Adverse event following immunization (AEFI) surveillance in India: Position paper of Indian Academy of Pediatrics, 2013

Adverse event following immunization (AEFI) is a critical component of immunization program. The risk of AEFI with vaccination is always weighed against the risk of not immunizing a child. There is an evolving AEFI surveillance system in India for the vaccines delivered through ‘universal immunization program’ (UIP) of government sector, but the reporting remained suboptimal for long in the country, and there is almost no participation from private sector. The AEFI reporting from private sector will provide vital information on the safety of new and underutilized vaccines, not part of the UIP in India. The national guidelines are recently revised and updated. The Indian Academy of Pediatrics believes that pediatricians, especially in private sector have a crucial role to play with reporting of AEFI with newer/underutilized vaccines. Programmatic error, vaccine reaction, injection reactions, coincidental and unknown are the five broad categories of AEFI for programmatic purposes. The serious AEFIs (death, disability, cluster and hospitalization) need to be reported immediately and investigated in detail as per the laid down procedures. Once a serious AEFI happens, primary or urban health centre should be immediately informed by the pediatricians practicing in rural or urban areas, respectively. This advocacy paper from the academy provides guidelines to practitioners on how to report cases, and suggests ways for IAP members to help in ongoing efforts of the government in improving AEFI surveillance in the country. The details about the diagnosis and management of known/expected AEFI with UIP and newer vaccines shall be published later.     

Vaccine Safety and Surveillance for Adverse Events Following Immunization (AEFI) in India

Rationale: Assured quality vaccines and safe immunization practices are pre-requisite to successful immunization programs. All vaccines go through stringent safety checks during pre-licensure stage. Adverse Events Following Immunization (AEFI) Surveillance program is an integral part of routine immunization program in India to monitor the vaccine safety in the post licensure phase. Indian AEFI Program: National AEFI surveillance relies on passive surveillance and reporting by the health functionaries and practitioners. Vigorous strengthening of AEFI surveillance has resulted in manifold rise in absolute number of AEFI reports across several reporting units in the country in the last decade. Establishment of National AEFI Secretariat, National Technical Collaborating Centre, and development of risk communication strategy as well as quality management certification are some of the unique aspects of this public health program. All serious AEFI reports undergo a systematic causality assessment as per WHO-algorithm by trained committees. National AEFI surveillance system has forged formal linkages with national pharmacovigilance program, the regulators, and professional bodies. Challenges: The number of the reported serious AEFIs are still far less than the expected numbers. Although the AEFI committees at the district and state levels have been established, a large proportion are far from functional. Way forward: As the national immunization program introduces newer vaccines for different age groups and coverage improves, the issues of vaccine hesitancy and confidence are likely to be raised more often and the AEFI surveillance program will have to assume greater responsibility to comprehensively respond to the community concerns and sustain public confidence in vaccines.     

Scope for Rotavirus Vaccination in India: Revisiting the Scientific Evidence

Rotavirus vaccines have been developed to prevent deaths resulting from severe diarrhea of rotavirus origin. The use of vaccines as an intervention at scale to prevent and control the burden of rotavirus diarrhea is supported by the argument that prevailing public health measures such as hygiene and sanitation, breast feeding and use of ORS have failed to prevent severe dehydration resulting from diarrhea. The article reviews the existing evidence on the rationale of using rotavirus vaccine as against the feasibility of scaling it up in developing countries like India. The vaccines currently available may not cover the strains circulating in Indian population. The diversity of Rotavirus infection in the country is tremendous and since the safety, immunogenicity and efficacy data has not been collected for India, there is first a need to conduct studies to measure the extent of protection and cross-protection provided by the available vaccines for local strains, before venturing into Rotavirus vaccination program. The potential benefits of immunization have to be first vetted against the risks involved by the policymakers and other stakeholders.     

Influenza vaccination in India: Position paper of Indian Academy of Pediatrics, 2013

Burden of Influenza is significantly higher in developing countries as compared to developed countries, but the data on the disease burden is less well defined in most of the developing countries including India, and consequently, constraints evolving strategies for prioritization of measures to prevent and control it. The ‘swine flu’ or ‘A(H1N1)’ pandemic is on the wane but the virus continues to circulate causing sporadic outbreaks even in 2013. The A(H1N1)pdm09 has replaced the previous circulating seasonal A (H1N1) virus and acquired the status of a seasonal virus. Limited influenza activity is usually seen throughout the year in India with a clear peaking during the rainy season. The rainy season in the country lasts from June to August in all the regions except Tamil Nadu where it occurs from October to December. IAP recommends the ideal time for offering influenza vaccines is just before the onset of rainy season. The efficacy/effectiveness data of trivalent inactivated influenza vaccines are also presented in different age groups and different categories of individuals. The IAP maintains its earlier recommendations of using the current trivalent inactivated influenza vaccine in all children with risk factors but not as a universal measure. IAP has now prioritized different target groups for influenza vaccination based on contribution of the group to the overall influenza burden, disease severity, and vaccine effectiveness in different age groups and categories. The current trivalent inactivated influenza vaccines incorporate the 2009 pandemic strain also, hence avert the need of a separate ‘A (H1N1)’ vaccine. IAP stresses the need of more refined surveillance; large scale studies on effectiveness of seasonal influenza vaccines in Indian children, and more effective, properly matched, highervalent influenza vaccines.     

Immunization in Practice - Clearing the Cobwebs

Vaccination is one of the most cost effective methods of prevention of diseases without even raising the socioeconomic status of the community. Small pox eradication from the world is the perfect example of the role of mass vaccination of the entire community of the universe. India is feeling proud to be polio free for the last 1 y and it is expected that the world would be polio free very soon. The most important purpose of National immunization program of any country is to prevent deaths due to vaccine preventable diseases followed by severe disability and morbidity in that order. Therefore keeping in view the above principle, Govt of India has included Baciilus Calmette Guerrin (BCG), Oral polio vaccine (OPV), Diphtheria, Pertussis & Tetanus (DPT), Measles, Hepatitis-B and now Hemophilus influenza type b (Hib) vaccines in the armamentarium of the National schedule. Every child in the country should receive basic vaccines as per Govt. of India schedule and is available free of cost at all health centers in India.     

Measles control strategies in India: Position paper of Indian academy of pediatrics

Measles continues to be a major cause of childhood morbidity and mortality in India. Recent studies estimate that 80,000 Indian children die each year due to measles and its complications, amounting to 4% of under-5 deaths. Immunization against measles directly contributes to the reduction of under-five child mortality and hence to the achievement of Millennium Development Goal 4 (MDG 4). The live attenuated measles vaccines are safe, effective and provide long-lasting protection. The key strategies being followed globally for measles mortality reduction are high coverage of measles first dose, sensitive laboratory supported surveillance, appropriate case management, and providing second dose of measles vaccine. Prior to 2010, India was the only country in the world that had not introduced a second dose of measles vaccine in its National immunization program. We herein discuss the current status of measles vaccination along with the rationale and challenges of providing a second opportunity for measles vaccination, and the principles of measles catch-up campaigns.     

Challenges in the final stage of polio eradication

India and many other countries of the world have supported the resolution taken by the World Health Organization (WHO) in 1988 to eradicate poliomyelitis globally by the year 2000. At the beginning of 2002, there were 10 countries in the world with endemic transmission. India included in the high transmission area. WHO is preparing guidelines on the program response (both immunization and surveillance) to wild poliovirus isolation from the environment. This technology will be useful in monitoring the disappearance of vaccine virus after ceasing OPV vaccination     

Meningococcal disease. new prevention strategies

Because conjugate C meningococcal vaccines represent a significant advance in the prevention of meningococcal disease, currently accepted recommendations on vaccination should be revised. The health authorities are responsible for carrying out national surveillance programs and for evaluating the need for vaccination programs. These programs should target all groups at risk for this disease and should confer adequate and lasting protection in vaccinated children.     

Vaccination schedule of the Spanish Association of Paediatrics: recommendations 2011

The Advisory Committee on Vaccines of the Spanish Paediatric Association updates annually the immunization schedule, taking into account epidemiological data as well as evidence of the effectiveness and efficiency of vaccines. This vaccination schedule includes grades of recommendation. The committee has graded as universal vaccines those that all children should receive, as recommended, those with a profile of universal vaccines of childhood and as are desirable those that all children may receive, but that can be prioritized based on public funding resources and for risk groups, targeting those groups of people in epidemiological situations of risk. The Committee considers as a priority to achieve a common immunization schedule for Spain. The Committee reaffirms the recommendation to include pneumococcal vaccination in the routine vaccination schedule. Vaccination against varicella in the second year of life is an effective strategy and therefore a desirable goal. Given the morbidity and high burden on the health care system, vaccination against rotavirus is recommended for all infants. Due to the current problems of availability of both vaccines, associated with the recent finding of circovirus, the committee urges that rotavirus vaccination is restarted as soon as possible as it is considered a desirable health benefit for all children in our country. The Committee adheres to the recommendations of the National Health Coordination Council in reference to routine vaccination against HPV for all girls aged 11 to 14 years and stresses the need to vaccinate all patients with risk factors for these diseases against influenza and hepatitis A. Finally, it stresses the need to update incomplete immunizations using accelerated immunization schedules.     

Pertussis vaccines: Position paper of Indian Academy of Pediatrics (IAP)

Pertussis continues to be a major public health problem in both developing and developed countries. Data on exact burden and incidence of pertussis in the developing countries including India is sparse. However, the disease is widespread, even if not adequately measurable. Pertussis incidence has been increasing steadily in the last decade especially in industrialized countries. Outbreaks are reported from many developed countries in recent years despite widespread use of acellular pertussis vaccines with high coverage. The current status of coverage with pertussis vaccines is still sub-optimal in many states of the country. There is scarcity of data on vaccine efficacies of both whole-cell and acellular pertussis vaccines from India and other developing countries. Most of the recommendations on pertussis vaccination are based on the experience gained from the use of them in industrialized countries. Taking in to the consideration the recent evidence of faster waning of acellular pertussis vaccines in comparison to whole-cell vaccines and superior priming with whole-cell than acellular pertussis vaccines, Indian Academy of Pediatrics has now revised its recommendations pertaining to pertussis immunization in office practice. The Academy has now proposed whole-cell pertussis vaccines for the primary series of infant vaccination. Guidelines are also now issued on the preference of a particular acellular product. The Academy has also recommended use of Tdap during each pregnancy to provide protection to the very young infants. It urges the Government of India to initiate studies on the quality of available pertussis vaccines in India and to set indigenous national guidelines for the manufacturers to produce and market different pertussis vaccines in the country.     

Beyond Vaccination Coverage: Population-Based Measurement of Early Childhood Immunization Schedule Adherence

The immunization schedule recommended by the U.S. Advisory Committee on Immunization Practices (ACIP) provides a structure for how 10 different vaccine series should be administered to children in the first 18 months of life. Progress toward US early childhood immunization goals has largely focused on measuring vaccination coverage at age 24 months. However, standard vaccination coverage measures do not reflect whether children received vaccine doses by recommended ages, or whether vaccines were given concomitantly, per the schedule. In this paper, we describe innovations in population-level measurement of immunization schedule adherence through quantifying vaccination timeliness and undervaccination patterns. Measuring vaccination timeliness involves comparing when children received vaccine doses relative to ACIP age recommendations. To assess undervaccination patterns, children's vaccination histories are analyzed to determine whether they were vaccinated consistent with the ACIP schedule. Some patterns, such as spreading out vaccines across visits, are indicative of parental hesitancy. Other patterns, such as starting all recommended series but missing doses, are largely indicative of other immunization services delivery challenges. Since 2003, at least 12 studies have used National Immunization Survey-Child, immunization information system, or integrated health plan data to measure vaccination timeliness or undervaccination patterns at national or state levels. Moving forward, these novel measures can be leveraged for population-based surveillance of vaccine confidence, and for distinguishing undervaccination due to parental vaccine hesitancy from undervaccination due to other causes. Broader adoption of these measures can facilitate identification of targeted strategies for improving timely and routine early childhood vaccination uptake across the United States.     

What will it take to fully protect all American children with vaccines?

Although 95% of children have had a full course of vaccines by the time they enter school, immunization levels among poor inner-city preschoolers may be substantially lower. Among the factors responsible for the disparity are the lack of a uniform data system to identify children who need vaccine; missed opportunities to offer immunizations; overinterpretation of contraindications; and administrative barriers to immunization. Remedies lie in a multifaceted approach: a tracking system that will prompt a reminder and then sound an alarm when an immunization is overdue; means of informing parents, probably best accomplished by an outreach worker of the same racial or ethnic background as the parent; removal of administrative barriers and increased access to services; incentives, either positive or negative, to raise the priority of immunizations; and more education for health care providers to ensure that they understand contraindications and do not miss opportunities to offer vaccines. Other possibilities are "express lane" services to immunize all children who come to a health care provider and the delivery of immunizations in child care settings and in programs such as Women, Infants, and Children, and Aid to Families With Dependent Children.     

Immunisation issues for Indigenous Australian children

Vaccination has provided major benefits to the health of indigenous children in the face of continuing poorer socioe‐conomic conditions but several issues have been identified for improvement. While indigenous children are vaccinated at high rates for the standard schedule vaccines, vaccination is more commonly delayed. Coverage for ‘targeted’ vaccines is substantially lower, and data on coverage for indigenous adolescents is non‐existent. Improved identification of indigenous clients by immunisation providers and the expansion of the childhood register are required. The progressive removal of early‐acting Haemophilus influenzae type b vaccines from schedules for indigenous children because of an international shortage raises the risk of disease re‐emergence and highlights the need for vigilant surveillance including carriage. The expanded use of existing vaccines (influenza) and early adoption of new vaccines (higher valency pneumococcal conjugates) are needed to maximise benefits, in particular the potential to impact on non‐invasive disease such as otitis media and non‐bacteraemic pneumonia that are so prevalent in indigenous children.     

Strategy for child survival.

The rates of infant and under-five mortality are too high in India. Almost half of these child deaths could, however, be avoided with greater primary health care. Evidence from other countries demonstrates the potential of primary health care programs to slash infant mortality by 50-60% over a 1-5 year period. Such programs should consider: prenatal care; delivery by trained birth attendant; care of newborn infants; primary care for diarrhea, acute respiratory infections, and other common diseases; immunizations; prophylaxis against anemia and vitamin and iodine deficiency; growth monitoring and nutritional guidance of staff; and stronger secondary and tertiary care. While components of this program may be in place, inadequate staff training and essential medicines and equipment combine with poor infrastructure, communication, and supervision to produce inadequate service coverage. This paper proposes the employment of female multipurpose workers to provide both primary health care and family planning services to rural communities. Each worker would be responsible for services in 5-6 villages of 5000 inhabitants within a 5-km radius of her headquarters. Elements of the program are discussed in the bulk of the paper.     

Indian Academy of Pediatrics (IAP) recommended immunization schedule for children aged 0 through 18 years — India, 2013 and updates on immunization

Justification

There is a need to review/revise recommendations about existing vaccines in light of recent developments in the field of vaccinology where new developments are taking place regularly at short intervals.

Process

Following an IAP ACVIP meeting on 3rd and 4th August, 2013, a draft of revised recommendations for the year 2013 and updates on certain new vaccine formulations was prepared and circulated among the meeting participants to arrive at a consensus.

Objectives

To review and revise recommendations for 2013 Immunization timetable for pediatricians in office practice and issue statements on new vaccine formulations.

Recommendations

The major change in the 2013 Immunization timetable was made in the recommendations pertaining to pertussis immunization. Taking in to the consideration of recent outbreaks of pertussis in many industrialized countries using acellular pertussis (aP) vaccines and subsequent finding of faster waning of the same in comparison to whole-cell pertussis (wP) vaccines and superior priming with wP vaccines than aP vaccines, the committee has now recommended wP vaccines for the primary series of infant vaccination. Guidelines are now also issued on the preference/selection of a particular aP vaccine in case it is not feasible to use wP vaccine, and use of Tdap vaccine during pregnancy. The administration schedule of monovalent human rotavirus vaccine, RV1 has been revised to 10 and 14 weeks from existing 6 and 10 weeks. Recommendation is made for the need of booster dose of live attenuated SA-14-14-2 JE vaccine. Updates and recommendations are issued on new typhoid conjugate vaccine, inactivated vero-cell culture derived SA-14-14-2 JE vaccine, inactivated vero-cell derived Kolar strain, 821564XY JE vaccine, and new meningococcal conjugate vaccines. This year the recommended immunization schedule with range for persons aged 0 through 18 years is being published together instead of two separate schedules. A subcategory of ‘general instruction’ is added in footnotes. The comments and footnotes for several vaccines are revised and separate instructions for ‘routine vaccination’ and ‘catch-up vaccination’ are added in the footnotes section wherever applicable.     

Improving drug safety monitoring

Drug safety monitoring is important in children. Young age, polypharmacy, prolonged hospitaliza-tion, being critically ill and use of unlicensed and off-label drugs have been identified as risk factors which predispose a child to experience an adverse drug reaction. In our country, the HIV/AIDS epidemic, setting up of intensive care units, increasing availability of imaging studies, and the introduction of several new drugs and vaccines have accentuated the need for improving drug safety monitoring in children. To achieve this aim, establishing in-hospital computerized event monitoring program in major hospitals and an effective national post- marketing drug surveillance network are the need of the hour.     

Association between maternal intimate partner violence victimization and childhood immunization in India

Empirical evidence regarding the relationship between use of child health services and maternal intimate partner violence (IPV) exposure is sparse. The present study examined the relationship between maternal IPV and childhood immunization status in India using the nationally representative NFHS-3 (n?=?6947). Exposure was past year IPV and the outcome was full immunization. IPV victimization was associated with decreased likelihood of being fully immunized after controlling for a range of socio-demographic variables. We also found that differences in measurement of the immunization status (self-report vs. health card) had different implications for the observed association; women reporting IPV and not having the vaccination card were most vulnerable to lack of immunization of their children. Findings suggest the need for increased programmatic efforts to prevent both the prevalence of IPV as well as the multiple MCH consequences of such violence.     

Immunizations in the United States: a rite of passage

Today, vaccination is a cornerstone of pediatric preventive health care and a rite of passage for nearly all of the approximately 11,000 infants born daily in the United States. This article reviews the US immunization program with an emphasis on its role in ensuring that vaccines are effective, safe, and available and highlights several new vaccines and recommendations that will affect the health of children and adolescents and the practice of pediatric medicine in future decades.     

Pediatric immunizations

The record of disease prevention in children is an impressive testament to our universal immunization program. However, these successes are being threatened by rates of vaccination in some areas of the country that are substantially less than those seen in the developing world. Unless the pediatric immunization rates are improved, epidemics of other vaccine-preventable diseases will recur, as evidenced by the measles outbreak. Although the tools needed for disease prevention are available, the means for their delivery are lacking. It is the obligation of us all to immunize the nation's children.     

Burden of congenital rubella syndrome (CRS) in India: <Emphasis Type="Italic">A systematic review</Emphasis>

Background

Rubella, though a mild, vaccine-preventable disease, can manifest with severe teratogenic effects in the fetus labeled as congenital rubella syndrome (CRS) due to primary maternal rubella infection. Despite a reduction in disease burden of several vaccine-preventable diseases through childhood immunization, CRS continues to account for preventable severe morbidity including childhood blindness, deafness, heart disease, and mental retardation.

Objective

To conduct a systematic review to describe the prevalence of CRS and its contribution to major long-term handicaps in Indian population. Another objective was to estimate the susceptibility to rubella infection in Indian adolescent girls and women of reproductive age-group. We also explored strategies to decrease CRS in India by identifying the immunogenicity of rubella containing vaccines (RCV) in Indian children and women, as well as their coverage in India.

Methods

Publications reporting ‘CRS prevalence in general population as well as selected subgroups i.e., suspected intra-uterine infection, congenital ocular abnormalities, deafness, congenital heart disease, mental retardation, and congenital malformations’, ‘seroprevalence to rubella (IgG) amongst women and adolescents’, and ‘immunogenicity and coverage of RCVs’ in Indian population were retrieved through a systematic search. Primary databases employed were Medline through PubMed and IndMed, websites of the WHO, and UNICEF. No restrictions were applied in terms of study designs. The primary outcome measure was ‘congenital rubella syndrome’ (CRS) which was further categorized as ‘suspected CRS’ and ‘confirmed CRS’ as defined by World Health Organization (WHO).

Results

Comprehensive evidence about the true burden of CRS in India is not available. Almost all studies have been done in institutional/hospital set-ups and community-based studies are grossly lacking. There are no studies assessing the prevalence of CRS in general population. All studies have evaluated the CRS burden in symptomatic cohorts of children. 1–15% of all infants suspected to have intra-uterine infection were found to have laboratory evidence of CRS. About 3–10% of suspected CRS cases are ultimately proven to have confirmed CRS with the aid of laboratory tests. CRS accounts for 10–15% of pediatric cataract. 10–50% of children with congenital anomalies have laboratory evidence of CRS. 10–30% of adolescent females and 12–30% of women in the reproductive age-group are susceptible to rubella infection in India. RCVs are highly immunogenic in Indian adolescents and women. The coverage data of RCVs in India is not available. However, the coverage of MMR vaccine has been reported as 42%, 30% and 5% from Delhi, Chandigarh and Goa, respectively.

Conclusion

This systematic review identifies and explores factors associated with the prevalence of CRS in India. There is a need for urgent action in terms of revamping the national immunization policy and introduction of RCVs in the national immunization program. Active surveillance of rubella and CRS is needed to redress the burden of CRS in India.