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INDIAN PEDIATRICS 1066 VOLUME 55__DECEMBER 15, 2018
Indian Academy of Pediatrics (IAP) Advisory Committee on Vaccines
and Immunization Practices (ACVIP) Recommended Immunization
Schedule (2018-19) and Update on Immunization for Children Aged
0 Through 18 Years
S BALASUBRAMANIAN, ABHAY S HAH, HARISH K PEMDE, PALLAB CHATTERJEE, S SHIVANANDA, VIJAY KUMAR GUDURU,
SANTOSH SOANS, DIGANT SHASTRI AND R EMESH KUMAR
From Advisory Committee on Vaccines and Immunization Practices (ACVIP), Indian Academy of Pediatrics, India.
Correspondence to: Dr Harish K Pemde, Director Professor, Department of Pediatrics, Lady Hardinge Medical College, Kalawati
Saran Childern’s Hospital, New Delhi, India. harishpemde@gmail.com
Justification: There is a need to revise/review recommendations regarding existing vaccines in view of current developments in
vaccinology. Process: Advisory Committee on Vaccines and Immunization Practices (ACVIP) of Indian Academy of Pediatrics (IAP)
reviewed the new evidence, had two meetings, and representatives of few vaccine manufacturers also presented their data. The
recommendations were finalized unanimously. Objectives: To revise and review the IAP recommendations for 2018-19 and issue
recommendations on existing and certain new vaccines. Recommendations. The major changes in the IAP 2018-19 Immunization
Timetable include administration of hepatitis B vaccine within 24 hours of age, acceptance of four doses of hepatitis B vaccine if a
combination pentavalent or hexavalent vaccine is used, administration of DTwP or DTaP in the primary series, and complete replacement
of oral polio vaccine (OPV) by injectable polio vaccine (IPV) as early as possible. In case IPV is not available or feasible, the child should
be offered three doses of bivalent OPV. In such cases, the child should be advised to receive two fractional doses of IPV at a
Government facility at 6 and 14 weeks or at least one dose of intramuscular IPV, either standalone or as a combination, at 14 weeks. The
first dose of monovalent Rotavirus vaccine (RV1) can be administered at 6 weeks and the second at 10 weeks of age in a two-dose
schedule. Any of the available rotavirus vaccine may be administered. Inactivated influenza vaccine (either trivalent or quadrivalent) is
recommended annually to all children between 6 months to 5 years of age. Measles-containing vaccine (MMR/MR) should be
administered after 9 months of age. Additional dose of MR vaccine may be administered during MR campaign for children 9 months to 15
years, irrespective of previous vaccination status. Single dose of Typhoid conjugate vaccine (TCV) is recommended from the age of 6
months and beyond, and can be administered with MMR vaccine if administered at 9 months. Four-dose schedule of anti-rabies vaccine
for Post Exposure Prophylaxis as recommended by World Health Organization in 2018, is endorsed, and monoclonal rabies antibody can
be administered as an alternative to Rabies immunoglobulin for post-exposure prophylaxis.
Keywords: Guidelines, Immunity, Infections, Prevention, Vaccination.
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The Indian Academy of Pediatrics (IAP)
Advisory Committee on Vaccines and
Immunization Practices (ACVIP) has recently
reviewed and updated the recommended
immunization schedule for children aged 0 through 18 years
based on recent evidence for the vaccines licensed in India.
The process of preparing the new recommendations
consisted of review of data and literature, consultative
meetings twice (4th and 5th August 2018 at Mangalore, and
22nd and 23rd September 2018 at Chennai), taking the
opinion of various National Experts and arriving at a
consensus and drafting the recommendations while taking
into consideration the existing National immunization
schedule and policies of the government. All decisions were
taken unanimously and voting was not required for any
issue. The recommendations in brief along with supporting
evidence from relevant literature are presented in this article.
The detailed information will be presented later in IAP
Guidebook on Immunization. While using these guidelines,
pediatricians are free to use their discretion in a particular
situation within the suggested framework.
The current IAP ACVIP recommendations for the 2018-
19 IAP Immunization Timetable are presented in Table I
and Fig. 1 , and this also include some alterations from the
earlier recommended schedule [1].
HEPATITIS B VACCINE
The burden of chronic hepatitis B virus infection is
substantial as the coverage of the birth-dose (estimated as
39% globally) is still low. World Health Organization
(WHO) Position paper 2017 states that hepatitis B vaccine
(HBV) should be administered as a birth dose, preferably
within 24 hours (timely birth dose) [2]. This dose may only
be delayed if the mother is known to be hepatitis-B surface
antigen (HBsAg) negative at the time of delivery. When the
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TABLE I KEY UPDATES AND MAJOR CHANGES IN RECOMMENDATIONS FOR IAP IMMUNIZATION TIMETABLE, 2018-2019
Hepatitis B vaccine
• One dose of hepatitis B vaccine within 24 hours of birth.
• In case of use of a combination vaccines a total of four doses of hepatitis B vaccine are justified.
DTwP, DTaP and combination vaccines
• DTwP or DTaP can be offered in primary series.
Polio vaccines
• Ideally IPV should replace OPV as early as possible.
• Three doses of intramuscular IPV in primary series is the best option.
• Two doses of intramuscular IPV instead of three for primary series if started at 8 weeks, with an interval of 8 weeks between two
doses is an alternative.
• In case IPV is not available or feasible, the child should be offered three doses of bOPV. In such cases, the child should be referred for
two fractional doses of IPV at a Government facility at 6 and 14 weeks or at least one dose of intramuscular IPV, either standalone or
as a combination vaccine, at 14 weeks of age.
Rotavirus vaccine
• In case of Rotavirus vaccine, RV1 can be used in 6, 10 weeks schedule.
Influenza vaccine
• Inactivated influenza vaccine (either trivalent or quadrivalent) is recommended routinely to all children below 5 years of age starting
from 6 months of age annually (2-4 weeks before influenza season).
Measles-containing vaccines
• Measles-containing vaccine (MMR/MR) should be administered after 9 months of age.
• MR vaccine as part of the national campaign is to be administered irrespective of previous vaccination.
Typhoid vaccines
• Single dose of any of Typhoid conjugate vaccine (TCV 25 mg) is recommended from 6 months onwards and can be administered with
MMR also.
• Booster dose of Typhoid conjugate vaccine not recommended in subsequent years.
Rabies vaccines
• ACVIP IAP endorses administration of a 4-dose schedule of Rabies vaccine recommended by WHO 2018 for Post-exposure
prophylaxis.
• ACVIP also endorses administration of Rabies monoclonal antibody as an alternative to Rabies immunoglobulin for category-III
bites.
ACVIP: Advisory Committee on Vaccines and Immunization Practices; IAP: Indian Academy of Pediatrics; IPV: Injectable polio vaccine;
OPV: Oral polio vaccine; bOPV: bivalent oral polio vaccine; MR: Measles-Rubella vaccine; MMR: Measles-Mumps-Rubella vaccine.
HBsAg report of the mother is not known or reported
incorrectly, or in case of infants born to HBsAg positive
mothers, this dose becomes a very important safety net [3].
Four doses of hepatitis B vaccine may be administered
for programmatic reasons (e.g., 3 doses of hepatitis B-
containing combination vaccine or monovalent HBV after a
single monovalent dose at birth [2].
DIPTHERIA, TETANUS AND PERTUSSIS VACCINES (DTwP
AND DTaP)
Long-term efficacy over 10 years has been observed to be
superior with whole cell pertussis vaccine (wP) [4]. Recent
outbreaks of pertussis in various developed countries
have sparked a debate on the effectiveness of acellular
pertussis (aP) vaccines. However, none of these countries
are planning to revert back to whole-cell pertussis vaccines
as that can result in an increase in the prevalence of the
disease due to poor acceptance of a vaccine that is much
more reactogenic [5]. Though the reasons for this
resurgence are complex and vary from place to place, the
lesser duration of protection and decreased impact on
transmission of the disease by acellular pertussis vaccines
appears to be crucial [6]. Waning of immunity has been
reported with whole cell and acellular vaccines over a
period of time. Current evidence suggests that the efficacy
of both aP and wP vaccines in preventing pertussis in the
first year is equivalent. After the first year, the immunity
wanes more rapidly with the aP vaccines and the impact on
transmission by aP vaccines is also inferior to wP vaccines
[7-9]. WHO clearly mentions that countries currently using
the wP vaccine in their national programs should continue
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FIG. 1 IAP-ACVIP Recommended immunization schedule for children aged 0-18 years (2018-19).
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the same for the primary series [10,11], while those using
the aP vaccine should continue the same and consider
additional boosters and strategies like immunization of
mothers in case of pertussis resurgence [10]. The duration
of protection for both the aP and wP vaccines after the
three primary doses and a booster dose at least after a year
varies from 6-12 years [11]. A German study reported
acellular pertussis vaccine being quite efficacious (88.7%)
(95% CI, 76.6% to 94.6%) [12].
Number of Components
In a couple of systematic reviews, it was concluded that
multi-component acellular pertussis vaccines are more
efficacious than the single- or two-component vaccines
[13,14]. However, effectiveness studies of long-term usage
of two-component acellular pertussis vaccines in Sweden
[15] and Japan [16], and the mono-component vaccine in
Denmark showed high effectiveness in prevention of
pertussis. Thus the higher efficacy for the multi-component
vaccine as demonstrated in the trials should be cautiously
interpreted, and at present the evidence is insufficient to
conclude categorically that the effectiveness of the aP
vaccines is related to the number of components alone [10].
IAP ACVIP Recommendation on Pertussis-containing
Vaccines
The primary series should be completed with three doses
of either wP or aP vaccines, irrespective of the number of
components. wP vaccine is definitely superior to aP
vaccine in terms of immunogenicity and duration of
protection but more reactogenic. In view of parental anxiety
and concerns for its reactogenicity, aP vaccine can also be
administered even in the primary series. The primary aim is
to increase the vaccination coverage with either of the
vaccines.
POLIO VACCINES
The elimination of circulating wild poliovirus from our
country and the decline worldwide in the number of cases
is the proof of efficacy of Oral polio vaccine (OPV). At the
beginning of 2013, 126 countries using OPV exclusively,
decided to introduce Injectable polio vaccine (IPV), at least
one dose, in their National Immunization Schedule. This
was part of WHO’s Endgame Plan to withdraw type-2 polio
virus and prepare for ‘the switch’ from trivalent OPV (tOPV)
to bivalent OPV (bOPV) in April 2016 [17,18]. However, IPV
introduction in these countries has increased the global
IPV demand, to over 200 million in 2016 from 80 million in
2013 [17,18]. The attempt to meet the global requirements for
IPV by rapidly increasing the IPV production has led to
multiple challenges, resulting in a shortage worldwide.
Intradermal IPV administration with fractional doses of IPV
(fIPV) (0.1 mL or one-fifth of a full dose) offers potential cost
reduction and allows immunization of a larger number of
persons with a given vaccine supply [19]. Two fractional
doses administered via the intradermal (ID) route offer
higher immunogenicity compared to one full intramuscular
(IM) dose of IPV [20-23]. As a result, a two-dose fIPV
schedule has been strongly recommended to countries that
are endemic and the those with high risk of importation of
wild polio virus [24].
Private medical practitioners have irregular and
inadequate access to standalone IPV, and are thus
compelled to administer combination vaccines, and thus
are not able to follow the Indian government schedule,
which consists of fIPV and standalone IPV. It is not feasible
for pediatricians in private settings to refer all children to
government facilities for the same. In addition, the recent
controversy of the contamination of OPV with type-2
Poliovirus has resulted in the awareness of vaccine-derived
paralytic poliomyelitis (VDPP) amongst public. In this
background, there is a need to recommend a regimen
containing IPV as combination vaccine in the private
settings.
IAP ACVIP Recommendations
• Birth dose of OPV is a must.
• Extra doses of OPV on all Supplementary immunization
activities should continue.
• No child should leave the health facility without polio
immunization (IPV or OPV), if indicated by the
schedule.
• bOPV should be continued in place of IPV, only if IPV is
not feasible, with a minimum of 3 doses at 6,10,14 weeks
of age.
• Minimum age of administration of IPV is 6 weeks with
the best option being 3 doses of IM IPV in 6-10-14
weeks schedule. This can be as a combination vaccine,
in view of non-availability of standalone IM IPV.
• Two doses of IM IPV, instead of 3 doses can be
administered provided the primary series is started at 8
weeks with the minimum interval between them being 8
weeks.
• In case IPV is not available or feasible, the child should
be offered 3 doses of bOPV in a 6-10-14 weeks
schedule. In such cases, the child should be advised to
receive two fractional doses of IPV at a Government
facility at 6 and 14 weeks of age or at least one dose of
IM IPV either standalone or as a part of combination
vaccine at 14 weeks.
ROTAVIRUS VACCINES
A review of studies from 38 populations found that all
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rotavirus gastroenteritis events (RVGE) occurred in 1%,
3%, 6%, 8%, 10%, 22% and 32% children by age 6, 9, 13, 15,
17, 26 and 32 weeks, respectively. Mortality was mostly
related to RVGE events occurring before 32 weeks of age
[25]. The highest risk of mortality was noted in the children
having earliest exposure to rotavirus, living in poor rural
households, and having lowest level of vaccine coverage
[26]. It is ideal if immunization schedule is completed early in
developing countries where natural infection might occur
early [27].
Infants in developing countries may be at risk of
developing RVGE at an earlier age than those in developed
countries. They also tend to have a higher risk of mortality
coupled with the risk of lower vaccine coverage. No
observational study has compared different ages at first
dose. A schedule of two doses at 10 and 14 weeks may
result in incomplete course of vaccination, especially in
developing countries because of restriction of upper age
limit for rotavirus vaccine administration. Such children
would remain immunologically susceptible to get rotavirus
infection. Early administration of the first dose of rotavirus
vaccine as soon as possible after 6 weeks of age has been
recommended by WHO recently [27]. Administration of
RV1 or RV5 vaccine at 6 weeks has also been recommended
and approved even in developed countries [28].
Two randomized controlled trials reported data on
severe rotavirus gastroenteritis with up to one year follow-
up, and directly compared children who received the first
dose of RV1 at age 6 weeks vs 10 to 11 weeks. No
statistically significant difference in efficacy was found
between these two schedules [29]. The South Africa and
Malawi RV1 trial [30] reported similar efficacy of vaccination
schedules beginning at 6 weeks or 10 to 11 weeks against
severe RVGE during the second year follow-up using only
the Malawi cohort. Indirect comparisons based on
stratification of RV1 and RV5 trials using different
schedules showed no impact on mortality for different
ages at first dose.
Considering these factors, ACVIP recommends RV1 in
a schedule of 6 and 10 weeks. The recommendations for the
schedule of other vaccines remain the same.
Currently the following live oral rotavirus vaccines are
available in India: (i) Human monovalent live vaccine
(RV1); (ii) Human bovine pentavalent live vaccine (RV5);
(iii) Indian neonatal rotavirus live vaccine, 116 E; (iv)
Bovine Rotavirus Vaccine – Pentavalent (BRV-PV). BRV-PV
is a recently introduced pentavalent rotavirus vaccine that
contains serotypes G1, G2, G3, G4, and G9 obtained from
Bovine (UK) X Human Rotavirus Reassortant strains. It is
a thermostable vaccine and can be stored below 24 0C till
the duration of the shelf life of 30 months. This vaccine
remains stable for 36 months at temperature below 25 0C ,
for 18 months between 37 0C and 40 0C , and a short-term
exposure at 55 0C [31].
IAP ACVIP Recommendation on Rotavirus Vaccines
Any of the available rotavirus vaccines may be routinely
administered as per the manufacturer’s recommendations.
All the available vaccines have been demonstrated to be
safe and immunogenic.
• Minimum age: 6 weeks for all available brands
• Only two doses of RV-1 are recommended at 6 and 10
weeks
• If any dose in series was RV-5 or RV-116E or vaccine
product is unknown for any dose in the series, a total of
three doses of RV vaccine should be administered.
Recommendations on the age limit for the first dose and
the last dose (16 and 32 weeks) should continue in spite of
recommendation for increase in the age limit as per recent
NIP guidelines.
TYPHOID VACCINE
Considering the continuation of significant burden of
typhoid fever, widespread prevalence of antibiotic-
resistant strains of S. typhi and availability of favorable
evidence on the efficacy, effectiveness, immunogenicity,
safety, and cost-effectiveness of typhoid vaccines, WHO
recommends use of typhoid vaccines in national programs
for the control of typhoid fever [32,33]. Typhoid conjugate
vaccine (TCV) is preferred at all ages as it has improved
immunological properties, can be used in younger children,
and is expected to provide longer duration of protection. A
meta-analysis summarized that typhoid cases across the
age groups; 14% to 29% in <5 years, 30% to 44% in 5-9
years and 28% to 52% in 10-14 years [34]. It has been
observed that more than one-fourth of all cases occur in
children aged below 4 years, with approximately 30% of
cases in children aged below 2 years, and 10% in children
aged below 1 year [35]. Based on this, WHO has
recommended TCV for infants and children from 6 months
of age as a 0.5 mL single dose [36], and the same is
endorsed by ACVIP.
Booster Doses/Revaccination
The need for revaccination with TCV is currently unclear
[36]. The protection with TCV may last for up to 5 years
after the administration of one dose, and natural boosting
may occur in endemic areas [37]. The evidence concerning
the need for booster vaccination is lacking currently. Until
more data is generated or available, the ACVIP recommends
only a single dose of TCV from 6 months onwards. If a child
has received Typhoid polysachharide vaccine, it is
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recommended to offer one dose of TCV at least 4 weeks
following the receipt of polysaccharide vaccine.
Currently, three products of TCV are licensed in India.
Two of them contain 25 µg of purified Vi PS of S. typhi, and
one of them containing 5 µg purified Vi PS of S. typhi. The
WHO position paper in 2018 has remarked that the body of
evidence for the 5 µg vaccine is very limited.
IAP ACVIP Recommendation on Typhoid Vaccines
Primary schedule
• A single dose of TCV 25 µg is recommended from the
age of 6 months onwards routinely.
• An interval of at least 4 weeks is not mandatory
between TCV and measles-containing vaccine when it
is offered at age of 9 months or beyond.
• For a child who has received only Typhoid
polysaccharide vaccine, a single dose of TCV is
recommended at least 4 weeks following the receipt of
polysaccharide vaccine. Routine booster for TCV at 2
years is not recommended as of now.
MEASLES, MUMPS AND R UBELLA (MMR/MR) VACCINES
Standalone measles vaccine is now not available for regular
use. Measles-containing vaccine (MMR/MR) should be
administered after 9 months of age (270 days). MR
(Measles-Rubella) vaccine is currently not available in the
private sector. Hence in view of morbidity following mumps
infection, it has been recommended that MMR is
administered instead of MR at 9 months, 15 months, and 4-
6 years [38], or as two doses at 12 to 15 months of age with
the second dose between 4 to 6 years of age. [39].
Additional dose of MR vaccine during MR campaign for
children 9 months to 15 years, irrespective of previous
vaccination status is to be administered, keeping in mind
the need to support national programs.
INFLUENZA VACCINE
A meta-analysis and systematic review evaluating studies
published between 1995 to 2010 estimated that children
under 5 years of age had 90 million (95% CI 49-162 million)
new influenza episodes, 20 million (95% CI 13-32 million)
cases of acute lower respiratory infections (ALRI) where
influenza was associated, and 1 million (95% CI 1-2 million)
cases of severe ALRI (associated with influenza). This
resulted in 28,000-111,500 deaths attributed to influenza,
with 99% of them from developing countries [40]. Another
study estimated that globally 160,000-450,000 children
below 5 years of age die in hospitals each year due to all-
cause ALRI [41].
A systematic literature review described that during the
peak rainy season, influenza accounted for 20-42% of
monthly acute medical illness hospitalizations in India [42].
This suggests that influenza is a substantial contributor to
severe respiratory illness and hospitalization. The findings
from the studies also show that influenza circulation and
influenza-associated hospitalization are major public health
concerns in India. There is poor uptake of the influenza
vaccine in India. IAP position paper on influenza in 2013
stated the while it may not be practical to recommend
routine influenza vaccination to everyone in India, the
vaccination for high-risk groups such as the elderly,
children below 5 years, medical practitioners and pregnant
women should be seriously considered [43]. Influenza
incidence in children below 5 years of age from developing
countries is three times higher than those from developed
countries, with a 15-fold higher case-fatality [41].
Health utilization surveys conducted in two rural sites
(Ballabgarh, Haryana and Vadu, Maharashtra) in 2010-2012
reported adjusted all-age incidence rates of influenza-
associated hospitalization as 3.8-5.4 per 10,000 in
Ballabgarh and 20.3-51.6 per 10,000 in Vadu [44]. The age-
specific influenza-associated hospitalization rates varied
from year to year. In 2010, these rates were highest among
persons aged <1 year, in 2011 among patients >59 years of
age, and in 2012 in children 1-4 years in Ballabhgarh.
Whereas in Vadu, in 2010, these rates were highest among
persons aged 1-4 years, in 2011 in children <1 year, and in
2012 in children 5-14 years. Influenza viruses were found
throughout the year and the peaks coincided with peaks in
rain fall at both the sites.
The Influenza Serotype-B is reported almost round the
year in India. A multi-site influenza study in India found that
27.8% isolates were Influenza A (H1N1) virus, 29.8% were
type A (H3N2), and 42.3% isolates were type B [45]. A global
influenza study found that during seasons, out of all
influenza B isolates, Victoria and Yamagata lineages
predominated or co-circulated (>20% of total detections),
and this accounted for 64% and 36% of seasons
respectively. The vaccine virus mismatch was found in 25%
of the seasons [46].
With the available data, there is enough reason to
believe that the magnitude of the problem is much higher in
developing countries (including India) vis-a-vis developed
countries. India lies within the northern hemisphere. Some
parts of the country experience a distinct tropical
environment because of its location close to the equator.
These areas have a southern hemisphere seasonality with
almost round-the-year circulation of influenza viruses
peaking during monsoon. Northern parts of India
experience another peak during winters similar to northern
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hemisphere pattern. There is continuous influenza activity
across the nation, with seasonal peaks during monsoon
and winter, and an ever increasing number of influenza-like
illnesses affecting a large number of children who can
transmit the disease to their peers and adult counterparts.
In view of influenza activity round the year with
seasonal peaks, high morbidity and mortality in high-risk
groups, including children below 5 years, paucity of
facilities for laboratory diagnosis, high transmission rate,
substantial socioeconomic burden, limitations of
oseltamivir, availability of moderately efficacious vaccine,
it would be justifiable to use Influenza vaccine routinely in
the high-risk group of children below age of 5 years.
Vaccine Strains
FDA recommended the following combinations for 2018-19
influenza vaccines.
• Trivalent vaccines-to have (i) an A/Michigan/45/2015
(H1N1)pdm09-like virus, (ii) an A/Singapore/INFIMH-
16-0019/2016 (H3N2)-like virus; and (iii) a B/Colorado/
06/2017-like virus (Victoria lineage).
• Quadrivalent vaccines to contain the above three, and
a B/Phuket/3073/2013-like virus (Yamagata lineage)
[47].
IAP ACVIP Recommendations
ACVIP recommends that quadrivalent/trivalent inactivated
influenza vaccine should be routinely offered annually to all
children between 6 months to 5 years of age. The latest
available influenza vaccine can be administered after 6
months of age, 2-4 weeks prior to the influenza season: two
doses at the interval of one month in the first year, and one
dose annually before the influenza season up to 5 years of
age.
RABIES VACCINE
Recent data indicate that duration and number of doses for
post-exposure prophylaxis (PEP) and pre-exposure
prophylaxis (PrEP) regimens can be shortened. ACVIP
endorses the new schedule suggested by WHO in 2018
[48].
Pre-exposure prophylaxis (Pre-EP) is recommended in
the following two situations.
• Children exposed to pets in home.
• Children identified to have a higher risk of being bitten
by dogs.
WHO recommends a “1-site vaccine administration on
days 0 and 7 for intramuscular administration” [48].
For post-exposure prophylaxis, recently the WHO [48]
has recommended a new 4-dose schedule of either of the
following: (i) 1-site intramuscular administration of vaccine
on days 0, 3, 7 and between day 14-28, or (ii) 2-sites
intramuscular administration on days 0 and 1-site on days
7, 21 (intramuscular).
Rabies Human Monoclonal Antibody (RHMAB)
Access to Rabies immunoglobulin (RIG) is limited resulting
in high rabies mortality. RHMAB is a completely human
IgG1 monoclonal antibody that binds to the ectodomain of
the G glycoprotein produced by recombinant technology. It
has been demonstrated to neutralize 25 different isolates of
wild-type or street isolates of rabies virus. A recent study
found that it is not inferior to Human rabies
immunoglobulin (HRIG) in producing rabies virus
neutralizing antibody in 200 subjects with WHO category-
III suspected rabies exposures. The study subjects
received either RMHAB or HRIG (1:1 ratio) in wounds, and
intramuscularly wherever necessary, on day-0. All these
patients also received five doses of rabies vaccine
intramuscularly on 0, 3, 7, 14 and 28 days [49].
This newly introduced monoclonal antibody has
emerged as a safe and potent alternative to rabies
immunoglobulin. The WHO position paper on Rabies in
2018 has also suggested encouragement of use of this
product, if available, instead of RIG. The comparative
advantages include easy availability, standardized
production quality, possibly greater effectiveness, no
requirement of animals in its production, and less adverse
events.
In view of the irregular availability and high cost of
Rabies immunoglobin (RIG), ACVIP endorses the use of
RHMAB as an alternative to RIG – human or equine – along
with rabies vaccines in all category-III bites. RHMAB is
licensed in India (as Rabisheild, Serum Institute of India; 40
IU/mL) since 2017. The recommended dose is 3.33 IU/kg
body weight, preferably at the time of the first vaccine dose.
However, this may also be administered up to the 7th day
after the first dose of vaccine is given. If the calculated dose
is insufficient (to infiltrate all the wounds), it should be
diluted in sterile normal saline to get a volume that is
enough to be infiltrated around all the wounds.
Funding: None. Indian Academy of Pediatrics provided the
consultative meetings’ expenses.
Competing interest: Representatives of a few vaccine
manufacturing companies also presented their data in the
consultative meetings. None stated for authors.
REFERENCES
1. Vashishtha VM, Choudhury P, Kalra A, Bose A, Thacker N,
Yewale VN, et al. Indian Academy of Pediatrics (IAP)
recommended immunization schedule for children aged 0
INDIAN PEDIATRICS 1073 VOLUME 55__DECEMBER 15, 2018
INDIAN A CADEMY OF PEDIATRICS IMMUNIZATION G UIDELINES 2018-19
through 18 years – India, 2014 and updates on
immunization. Indian Pediatr. 2014;51:785-800.
2. Hepatitis B vaccines: WHO position paper – No 27, 2017,
World Health Organization. Weekly epidemiological record.
No 27, 2017, 92, 369-392.
3. Elizabeth D. Barnett, Give first dose of HepB vaccine
within 24 hours of birth: American Academy of Pediatrics
August 28, 2017. Available from: http://
www.aappublications.org/news/2017/08/28/HepB082817.
Accessed Nov 6, 2018.
4. Cherry JD. Pertussis and Immunizations: Facts, Myths, and
Misconceptions. Available from: http://aap-ca.org/
pertussis-and-immunizations-facts-myths-and-
misconceptions. Accessed November 6, 2018.
5. Munoz FM. Safer pertussis vaccines for children: Trading
efficacy for safety. Pediatrics. 2018;142:e20181036.
6. Jackson DW, Rohani P. Perplexities of pertussis: Recent
global epidemiological trends and their potential causes.
Epidemiol Infect. 2013;16:1-13.
7. Winter K, Harriman K, Zipprich J, Schechter R, Talarico J,
Watt J, et al. California pertussis epidemic, 2010. J Pediatr.
2012;161:1091-6.
8. Centers for Disease Control and Prevention (CDC).
Pertussis epidemic—Washington, 2012. Morb Mortal
Wkly Rep. 2012;61:517-22.
9. Pertussis vaccines: WHO Position Paper – August 2015
No. 35. World Health Organization. Weekly
Epidemiological Record. 2015;90:433-60.
10. World Health Organization. Pertussis Vaccine Evidence to
Recommendations (WHO). Available from: http://
www.who.int/immunization/position_papers/Pertussis
GradeTable3.pdf. Accessed November 6, 2018.
11. WHO Position paper on Pertusis Vaccine, 2005. World
Health Organization. Weekly Epidemiological Record.
2005;4:29-40.
12. Schmitt HJ, von König CH, Neiss A, Bogaerts H, Bock HL,
Schulte-Wissermann H, et al. Efficacy of acellular pertussis
vaccine in early childhood after household exposure. JAMA.
1996;275:37-41.
13. Jefferson T, Rudin M, DiPietrantonj C. Systematic review
of the effects of pertussis vaccines in children. Vaccine.
2003;21:2003-14.
14. Carlsson R, Trollfors B. Control of pertussis-lessons learnt
from a 10-year surveillance programme in Sweden. Vaccine.
2009;27:5709-18.
15. Okada K, Ohashi Y, Matsuo F, Uno S, Soh M, Nishima S.
Effectiveness of an acellular pertussis vaccine in Japanese
children during a non-epidemic period: a matched case-
control study. Epidem Infection. 2009:137:124-30.
16. World Health Organization. WHO SAGE Pertussis Working
Group. Background Paper. SAGE April 2014. Available
from: http://www.who.int/immunization/sage/ meetings/
2014/april/1_Pertussis_background_FINAL4_web.pdf?
ua=. Accessed November 15, 2018.
17. World Health Organization. Use of Fractional Dose IPV in
Routine Immunization Programmes: Considerations for
Decision-making. Available from: http://www.who.
int/immunization/diseases/poliomyelitis/endgame_
objective2/inactivated_polio_vaccine/fIPV_considerations_
for_decision-making_April2017.pdf?ua=1. Accessed
November 6, 2018.
18. Indian Academy of Pediatrics (IAP) Advisory committee on
vaccines and Immunization Practices (ACVIP), Vasishtha
VM, Choudhary J, Yadav S, Unni JC, Jog P, Kamath SS,
et al. Introduction of inactivated poliovirus vaccine in
National Immunization Program and polio endgame
strategy. Indian Pediatr. 2016;53(Suppl.1):S65-9.
19. Bahl S, Verma H, Bhatnagar P, Haldar P, Satapathy A, Arun
Kumar KN, et al. Fractional-dose inactivated poliovirus
vaccine immunization campaign — Telangana State, India,
June 2016. MMWR. 2016;65:859-63.
20. Resik S, Tejeda A, Mach O, Fonseca M, Diaz M, Alemany
N, et al. Immune responses after fractional doses of
inactivated poliovirus vaccine using newly developed
intradermal jet injectors: A randomized controlled trial in
Cuba. Vaccine. 2015;33:307-13.
21. Clarke E, Saidu Y, Adetifa JU, Adigweme I, Hydara MB,
Bashorun AO, et al. Safety and immunogenicity of
inactivated poliovirus vaccine when given with measles-
rubella combined vaccine and yellow fever vaccine and when
given via different administration routes: A phase 4,
randomised, non-inferiority trial in The Gambia. Lancet
Glob Health. 2016;4:e534-47.
22. Troy SB, Kouiavskaia D, Siik J, Kochba E, Beydoun H,
Mirochnitchenko O, et al. Comparison of the
immunogenicity of various booster doses of inactivated
polio vaccine delivered intradermally versus intramuscularly
to HIV-infected adults. J Infect Dis. 2015;15:1969-76.
23. Saleem AF, Mach O, Yousafzai MT, Khan A, Weldon WC,
Oberste MS, et al. Needle adapters for intradermal
administration of fractional dose of inactivated poliovirus
vaccine: Evaluation of immunogenicity and programmatic
feasibility in Pakistan. Vaccine. 2017;35:3209-14.
24. Polio vaccines: WHO Position Paper, March 2016. World
Health Organization. Weekly Epidemiological Record.
2016;91:145-68.
25. World Health Organization. Detailed Review Paper on
Rotavirus Vaccines (presented to the WHO Strategic
Advisory Group of Experts (SAGE) on Immunization in
April 2009). Geneva, World Health Organization, 2009.
Available from: http://www.who.int/immunization/sage/
3_Detailed_Review_Paper_on_Rota_Vaccines_17_3_2009.pdf.
Accessed November 08, 2018.
26. Phua KB, Lim FS, Lau YL, Nelson EA, Huang LM, Quak
SH, et al. Rotavirus vaccine RIX4414 efficacy sustained
during the third year of life: A randomized clinical trial in an
Asian population. Vaccine. 2012;30:4552-7.
27. Rotavirus vaccines WHO Position Paper – January 2013.
Weekly Epidemiological Record. 2013;88:49-64.
28. Rotavirus. In: Hamborsky J, Kroger A, Wolfe S, eds.
Centers for Disease Control and Prevention. Epidemiology
and Prevention of Vaccine-preventable Diseases. 13th ed.
Washington DC: Public Health Foundation, 2015. Available
from:https://www.cdc.gov/vaccines/pubs/pinkbook/
downloads/rota.pdf. Accessed November 15, 2018.
29. World Health Organization. Rotavirus Report, February
2012. Rotavirus Vaccines Schedules: A Systematic Review
of Safety and Efficacy from Randomized Controlled Trials
INDIAN PEDIATRICS 1074 VOLUME 55__DECEMBER 15, 2018
INDIAN A CADEMY OF PEDIATRICS IMMUNIZATION G UIDELINES 2018-19
and Observational Studies of Childhood Schedules Using
RV1 and RV5 Vaccines. Available from: http://www.who.int/
immunization/ sage/meetings/2012/ april/Soares_K_et_al_
SAGE_April_rotavirus.pdf. Accessed November 08, 2018.
30. World Health Organization. Grading of Scientific Evidence –
Tables 1–4: Does RV1and RV5 induce protection against
rotavirus morbidity and mortality in young children both in
low and high mortality settings? Available from: http://
www.who.int/immunization/position_papers/rotavirus_
grad_rv1_rv5_protection. Accessed November 8, 2018.
31. Naik SP, Zade JK, Sabale RN, Pisal SS, Menon R, Bankar SG,
et al. Stability of heat stable, live attenuated rotavirus
vaccine (ROTASIIL®). Vaccine. 2017;35:2962-9.
32. World Health Organization. Background Paper on Typhoid
Vaccines for SAGE Meeting (October 2017). Available
from: http://www.who.int/immunization/sage /meetings/
2017/october/1_Typhoid_SAGE_background_paper_
Final_v3B.pdf. Accessed November 08, 2018.
33. World Health Organization. Guidelines on The Quality,
Safety and Efficacy of Typhoid Conjugate Vaccines, 2013.
Available from: http://www.who.int/biologicals/areas/
vaccines/TYPHOID_BS2215_doc_v1.14_WEB_ VERSION.
pdf. Accessed July 12, 2016.
34. Britto C, Pollard AJ, Voysey M, Blohmke CJ. An appraisal
of the clinical features of pediatric enteric fever: Systematic
review and meta-analysis of the age-stratified disease
occurrence. Clin Infect Dis. 2017;64:1604-11.
35. World Health Organization. Background Paper to SAGE on
Typhoid Policy Recommendations. 2017. Available from:
http://www.who.int/immunization/sage/meetings/2017/
october/1_Typhoid_SAGE_background_paper_Final_v3B.
pdf?ua=1. Accessed November 08, 2018.
36. Typhoid vaccines: WHO Position Paper – March 2018.
Weekly Epidemiological Record. 2018;93:153-72.
37. Voysey M, Pollard AJ. Sero-efficacy of Vi-polysaccharide
tetanus-toxoid typhoid conjugate vaccine (Typbar-TCV).
Clin Infect Dis. 2018;67:18-24.
38. Vashishtha VM, Yewale VN, Bansal CP, Mehta PJ. Indian
Academy of Pediatrics, Advisory Committee on Vaccines
and Immunization Practices (ACVIP). IAP perspectives on
measles and rubella elimination strategies. Indian Pediatr.
2014;51:719-22.
39. Centers for Disease Control and Prevention. Measles,
Mumps, and Rubella (MMR) Vaccination: What Everyone
Should Know. Available from: https://www.cdc.gov/
vaccines/vpd/mmr/public/index.html. Accessed November
18, 2018.
40. Nair H, Brooks WA, Katz M, Roca A, Berkley JA, Madhi
SA, et al. Global burden of respiratory infections due to
seasonal influenza in young children: A systematic review
and meta-analysis. Lancet. 2011;378:1917-30.
41. Rudan I, Theodoratou E, Zgaga L, Nair H, Chan KY,
Tomlinson M, et al. Setting priorities for development of
emerging interventions against childhood pneumonia,
meningitis and influenza. J Glob Health. 2012;2:10304.
42. Venkatesh M, Doarn CR, Steinhoff M, Yung J. Assessment
of burden of seasonal influenza in India and consideration of
vaccination policy. Glob J Med Pub Health. 2016;5:1-10.
Available from: http://www.gjmedph.com/uploads/R1-
Vo5No5.pdf. Accessed November 18, 2018.
43. Vashishtha VM, Kalra A, Choudhury P. Influenza
vaccination in India: Position Paper of Indian Academy of
Pediatrics, 2013. Indian Pediatr. 2013;50:867-74.
44. Hirve S, Krishnan A, Dawood FS, Lele P, Saha S, Rai S, et al.
Incidence of influenza-associated hospitalization in rural
communities in western and northern India, 2010-2012: A
multi-site population-based study. J Infect. 2015;70:
160-70.
45. Chadha MS, Broor S, Gunasekaran P, Potdar VA, Krishnan
A, Chawla-Sarkar M, et al. Multisite virological influenza
surveillance in India: 2004-2008. Influenza Other Respir
Viruses. 2012;6:196-203.
46. Caini S, Huang QS, Ciblak MA, Kusznierz G, Owen R,
Wangchuk S, et al. Epidemiological and virological
characteristics of influenza B: results of the Global Influenza
B Study. Influen Other Respir Viruses. 2015;9:3-12.
47. Grohskopf LA, Sokolow LZ, Broder KR, Walter EB, Fry
AM, Jernigan DB. Prevention and control of seasonal
influenza with vaccines: Recommendations of the Advisory
Committee on Immunization Practices – United States,
2018-19 Influenza Season. MMWR Recomm Rep.
2018;67:1-20.
48. World Health Organization. Rabies vaccines: WHO
Position Paper, April 2018 Recommendations. Vaccine.
2018;36:5500-3.
49. Gogtay NJ, Munshi R, Ashwath Narayana DH, Mahendra
BJ, Kshirsagar V, Gunale B, et al. Comparison of a novel
human rabies monoclonal antibody to human rabies
immunoglobulin for postexposure prophylaxis: A phase 2/
3, randomized, single-blind, noninferiority, controlled
study. Clin Infect Dis. 2018;66:387-95.
ANNEXURE I IAP ADVISORY COMMITTEE ON VACCINES AND
IMMUNIZATION PRACTICES, 2018-19
Office-bearers: Santosh Soans (Chairperson), Digant Shastri
(Co-Chairperson), S Balasubramanian (Convener); Members:
Abhay Shah, G Vijaykumar, Harish K Pemde, Pallab Chatterjee,
S Shivananda
Rapporteur: Abhay Shah
Indian Academy of Pediatrics: Santosh Soans (President),
Digant Shastri (President-Elect), Anupam Sachdeva (Immediate
Past President), Vineet K Saxena, Arup Roy, Kedar S
Malwatkar, Harmesh Singh, D Gunasingh (Vice-Presidents),
Remesh Kumar (Secretary General), Upendra S Kinjawadekar
(Treasurer), Dheeraj Shah (Editor-in-Chief, Indian Pediatrics),
NC Gowrishankar (Editor-in-Chief, Indian Journal of Practical
Pediatrics), Sangeeta Yadav, Sandeep B Kadam (Joint
Secretaries)
Writing committee: S Balasubramanian, Abhay Shah, Harish K
Pemde, Pallab Chatterjee, S Shivananda, Vijay Kumar Guduru,
Santosh Soans, Digant Shastri, Remesh Kumar
