Four New Vaccines for Routine Immunization in India: What About Hemophilus Influenza B and Pneumococcal Vaccine?

Abstract

Immunization is the process whereby a person is made immune or resistant to an infectious disease, typically by the administration of a vaccine. The Expanded Program on Immunization (EPI) was flagged off in India in 1978. According to the recommendation of National technical advisory group of India (NATGI), Government of India is going to include four new vaccines in the UIP for whole India. The four new vaccines are Inactivated Poliomyelitis Vaccine (IPV) for polio, rota viral vaccine, vaccine against rubella, and Japanese encephalitis vaccine (179 districts in India). Here, authors have tried to show a comparative descriptive analysis of the hemophilus influenza and pneumococcal pneumonia with rota virus, so that in near future Government of India can also consider their inclusion in the national UIP. In India, 39.2% of all diarrheal death are due to rota virus, whereas 0.72 million deaths are due to hemophilus influenza B and 1.3 million are due to pneumococcal pneumonia in <5 years age-group. India's indigenous developed rota viral vaccine's (Rotavac) efficacy is 56% in 1^st year compared to H influenza B (Hib) efficacy 95% and PCV13 vaccine “3 + 1” dose efficacy 100% (South Africa). Rotarix incremental cost-effectiveness ratio is US $21.4 to US $34 per disability-adjusted life years (DALYs) compared to Hib US $ 819 per DALYs in India. In case of pneumococcal vaccine, India needs more trails on the serotype specificity, efficacy, and cost-effectiveness but there is enough evidence that hemophilus influenza burden is high in India and the present Hib vaccine is safe and highly effective. In future with the help of donor agencies, India should include the hemophilus influenza B and pneumococcal pneumonia vaccine in national UIP which will save millions of poor children's life.

Introduction

Immunization is the process whereby a person is made immune or resistant to an infectious disease, typically by the administration of a vaccine. Smallpox eradication program was successful in India in 1970 which drew the attention to the immunization program in India.[1] The Expanded Program on Immunization (EPI) was flagged off in 1978 mainly in the urban areas for immunizing children <1 years age-group. Through the subsequent years, more vaccines were included in the program, e.g. oral polio vaccine (OPV) in 1979 and the vaccine to immunize pregnant mothers with tetanus toxoid (TT) vaccine in 1983. In 1985, the program was renamed as the Universal Immunization program (UIP) focusing mainly on infants and pregnant mothers. Measles vaccine was included in the program in 1990 and the program had been expanded to spread across the country.[2] UIP became a part of Child Survival and Safe Motherhood (CSSM) program in 1992 and then of Reproductive and Child Health (RCH) program in 1997.[1,2] India included 2^nd dose of measles in the national immunization program in 2010. Hepatitis B vaccination was included in UIP in 2002-2003 and in 2011 it covered whole over India. With the financial support from Global alliance for vaccine and immunization (GAVI), Indian government included Pentavac vaccine as a pilot project in few selected states in 2011.[3] According to the recommendation of National technical advisory group of India (NATGI), Government of India are going to included four new vaccines for polio (injectable), rota virus, rubella, and japanese encephalitis (179 districts) in the UIP for whole India. So, at present UIP will fight against 10 vaccine preventable disease.[4] Disease burden, safety, efficacy, cost-effectiveness, and operational requirements of the vaccination program are some of the important factors considered before including a vaccine in the national UIP. There are two more vaccines i.e. hemophilus influenza vaccine (Hib) and pneumococcal vaccine which are also relevant from Indian's prospective to fight against vaccine preventable diseases. In this present article, authors have tried to show a comparative descriptive analysis of the hemophilus influenza and pneumococcal pneumonia with rota virus, so that in near future Government of India can also consider their inclusion in the national UIP.

Why Hib or Pneumococcal Vaccine should be Included in UIP of India?

Hemophilus influenza type B (Hib) and streptococcus pneumoniae (pneumococcus) are the most common cause of pneumonia. Countries with high child mortality, pneumonia stands in front as a leading cause and United Nations International Children Emergency Fund (UNICEF), World Health Organization (WHO) has termed it as “Forgotten killers of children.”[32,33] Strategic advisory group of experts (SAGE) recommend that, countries with under five mortality rate >50 deaths/1000 births, or with >50 000 annual deaths among children, should make the introduction of conjugate pneumococcal vaccine a high priority for their immunization programs.[34] There were many challenges in front of the Indian government before introducing the rota viral vaccine in national UIP. But one of the biggest hindrances was solved because of introduction of low cost and effective indigenously developed rotavac vaccine. Many of the challenges of rota viral vaccine are same for Hib and pneumococcal vaccine. At this present juncture, India is not able to develop any indigenous vaccine against pneumonia but GAVI has promised to offer present PCV13 vaccine at a cost of 0.15–0.3 USD/dose for inclusion in the national immunization schedule.[35] In future with the help of donor agencies like GAVI, World bank, WHO, UNICEF, Bill Gates Foundation, Indian government can think of introducing low cost Hib and pneumococcal pneumonia vaccine for national UIP. Promising experiences are available from different countries that had included Hib and pneumococcal vaccine into their routine immunization program. A study in Kenya showed after 3 year of introduction of Hib conjugate vaccine the incidence of invasive Hib disease declined drastically to 12% from baseline.[36] Similar impact of the Hib vaccine within 5 years of its introduction into routine child immunization showed 65% decrease in absolute number of invasive H. Influenza diseases.[37] Another impressive impact of Hib vaccine is that it provides herd immunity in the population.[38,39] Similarly pneumococcal conjugate vaccine in USA, Canada, and Australia, both Invasive Pneumococcal Disease and pneumococcal pneumonia hospitalizations and deaths had decreased substantially.[40,41,42] Pneumococcal vaccine gives protection not only against pneumonia but also other diseases like meningitis, otitis media, and bacteremia also.[24] Globally 160 countries have included Hib vaccine in national immunization schedule.[43] Indian government has already started inclusion of Hib vaccine (in the form of Pentavac) as pilot project in eight states (Tamil Nadu, Kerala, Haryana, Jammu and Kashmir, Gujarat, Karnataka, Goa, Pondicherry) of India.[44] Given the experiences from other countries Hib and Pentavac should be considered for developing country like India. Introduction of Hib vaccination can be done through either scaling up the coverage of ‘Pentavac vaccine’ or introducing single shot Hib vaccine. But hindrances like financial burden and limitation of cold chain system should be looked after first before introducing new vaccine.[45] Pentavac vaccine may be the answer to introduce new vaccine like Hib, without producing extra burden on the cold chain system. As the schedule of Pentavac, Hib and pneumococcal vaccine are same with the present vaccination schedule under UIP, introduction of new vaccines will not increase the visit to health facility which in turn will not affect the cost and coverage of the programme. Table 1 shows the comparison between Rota virus, Hemophilus influenza and Streptococcus pneumonia in India.

Table 1.

Comparative analysis of rota virus, hemophilus influenza, and streptococcus pneumonia in India

Conclusion

Inclusion of rota viral vaccine in spite of all the challenges in national immunization schedule is one of the major commitments of India against vaccine preventable diseases (VPDs). Indigenously developed rota viral vaccine (rotavac) was a result of a public-private partnership between Ministry of health and family welfare, Ministry of science and technology, and Bharat Biotech.[4] India need more trail on the serotype specificity, efficacy, and cost-effectiveness before including pneumococcal vaccine in UIP. Present burden of hemophilus influenza and pneumococcal disease are not less than rota viral disease and vaccine efficacy and safety level are also above the level of WHO criteria to include it into a public health program. So, policy makers in India should consider including Hib vaccine (alone or Pentavac) and pneumococcal vaccine in national UIP to save life of millions of poor children.