Vaccination

Introduction

Bacilli derived from subcultures of live attenuated M. bovis à Calmette-Guerin strain

Vaccine

Type è Live attenuated

Strain è Copenhagen (Danish 1331) - Guindy, tamilnadu

Vial è Lyophilised powder in vacuum sealed, Dark multidose vial (MDV)

Dose è Reconstitute with NS à 0.1ml/dose contain à 0.1 to 0.4 million live viable bacilli

0.05 ml until one month,

0.1 ml beyond the age of one month.

Sensitivity è Heat and Light sensitive

Stability è Stable in lyophilised form at 2-8˚C * 1year

Discard reconstituted vaccine after 4 hr

Site & Method è

Left upper arm at insertion of deltoid muscle

Intradermal by 26G needle

Various type of vaccine è

Storage

 2 to 8˚ C

Schedule

NIS è Birth dose, catch up till 1yr

IAP è Birth  dose, catch up till 5yr

Catch Up è

Adverse Event

-         Local ulceration, discharging sinus, axillary lymphadenitis.

-         Inadvertent S/C inj à persistent ulceration, I/L axillary and cervical LN-pathy

-         Immunodeficient child à develop severe disseminated BCG disease after 6-12 mo of vaccination. osteomyelitis, scrofuloderma.

Contraindication

Cellular immunodeficiency

Symptomatic HIV positive

In SCID

Pregnancy

Radiation therapy

Special Situation

FAQ

Introduction

2 Types of Vaccine

PPSV à Polysaccharide vaccine (only for high risk children) / 23 Valent / >80% cases of serious disease cover

PCV à Conjugate vaccine (for Universal immunisation) / 10, 13 valent / 49 – 88% of IPD related death cover

(PCV-7 no available, PCV-15,20 Under development)

Vaccine

PPSV– 23

PCV

PCV 13 (Prevenar)

PCV 10 (Synflorix / pneumosiil)

SEROTYPE

23 serotype - 1,2,3,4,5,6B,7F,8,

9N,9V,10A,11A112F,14,15B,17F,

18C,19F, 19A,20A,22F, 23F,33F

Capsular polyasachharide Ag of 13 Serotype– 1,3,4,5,6A,6B,7F,9V,14,

18C,19A,19F,23F

Conjugate to CRM197 (non toxic diphtheria cross reactive material carrier protein)

Capsular Polyasachharide Ag of 10 Serotype

®   Synflorix- 1,4,5,6B,7F,

9V,14, 18C,19F,23F

Conjugate to 3 different carrier protein – Tetanus toxoid, Diphtheria toxoid, non-typeable H.influenzae protein D

®   Pneumosiil-1,5,6A, 6B,7F,9V,14,19A,19F,

23F

Conjugate to CRM197 (non toxic diphtheria cross reactive material carrier protein)

IMMUNOGENECITY

Poorly immunogenic in children <2 years, doesn’t reduce nasopharyngeal carrer

Content

0.5ml / Single dose vial / 25սg of each serotype Ag

0.5ml / Single dose vial

Storage

2 to 8˚ C

2 to 8˚ C

2 to 8˚ C

DOSE

0.5 ml/ dose

0.5 ml/ dose

0.5 ml/ dose

Site & Method

IM or S/C

Anterolateral thigh or Deltoid

IM

Anterolateral thigh or Deltoid

Efficacy

T-cell independent vaccine à poorly immunogenic below 2 yr age, low memory, no heard immunity.

PPSV single dose induce serotype specific immunoglobin , also IgA.

IgG level ≥0.35սg/ml for all serotypes collectively

All PCVs comparably immunogenic with seroprotection rates of >90% following primary dose.

Safety (A/E)

Rare except

Local pain, transient fever

Rare except

Local reaction , fever, irritability à 10%

gastrointestinal symptoms à 1%

Hypersensitivity reaction, Seizure, hypotonic – hyporesponsive episode à <0.01%

Contraindication

Sever allergic reaction to prior dose

Sever allergic reaction to prior dose or any other vaccine containing diptheria toxoid as carrier protein

Schedule

NIS è

-         Not in NIS

-         Indicated only in high risk children along with PCV

-         Age group – 2 to 18 years

-         All high risk case receive PPSV after complete PCV, 8 Weeks after last dose of PCV

-         Revaccination advised after 3-5 year in high risk cases

-         Not more than 2 life time dose advised à bcz immunological HYPORESPONSIVENESS on repeted vaccination

-         PCV gradually introduced since 13/05/2017

-         Total 3 dose à 3Primary at 6, 14 weeks + 1 Booster at 9 months

-         Upper age limit – 1 year

-         PCV 10 is being used in NIS

IAP è

-         PCV 13 > PCV10 recommended

-         Total 4 dose à 3Primary at 6,10,14 weeks + 1 Booster at 12-15 month age

Catch Up è FOR PCV upto 5 years as IAP

-         <6 Month à 3 P at 4 week apart + 1 B at 12-15  month or 6 month after 3^rd dose

-         6-12 month à 2P at 4 week apart + 1B in second year

-         12-23 month à 2P at 2 month apart + no Booster

-         24-59 month à 2 dose of PCV-10 at 8 week apart or single dose PCV-13+ no BOOSTER

-         Who recommend à 2P+1 / 3P+0

-         NIS adopted à 2P+1

-         PCV -13 may be used as a single dose in high risk children (6-17 years) and adult >50 year

Special Situation

Pneumococcal immunisation of high-risk children(HRC) è

-         HRC/2-6 year age à

-         If vaccinated with 3 dose à should vaccinate with Single dose PCV13/10

-         If vaccinated with <3 dose à should vaccinate with 2 dose PC at least 8 week apart

Followed by single dose of PPSV at least 8 week apart after last dose of PCV

Followed by 2^nd dose of PPSV at least 8 week apart after last dose of PCV

-         HRC/ 6 -18 year age à

           Vaccinate with single dose of PCV 13/10

Followed by PPSV at least 8 week apart after last dose of PCV

Followed by 2^nd dose of PPSV at least 8 week apart after last dose of PCV

-         Planned splenectomy / cochlear implant / immunosuppressive therapy à

PCV – 13/10 and PPSV vaccination should be complete at least 2 week before surgery or therapy initiation

-        

FAQ

1.     Preferable vaccine?

Ans. Only PCV in healthy children / PPSV used only in high risk children, no role in healthy children / all PCV same effective / PCV13 >> PCV10 à Cover 10-15% more serotype

2.     Why PPSV-23 given as additional to PCV-13/10 vaccine in HRC ?

Ans. to expand serotype cover after routine immunisation. PPSV should never be used alone in HRC and always to be preceded with PCV recommendation dose.

3.     PCV & PPSV concurrent administration possible? Is it safe ?

Ans. not studied and not recommended, at least 8 week minimum interval required B/W both vaccine.

4.     Interchange of vaccine b/w PCV10 & 13?

Ans. not advisable, but permitted if unavoidable.

5.     PCV for Pre-term and LBW babies ?

Ans. recommended on priority based as they have 9 time higher IPD then to full term baby.

6.     Newer pneumococcal vaccine underdevelopment ?

Ans. PCV-15 = PCV-13 + (22F,33F) à Merc

PCV-20 = PCV-13 + (8,10A,11A,12F,15BC,22F,33F) à Pfizer

Also underway Serutype independent pneumococcal vaccine à

a)     Common protein based

b)    Combination (protein vaccine Ag+polysachharide conjugates)

c)     Whole cell vaccine of killed S. Pneumoniae à simultaneous present multiple surface protein Ag.

7.     Why 3 dose schedule NIS vs 4 dose schedule in IAP?

Ans. NIS à Cost consideration without compromise on efficacy

WHO à minimum 3 dose from 6 week age (2p+1B / 3p+0B)

India in NIS adopted 2P+1B schedule àBooster at 9 month to align with MR vaccine. Ab titre achieved is higher with (2 dose at 2 month interval >> 2 dose 1 month interval )

8.