Indian Academy of Pediatrics (IAP) Recommended Immunization … · 2017. 8. 27. · INDIAN...

INDIAN PEDIATRICS 785 VOLUME 51__OCTOBER 15, 2014

Indian Academy of Pediatrics (IAP) Recommended ImmunizationSchedule for Children Aged 0 through 18 years – India, 2014 and Updateson ImmunizationVIPIN M VASHISHTHA, PANNA CHOUDHURY, AJAY KALRA, ANURADHA BOSE, NAVEEN THACKER, VIJAY N YEWALE,CP BANSAL AND PRAVIN J MEHTAIndian Academy of Pediatrics, Advisory Committee on Vaccines and Immunization Practices (ACVIP)Correspondence to: Dr Vipin M Vashishtha, Convener, IAP Advisory Committee on Vaccines and Immunization Practices, ManglaHospital and Research Center, Shakti Chowk, Bijnor, Uttar Pradesh 246 701, India. [email protected]

The IAP Advisory Committee on Vaccines andImmunization Practices (ACVIP) has recentlyreviewed and revised the recommendedimmunization schedule for children aged 0through 18 years to ensure that the schedule reflectsrecommendations based on recent evidences for licensedvaccines in the country. The first annual meeting of the IAPACVIP was held on 19th and 20th April 2014 in NewDelhi. IAP ACVIP members and invited experts whoattended the meeting are listed in Annexure 1. The aim ofthe meeting was to discuss and debate recentdevelopments in the field, to revise recommendations forthe IAP Immunization Timetable for the year 2014, and toissue recommendations for available licensed vaccines inthe country. Following the meeting, a draft of revisedimmunization schedule for the year 2014 was preparedand circulated among the meeting participants to arrive ata consensus.

The detailed process behind issuing IAP recommen-dations on immunization – primarily for the pediatricians

in office practice has been described earlier [1]. Theserecommendations provide guidelines to a pediatrician onhow best to utilize available licensed vaccines in theiroffice-practice settings. The members may use their owndiscretion while using them in a given situation within theframework suggested [2]. The existing Nationalimmunization schedule and government policies are alsotaken into account while drafting recommendations.

AIMS AND OBJECTIVES

To revise IAP Immunization Timetable for the year 2014,and review and issue recommendations on the availablelicensed vaccines.

RECOMMENDATIONS FOR IAP IMMUNIZATIONTIMETABLE, 2014

The IAP ACVIP has issued recommendations for the IAPImmunization Timetable (Table I and Fig. 1) for the year2014 that includes the following major changes from lastyear:

G U I D E L I N E SG U I D E L I N E SG U I D E L I N E SG U I D E L I N E SG U I D E L I N E S

Justification: There is a need to review/revise recommendationsabout existing vaccines in light of recent developments in the fieldof vaccinology.

Process: Following an IAP ACVIP meeting on April 19 and 20,2014, a draft of revised recommendations for the year 2014 andupdates on certain vaccine formulations was prepared andcirculated among the meeting participants to arrive at aconsensus.

Objectives: To review and revise recommendations for 2014Immunization timetable for pediatricians in office practice andissue statements on certain new and existing vaccineformulations.

Recommendations: The major changes in the 2014Immunization Timetable include two doses of MMR vaccine at 9and 15 months of age, single dose recommendation foradministration of live attenuated H2 strain hepatitis A vaccine,inclusion of two new situations in ‘high-risk category of children’ incontext with ‘pre-exposure prophylaxis’ of rabies, creation of a

new slot at 9-12 months of age for typhoid conjugate vaccine forprimary immunization, and recommendation of two doses ofhuman papilloma virus vaccines with a minimum interval of 6months between doses for primary schedule of adolescent/preadolescent girls aged 9-14 years. There would not be anychange to the committee’s last year’s (2013) recommendationson pertussis vaccination and administration schedule ofmonovalent human rotavirus vaccine. There is no need ofproviding additional doses of whole-cell pertussis vaccine tochildren who have earlier completed their primary schedule withacellular pertussis vaccine-containing products. A brief update onthe new Indian Rotavirus vaccine, 116E is also provided. Thecommittee has reviewed and offered its recommendations on thecurrently available pentavalent vaccine (DTwP+Hib+Hepatitis-B)combinations in Indian market. The comments and footnotes forseveral vaccines are also updated and revised.

Keywords: Immunity, Child, Guidelines, MMR Vaccine,Vaccination.


INDIAN ACADEMY OF PEDIATRICS IMMUNIZATION SCHEDULE, 2014

TABLE I IAP IMMUNIZATION TIMETABLE 2014I. IAP recommended vaccines for routine use

Age (completed Vaccines Commentswks/mo/y)

Birth BCG Administer these vaccines to all newborns before hospital dischargeOPV 0Hep-B 1

6 weeks DTwP 1 DTP:IPV 1 • DTaP vaccine/combinations should preferably be avoided for theHep-B 2 primary seriesHib 1 • DTaP vaccine/combinations should be preferred in certain specificRotavirus 1 circumstances/conditions onlyPCV 1 • No need of repeating/giving additional doses of whole-cell pertussis (wP) vaccine

to a child who has earlier completed their primary schedule with acellular pertussis(aP) vaccine-containing products

Polio:• All doses of IPV may be replaced with OPV if administration of the former is not

feasible• Additional doses of OPV on all supplementary immunization activities (SIAs)• Two doses of IPV instead of 3 for primary series if started at 8 weeks, and 8 weeks

interval between the doses• No child should leave the facility without polio immunization (IPV or OPV), if

indicated by the scheduleRotavirus:• 2 doses of RV1 and 3 doses of RV5• RV1 should be employed in 10 and 14 week schedule, instead of 6 and 10 week• 10 and 14 week schedule of RV1 is found to be far more immunogenic than existing

6 and 10 week schedule10 weeks DTwP 2 Rotavirus:

IPV 2 • If RV1 is chosen, the first dose should be given at 10 weeksHib 2Rotavirus 2PCV 2

14 weeks DTwP 3 Rotavirus:IPV 3 • Only 2 doses of RV1 are recommended at presentHib 3 • If RV1 is chosen, the 2nd dose should be given at 14 weeksRotavirus 3PCV 3

6 months OPV 1 Hepatitis-B:Hep-B 3 • The final (third or fourth) dose in the HepB vaccine series should be administered

no earlier than age 24 weeks and at least 16 weeks after the first dose9 months OPV 2 MMR:

MMR-1 • Measles-containing vaccine ideally should not be administered before completing270 days or 9 months of life

• The 2nd dose must follow in 2nd year of life• No need to give stand-alone measles vaccineTyphoid:

9-12 months Typhoid • Currently, two typhoid conjugate vaccines, Typbar-TCV and PedaTyph available inConjugate Vaccine Indian market

• PedaTyph is not yet approved; the recommendation is applicable to Typbar-TCV only• An interval of at least 4 weeks with the MMR vaccine should be maintained while

administering this vaccine• Should follow a booster at 2 years of age



12 months Hep-A 1 Hepatitis A:• Single dose for live attenuated H2-strain Hep-A vaccine• Two doses for all killed Hep-A vaccines are recommended now

15 months MMR 2 MMR:Varicella 1 • The 2nd dose must follow in 2nd year of lifePCV booster • However, it can be given at anytime 4-8 weeks after the 1st dose during 2nd year

Varicella:• The risk of breakthrough varicella is lower if given 15 months onwards

16 to 18 months DTwP B1/DTaP B1 • The first booster (4th dose) may be administered as early as age 12 months, provided atIPV B1, Hib B1 least 6 months have elapsed since the third dose.

DTP:• First and second boosters should preferably be of DTwP• Considering a higher reactogenicity of DTwP, DTaP can be considered for the boosters

18 months Hep-A 2 • 2nd dose for killed vaccines; only single dose for live attenuated H2- strain vaccine2 years Typhoid booster • Either Typbar-TCV® or Vi-polysaccharide (Vi-PS) can be employed as booster;

• Typhoid revaccination every 3 years, if Vi-polysaccharide vaccine is used• Need of revaccination following a booster of Typbar-TCV® not yet determined

4 to 6 years DTwP B2/DTaP B2 Varicella:OPV 3 Varicella 2 • 2nd dose can be given at anytime 3 months after the 1st doseTyphoid booster

10 to 12 years Tdap/Td Tdap:HPV • Tdap is preferred to Td followed by Td every 10 years

HPV:• Only 2 doses of either of the two HPV vaccines for adolescent/pre-adolescent girls aged

9-14 years• For girls 15 years and older, and immunocompromised individuals 3 doses are

recommended• For two-dose schedule, the minimum interval between doses should be 6 months.• For 3 dose schedule, the doses can be administered at 0, 1-2 (depending on brands)

and 6 months

A. Measles and MMR vaccination

Recommendation: The committee has revised itsrecommendations on Measles and MMR vaccinationschedule. The new schedule will have a dose of MMR at 9months instead of measles, and another dose (2nd) at 15months of age. The earlier recommendation of 2nd dose ofMMR at 4-6 years of age has been removed.

The need and justification: NTAGI Standing TechnicalSub-Committee (STSC) recommended two doses ofMeasles – Rubella (MR) vaccines in the Universalimmunization program (UIP) at 9 months and 16-24months at the time of 1st booster of DTP vaccine. Since theAcademy has argued very strongly in favor of MMRinstead of MR vaccine in UIP schedule, the revisedrecommendations will facilitate inclusion of Mumps

II. IAP recommended vaccines for High-risk* children (Vaccines under special circumstances)

1-Influenza Vaccine2-Meningococcal Vaccine3-Japanese Encephalitis Vaccine4-Cholera Vaccine5-Rabies Vaccine6-Yellow Fever Vaccine7-Pneumococcal Polysaccharide vaccine (PPSV 23)

* High-risk category of children: Congenital or acquired immunodeficiency (including HIV infection); Chronic cardiac, pulmonary(including asthma if treated with prolonged high-dose oral corticosteroids), hematologic, renal (including nephrotic syndrome) andliver disease; Children on long term steroids, salicylates, immunosuppressive or radiation therapy; Diabetes mellitus, Cerebrospinalfluid leak, Cochlear implant, Malignancies; Children with functional/ anatomic asplenia/ hyposplenia; During disease outbreaks;Laboratory personnel and healthcare workers; Travelers; Children having pets in home; Children perceived with higher threat of beingbitten by dogs such as hostellers, risk of stray dog menace while going outdoor.



vaccine in the National immunization program in nearfuture. Furthermore, it will be more in sync with theupcoming UIP schedule. The detailed reasons arediscussed in another recent position paper from IAPpublication [3].

The evidence: There are many studies both from India andfrom other countries demonstrating efficacy and safety ofMMR vaccine given at 9 month of age [3-8].

B. Live attenuated Hepatitis A vaccine

Recommendation: The committee has revised itsrecommendations on administration schedule of liveattenuated hepatitis A vaccine, based on the viral H2 strain(Chinese vaccine). Now a single dose of this vaccine isrecommended at 12 months of age over-riding theprevious recommendation [9] of two doses of the samevaccine.

The justification and evidence: The committee reviewedboth published [11,12] and unpublished long term follow-up data on immunogenicity and safety of a single dose ofthis vaccine from trials in India. The data showed 79.3% of121 children were seroprotected (anti-HAV titers >20mIU/mL) up to 6 years follow-up in the pivotal singlecenter study, whereas 97.3% of 111 children had shownseroprotection after 5 years of follow-up period in themulti-centric group. In the multi-centric study [12], the testsubjects maintained good GMT levels even after 5 years offollow-up. The committee had earlier shown its concernon waning of seroprotection in a subgroup of individualsof original single-center study cohort [2]. However, it waslater disclosed that only ten subjects had shown thisphenomenon, and most of these subjects were ofcomparatively higher age groups than other study subjects.The decision was also facilitated by the SAGE/WHOrecommendations of single dose of live attenuatedhepatitis A vaccine [10].

C. Rotavirus Vaccines

Monovalent rotavirus vaccine, RV1

The committee reviewed new data on administrationschedule of RV1 (Rotarix) from Pakistan [13] and Ghana[14]. In both studies, the seroconversion and GMTs werehigher at delayed (10 and 14 weeks) than early (6 and 10weeks) schedule, though not statistically significant [13,14]. In Ghana study, the seroconversion and GMTs weresignificantly higher in 3-dose (6, 10 and 14 week) schedulethan 2-dose early (6 and 10 week) schedule [14]. As thesestudies are yet unpublished, full methodology and resultsare not available for scrutiny. The available results do notwarrant any change in the existing schedule of RV1vaccine that includes the first dose at 10 weeks of ageinstead of 6 weeks in order to achieve better immune

response, and the second dose at 14 weeks to fit withexisting National immunization schedule [9].

Indian rotavirus vaccine, 116 E

This vaccine developed by Bharat Biotech (Rotavac) is alive, naturally attenuated vaccine containing monovalent,bovine human reassortant strain characterized as G9 P[11], with the VP4 of bovine rotavirus origin, and all othersegments of human rotavirus origin. The vaccine strainwas isolated from asymptomatic infants with mild diarrheaby Indian researchers in 1985 at AIIMS, New Delhi.Follow up of these infants indicated that they wereprotected against severe rotavirus diarrhea for up to 2years. This strain was sent for vaccine development to theNational Institute of Health by Department ofBiotechnology, India, and later transferred to BharatBiotech International Limited in 2001 for furtherdevelopment.

In a phase II study, both low (104 ffu) and high (105ffu) dosages of 116E were found safe in infants between 8and 20 weeks of age. IgA immunogenicity rates for the 105ffu dosage were 64.7% after 1 dose, and 89.7% after 3doses. The vaccine virus was shed in about 20% of infants[15].

A randomized, double-blind, placebo-controlledphase III clinical trial [16] amongst 6,799 infants wasconducted at three sites in India. The first year efficacyagainst severe rotavirus diarrhea was 53·6% (95% CI35·0-66·9; P=0·001) with protection continuing into thesecond year of life also. The vaccine also showed 20%efficacy against all-cause severe diarrhea admission. Sixcases of intussusceptions (all occurring afteradministration of 3rd dose) were recorded in the vaccineesand two in the control group. This vaccine has alreadybeen licensed in India and would soon be available for usein Indian market.

The committee reviewed the evidence and opined it tobe a moderately effective vaccine against rotavirusdiarrhea in India. As this is the only vaccine that hasundergone large scale field- efficacy trial in India, the levelof evidence regarding its efficacy is rated higher by thecommittee. However, the committee stresses the need ofhaving large scale studies, particularly post-marketingsurveillance to monitor occurrence of acuteintussusception amongst vaccinated children. There seemsto be one excess case of intussusception for every 2000children vaccinated. Apparently, the sample size was notadequately powered to look for statistical significance[16]. Regarding use of the vaccine in office-practice, it isnot clear whether pediatricians would be able to use it incoming months since information about formulation andcommercial availability of the vaccine is not yet available.



FIG

. 1 IA

P Re

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ead

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Foot

note

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ecom

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ded

Imm

uniz

atio

n Sc

hedu

le fo

r Per

sons

Age

d 0

thro

ugh

18 Y

ears

— IA

P, 2

014

I. G

ener

al in

stru

ctio

ns:

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ccin

atio

n at

bi

rth

mea

ns

as

early

as

poss

ible

with

in 2

4 to

72

hour

s af

ter

birth

or

at le

ast n

ot la

ter t

han

one

wee

k af

ter b

irth

•W

hene

ver m

ultip

le v

acci

natio

ns a

re t

o be

give

n si

mul

tane

ousl

y, th

ey s

houl

d be

giv

enw

ithin

24

ho

urs

if si

mul

tane

ous

adm

inis

tratio

n is

not

fea

sibl

e du

e to

som

ere

ason

s•

The

reco

mm

ende

d ag

e in

wee

ks/m

onth

s/ye

ars

mea

n co

mpl

eted

wee

ks/m

onth

s/ye

ars

•A

ny

dose

no

t ad

min

iste

red

at

the

reco

mm

ende

d ag

e sh

ould

be

adm

inis

tere

dat

a s

ubse

quen

t vi

sit,

whe

n in

dica

ted

and

feas

ible

.•

The

use

of a

com

bina

tion

vacc

ine

gene

rally

is p

refe

rred

ove

r se

para

te i

njec

tions

of

itseq

uiva

lent

com

pone

nt v

acci

nes

•W

hen

two

or m

ore

live

pare

nter

al/in

trana

sal

vacc

ines

are

not

adm

inis

tere

d on

the

sam

eda

y, th

ey s

houl

d be

giv

en a

t lea

st 2

8 da

ys (4

wee

ks) a

part;

this

rule

doe

s no

t app

ly to

live

oral

vac

cine

s•

Any

inte

rval

can

be

kept

bet

wee

n liv

e an

din

activ

ated

vac

cine

s.•

If gi

ven

5 da

ys b

efor

em

inim

um p

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d it

is c

ount

ed a

s in

valid

dose

.•

Any

num

ber o

f ant

igen

s ca

n be

giv

en o

n th

esa

me

day

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hang

ing

need

les

betw

een

draw

ing

vacc

ine

into

the

syrin

ge a

nd in

ject

ing

it in

to th

e ch

ildis

not

nec

essa

ry.

•D

iffer

ent

vacc

ines

sho

uld

not

be m

ixed

in

the

sam

e sy

ringe

un

less

sp

ecifi

cally

licen

sed

and

labe

led

for s

uch

use.

•P

atie

nts

shou

ld b

e ob

serv

ed fo

r an

alle

rgic

reac

tion

for 1

5 to

20

min

utes

afte

r rec

eivi

ngim

mun

izat

ion(

s).

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hen

nece

ssar

y, 2

vac

cine

s ca

n be

giv

en in

the

sam

e lim

b at

a s

ingl

e vi

sit.

•Th

e an

tero

late

ral a

spec

t of t

he th

igh

is th

epr

efer

red

site

fo

r 2

sim

ulta

neou

s IM

inje

ctio

ns b

ecau

se o

f its

gre

ater

mus

cle

mas

s.•

The

dist

ance

sep

arat

ing

the

2 in

ject

ions

isar

bitra

ry b

ut s

houl

d be

at l

east

1 in

ch s

o th

atlo

cal r

eact

ions

are

unl

ikel

y to

ove

rlap

•A

lthou

gh

mos

t ex

perts

re

com

men

d“a

spira

tion”

by

gent

ly p

ullin

g ba

ck o

n th

esy

ringe

bef

ore

the

inje

ctio

n is

giv

en,

ther

ear

e no

dat

a to

doc

umen

t th

e ne

cess

ity f

orth

is

proc

edur

e.

If bl

ood

appe

ars

afte

rne

gativ

e pr

essu

re,

the

need

le s

houl

d be

with

draw

n an

d an

othe

r si

te

shou

ld

bese

lect

ed u

sing

a n

ew n

eedl

e.•

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revi

ous

imm

uniz

atio

n w

ith a

dos

e th

at w

asle

ss

than

th

e st

anda

rd

dose

or

on

ead

min

iste

red

by a

non

-sta

ndar

d ro

ute

shou

ldno

t be

coun

ted,

and

the

pers

on s

houl

d be

re-

imm

uniz

ed a

s ap

prop

riate

for a

ge.

II. S

peci

fic in

stru

ctio

ns:

1. B

CG

Vac

cine

Rou

tine

vacc

inat

ion:

•S

houl

d be

giv

en a

t birt

h or

at f

irst c

onta

ctC

atch

up

vacc

inat

ion:

may

be

give

n up

to

5ye

ars

2. H

epat

itis

B (H

epB

) vac

cine

Rou

tine

vacc

inat

ion:

•M

inim

um a

ge: b

irth

•A

dmin

iste

r m

onov

alen

t Hep

B v

acci

ne to

all

new

born

s w

ithin

48

hour

s of

birt

h.•

Mon

oval

ent

Hep

B v

acci

ne s

houl

d be

use

dfo

r dos

es a

dmin

iste

red

befo

re a

ge 6

wee

ks.

•A

dmin

istra

tion

of a

tota

l of 4

dos

es o

f Hep

Bva

ccin

e is

per

mis

sibl

e w

hen

a co

mbi

natio

nva

ccin

e co

ntai

ning

Hep

B i

s ad

min

iste

red

afte

r the

birt

h do

se.

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fant

s w

ho d

id n

ot r

ecei

ve a

birt

h do

sesh

ould

re

ceiv

e 3

dose

s of

a

Hep

Bco

ntai

ning

va

ccin

e st

artin

g as

so

on

asfe

asib

le.

•Th

e id

eal m

inim

um in

terv

al b

etw

een

dose

1an

d do

se 2

is 4

wee

ks, a

nd b

etw

een

dose

2an

d 3

is 8

wee

ks. I

deal

ly, th

e fin

al (3

rd o

r 4th)

dose

in th

e H

epB

vac

cine

ser

ies

shou

ld b

ead

min

iste

red

no e

arlie

r th

an a

ge 2

4 w

eeks

and

at le

ast

16 w

eeks

afte

r th

e fir

st d

ose,

whi

chev

er is

late

r.•

Hep

B v

acci

ne m

ay a

lso

be g

iven

in a

ny o

fth

e fo

llow

ing

sche

dule

s: B

irth,

1,

& 6

mo,

Birt

h, 6

and

14

wee

ks; 6

, 10

and

14 w

eeks

;B

irth,

6 ,1

0 an

d 1

4 w

eeks

, etc

. All

sche

dule

sar

e pr

otec

tive.

Cat

ch-u

p va

ccin

atio

n:•

Adm

inis

ter

the

3-do

se s

erie

s to

tho

se n

ot

prev

ious

ly v

acci

nate

d.•

In c

atch

up

vacc

inat

ion

use

0, 1

, an

d 6

mon

ths

sche

dule

.3.

Pol

iovi

rus

vac

cine

sR

outin

e va

ccin

atio

n:•

Birt

h do

se o

f OP

V u

sual

ly d

oes

not l

ead

toVA

PP.

•O

PV

in

plac

e of

IP

V, i

f IP

V i

s un

feas

ible

,m

inim

um 3

dos

es.

•A

dditi

onal

dos

es o

f OP

V o

n al

l SIA

s.•

IPV:

Min

imum

age

- 6

wee

ks.

•IP

V: 2

inst

ead

of 3

dos

es c

an b

e al

so u

sed

ifpr

imar

y se

ries

star

ted

at 8

wee

ks a

nd t

hein

terv

al b

etw

een

the

dose

s is

kep

t 8 w

eeks

•N

o ch

ild s

houl

d le

ave

your

fac

ility

with

out

polio

im

mun

izat

ion

(IPV

or

O

PV

), if

indi

cate

d by

the

sche

dule

!!C

atch

-up

vacc

inat

ion:

•IP

V c

atch

-up

sche

dule

: 2 d

oses

at 2

mon

ths

apar

t fol

low

ed b

y a

boos

ter a

fter 6

mon

ths

ofpr

evio

us d

ose.

4.D

ipht

heria

an

d te

tanu

s to

xoid

s an

dpe

rtus

sis

(DTP

) vac

cine

.R

outin

e va

ccin

atio

n:•

Min

imum

age

: 6 w

eeks

•Th

e fir

st

boos

ter

(4thth

do

se)

may

be

adm

inis

tere

d as

ear

ly a

s ag

e 12

mon

ths,

prov

ided

at

leas

t 6

mon

ths

have

ela

psed

sinc

e th

e th

ird d

ose.

•D

TaP

vacc

ine/

com

bina

tions

sh

ould

pref

erab

ly b

e av

oide

d fo

r the

prim

ary

serie

s.•

DTa

P m

ay b

e pr

efer

red

to D

TwP

in c

hild

ren

with

his

tory

of s

ever

e ad

vers

e ef

fect

s af

ter

prev

ious

dos

e/s

of D

TwP

or

child

ren

with

neur

olog

ic d

isor

ders

.•

Firs

t an

d se

cond

boo

ster

s m

ay a

lso

be o

fD

TwP.

H

owev

er,

cons

ider

ing

a hi

gher

reac

toge

nici

ty, D

TaP

can

be

cons

ider

ed fo

rth

e bo

oste

rs.

•If

any

‘ace

llula

r per

tuss

is’ c

onta

inin

g va

ccin

eis

use

d, i

t m

ust

at l

east

hav

e 3

or m

ore

com

pone

nts

in th

e pr

oduc

t.•

No

need

of

re

peat

ing/

givi

ng

addi

tiona

ldo

ses

of w

hole

-cel

l per

tuss

is (

wP

) va

ccin

eto

a c

hild

who

has

ear

lier

com

plet

ed t

heir

prim

ary

sche

dule

with

ace

llula

r pe

rtuss

is(a

P) v

acci

ne-c

onta

inin

g pr

oduc

tsC

atch

-up

vacc

inat

ion:

•C

atch

-up

sche

dule

: The

2nd

chi

ldho

odbo

oste

r is

not r

equi

red

if th

e la

st d

ose

has

been

give

n be

yond

the

age

of 4

yea

rs•

Cat

ch u

p be

low

7 y

ears

: DTw

P/D

TaP

at 0

, 1an

d 6

mon

ths;

•C

atch

up

abov

e 7

year

s: T

dap,

Td,

and

Td

at0,

1 a

nd 6

mon

ths.

5.Te

tanu

s an

d di

phth

eria

to

xoid

s an

dac

ellu

lar p

ertu

ssis

(Tda

p) v

acci

neR

outin

e va

ccin

atio

n:•

Min

imum

ag

e:

7 ye

ars

(Ada

cel®

isap

prov

ed fo

r 11

-64

year

s by

AC

IP a

nd 4

to64

yea

r old

s by

FD

A, w

hile

Boo

strix

® fo

r 10

year

s an

d ol

der b

y A

CIP

and

4 y

ears

of a

gean

d ol

der b

y FD

A in

US

).•

Adm

inis

ter

1 do

se o

f Td

ap v

acci

ne t

o al

lad

oles

cent

s ag

ed 1

1 th

roug

h 12

yea

rs.

•Td

ap d

urin

g pr

egna

ncy:

One

dos

e of

Tda

pva

ccin

e to

pre

gnan

t m

othe

rs/a

dole

scen

tsdu

ring

each

pre

gnan

cy (p

refe

rred

dur

ing

27th

roug

h 36

wee

ks g

esta

tion)

reg

ardl

ess

ofnu

mbe

r of

yea

rs f

rom

prio

r Td

or

Tdap

vacc

inat

ion.

Cat

ch-u

p va

ccin

atio

n:•

Cat

ch u

p ab

ove

7 ye

ars:

Tda

p, T

d, T

d at

0, 1

and

6 m

onth

s.•

Per

sons

age

d 7

thro

ugh

10 y

ears

who

are

not

fully

im

mun

ized

w

ith

the

child

hood

DTw

P/D

TaP

vacc

ine

serie

s, s

houl

d re

ceiv

eTd

ap v

acci

ne a

s th

e fir

st d

ose

in th

e ca

tch-

up s

erie

s; i

f ad

ditio

nal

dose

s ar

e ne

eded

,us

e Td

va

ccin

e.

For

thes

e ch

ildre

n,

anad

oles

cent

Tda

p va

ccin

e sh

ould

no

t be

give

n.•

Per

sons

age

d 11

thro

ugh

18 y

ears

who

hav

eno

t rec

eive

d Td

ap v

acci

ne s

houl

d re

ceiv

e a

dose

fol

low

ed b

y te

tanu

s an

d di

phth

eria

toxo

ids

(Td)

boo

ster

dos

es e

very

10

year

sth

erea

fter.

•Td

ap

vacc

ine

can

be

adm

inis

tere

dre

gard

less

of

the

inte

rval

sin

ce t

he l

ast

teta

nus

and

diph

ther

ia

toxo

id–c

onta

inin

gva

ccin

e.6.

Hae

mop

hilu

s in

fluen

zae

type

b

(Hib

)co

njug

ate

vacc

ine

Rou

tine

vacc

inat

ion:

•M

inim

um a

ge: 6

wee

ks•

Prim

ary

serie

s in

clud

es

Hib

co

njug

ate

vacc

ine

at a

ges

6, 1

0, 1

4 w

eeks

with

abo

oste

r at a

ge 1

2 th

roug

h 18

mon

ths.

Cat

ch-u

p va

ccin

atio

n:•

Cat

ch-u

p is

rec

omm

ende

d til

l 5

year

s of

age.

•6-

12 m

onth

s; 2

prim

ary

dose

s 4

wee

ks a

part

and

1 bo

oste

r;•

12-1

5 m

onth

s:

1 pr

imar

y do

se

and

1bo

oste

r;•

Abo

ve 1

5 m

onth

s: s

ingl

e do

se.



•If

the

first

dos

e w

as a

dmin

iste

red

at a

ge 7

thro

ugh

11 m

onth

s, a

dmin

iste

r th

e se

cond

dose

at l

east

4 w

eeks

late

r and

a fi

nal d

ose

at a

ge 1

2-18

mon

ths

at le

ast 8

wee

ks a

fter

the

seco

nd d

ose

7. P

neum

ococ

cal c

onju

gate

vac

cine

s (P

CVs

)R

outin

e va

ccin

atio

n:•

Min

imum

age

: 6 w

eeks

•B

oth

PC

V10

and

PC

V13

are

lic

ense

d fo

rch

ildre

n fro

m 6

wee

ks t

o 5

year

s of

age

(alth

ough

the

exa

ct l

abel

ing

deta

ils m

aydi

ffer

by c

ount

ry).

Add

ition

ally,

PC

V13

is

licen

sed

for t

he p

reve

ntio

n of

pne

umoc

occa

ldi

seas

es in

adu

lts >

50 y

ears

of a

ge•

Prim

ary

sche

dule

(Fo

r bo

th P

CV

10 a

ndP

CV

13):

3 p

rimar

y do

ses

at 6

, 10,

and

14

wee

ks w

ith a

boo

ster

at a

ge 1

2 th

roug

h 15

mon

ths.

Cat

ch-u

p va

ccin

atio

n:•

Adm

inis

ter 1

dos

e of

PC

V13

or P

CV

10 to

all

heal

thy

child

ren

aged

24

thro

ugh

59 m

onth

sw

ho a

re n

ot c

ompl

etel

y va

ccin

ated

for t

heir

age.

•Fo

r PC

V 13

: C

atch

up

in 6

-12

mon

ths:

2do

ses

4 w

eeks

apa

rt an

d 1

boos

ter;

12-2

3m

onth

s: 2

dos

es 8

wee

ks a

part;

24

mo

&ab

ove:

sin

gle

dose

•Fo

r PC

V10:

Cat

ch u

p in

6-1

2 m

onth

s: 2

dose

s 4

wee

ks a

part

and

1 bo

oste

r; 12

mon

ths

to 5

yea

rs: 2

dos

es 8

wee

ks a

part

•Va

ccin

atio

n of

per

sons

with

hig

h-ris

kco

nditi

ons:

oP

CV

and

pne

umoc

occa

l po

lysa

ccha

ride

vacc

ine

[PP

SV

] bo

th a

re u

sed

in c

erta

inhi

gh ri

sk g

roup

of c

hild

ren.

oFo

r chi

ldre

n ag

ed 2

4 th

roug

h 71

mon

ths

with

ce

rtain

un

derly

ing

med

ical

cond

ition

s, a

dmin

iste

r 1 d

ose

of P

CV

13 if

3 do

ses

of P

CV

wer

e re

ceiv

ed p

revi

ousl

y,or

adm

inis

ter 2

dos

es o

f PC

V13

at l

east

8w

eeks

apa

rt if

few

er th

an 3

dos

es o

f PC

Vw

ere

rece

ived

pre

viou

sly.

oA

si

ngle

do

se

of

PC

V13

m

ay

bead

min

iste

red

to p

revi

ousl

y un

vacc

inat

edch

ildre

n ag

ed 6

thr

ough

18

year

s w

hoha

ve

anat

omic

or

fu

nctio

nal

aspl

enia

(incl

udin

g si

ckle

ce

ll di

seas

e),

HIV

infe

ctio

n or

an

im

mun

ocom

prom

isin

gco

nditi

on,

coch

lear

im

plan

t or

cere

bros

pina

l flu

id le

ak.

oA

dmin

iste

r P

PS

V23

at

leas

t 8

wee

ksaf

ter

the

last

dos

e of

PC

V t

o ch

ildre

nag

ed

2 ye

ars

or

olde

r w

ith

certa

inun

derly

ing

med

ical

con

ditio

ns.

8.

Pneu

moc

occa

l po

lysa

ccha

ride

vacc

ine

(PPS

V23)

.•

Min

imum

age

: 2 y

ears

•N

ot re

com

men

ded

for r

outin

e us

e in

hea

lthy

indi

vidu

als.

R

ecom

men

ded

only

fo

r th

eva

ccin

atio

n of

per

sons

with

cer

tain

hig

h-ris

kco

nditi

ons.

•A

dmin

iste

r PP

SV

at l

east

8 w

eeks

afte

r the

last

dos

e of

PC

V to

chi

ldre

n ag

ed 2

yea

rs o

rol

der

with

ce

rtain

un

derly

ing

med

ical

cond

ition

s lik

e an

atom

ic

or

func

tiona

las

plen

ia (i

nclu

ding

sic

kle

cell

dise

ase)

, HIV

infe

ctio

n, c

ochl

ear

impl

ant o

r ce

rebr

ospi

nal

fluid

leak

.•

An

addi

tiona

l do

se o

f P

PS

V s

houl

d be

adm

inis

tere

d af

ter

5 ye

ars

to c

hild

ren

with

anat

omic

/func

tiona

l as

plen

ia

or

anim

mun

ocom

prom

isin

g co

nditi

on.

•P

PS

V

shou

ld

neve

r be

us

ed

alon

e fo

rpr

even

tion

of

pneu

moc

occa

l di

seas

esam

ongs

t hig

h–ris

k in

divi

dual

s.•

Chi

ldre

n w

ith

follo

win

g m

edic

alco

nditi

ons

for w

hich

PPS

V23

and

PCV1

3ar

e in

dica

ted

in th

e ag

e gr

oup

24 th

roug

h71

mon

ths:

oIm

mun

ocom

pete

nt c

hild

ren

with

chr

onic

hear

t di

seas

e (p

artic

ular

ly

cya-

notic

cong

enita

l he

art

dise

ase

and

card

iac

failu

re);

chro

nic

lung

dis

ease

(in

clud

ing

asth

ma

if tre

ated

w

ith

high

-dos

e or

alco

rtico

ster

oid

ther

apy)

, dia

bete

s m

ellit

us;

cere

bros

pina

l flu

id

leak

s;

or

coch

lear

impl

ant.

oC

hild

ren

with

an

atom

ic

or

func

tiona

las

plen

ia (i

nclu

ding

sic

kle

cell

dise

ase

and

othe

r he

mog

lobi

nopa

thie

s, c

onge

nita

l or

acqu

ired

aspl

enia

, or s

plen

ic d

ysfu

nctio

n);

oC

hild

ren

with

im

mun

o-co

mpr

omis

ing

cond

ition

s: H

IV i

nfec

tion,

chr

onic

ren

alfa

ilure

and

nep

hrot

ic s

yndr

ome,

dis

ease

sas

soci

ated

w

ith

treat

men

t w

ithim

mun

osup

pres

sive

dr

ugs

or

radi

atio

nth

erap

y, i

nclu

ding

mal

igna

nt n

eopl

asm

s,le

ukem

ias,

ly

mph

omas

an

d H

odgk

indi

seas

e; o

r so

lid o

rgan

tra

nspl

anta

tion,

cong

enita

l im

mun

odef

icie

ncy.

9. R

otav

irus

(RV)

vac

cine

sR

outin

e va

ccin

atio

n:•

Min

imum

ag

e:

6 w

eeks

fo

r bo

th

RV-

1[R

otar

ix] a

nd R

V-5

[Rot

aTeq

])•

Onl

y tw

o do

ses

of R

V-1

are

reco

mm

ende

dat

pre

sent

•R

V1

shou

ld p

refe

rabl

y be

em

ploy

ed i

n 10

and

14 w

eek

sche

dule

, ins

tead

of 6

and

10

wee

k; th

e fo

rmer

sch

edul

e is

foun

d to

be

far

mor

e im

mun

ogen

ic th

an th

e la

ter

•If

any

dose

in s

erie

s w

as R

V-5

or v

acci

nepr

oduc

t is

unk

now

n fo

r an

y do

se i

n th

ese

ries,

a t

otal

of

3 do

ses

of R

V v

acci

nesh

ould

be

adm

inis

tere

d.C

atch

-up

vacc

inat

ion:

•Th

e m

axim

um a

ge f

or t

he f

irst

dose

in t

hese

ries

is 1

4 w

eeks

, 6 d

ays

•Va

ccin

atio

n sh

ould

no

t be

in

itiat

ed

for

infa

nts

aged

15

wee

ks, 0

day

s or

old

er.

•Th

e m

axim

um a

ge fo

r th

e fin

al d

ose

in th

ese

ries

is 8

mon

ths,

0 d

ays.

10.

Mea

sles

, m

umps

, an

d ru

bella

(M

MR

)va

ccin

eR

outin

e va

ccin

atio

n:•

Min

imum

age

: 9

mon

ths

or 2

70 c

ompl

eted

days

.•

Adm

inis

ter t

he fi

rst d

ose

of M

MR

vac

cine

at

age

9 th

roug

h 12

mon

ths,

and

the

sec

ond

dose

at a

ge 1

5 th

roug

h 18

mon

ths.

•Th

e 2n

d do

se m

ust f

ollo

w in

2nd

yea

r of

life

.H

owev

er,

it ca

n be

giv

en a

t an

ytim

e 4-

8w

eeks

afte

r the

1st d

ose

•N

o ne

ed

to

give

st

and-

alon

e m

easl

esva

ccin

eC

atch

-up

vacc

inat

ion:

•E

nsur

e th

at a

ll sc

hool

-age

d ch

ildre

n an

dad

oles

cent

s ha

ve h

ad 2

dos

es o

f M

MR

vacc

ine;

the

min

imum

inte

rval

bet

wee

n th

e2

dose

s is

4 w

eeks

.•

One

dos

e if

prev

ious

ly v

acci

nate

d w

ith o

nedo

se•

‘Sta

nd a

lone

’ m

easl

es/m

easl

es c

onta

inin

gva

ccin

e ca

n be

adm

inis

tere

d to

infa

nts

aged

6 th

roug

h 8

mon

ths

durin

g ou

tbre

aks.

How

ever

, thi

s do

se s

houl

d no

t be

coun

ted.

11. V

aric

ella

vac

cine

Rou

tine

vacc

inat

ion:

•M

inim

um a

ge: 1

2 m

onth

s•

Adm

inis

ter

the

first

dos

e at

age

15

thro

ugh

18 m

onth

s an

d th

e se

cond

dos

e at

age

4th

roug

h 6

year

s.•

The

seco

nd

dose

m

ay

be

adm

inis

tere

dbe

fore

age

4 y

ears

, pr

ovid

ed a

t le

ast

3m

onth

s ha

ve e

laps

ed s

ince

the

first

dos

e. If

the

seco

nd d

ose

was

adm

inis

tere

d at

leas

t 4w

eeks

afte

r the

firs

t dos

e, it

can

be

acce

pted

as v

alid

.•

The

risk

of b

reak

thro

ugh

varic

ella

is lo

wer

ifgi

ven

15 m

onth

s on

war

ds.

Cat

ch-u

p va

ccin

atio

n:•

Ens

ure

that

all

pers

ons

aged

7 th

roug

h 18

year

s w

ithou

t ‘ev

iden

ce o

f im

mun

ity’ h

ave

2do

ses

of th

e va

ccin

e.•

For

child

ren

aged

12

mon

ths

thro

ugh

12ye

ars,

the

reco

mm

ende

d m

inim

um in

terv

al

betw

een

dose

s is

3 m

onth

s. H

owev

er, i

f the

seco

nd d

ose

was

adm

inis

tere

d at

lea

st 4

wee

ks a

fter t

he fi

rst d

ose,

it c

an b

e ac

cept

edas

val

id.

•Fo

r pe

rson

s ag

ed 1

3 ye

ars

and

olde

r, th

em

inim

um

inte

rval

be

twee

n do

ses

is

4w

eeks

.•

For

pers

ons

with

out

evid

ence

of

imm

unity

,ad

min

iste

r 2

dose

s if

not

prev

ious

lyva

ccin

ated

or t

he s

econ

d do

se if

onl

y 1

dose

has

been

adm

inis

tere

d.•

‘Evi

denc

e of

imm

unity

’ to

varic

ella

incl

udes

any

of th

e fo

llow

ing:

•do

cum

enta

tion

of

age-

appr

opria

teva

ccin

atio

n w

ith a

var

icel

la v

acci

ne•

labo

rato

ry

evid

ence

of

im

mun

ity

orla

bora

tory

con

firm

atio

n of

dis

ease

•di

agno

sis

or

verif

icat

ion

of

a hi

stor

y of

varic

ella

dis

ease

by

a he

alth

-car

e pr

ovid

er•

diag

nosi

s or

ve

rific

atio

n of

a

hist

ory

ofhe

rpes

zos

ter b

y a

heal

th-c

are

prov

ider

12. H

epat

itis

A (H

epA

) vac

cine

sR

outin

e va

ccin

atio

n:•

Min

imum

age

: 12

mon

ths

•K

illed

Hep

A va

ccin

e: S

tart

the

2-do

se H

epA

vacc

ine

serie

s fo

r chi

ldre

n ag

ed 1

2 th

roug

h23

mon

ths;

sep

arat

e th

e 2

dose

s by

6 to

18

mon

ths.

•Li

ve

atte

nuat

ed

H2-

stra

in

Hep

atiti

s A

vacc

ine:

Sin

gle

dose

sta

rting

at 1

2 m

onth

san

d th

roug

h 23

mon

ths

of a

geC

atch

-up

vacc

inat

ion:

•E

ither

of

the

two

vacc

ines

can

be

used

in‘c

atch

-up’

sch

edul

e be

yond

2 y

ears

of a

ge•

Adm

inis

ter 2

dos

es fo

r kill

ed v

acci

ne a

t lea

st6

mon

ths

apar

t to

unva

ccin

ated

per

sons

•O

nly

sing

le d

ose

of li

ve a

ttenu

ated

H2-

stra

inva

ccin

e•

For

catc

h up

vac

cina

tion,

pre

vac

cina

tion

scre

enin

g fo

r H

epat

itis

A an

tibod

y is

reco

mm

ende

d in

chi

ldre

n ol

der

than

10

year

s as

at

this

age

the

est

imat

ed s

ero-

posi

tive

rate

s ex

ceed

50%

.13

. Typ

hoid

vac

cine

sR

outin

e va

ccin

atio

n:•

Bot

h V

i-PS

co

njug

ate

and

Vi-P

S(p

olys

acch

arid

e) v

acci

nes

are

avai

labl

e•

Min

imum

age

s:o

Vi-P

S (T

ypba

r-TC

V®

): 6

mon

ths;

oVi

-PS

(pol

ysac

char

ide)

vac

cine

s: 2

yea

rs•

Vacc

inat

ion

sche

dule

:•

Typh

oid

conj

ugat

e va

ccin

es (V

i-PS

): S

ingl

edo

se a

t 9-

12 t

hrou

gh 2

3 m

onth

s an

d a

boos

ter d

urin

g se

cond

yea

r of l

ife•

Vi-P

S (

poly

sacc

harid

e) v

acci

nes:

S

ingl

e



dose

at 2

yea

rs; r

evac

cina

tion

ever

y 3

year

s;•

Cur

rent

ly,

two

typh

oid

conj

ugat

e va

ccin

es,

Typb

ar-T

CV

® a

nd P

edaT

yph®

ava

ilabl

e in

Indi

an m

arke

t;•

Ped

aTyp

h®

is

not

yet

appr

oved

; th

ere

com

men

datio

n is

app

licab

le t

o Ty

pbar

-TC

V®

onl

y•

An

inte

rval

of a

t lea

st 4

wee

ks w

ith th

e M

MR

vacc

ine

shou

ld

be

mai

ntai

ned

whi

lead

min

iste

ring

Typb

ar-T

CV

® v

acci

ne•

Prim

ary

dose

of

conj

ugat

e va

ccin

e sh

ould

follo

w a

boo

ster

at 2

yea

rs o

f age

•E

ither

Typ

bar-

TCV

® o

r Vi

-pol

ysac

char

ide

(Vi-P

S) c

an b

e em

ploy

ed a

s bo

oste

r;•

Typh

oid

reva

ccin

atio

n ev

ery

3 ye

ars,

if V

i-po

lysa

ccha

ride

vacc

ine

is u

sed

•N

o ev

iden

ce o

f hy

po-r

espo

nsiv

enes

s on

repe

ated

re

vacc

inat

ion

of

Vi

-po

lysa

ccha

ride

vacc

ine

so fa

r•

Nee

d of

reva

ccin

atio

n fo

llow

ing

a bo

oste

r of

Typb

ar-T

CV

® n

ot y

et d

eter

min

edC

atch

-up

vacc

inat

ion:

•R

ecom

men

ded

thro

ugho

ut t

he a

dole

scen

tpe

riod,

i.e.

18

year

s14

. Inf

luen

za v

acci

neR

outin

e va

ccin

atio

n:•

Min

imum

ag

e:

6 m

onth

s fo

r tri

vale

ntin

activ

ated

influ

enza

vac

cine

(TIV

)•

Rec

omm

ende

d on

ly f

or t

he v

acci

natio

n of

pers

ons

with

cer

tain

hig

h-ris

k co

nditi

ons.

•Fi

rst t

ime

vacc

inat

ion:

6 m

onth

s to

bel

ow 9

year

s:

two

dose

s 1

mon

th a

part;

9 y

ears

and

abov

e: s

ingl

e do

se•

Ann

ual r

evac

cina

tion

with

sin

gle

dose

.•

Dos

age

(TIV

) : a

ged

6–35

mon

ths

0.25

ml;

3ye

ars

and

abov

e: 0

.5 m

l•

For c

hild

ren

aged

6 m

onth

s th

roug

h 8

year

s:A

dmin

iste

r 2 d

oses

(sep

arat

ed b

y at

leas

t 4w

eeks

) to

ch

ildre

n w

ho

are

rece

ivin

gin

fluen

za v

acci

ne fo

r the

firs

t tim

e.•

All

the

curr

ently

ava

ilabl

e TI

Vs

in th

e co

untry

cont

ain

the

‘Sw

ine

flu’ o

r ‘A

(H1N

1)’ a

ntig

en;

no n

eed

to v

acci

nate

sep

arat

ely.

•B

est t

ime

to v

acci

nate

:o

As

soon

as

the

new

vac

cine

is r

elea

sed

and

avai

labl

e in

the

mar

ket

oJu

st b

efor

e th

e on

set o

f rai

ny s

easo

n.15

.Hum

an p

apill

omav

irus

(HPV

) vac

cine

sR

outin

e va

ccin

atio

n:•

Min

imum

age

: 9 y

ears

•H

PV

4 [G

arda

sil]

and

HP

V2

[Cer

varix

] ar

elic

ense

d an

d av

aila

ble.

•O

nly

2 do

ses

of e

ither

of

the

two

HP

Vva

ccin

es (

HP

V4

& H

PV

2) f

or a

dole

scen

t/

prea

dole

scen

t girl

s ag

ed 9

-14

year

s;•

For

girls

15

ye

ars

and

olde

r, an

dim

mun

ocom

prom

ised

ind

ivid

uals

3 d

oses

are

reco

mm

ende

d•

For

two-

dose

sc

hedu

le,

the

min

imum

inte

rval

bet

wee

n do

ses

shou

ld b

e 6

mon

ths.

•E

ither

HP

V4

(0, 2

, 6 m

onth

s) o

r HP

V2

(0, 1

,6

mon

ths)

is

reco

mm

ende

d in

a 3

-dos

ese

ries

for f

emal

es a

ged

15 y

ears

and

old

er•

HP

V4

can

also

be

give

n in

a 3

-dos

e se

ries

for

mal

es a

ged

11 o

r 12

yea

rs, b

ut n

ot y

etlic

ense

d fo

r use

in m

ales

in In

dia.

•Th

e va

ccin

e se

ries

can

be s

tarte

d be

ginn

ing

at a

ge 9

yea

rs.

•Fo

r th

ree-

dose

sc

hedu

le,

adm

inis

ter

the

2nd d

ose

1 to

2 m

onth

s af

ter t

he 1

stdo

se a

ndth

e 3r

d dos

e 6

mon

ths

afte

r th

e 1s

tdos

e (a

tle

ast 2

4 w

eeks

afte

r the

firs

t dos

e).

Cat

ch-u

p va

ccin

atio

n:•

Adm

inis

ter

the

vacc

ine

serie

s to

fem

ales

(eith

er H

PV

2 or

HP

V4)

at a

ge 1

3 th

roug

h 45

year

s if

not p

revi

ousl

y va

ccin

ated

.•

Use

rec

omm

ende

d ro

utin

e do

sing

inte

rval

s(s

ee a

bove

) for

vac

cine

ser

ies

catc

h-up

.16

. Men

ingo

cocc

al v

acci

ne.

•R

ecom

men

ded

only

for

cer

tain

hig

h ris

kgr

oup

of c

hild

ren,

dur

ing

outb

reak

s, a

ndin

tern

atio

nal

trave

lers

, in

clud

ing

stud

ents

goin

g fo

r stu

dy a

broa

d an

d tra

vele

rs to

Haj

jan

d su

b-S

ahar

a A

frica

.•

Bot

h M

enin

goco

ccal

co

njug

ate

vacc

ines

(Qua

driv

alen

t M

enA

CW

Y-D

, Men

actra

® b

yS

anof

i Pas

teur

and

m

onov

alen

t g

roup

A,

PsA

–TT,

Men

Afri

Vac®

by

Ser

um In

stitu

te o

fIn

dia)

and

pol

ysac

char

ide

vacc

ines

(bi-

and

quad

rival

ent)

are

licen

sed

in In

dia.

PsA

–TT

is n

ot fr

eely

ava

ilabl

e in

mar

ket.

•C

onju

gate

va

ccin

es

are

pref

erre

d ov

erpo

lysa

ccha

ride

vacc

ines

du

e to

th

eir

pote

ntia

l fo

r he

rd

prot

ectio

n an

d th

eir

incr

ease

d im

mun

ogen

icity

, pa

rticu

larly

in

child

ren

1 ye

ar o

ld.

18. J

apan

ese

ence

phal

itis

(JE)

vac

cine

.R

outin

e va

ccin

atio

n:•

Rec

omm

ende

d on

ly fo

r in

divi

dual

s liv

ing

inen

dem

ic a

reas

•Th

e va

ccin

e sh

ould

be

of

fere

d to

th

ech

ildre

n re

sidi

ng i

n ru

ral

area

s on

ly a

ndth

ose

plan

ning

to

vi

sit

ende

mic

ar

eas

(dep

endi

ng u

pon

the

dura

tion

of s

tay)

•Th

ree

type

s of

new

gen

erat

ion

JE v

acci

nes

are

licen

sed

in In

dia

: one

, liv

e at

tenu

ated

,ce

ll cu

lture

der

ived

SA

-14-

14-2

, an

d tw

oin

activ

ated

JE

vac

cine

s, n

amel

y ‘v

ero

cell

cultu

re-d

eriv

ed S

A 1

4-14

-2 J

E va

ccin

e’(J

EEV®

by

B

E In

dia)

an

d ‘v

ero

cell

cultu

re-d

eriv

ed,

8215

64XY

, JE

vac

cine

’(J

ENVA

C®

by

Bha

rat B

iote

ch)

•Li

ve a

ttenu

ated

, cel

l cul

ture

der

ived

SA

-14

-14-

2:o

Min

imum

age

: 8

mon

ths;

oTw

o do

se s

ched

ule,

firs

t dos

e at

9 m

onth

sal

ong

with

mea

sles

vac

cine

and

sec

ond

at16

to 1

8 m

onth

s al

ong

with

DTP

boo

ster

oN

ot a

vaila

ble

in p

rivat

e m

arke

t fo

r of

fice

use

•In

activ

ated

cel

l cul

ture

der

ived

SA

-14-

14-

2 (J

EEV®

by

BE

Indi

a) :

oM

inim

um a

ge: 1

yea

r (U

S-F

DA

: 2 m

onth

s)o

Prim

ary

imm

uniz

atio

n sc

hedu

le:

2 do

ses

of

0.25

ml

each

ad

min

iste

red

intra

mus

cula

rly

on

days

0

and

28

for

child

ren

aged

≥ 1

to ≤

3 y

ears

o2

dose

s of

0.5

ml f

or c

hild

ren

>3ye

ars

and

adul

ts a

ged

≥ 18

yea

rso

Nee

d of

boo

ster

s st

ill u

ndet

erm

ined

•In

activ

ated

Ve

ro

cell

cultu

re-d

eriv

edK

olar

st

rain

, 82

1564

XY,

JE

vacc

ine

(JEN

VAC

® b

y B

hara

t Bio

tech

)o

Min

imum

age

: 1 y

ear

oP

rimar

y im

mun

izat

ion

sche

dule

: 2

dose

sof

0.

5 m

l ea

ch

adm

inis

tere

din

tram

uscu

larly

at 4

wee

ks in

terv

alo

Nee

d of

boo

ster

s st

ill u

ndet

erm

ined

.C

atch

up

vacc

inat

ion:

•A

ll su

scep

tible

chi

ldre

n up

to 1

5 yr

s sh

ould

be a

dmin

iste

red

durin

g di

seas

e ou

tbre

ak/

ahea

d of

ant

icip

ated

out

brea

k in

cam

paig

ns19

. Rab

ies

vacc

ine:

•P

ract

ical

ly

all

child

ren

need

va

ccin

atio

nag

ains

t rab

ies

•Fo

llow

ing

two

situ

atio

ns i

nclu

ded

in ‘

high

-

risk

cate

gory

of

ch

ildre

n’

for

rabi

esva

ccin

atio

n an

d sh

ould

be

offe

red

‘Pre

-ex

posu

re p

roph

ylax

is’ (

Pre

-EP

):o

Chi

ldre

n ha

ving

pet

s in

hom

e;o

Chi

ldre

n pe

rcei

ved

with

hig

her

thre

at o

fbe

ing

bitte

n by

dog

s su

ch a

s ho

stel

lers

, ris

kof

stra

y do

g m

enac

e w

hile

goi

ng o

utdo

or.

•O

nly

mod

ern

tissu

e cu

lture

va

ccin

es(M

TCV

s) a

nd I

M r

oute

s ar

e re

com

men

ded

for

both

‘pos

t-exp

osur

e’ a

nd ‘p

re-e

xpos

ure’

prop

hyla

xis

in o

ffice

pra

ctic

e•

Pos

t-exp

osur

e pr

ophy

laxi

s (P

EP

) is

reco

mm

ende

d fo

llow

ing

a si

gnifi

cant

cont

act

with

dog

s, c

ats,

cow

s, b

uffa

loes

,sh

eep,

go

ats,

pi

gs,

donk

eys,

ho

rses

,ca

mel

s,

foxe

s,

jack

als,

m

onke

ys,

mon

goos

e,

squi

rrel

, be

ars

and

othe

rs.

Dom

estic

rod

ent

(rat

) bi

tes

do n

ot r

equi

repo

st e

xpos

ure

prop

hyla

xis

in In

dia.

•P

ost-e

xpos

ure

prop

hyla

xis:

oM

TCV

s ar

e re

com

men

ded

for a

ll ca

tego

ryII

and

III b

ites.

oD

ose:

1.0

ml i

ntra

mus

cula

r (IM

) in

ante

ro-

late

ral

thig

h or

del

toid

(ne

ver

in g

lute

alre

gion

) fo

r H

uman

Dip

loid

Cel

l Va

ccin

e(H

DC

V),

Pur

ified

C

hick

E

mbr

yo

Cel

l(P

CE

C)

vacc

ine,

Pur

ified

Duc

k E

mbr

yoVa

ccin

e (P

DE

V);

0.5

ml f

or P

urifi

ed V

ero

Cel

l Va

ccin

e (P

VR

V).

Intra

derm

al

(ID)

adm

inis

tratio

n is

no

t re

com

men

ded

inin

divi

dual

pra

ctic

e.o

Sch

edul

e: 0

, 3, 7

, 14,

and

30

with

day

‘0’

bein

g th

e da

y of

co

mm

ence

men

t of

vacc

inat

ion.

A s

ixth

dos

e on

day

90

isop

tiona

l an

d m

ay b

e of

fere

d to

pat

ient

sw

ith s

ever

e de

bilit

y or

tho

se w

ho a

reim

mun

osup

pres

sed

oR

abie

s im

mun

oglo

bin

(RIG

) al

ong

with

rabi

es v

acci

nes

are

reco

mm

ende

d in

all

cate

gory

III b

ites.

oE

quin

e ra

bies

im

mun

oglo

bin

(ER

IG)

(dos

e 40

U/k

g) c

an b

e us

ed i

f hu

man

rabi

es im

mun

oglo

bin

is n

ot a

vaila

ble;

•P

re -e

xpos

ure

prop

hyla

xis:

oTh

ree

dose

s ar

e gi

ven

intra

mus

cula

rly in

delto

id/

ante

rola

tera

l th

igh

on d

ays

0, 7

and

28 (

day

21 m

ay b

e us

ed i

f tim

e is

limite

d bu

t day

28

pref

erre

d).

oFo

r re

-exp

osur

e at

any

poi

nt o

f tim

e af

ter

com

plet

ed (

and

docu

men

ted)

pre

or

post

expo

sure

pro

phyl

axis

, tw

o do

ses

are

give

non

day

s 0

and

3.o

RIG

is

not

requ

ired

durin

g re

-exp

osur

eth

erap

y.



D. Pre-exposure prophylaxis for rabies

Recommendations for office practice: The committee hasnow recommended that practically all children needvaccination against rabies and following two situations tobe included in high-risk category of children for rabiesvaccination: (i) children having pets at home; and (ii)children perceived with higher threat of being bitten bydogs such as hostellers, and those with risk of stray dogbite while going outdoor. These children should be offeredpre-exposure prophylaxis (Pre-EP) against rabies. Thismust be preceded by a one-to-one discussion with theparents. The Pre-EP is not included in the IAPimmunization schedule for all children. Three doses arerecommended to be given intramuscularly on days 0, 7 and28 (day 21 may be used if time is limited, as with imminenttravel, but day 28 is preferred). The intradermal schedulehas been shown to be effective, but is not approved for thispurpose in office practice.

There are studies to show that good antibody levelspersist up to 10 years even after a 3 dose pre-exposureprophylaxis followed by a booster at one year. However,on account of the nature of the disease, for re-exposure atany point of time after completed and documented, pre-orpost-exposure prophylaxis, two doses are to be given ondays 0 and 3. Rabies immunoglobulins (RIG) are notneeded in these children. There is no change in the IAPrecommendations for post-exposure prophylaxis (PEP) ofrabies.

Public use: The committee urges the Government of India(GoI) to urgently take remedial measures to address thehuge burden of rabies in India [17]. These measuresinclude public education campaigns, need to ensure theuninterrupted availability of vaccines and anti-rabiesimmunoglobulin in primary health care facilities andtraining of primary care providers (includingpediatricians), vaccination of dogs, sterilization of straydogs, and declaration of rabies as a notifiable disease. Thecommittee reiterated its position that universal Pre-EPvaccination, especially for children, could reduce thenumber of human rabies dramatically. Use of intradermalvaccination would bring down the vaccine cost foruniversal vaccination program dramatically [2].

Justifications: The advantages of the Pre-EP includeelimination of the need for RIG, reduction in the number ofvaccine doses on exposure and provision of immunity toindividuals whose post-exposure prophylaxis is delayed.Further, the likelihood of lack of documentation of a dogbite amongst young children who may not report scratchesand small playful bites from dogs and cats are other reasonswhy Pre-EP would be useful. However, it was agreed uponthat inclusion of Pre-EP in only IAP schedule for office

practice would not serve the desired purpose since majorityof deaths occur among children belonging to lowsocioeconomic strata and those living in remote areas [17].WHO encourages the implementation of carefullydesigned studies on the feasibility, cost-effectiveness andlong-term impact of incorporating ‘Cell Culture Vaccinesand Embryonated egg-based vaccines’ (CCEEVs) into theimmunization programs of infants and children wherecanine rabies is a public health problem [18].

E. Typhoid conjugate vaccines

Recommendation for office practice

Primary schedule: The committee has now created a newslot for typhoid conjugate vaccine for primaryimmunization at 9-12 months of age in the IAPImmunization schedule. There are currently two typhoidconjugate vaccines (Typbar-TCV and PedaTyph),available and licensed in the country. However, thisrecommendation would be applicable only to the former asthe committee is awaiting more data on the latter. Only asingle dose of the vaccine is recommended for primaryseries. An interval of at least 4 weeks with the measles/MMR vaccine should be maintained since the data oninterference with the measles/MMR vaccine are not yetavailable.

Boosters: Those who received a dose of conjugate vaccineat 9-12 months can be prescribed booster of either Vi-polysaccharide (Vi-PS) or the conjugate vaccine at 2 yearsof age. Those who have received booster of Vi-PS vaccinewill need revaccination every 3 years till the intendedduration of protection. There is no evidence of hypo-responsiveness on repeated vaccination so far. The needof further boosters after conjugate vaccine is not yetdetermined since long term data are not yet available.

Catch-up schedule: Catch-up vaccination is recommendedthroughout the adolescent period, i.e. up to 18 years of age.Below 2 years, only conjugate vaccine is recommendedwhile above 2 years of age any of the two can be employed.The details about further schedule should be followed asdescribed above in the ‘boosters’ section.

Recommendations for public use

The committee strongly urges the GoI to include universaltyphoid vaccination in its UIP all over the country at theearliest.

Evidence and justification: The committee believes thatconsidering the epidemiology of typhoid in the country,there is definite need of protection against typhoid feverbelow 2 years of age. The Vi-PS vaccines are ineffectivebelow 2 years of age and provide modest and short lastingprotection. There is definite need of typhoid conjugate



vaccines, effective below 2 years of age and capable ofproviding superior long-lasting protection. The committeereviewed the published [19] and unpublished data of newtyphoid conjugate vaccines, (BBIL’s Typbar-TCV,BioMed’s PedaTyph and Novartis’s Vi-CRM197). Allthese vaccines can be administered at and around 9 monthsof age. Only a single dose is sufficient for adequateseroconversion for primary immunization, and the seconddose failed to show incremental effect on antibody titers(data after 2nd dose of PedaTyph are not yet available). Inthe published trial of Novartis’s Vi-CRM197 conjugatetyphoid vaccine [19], a low response was noted to measles,hepatitis B and H influenza type b both in reference(PCV13) and test vaccine (conjugate typhoid vaccine)groups, with a non-significant reduction in the rate ofmeasles seroconversion in the test vaccine group in onecenter. The committee has thus recommended maintainingan interval of at least 4 weeks with the measles/MMRvaccine while administering this vaccine. The committeehas also asked the manufacturer to undertake a ‘measles/MMR interference study’ with vaccination at 9 months.

Regarding the need and timing of boosters, the dataprovided by the manufacturer of Typbar-TCV vaccineshow almost 100% seroprotection (>7.2 EU/mL) of testvaccine in both the cohorts (6 mo-2 years and 2-45 years)till 18 months of follow-up, although both seroconversion(>4-fold rise of antibody level) and GMT levels wanedsignificantly in both cohorts. Regarding comparison of Vi-PS non-conjugate vaccine with the Vi-PS conjugatevaccine, both fared equally well above 2 years of age as faras immediate and long-term seroconversion areconcerned, although the latter had significantly higherGMTs and slightly better seroconversion rates than theformer. The committee has thus recommended either of thevaccines as a booster at 2 years of age. The need of repeatdoses/boosters for conjugate vaccine shall only bedetermined after long-term efficacy data are available.

F. Human Papillomavirus (HPV) vaccinationschedule

Recommendations: Two doses of HPV vaccine areadvised for adolescent/pre-adolescent girls aged 9-14years; for girls 15 years and older, current 3 dose schedulewill continue. For two-dose schedule, the minimuminterval between doses should be 6 months. The intervalbetween the first and second dose may be extended upto12months, should this facilitate administration – say inschool settings. For girls, primed before the age of 15years, even if older at the time of second dose, a two-doseschedule will be applicable. However, for immuno-compromised individuals, including HIV-infected, thethree-dose schedule is recommended, irrespective of age.

Evidence and justification: IAP had recommended use ofHPV vaccine in its immunization schedule way back in2007. Though there is no coverage data on uptake of thisvaccine through private sector, the common perception isthat acceptance is poor and the coverage still remainsminiscule. The move to revise HPV vaccine immunizationschedule for adolescent girls from existing three to twodoses would not only be cost-saving, but would alsosimplify logistics like increased flexibility of the intervals,and annual doses for school-based delivery. Hence, therevised recommendations may help in improvingacceptance, facilitating delivery, and enhancing coverageof the vaccine.

The WHO’s Strategic Advisory Group of Experts(SAGE) working group (WG) on HPV has recommendedrevision of vaccination schedule for pre-adolescent andadolescent girls from three primary doses to two in itsApril 2014 meeting [20]. The committee has reviewed thebackground material and various trials conducted in thisregard so far [21]. The main source of evidence is providedby a systematic review commissioned by SAGE WG [22].The other sources include review of the data fromobservational studies on 2 versus 3 dose schedule, andproceedings of an Ad hoc Expert Consultation on HPVvaccine schedules organized in Geneva, 2013 [21]. TheEuropean Medicines Agency (EMA) has also approvedtwo doses for pre-adolescent and adolescent girls aged 9-14 years for the bivalent HPV vaccine and also offeredpositive opinion for a similar schedule for quadrivalentvaccine [23]. Many countries have either already adoptedor are planning to adopt a two-dose schedule [21]. Fewcountries like Brazil, Mexico, Columbia and BritishColumbia are running an extended schedule (2+1, i.e. 0, 6,60 months) where the last dose at 5 years depends onfollow-up assessment of the need [21]. In Costa Rica,strong 4 year protection was reported in women whoreceived just one dose of bivalent HPV vaccine [21].

The systematic review [22] has identified variousstudies that include both randomized and non-randomizedtrials of both the vaccines, bivalent and quadrivalent, fromvarious high income group countries like Canada,Australia, Sweden, Denmark, Germany, and low andmiddle income (LMI) countries like Uganda, Mexico, andIndia. In randomized comparisons of two-dose and three-dose schedules (overall 3 RCTs), seroconversion andseropositivity were non-inferior or inconclusive at all-timepoints. In non-randomized comparisons, all available datafor seroconversion and seropositivity showed non-inferiority of the 2-dose compared with the 3-doseschedule. The efficacy against virological endpoints ininitially HPV-naïve subjects who received 2 doses ofbivalent vaccine at 48th month indicates that the two-dose



schedule prevents HPV-16/18 infection in subjects whodid not receive a complete 3-dose vaccination course. Thereview also compared different intervals between doses ofHPV vaccine. The 6-month interval resulted in superiorGMCs compared with the 2-month interval one monthafter the last vaccine dose in all the age groups enrolled.

The mathematical models also support the two-doseschedule for girls aged 9-14 years. In one such model itwas shown that in high-income settings (such as the UKand Canada), if it was documented that a 2-dosevaccination conferred more than 10-20 years protectionthen adding the third dose would not be cost-effective [21].The cost-effectiveness of 2-dose vs. 3-dose vaccination inlow/middle income settings still needs to be explored.

The committee’s recommendations are also facilitatedby the evidence generated by an ongoing multi-centricRCT on alternative dosing schedule of quadrivalent HPVvaccine in India [24-2

Indian Academy of Pediatrics (IAP) Recommended Immunization … · 2017. 8. 27. · INDIAN...

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