As stated earlier [1] it was decided in 2012 to revise IAP Immunization Timetable every year. The IAP Advisory Committee on Vaccines and Immunization Practices (ACVIP) has recently reviewed and revised the recommended immunization schedules for children aged 0 through 18 years to ensure that the schedule reflects recommendations based on recent evidence for licensed vaccines in the country. The mid-term meeting of the IAP ACVIP was held on 3rd and 4th August, 2013 in New Delhi. IAP ACVIP members and invited experts who attended the meeting are listed at the end of this paper. The aim of the meeting was to discuss and debate recent developments in the field, to revise recommendations for the IAP Immunization Timetable for the year 2013, and to issue recommendations for newly licensed vaccines in the country. Following the meeting, a draft of revised immunization schedule for the year 2013 was prepared and circulated among the meeting participants to arrive at a consensus.

The detailed process behind issuing IAP recommendations on immunization is described earlier [1]. We reaffirm that the recommendations of IAP are primarily for the pediatricians in office practice. These recommendations provide guidelines to a pediatrician on how best to utilize available licensed vaccines in their office-practice settings. The members may use their own discretion while using them in a given situation within the framework suggested [2]. The existing national immunization schedule and government policies are also taken in to account while drafting recommendations.

The IAP ACVIP has issued recommendations for the IAP Immunization Timetable for the year 2013 that includes the following major changes from last year:

IAP ACVIP has now issued following recommendations on use of pertussis vaccines for office-practice in private health care:

Primary immunization: The primary infant series should be completed with 3 doses of whole-cell pertussis (wP) vaccines. Vaccination must start at 6 weeks. Acellular pertussis (aP) vaccines should be avoided for the primary series of infant vaccination until or unless there is a genuine compelling reason to use aP vaccine in a given child.

The recommendation on the use of wP vaccine in primary immunization series is based on the experience with wP vaccines in India and on demonstration of faster waning with aP vaccines in comparison to wP vaccines, and superior priming with wP vaccines than aP vaccines in studies conducted in the industrialized countries after recent resurgence of pertussis in many of these countries using aP vaccines. The evidences and reasons behind above recommendations are discussed in detail in IAP Position Paper on Pertussis immunization [3].

The aP vaccine combinations should be avoided for the primary series. However, the aP vaccines may be preferred to wP vaccines in those children with history of severe adverse effects after previous dose/s of wP vaccines or children with neurologic disorders, if resources permit. The parents should be counseled about the probable efficacy related disadvantages of using aP vaccines for the primary series. The schedule is same as with wP (DTwP) vaccines. Like DTwP vaccines, DTaP vaccines must not be used in children 7 years or older because of increased reactogenicity.

Boosters: The 1st and 2nd booster doses of pertussis vaccines should also be of wP vaccine. However, considering a higher reactogenicity, aP vaccine/combination can be considered for the boosters, if resources permit.

Tdap during pregnancy: Maternal immunization, particularly of pregnant women may be an effective approach to protect very young infants and neonates [3]. IAP ACVIP therefore now suggests immunization of pregnant women with a single dose of Tdap during the third trimester (preferred during 27 through 36 weeks gestation) regardless of number of years from prior Td or Tdap vaccination. Tdap has to be repeated in every pregnancy irrespective of the status of previous immunization (with Tdap). Even if an adolescent girl who had received Tdap one year prior to becoming pregnant will have to take it since there is rapid waning of immunity following pertussis immunization.

However, only single administration of Tdap is permitted to all adolescents. Persons aged 7 through 10 years who are not fully immunized with the childhood DTwP/DTaP vaccine series, should receive Tdap vaccine as the first dose in the catch-up series; if additional doses are needed, use Td vaccine. For these children, an adolescent Tdap vaccine is not required.

Monovalent (RV1) and pentavalent rotavirus (RV5) vaccines when started at 8 weeks of age and given at 2 or 3 dose schedule respectively, has been found to be highly effective in preventing rotavirus gastroenteritis [4]. WHO position paper [5] recommends that 1st dose of rotavirus vaccination should be given with 1st dose of DPT vaccination both for RV1 and RV5, which effectively means starting the schedule at 6 weeks in India. It is also known that if rotavirus vaccines are to be co-administered with OPV in a setting with an EPI vaccination schedule beginning at 6 weeks of age, the second dose of RV1 may not be sufficient to provide adequate immunity against severe rotavirus disease [6]. The IAP committee on Immunization has already expressed its concerns on the proper administration schedule of rotavirus vaccines, particularly two-dose schedule of RV1 in India in order to achieve higher yields in term of protective efficacy [1].

Several studies from South Africa, Vietnam, and Philippines have indicated that the older the infant when they receive the first dose of vaccine, the better the immune response in terms of sero-conversion and GMCs [7]. The titers of circulating maternal antibody in the infants and OPV co-administration have a negative impact on the immune response of the first rotavirus vaccine dose (lower sero-conversion rates and reduced GMCs) [7]. It is a well known fact that first dose of RV1 administered at 6 weeks along with OPV is non-immunogenic. In a study conducted in South Africa, the seroconversion of first dose of RV1 when administered at 6 weeks along with OPV was found to be only 13%, whereas when the same dose was administered at 10 weeks along with IPV, the seroconversion rose to 43% [8]. In the same study, the anti-rotavirus IgA antibody sero-conversion rates were higher for the 10-14 weeks schedule (55-61%) compared to the 6-10 weeks schedule (36-43%) [7].

In Africa trial, the 2 dose and 3 dose schedule of RV1 starting at 6 weeks of age showed that vaccine efficacy against severe rotavirus diarrhea for the first year with 2 dose schedule was 58.7 (95% CI 35.7 -74) while for 3 dose schedule the same was 63.7 (95% CI 42.4 – 77.8) [8]. There was no difference on the first year efficacy of both the schedules in Malawi, but a definite gradient favoring 3-dose schedule in South Africa (81.5, 95% CI, 55.1-93.7 for 3-dose versus 72.2, 95% CI, 40.4-88.3 for 2-dose) [8]. However, when second year efficacy against severe rotavirus diarrhea was considered, there was significant difference in the efficacy of the two schedules in both the countries (85% for 3-dose versus 32% for 2-dose in South Africa, and 49% versus 18%, respectively in Malawi) [8-10].

Most of the comparative studies with 2 versus 3 dose schedule have employed RV1 in 10, 14 weeks instead of recommended 6, 10 weeks schedule [8-11]. An immunogenicity study from India has shown that RV1 given in a 2 dose schedule, with 1st dose between 8 to 10 weeks and 2nd dose between 12 to 16 weeks is immunogenic and well tolerated in healthy Indian infants [12]. Pentavalent vaccine given in 3 doses has shown adequate immunogenicity in Indian infants when started at 6 weeks of age [13]. A 3-dose schedule of RV 116E starting at 8 weeks demonstrated a robust immune response [14]. Two ongoing studies in Pakistan and Ghana are studying the immunogenicity of 2 versus 3-dose schedule of RV1.

Considering all the above mentioned facts, the IAP ACVIP is of the opinion that if RV1 vaccine is to be administered in a 2-dose schedule, the first dose should start at 10 weeks of age instead of 6 weeks in order to achieve better immune response. The second dose can be administered at 14 weeks to fit with existing national immunization schedule. However 3-dose schedule of any rotavirus vaccine can start at 6 weeks of age with minimum interval of 4 weeks between the doses.

Typbar-TCV® is a Vi-capsular polysaccharide conjugate typhoid vaccine conjugated with tetanus toxoid. The manufacturer has used a dose of 25 µg/0.5 mL of Conjugate Vi Content polysaccharide which is the highest having been used in other trials as well on conjugate vaccine the world over.

Long-term immunogenicity: The manufacturer has planned a 3-year follow-up for seroconversion data of phase III. So far, they have shared 18 months follow-up data which show significant waning of GMTs and seroconversion levels in both the cohorts from day 42 levels while 100% of subjects of test vaccine subjects were still seroprotected (the protective level: Vi antibody > 7.4 Elisa unit/mL). Similar trend was observed in the subgroup of cohort-II that received reference vaccine.

Safety issues: No serious adverse event was noted. The most common local and systemic events reported were pain at injection site and fever, respectively in both the cohorts. Fever was noticed in 10.0%, 4.28%, and 2.75% in cohort-I, test, and reference vaccine groups of cohort-II, respectively. None of the enrolled subjects were withdrawn from study for vaccine related adverse reaction. The manufacturer has indicated to follow all subjects for up to 12 weeks post vaccination.

The vaccine has been licensed by the Drug Controller General of India (DCGI) in August, 2013 for clinical use in India.

The IAP ACVIP has reviewed the above pivotal trial (unpublished) and considers it to be a promising vaccine, fulfilling the critical gap of providing protection under 2 years of age. However, before a slot is created for the vaccine in the existing IAP Immunization Timetable, the committee has pinpointed following issues to be addressed:

Considering the typhoid epidemiology in the country and analyzing the available data of the vaccine, IAP recommends the new Vi-PS conjugate vaccine below one year of age, preferably between 9-12 months (minimum age 6 months). Since the incompatibility data with measles vaccine is not available, it would be prudent to maintain an interval of at least 4 weeks with the former. The committee believes there is a definite need of a booster dose during second year of life; however, the available data is insufficient to specify exact timing of the same. The committee stresses the need of large scale field effectiveness trials in real life settings to establish superiority of the product over the existing Vi-PS vaccines, and to ascertain translation of higher GMTs and better seroconversion rates in to greater protection.

The committee reviewed the efficacy of this vaccine in India. A small case–control study from Lucknow, India found an efficacy of 94.5% (95% CI, 81.5 to 98.9) after a single dose of this vaccine within 6 months after its administration [16]. However, data from post marketing surveillance (PMS) in India (ICMR unpublished study) showed that protective efficacy of the vaccine in India is not as high as that seen in Nepal. According to the study, sero-conversion rates at 28 days after vaccination were 73.9% and 67.2% in all individuals and in those who were nonimmune pre-vaccination, respectively. The protective efficacy of the vaccine at one year was 43.1% overall and 35% for those who were non-immune pre-vaccination, respectively [17]. Preliminary results of a recent case control study show an unadjusted protective effect of 62.5% in those with any report of vaccination [17]. According to this report, the JE vaccine efficacy has been around 60% in Uttar Pradesh and around 70% in Assam.

Inactivated Vero cell culture-derived SA 14-14-2 JE vaccine (JE-VC), (IXIARO® and JEEV®)

JENVAC® is a Vero cell culture derived, inactivated, adjuvanted and thiomersal containing vaccine developed by Bharat Biotech International Limited (BBIL). The original virus strain used in the vaccine was isolated from a patient in the endemic zone in Kolar, Karnataka, India by National Institute of Virology (NIV), Pune and later transferred to BBIL for vaccine development.

The vaccination against JE is not recommended for routine use, but only for individuals living in endemic areas.

JENVAC® by BBIL: The committee reviewed the data provided by the manufacturer on the clinical trials of JENVAC® in India. Although it lacks the experience of multinational trials of IXIARO® in different settings, nevertheless the results of a pivotal phase II/III study conducted in India appear satisfactory for issuing recommendations for clinical use. The committee recommends two doses of the vaccine (0.5 ml each) administered intramuscularly at 4 weeks interval for the primary immunization series for office practice starting from 1 year of age. Since appreciable waning was noted in both seroconversion and seroprotection rates, and GMTs were also waned significantly, there is definitely a need of booster dose at later stage. The exact timing of the booster along with feasibility of single dose for primary series can be determined only after obtaining the long term follow-up data.

Currently two different types of meningococcal conjugate vaccines (MCVs) are licensed in India. The first which is now readily available in private market also, is a quadrivalent vaccine Menactra® from Sanofi Pasteur, and another a monovalent serogroup A vaccine from Serum Institute of India (SII).

Quadrivalent meningococcal polysaccharide-protein conjugate vaccine (MenACWY-D, Menactra®,)

This is a quadrivalent (A,C,W135,Y) meningococcal conjugate vaccine using diphtheria toxin as carrier protein (A,C,W135,Y-D), and was licensed in US in 2005. However, it is licensed in India only in 2012 for use among persons aged 2 through 55 years. In 2011, ACIP recommended a two-dose series of this vaccine for use in children aged 9-23 months. It contains 4 µg each of A, C, Y and W-135 polysaccharide conjugated to 48 µg of diphtheria toxoid. A single dose of 0.5 mL IM is recommended. Recent estimates of the effectiveness of MenACWY-D, the first licensed quadrivalent vaccine suggest that within 3 to 4 years after vaccination, effectiveness is 80% to 85% [25, 26]. It is associated with minor local side effects such as pain, and swelling. Guillain-Barré Syndrome was noted as a possible but unproven risk in some adolescents following immunization [27]. Interference with PCV13 immune responses was noted when MenACWY-D and PCV13 were administered simultaneously in patients with asplenia. Hence, it is now recommended that at least one month interval should be kept between PCV13 and MenACWY-D, and PCV13 should be administered first [27].

Monovalent serogroup A conjugate vaccine (PsA–TT, MenAfriVac®,)

Meningococcal Group A Conjugate Vaccine is a lyophilized vaccine of purified meningococcal A polysaccharide covalently bound to tetanus toxoid (TT) which acts as a carrier protein. It contains 10 µg of group A polysaccharide conjugated to 10-33 µg tetanus toxoid, with alum as adjuvant and thiomersal as preservative [28]. The vaccine is licensed in India since 2009 and prequalified by WHO in 2010, but surprisingly, the company has not launched this inexpensive vaccine (costing around half a cent to African nations) in India so far. It has been used in large campaigns in Burkina Faso, Mali, and Niger and is being progressively introduced in other countries of the African meningitis belt [28].

It should be administered as a single intramuscular injection of 0.5 mL to individuals 1-29 years of age [28]. The possible need for a booster dose has not yet been established. Persons who have previously received a meningococcal A polysaccharide-containing vaccine can be vaccinated with the conjugate vaccine.

The current epidemiology and burden of meningococcal diseases (MD) in India do not justify routine use of meningococcal vaccines. Meningococcal vaccines are recommended only for certain high-risk conditions and situations as enumerated below in children aged 2 years or more (3 months or older if risk of meningococcal disease is high, e.g. outbreaks/ close household contact). Conjugate vaccines are preferred over polysaccharide vaccines due to their potential for herd protection and their increased immunogenicity, particularly in children <2 years of age.

Sporadic outbreaks of meningococcal disease have been recorded for last many decades in India. These outbreaks, particularly the larger epidemics have almost universally been caused by serogroup A meningococci [33]. The committee believes that the new affordable serogroup A-containing monovalent conjugate vaccine manufactured by SII should have a critical role in containing future epidemics. The Academy urges the Indian manufacturer to make this vaccine available in the country also. The quadrivalent MenACWY-D should be employed in individuals having certain high-risk conditions and situations (mentioned below) and amongst international travelers.

IAP recommendations on dosage in different categories: IAP now recommends the use of MCVs in different categories as per following description:

A. During disease outbreaks: Polysaccharide vaccines can be used to control outbreaks in countries where limited economic resources or insufficient supply restrict the use of MCVs [28]. However, due to the limited efficacy of polysaccharide vaccines in children <2 years of age, conjugate vaccines should be used for protection of those aged 12–24 months, particularly for Men A disease. Since majority of documented outbreaks in India are caused by Men A, monovalent MCV, like PsA-TT should be employed in mass vaccination.

No change is made to the existing polio immunization schedule. However, in the comment section of Table 1 and in the footnotes after Figure 1, extra-emphasis is given to the need of vaccinating all eligible children with polio vaccines, IPV or OPV. The Academy is committed to polio eradication initiative in the country. This is to reaffirm again that the current IAP recommendations on polio immunization are one suggested way to the practitioners on how to best utilize available polio vaccines (OPV and IPV) in their office practices. However, they may use the polio immunization schedule as suggested by the Universal Immunization Program (UIP), if it is not feasible to follow IAP schedule. The members/pediatricians are advised to encourage administration of all OPV doses during the ongoing campaigns, NIDs or SNIDs of GoI/NPSP.

Pertussis immunization:

• Whole-cell pertussis vaccines for primary infant series of immunization

• Acellular pertussis vaccines in certain specific circumstances/conditions only

• Multicomponent (≥3) aP vaccine products to be preferred over other aP vaccines

• Tdap vaccine recommended for pregnant women with every pregnancy

Rotavirus immunization:

• Administration schedule of RV1 revised

• Two-dose schedule to begin at 10 weeks, 2nd dose at 14 weeks

Typhoid immunization:

• Guidelines are provided for the use of new Vi-polysaccharide conjugate typhoid vaccine

JE immunization:

• Two doses of live attenuated SA-14-14-2 vaccine

• Guidelines are provided for the use of new inactivated JE vaccines, JEEV® and JENVAC ®

Meningococcal immunization: 

• Guidelines are provided for the use of new meningococcal conjugate vaccines

• Recommendations are issued on the dosage of meningococcal use in different categories 

Polio immunization: 

• Emphasis is given to the need of vaccinating all eligible children with polio vaccines 

• Encouragement for administration of all OPV doses during campaigns

Other changes:

• Only single figure to illustrate recommended immunization schedule with catch-up range 

  for persons aged 0 through 18 years

• Footnotes are revised and updated.

Conflicts of interests: None. Funding: None.

IAP Advisory Committee on Vaccines & Immunization Practices, 2013-14: Office-bearers: C.P. Bansal (Chairperson), Rohit Agarwal (Co-chairperson), Vijay Yewale (Co-chairperson), Vipin M. Vashishtha (Convener), Sailesh Gupta (lAP Coordinator), Members: Shashi Vani, Anuradha Bose, Ajay Kalra, AK Patwari, Surjit Singh; Consultants: Naveen Thacker, NK Arora, Rajesh Kumar, HP Sachdev, VG Ramchandran, Ajay Gambhir; Rapporteur: Panna Choudhury. Special invitees: Meenu Singh, PGIMER, Chandigarh; Pravin J. Mehta, Mumbai, Treasurer, IAP.

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