contains 20,8,32 D antigen units against type 1,2,3 polio viruses respectively Seroconversion 90-95% after 2 doses,99% after 3 doses

Thermo stable and indicated in immunocompromised and HIV

DPT

Diphteria toxoid(Ramon &Glenny,1923) Killed Bordetella pertusis(Madsen ,1923) Tetanus toxoid(Ramon & Zoeller,1927) Toxoids adjuvated (Aluminium hydroxide/ phosphate) Vaccine supplied as liquid, stored refrigerated Aluminium adjuvated vaccine must not be frozen 0.5 ml injected IM on anterolateral asoect of thigh.

Parents must be alerted about local reaction and fever(PCT given) IAP recommends 2nd booster at 5 yrs H/O convulsion not contradiction Progressive neurological disease or serious adverse reaction to earlier dose are contraindications for DPT(replace with DT)

Measles

Live attenuated vaccine developed by Enders-1960 Vaccine further attenuated by Schwarz, EdmonstonZagreb Supplied freeze dried- store frozen or refrigerated Use reconstituted vaccine in 4-6 hrs(refrigerate do not freeze) 0.5 ml injected S/C preferably right upper arm Age at which recommended 9 months During outbreak>6 months If given < 9 mo repeat dose after 3 mo Possibility of fever for 5-10 days MMR-0.5ml S/C over deltoid(15 mo)

Typhoid
WHOLE CELL:

Killed S.typhi often with S.paratyphi A(TA) Developed by Wright ,1896 Liquid,store refrigerated,inject S/C Primary course:2 doses 4 wks apart at 6-9 mo of age or at any age Boosters once in 3-5 yrs Dose :0.25-0.5 ml S/C for primary,0.1ml for booster

Vi POLSACCHARIDE:

Developed by Robbins,1984 Liquid, adjuvated,store refrigerated Inject IM at or after 2 yrs of age(0.5 ml) Booster after 3 yrs

ORAL:

Live attenuated S.typhi developed by Germanier,1975 Strain name:Ty 21a Enteric coated capsules,store refrigerated, administer orally 3 doses on alternate days Repeat 3-5 yrs later Recommende age7 yrs or above

Hib vaccine

H . Influenza B-capsular polysaccharide Liquid or freeze dried Age of initiation 6 wks 3 doses 6,10,14 wks/2,4,6 mo Booster 1 yr after primary dose Dose 0.5 ml SC/IM over deltoid or anterolateral aspect of thigh

ADDITIONAL VACCINES

Varicella vaccine:

Developed by Takahashi in 1971,Japan Live attenuated Oka strain. Vaccine available as lyophilized powder Dissolve in 0.5 ml diluent SC 0.5 ml Single dose 1-12 yrs >13 yrs 2 doses at 1 mo interval

Hepatitis A

Inactivated vaccine containing H M 175 strain grown in MRC5 cell line. Pediatric formulation 720 ELU IM; 2 doses 6 mo apart between 2-18 yrs >19 yrs 1440 ELU 2 doses 6 months apart Efficacy 94-100% No boosters

Vaccines recommended during epidemics

Japanese B Encephalitis vaccine Meningococcal A&C

Vaccines for high risk group

PNEUMOCOCCAL VACCINE:

Polysaccharide vaccine(23 valent) 7 Valent conjugated with CRM 197 diphtheria toxin 23 valent effective after 2 yrs of age Single dose 0.5 ml IM with booster every 3-5 yrs

Indications

Sickle cell disease Nephrotic syndrome in remission Congenital or acquired asplenia/splenic dys function HIV Chronic cardiac/pulmonary disease Immunodeficient conditions CSF leak Diabetes mellitus

Combination vaccines
DPT/HiB/HepB Benefits: 1. Reduced number of injections 2. Reduced pain and parental anxiety 3. High compliance, low drop out rates,enhanced coverage 4. Reduced no: of visits 5. Less storage space 6. Less burden on cold chain

Vaccination schedule for unimmunized child

<5 yrs First visit 2ND visit(1 mo later) 3RD visit(1 mo later) 1 yr later Every 3 yrs >5 yrs

BCG,OPV,DPT,H TT/Td,HB B OPV,DPT,HB TT/Td,HB OPV,DPT,MMR/ Measles,Typh OPV,DPT,HB Typh booster MMR,Typh HB Typh booster

Newer vaccines

Live attenuated varicella(oka)strain Killed hep A virus vaccine 23 valent pneumococcal vaccine Influenza virus vaccine Combination vaccines

Vaccines available in other countries

Conjugated pneumococcal vaccine(7 valent) Conjugated S.typhi Vi vaccine Rota virus vaccine Combination vaccines

ADVERSE EFFECTS FOLLOWING IMMUNIZATION (AEFI)

ADVERSE EVENT

VACCINE SYMPTOMS

MANAGEMENT

Anaphylaxis

any

W/I minutes,acute decompensation of circ. System,hypovolemi c shock,laryngeal spasm/edema.Acute respiratory distress

Adrenaline,CPR,I V volume expanders or dopamine/dobuta mine, hydrocortisone

Hypotensive, DPT hyporesponsi ve episodes

Within 12 hrs.Acute IV fluids, paleness.Transient dexamethasone,ox decreased levels/loss ygen of consciousness.Dec muscle tone

ADVERSE EVENT

VACCINE SYMPTOMS

MANAGEMENT

Incessant cry DPT

Within 48-72 Sedation with hrs.Excessive triclofosinconsolable crying 50mg/kg/day+PCT+ feeding advice

Toxic shock syndrome

Measles contamina tion by S. Aureus

Within 30 min- few hrs. Mounting fever,vomiting, diarrhoea,septic shock

IV fluids,anti microbials,cloxacilli n 50-100 mg/kg/day, steroids,antipyretics, supportive therapy

ADVERSE EVENT

VACCINE SYMPTOMS Within 2-6 months firm-soft axillary lmphadenitis1.5-3 cm with/ without sinus

MANAGEMENT If firm no treatment.If soft&fluctuant HR3.Aspiration if needed.Steroid if sinus present

lymphadenitis BCG

Bacterial abcess

Any vaccine

Within 72 hrs,fluctuant or firm abcess with or without fever

Antibiotics, Anti pyretics,drainage if needed

ADVERSE EVENT

VACCINE SYMPTOMS By 72 hrs ,minimum inflamation, no fever

MANAGEMENT Drainage if needed

Sterile abcess DPT,DT,T T,Typhoid & HEP B

Moderate to severe local reaction

Any vaccine

Non fluctuant Paracetamol swelling/redness 310 cm in size at injection site

ADVERSE VACCINE SYMPTOMS EVENT Seizures with fever(rare) DPT, measles Always generalised simple/complex

MANAGEMENT

Anticonvulsant,anti pyretic,IV fluids (if needed)

IAP recommendations on Immunization

The IAPCOI-Indian Academy of Pediatrics Committee On Immunisation,has formulated several scientific recommendations to other agencies pertaining to Immunisation

Recommendation to federation of OBG societies of India

To adopt routine testing of all pregnant women for HBV infection and if mother is positive baby should be given HBIG+HB vaccine soon after birth

Recommendations to Ministry of Health, Govt of India

1.

2. 3.

4.

5.

6. 7.

The academy should be represented on National Technical Advisory Group on Immunisation At 5 yrs booster immunisation with DPT rather than DT. Inactivated polio vaccine should be licensed and gradually introduced in phased manner Hep B and MMR vaccine should be included in national immunisation schedule immediately Govt. should consider inclusion of typhoid vaccine(Vi polysaccharide/whole cell inactivated) in the national immunisation schedule Another vaccine to be included is Hib Ensuring adequate supply of chick embryo/ tissue culture rabies vaccine