key: cord-0055723-veai4dlb
authors: Kasi, Srinivas G.; Shivananda, S.; Marathe, Sanjay; Chatterjee, Kripasindhu; Agarwalla, Sunil; Dhir, Shashi Kant; Verma, Sanjay; Shah, Abhay K.; Srirampur, Sanjay; Kalyani, Srinivas; Pemde, Harish Kumar; Balasubramanian, S.; Parekh, Bakul J.; Basavaraja, G. V.; Gupta, Piyush
title: Indian Academy of Pediatrics (IAP) Advisory Committee on Vaccines and Immunization Practices (ACVIP): Recommended Immunization Schedule (2020–21) and Update on Immunization for Children Aged 0 Through 18 Years
date: 2020-11-29
journal: Indian Pediatr
DOI: 10.1007/s13312-021-2096-7
sha: 37c5e300dec8ee7b138edeeeb0c51207896cb9f5
doc_id: 55723
cord_uid: veai4dlb

JUSTIFICATION: In view of new developments in vaccinology and the availability of new vaccines, there is a need to revise/review the existing immunization recommendations. PROCESS: Advisory Committee on Vaccines and Immunization Practices (ACVIP) of Indian Academy of Pediatrics (IAP) had a physical meeting in March, 2020 followed by online meetings (September-October, 2020), to discuss the updates and new recommendations. Opinion of each member was sought on the various recommendations and updates, following which an evidence-based consensus was reached. OBJECTIVES: To review and revise the IAP recommendations for 2020–21 and issue recommendations on existing and new vaccines. RECOMMENDATIONS: The major changes include recommendation of a booster dose of injectable polio vaccine (IPV) at 4–6 years for children who have received the initial IPV doses as per the ACVIP/IAP schedule, re-emphasis on the importance of IPV in the primary immunization schedule, preferred timing of second dose of varicella vaccine at 3–6 months after the first dose, and uniform dosing recommendation of 0.5 mL (15 µg HA) for inactivated influenza vaccines.

T he Advisory Committee on vaccines and Immunization Practices (ACVIP) of the Indian Academy of Pediatrics met on 7 March, 2020, in Kolkata. ACVIP members and invitees who attended the meeting are listed in Annexure I. The aim of the meeting was to discuss and debate recent developments in the field of vaccinology, to issue the relevant recommendations based on them, and to revise IAP Immunization Timetable for the year 2020-21. This document presents the consensus recommendations, arrived at after detailed literature review, debates and discussions, held during the first physical meeting and subsequent meetings held online (dIAP platform), in view of the prevailing corona virus disease pandemic and inability to have physical meetings.

The process for issuing recommendations included review of recent published literature including standard indexed journals, vaccine trials, recommendations of reputed international bodies like Advisory Committee on Immunization Practices, Center for Disease Control and Prevention (CDC), USA, World Health Organization (WHO) and unpublished data from vaccine manufacturers. Data generated by studies done in India was specifically looked at and available local information was given preference. The summary of the key updates of ACVIP 2020-2021 recommendations is given in Box I.

The ACVIP-IAP recommendations for the year VOLUME 58 __ JANUARY 15, 2021 INDIAN ACADEMY OF PEDIATRICS VACCINES AND IMMUNIZATION PRACTICES 2020-21 are being given in Table I and Fig. 1 . The recommendations about the newly introduced vaccines are summarized in Box II and vaccines for high risk children are summarized in Box III.

The last case of wild polio virus (WPV) in India was reported on 13 January, 2011 and on 27 March, 2014, India along with the rest of Southeast Asia was declared poliofree [1] . It needs to be emphasized that until worldwide

Polio immunization • A booster of the injectable polio vaccine (IPV) is recommended at 4-6 years. • The importance of IPV in the immunization schedule is re-emphasized. [2] . In the absence of inapparent infection, universal vaccination of infants and children is the only way to establish and maintain population immunity against polio. In 2018, the ACVIP had recommended an all IPV schedule at 6-10-14 weeks followed by an IPV booster at 15-18 months, and the recommendation for the OPV booster at 4-6 years was dropped [3] . A birth dose of OPV continues to be recommended.

IPV is immunogenic in an EPI schedule (6-10-14 weeks), but the titers achieved and the seroconversion rates are reported to be lower, compared with vaccination of infants at older ages (2-4-6 months) [4] . Studies examining the long-term persistence of antibodies following IPV vaccination, have shown persistence of antibodies only up to the school-entry age, with the highest titers observed with the 3+1 schedule [4] , as all IPV using countries recommend a school age booster [5] . A pre-school booster resulted in SPR rising to 100% for VOLUME 58 __ JANUARY 15, 2021 INDIAN ACADEMY OF PEDIATRICS VACCINES AND IMMUNIZATION PRACTICES all 3 serotypes and GMTs rising 32-fold to 55-fold for the 3 serotypes [6, 7] . Following a pre-school booster, almost 100% SPR and high antibody titers persist for at least 5 years [8] .

In the absence of a booster at 4-6 years, the seroprotection rates (SPR) against PV 1 and PV2 had fallen to 91% and 91.2% compared to a SPR of 100% in those who had received a school entry booster at 4-6 years [9] . There is low scientific evidence for ≥80% longterm (>5-10 years) persistence of protective antibodies following ≥3-4 doses of IPV before school age [10] . There are no studies regarding the long-term persistence of antibodies with the EPI schedule of 6-10-14 weeks or 2 doses of fractional doses intradermal IPV [4] .

Some studies have suggested an inverse correlation between circulating levels of preexisting homotypic antibodies and excretion of poliovirus types 1, 2, and 3 following the administration of trivalent OPV, indicating better mucosal immunity with higher serum antibody titers [11] . There are no conclusive studies to demonstrate that the booster response occurs sufficiently rapidly to prevent re-infection or paralytic disease and that it is as effective as pre-existing immunity [12] . It has been recommended that "a minimal position would be to recommend four to five doses of an IPVcontaining vaccine with the last one administered at school-entry age" [4] .

In a country like India, where risk of importation of polio virus (wild and cVDPV) is high, ACVIP reemphasizes the use of OPV during national and subnational pulse polio days for all children. At this stage, these additional OPV doses in IPV primed children, will help in augmenting their gut immunity, which could be crucial for preventing circulation of polio virus.

• A booster dose of IPV at 4-6 years of age for children who have received the initial IPV doses as per the ACVIP/IAP schedule.

• In case of non-availability of standalone IPV, this dose can be administered as a combination with DPT vaccines.

In April 2016, a synchronous global switch was implemented from trivalent OPV (tOPV) to bivalent OPV (bOPV) in routine immunization programs. Simultaneously, IPV was introduced in the routine Immunization in all OPV-only using countries. Introduction of IPV was a risk mitigation strategy to overcome the risk associated with this switch. The switch was preceded by high quality SIAs with tOPV, to raise population immunity against type 2 PV [13] . Modelling studies done prior to the switch suggested that the risk of cVDPV would not last beyond a year and a half of the switch [14] .

With a massive surge in requirements for IPV, a shortage resulted. According to the data published by the WHO, global coverage with one dose of IPV was about 50% in 2016, 60% in 2017, and only 72% in 2018 [15] . Thus, population immunity against PV type 2 has decreased, with resultant increase in cVDPV cases/outbreaks [16, 17] . In 2017, there were two countries with cVDPV2 outbreaks with 96 cases; whereas, as of 13 October, 2020, worldwide there were 449 cases of cVDPV2 [18] . This data suggests that India is not free from the risks of cVDPV. In fact, India comes under the category of countries at high risk for cVDPV. Moreover, India has a long border with Pakistan, a country which is still endemic for WPW type 1. There is an imperative need to maintain population immunity against type 2 PV, which can only be achieved by administering IPV either in the IAP schedule or 2 doses of fractional dose intradermal IPV at 6 weeks and 14 weeks or a single dose of full-dose intramuscular IPV at 14 weeks. No child born after the switch should be left unprotected against type 2 PV.

• No child should be administered only pentavalent vaccine and bOPV in infancy without IPV (two doses of fractional dose intradermal IPV at 6 weeks and 14 weeks or a single dose of full-dose intramuscular IPV/ hexavalent combination at 14 weeks). If hexavalent vaccines are unaffordable/unavailable, the infant must be referred to a government healthcare facility for the primary immunization as per UIP schedule.

• Infants and young children, born after the switch (25 April, 2016), who have not received IPV in any schedule, should receive at least one dose of an IPV/ IPV combination vaccine, intramuscularly, at the earliest opportunity.

Since the 1970s, when whole virion vaccines were in use, the standard-dose of IIVs in children less than 3 years of age has been 7.5 mcg per antigen, which is half the dose, given to older children and adults. As higher dose increased the reactogenicity, the lower dose was adopted to reduce reactogenicity and febrile convulsions observed with the whole virus vaccines that were in use at that time [19] . However, the immune response in young children was very variable, especially against the B strains in the vaccine. This was particularly significant in children younger than 3 years of age, who were vaccine-naïve [20] . Higher dose of 0.5 mL (15µg) in the 6-23 months age group is expected to result in higher levels of post vaccination HI antibody titer, which may result in increased efficacy [21] . Since, the complications of influenza are much higher in infants, studies were done to evaluate the safety, immunogenicity and superiority of full dose (0.5 ml; 15 µg) in the age group of 6-35 months to have uniform dosage recommendations in all age groups.

Studies have generally shown comparable reactogenicity and non-inferior immunogenicity with the full dose, in comparison with the half dose, in children 6-35 months of age [22] [23] [24] [25] . Statistically superior immunogenicity was seen only in infants between 6-11 months of age, for H3N2 and B/Yamagata and not for H1N1 [25] . Superior GMTs were demonstrated against both vaccine B strains in children 6-17 months of age and unprimed children 6-35 months of age [24] .

In children 6-35 months of age, the quadrivalent vaccine in a dose of 0.5 ml, demonstrated an efficacy of 63% (97·5% CI 52-72) against moderate-severe influenza, in a season when there was a 68% mismatch between the vaccine strains and the strains isolated in the study [25] .

Several countries including USA, Finland, Australia, VOLUME 58 __ 

• ACVIP endorses the use of a uniform dosing schedule of inactivated influenza vaccines (15 µg/0.5 mL) for all children older than 6 months.

So far, two brands, Influvac Tetra (Abbott) and Fluarix Tetra (Glaxo Smithkline) have received DCGI approval for this uniform dosage recommendation [26, 27] . ACVIP endorses a dose of 0.5 mL per dose in children older than 6 months for these brands. Uniform dosage recommendations shall be extended to other brands also, once they get approval from the licensing authority (DCGI) in India. Till then, the manufacturer's age specific recommendations regarding dosage may be followed.

The timing of the second dose would depend on the relative contributions of primary and secondary vaccine failure to the incidence of breakthrough varicella. Primary vaccine failure could be defined as the failure to seroconvert or the failure to mount a protective immune response after vaccination despite seroconversion, whereas secondary vaccine failure is the gradual waning of immunity over time. Primary vaccine failure will favor an early second dose (few months after dose 1), whereas secondary vaccine failure will favor a delayed second dose (few years after dose 1).

Studies examining the immunological response to the second dose given after 6 weeks and given after 4-5 years have shown that the SPR (>5 U/mL by gpELIZA) are similar with both schedules, while the GMTs are higher with the longer interval schedule. However, the mean Stimulation Index (SI), which is a marker of the CMI is superior when the second dose is administered at 4-5 years [28, 29] . Increases of GMTs by > 10-fold is observed following the second dose, irrespective of the interval between doses [30, 31] . This is not seen with other viral vaccines. Such large increases suggest an inadequate priming and that the second dose is for completing the immune response initiated by the first dose.

Persistence of antibody in children after 1 dose of varicella vaccine has been demonstrated in both shortterm and long-term follow-up studies [32] [33] [34] , for periods as long as 9-20 years, with titers rising during the period of follow-up [32, 34] , indicating an absence of waning of antibody titers with time especially when there are occasions for natural boosting, thus suggesting a primary vaccine failure rather than waning immunity.

The highest incidence rate of breakthrough varicella was seen in the first 4-5 years after vaccination [35] . Vaccine effectiveness dropped from 97% in the first year post-vaccination to 86% in the second year and then remained stable till 8 years [36] . In a study from China, effectiveness was also shown to drop after the first year and then remain stable over the next 5 years [37] . These patterns are seen in primary vaccine failure, rather than waning immunity.

A single retrospective study has demonstrated an increasing incidence and severity over 10 years [38] . Some outbreak studies, which do not represent the entire population, have suggested waning immunity as a cause of vaccine failure [39] .

Globally, as of end 2018, about 36 countries had included the varicella vaccine in their NIPs, about 23 have introduced a 2-dose schedule [40] . Approximately half of these 23 have preferred the shorter interval between doses.

Generally, there is more robust evidence for a primary vaccine failure following 1 dose of varicella vaccine and very limited evidence for secondary vaccine failure. A short interval between 2 doses of the varicella vaccine might be preferable to reduce breakthrough varicella, especially in countries with poor coverage and where the wild-type virus circulates predominantly. In India, in the bigger cities, 2-3 years is the usual entry age for preschool. This may result in breakthrough varicella before the receipt of a delayed second dose. In India, varicella vaccine is not in the NIP and is recommended only by the IAP and the overall uptake is low and exposure to varicella following 1 dose may give rise to breakthrough varicella. Since the aim of varicella vaccination, in office practice, is the best possible protection for the individual child, an earlier second dose will be beneficial over a delayed second dose.

• The second dose of varicella vaccine should be preferably administered 3-6 months after the first dose.

The newly introduced vaccine products are detailed below and the ACVIP recommendations for these are given in Box II.

The quadrivalent conjugate meningococcal vaccine, Menveo (Glaxo SmithKline) has been licensed by the Drug Controller General of India (DCGI). Menveo contains N. meningitidis serogroup A, C, Y, and W-135 [41] .

In general, in pooled cohort of 2-10 years and 11-18 years age group, non-inferiority of MENVEO to MenACWY-DT (Menactra-Sanofi Pasteur Inc)was demonstrated for all serogroups. Persistence of antibodies were demonstrated in children and adolescents up to 5 years post-vaccination. Menveo demonstrated a favorable tolerability profile in all the age groups [42, 43] .

In the Indian licensure study, 72%, 95%, 94%, and 90% of subjects achieved a post-vaccination hSBA >8, for serogroups A, C, W, and Y, respectively, which were similar across all the 3 age groups [4] . Post-vaccination GMTs showed increases of 17-fold against serogroup A, 42-fold against serogroup C, 7-fold against serogroup W, and 15-fold against serogroup Y, compared to prevaccination GMTs. Post-vaccination GMTs were generally somewhat higher with increasing age. The vaccine was well tolerated with no safety concerns [44] . This vaccine is recommen-ded for use only in special situations, as published before [45] .

Typhibev (Biological E vaccines) is a typhoid conjugate vaccine where the source of the Vi antigen is C. frenundii, which is in conformity with WHO specifications. Each dose of 0.5 ml contains Typhoid Vi Polysaccharide (produced from C. Freundii sensu lato 3056): 25 µg conjugated to 16.7 µg to 100 µg of CRM197 [46] .

A multicentric phase II/III study showed that seroconversion (anti-Vi IgG >2 ug/ml) was obtained in 99% subjects (95%CI: 97.06, 99.79) in Typhibev compared to 99.4% in comparator group Typbar-TCV (Bharat Biolech India Limited). Non inferiority was established with comparator TCV. Anti Vi IgG >4.3 ug/ml (criteria defined for having sustained protection for at least 4 years) also fulfilled predefined non inferiority criteria. The side effects profile was comparable with the comparator vaccine [47] .

Typhibev was licensed for use in India by DCGI in February, 2020; approved for those aged older than 6 months to 45 years, to be given in 0.5 mL single dose, intramuscular injection [46] .

In the 2018-19 recommendations, the ACVIP, strongly endorsed the use of monoclonal antibodies (mAbs) for rabies post-exposure prophylaxis (PEP) [3, 48] . Twinrab (Zydus Vaxxicare) is the second rabies mAb to receive DCGI approval. Twinrab is a combination of two murine anti-rabies mAb, docaravimab (62-71-3) and miromavimab (M777-16-3). The two mAbs individually bind to and neutralize both rabies and rabies-like virus strains isolated from canine, human, and bovine sources, preventing their entry into the neighboring cells [49] .

In a phase 3, randomized study, comparing anti-rabies monoclonal antibody cocktail (Twinrab) against Human Rabies Immunoglobulin (HRIG), the GMTs of the antibodies induced with Twinrab were shown to be noninferior to the antibodies induced with HRIG, with no statistically significant difference in the two groups and a similar adverse effect profile was seen in the two groups [50] .

The recommended dose of Twinrab is 40 IU/kg of body weight. Twinrab is indicated for post exposure prophylaxis in individuals with suspected rabies exposure. Twinrab must always be used in combination with rabies vaccine as part of post-exposure prophylaxis in line with the recommendation of WHO [3, 48] .

Tetraxim (Sanofi Pasteur) is a fully liquid, DTaP/IPV combination vaccine to be administered by intramuscular route. Each 0.5 ml dose contains: Diphtheria toxoid (≥30 IU), Tetanus toxoid (≥40 IU), Bordetella pertussis antigens: pertussis toxoid and filamentous haemagglutinin (25 µg each), inactivated poliomyelitis virus (type 1: 40 D antigen Units (DU), type 2:8 DU, type 3:32 DU [51] .

In a review done over 619 subjects in five clinical studies, it was found the DTaP-IPV combination vaccine was highly immunogenic [52] . Tetraxim booster at 4-6 years of age has been shown to be associated with strong anamnestic responses to all antigens [6] and has been shown to be as immunogenic as DTwP-IPV when given as a school-entry booster [7] . The vaccine induced seroprotective titers (>0.01IU/mL) against diphtheria and tetanus, persist till at least 5 years after the pre-school booster [8] .

Pneumosil (Previously SIIPL-PCV) (Serum Institute of India Pvt Ltd Pneumococcal Conjugate Vaccine) is a pneumococcal polysaccharide conjugate vaccine that has been pre-qualified for use by WHO on 18 December, 2019 [53] . This is the third pre-qualified PCV vaccine after Prevenar-13 (Pfizer) and Synflorix (GSK vaccines).

Pneumosil is a pneumococcal polysaccharide VOLUME 58 __ [53] . It is available as a ready to use vial containing vaccine in liquid form with a vaccine vial monitor [54] .

In the phase 1/2 study done in Gambia, in infants, seroprotection rates (SPR) of >90% was observed for all serotypes with PCV 13 following the primary immunization, whereas SPR of > 90% was observed for all serotypes except serotypes 6A and 6B, following SIIPL-PCV. Serotype-specific IgG GMCs estimates after the primary series were above 1 mg/mL for all serotypes following both vaccines. The serotype-specific OPA GMTs following the primary series were comparable for the two vaccines for six (1, 5, 6B, 14, 19F , and 23F) of 10 serotypes, while the responses were lower following SIIPL-PCV TM for the remaining 4 serotypes [55] .

A significant booster response (except for type 5) was noted with both vaccines in children primed at 6-10-14 weeks with the SIIPL-PCV and the comparator vaccines. The magnitude of the booster response was higher for 1, 6B, 9V, 19A, and 23F with SIIPL-PCV, while it was higher for 5, 19A and 19F with PCV 13. The OPA GMTs following the booster vaccination in toddlers were generally comparable with both vaccines [55] .

In comparison with Synflorix, both vaccines elicited a significant booster immune response for all 10 serotypes except serotype 5, while the OPA GMTs showed a booster response for all 10 serotypes. Persistence of antibodies was seen for all serotypes till 1 year of follow up [56] .

The DCGI has approved it for active immunization against invasive disease and pneumonia caused by Streptococcus pneumoniae serotypes 1, 5, 6A, 6B, 7F, 9V, 14, 19A, 19F and 23F in infants from 6 weeks of age group for three dose regimen (dosing schedule: 6, 10 and 14 weeks) [57] . The WHO has approved it for active immunization against invasive disease, pneumonia and acute otitis media caused by Streptococcus pneumoniae serotypes 1, 5, 6A, 6B, 7F, 9V, 14, 19A, 19F and 23F, till the age of 2 years [58] .

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Competing interests: Representatives of a few vaccine manufacturing companies also presented their data in the consultative meetings. None were involved in formulating the recommendations. Funding: None. The first physical meeting was held during Vaccicon 2020 at Kolkata. The organizers provided the premises for the meeting. Indian Academy of Pediatrics provided the online platform for subsequent online meetings.