Mis - information campaigns against Hib Vaccine introduction in NIP

1. Mis - information campaigns against Hib Vaccine  introduction in NIP Prof. A. PARTHASARATHY Distinguished Professor of Pediatrics, The Tamil Nadu Dr. MGR Medical University, Chennai - 600 032 Former Senior Clinical Professor of Pediatrics, Madras Medical College & Deputy Superintendent, Institute of Child Health And Hospital for Children, Chennai 600008. National President (1997), Indian Academy of Pediatrics, Regional Advisor (1997–1999) Association of Pediatric Societies of South East Asia Region, Editor-in-chief, IAP Text Book of Pediatrics since 1997 Associate Editor, Color Atlas of Tropical Pediatrics, AAP publication (2009) Advisor, IAP Committee on Immunization, (2011-2013) Email: apartha2020@gmail.com Mobile: 090422 60053 24-May-14 1

2. Agenda • Combination Vaccines-Concept and concerns • IAPCoI recommendations in 2000 & 2011 • Evidence based Safety Profile • The PIL in Delhi High Court on the paucity of Epidemiologic Data • The misinformation Campaigns, Rejoinders & Expert opinions in Regional and National News Papers in Kerala and Tamil Nadu

3. COMBINATION VACCINES – DEFINITION, CONCEPT • DEFINITION: • A Combination Vaccine consist of 2 or more separate Immunogens that have been physically combined in a single vaccine formulation. • These Immunogens may pertain to the many antigens / serotypes of one given pathogen (Eg: Polio Virus Vaccine) or of multiple pathogens (Eg: DTP Vaccine) • CONCEPT: • This concept differs from that of simultaneous administration of vaccines, which, although administered concurrently are physically separate. • The combining of multiple related or unrelated antigens into a single vaccine is NOT New.

4. COMBINATION VACCINES –HISTORY, CAUTION • HISTORY: • The 1st combined vaccine was trivalent Influenza vaccine developed in 1945, Hexavalent Pneumococcal vaccine was developed in 1947 & DTP vaccine was developed in 1948. • Subsequently many other vaccine combinations (Bacterial / Viral) were developed. • DTP became a vehicle for vaccine like Hep B / Hib / IPV, etc. Eg:DTwP – Hep B,DTwP – Hib,DTwP – Hep B – Hib, DTaP – IPV, DTaP – Hep B – Hib. • Even 3 / 4 Live Viral Immunogens were combined subsequently. Eg: MMR Vaccine, MMR-V Vaccine. • CAUTION: • The Manufacturers recommendation should be followed strictly while extraneously mixing the lyophilized preparation with a liquid formulation or while administering a ready to use liquid vaccine.

5. COMBINATION VACCINES - I ‘Lyophilized / Liquid’ combinations Why combination vaccines? • Comprehensive: Incorporates many essential vaccines, as well as offer the opportunity to introduce newer vaccines • Concise: Delivers various antigens in the recommended quantity and timing for their age and ensure timely immunization • Compliance: Improves adherence to immunization schedule • Convenience: Convenient for the physician, parents and children • Cost effective: Transporting, handling and storage of a plethora of vaccines are burdensome and expensive Pediatr Infect Dis J 2001; 20:S10-S18

6. ACIP, AAP and AAFP have stated that the use of licensed combination vaccines is preferred over separate injections of their equivalent component vaccines IAP recommends that wherever combination vaccines are available, they can be substituted for monovalent formulations in the National Immunization Schedule. IAP guidebook on immunization ;76 2001. The IAPCoI concludes that all currently licensed combination vaccines in India have an immunogenecity, efficacy and safety profile comparable to separately administered vaccines as of currently available data. However the manufacturer’s recommendations for mixing the vaccines in the same syringe should be strictly followed. IAP Guide Book on Immunization:85: 2011 COMBINATION VACCINES - II ‘Lyophilized / Liquid’ combinations Endorsement from Scientific Bodies J Pediatr Health Care 2003; 17: 53-57

7. COMBINATION VACCINES – III‘Lyophilised / Liquid’ combinationsWhat we need to know? • Is immunogenicity disturbed? No • Are they safe? Yes • Have they been tested in Indian infants? Yes • Can we use them even for booster series? Yes

8. COMBINATION VACCINES - IV ‘Lyophilised / Liquid’ combinations Percentage of infants having post immunization antibody titres above minimum protective levels – Asian and Indian experience 100% Diptheria(>0.01 IU/ml) 100% Tetanus (>0.1 IU/ml) 97% Pertussis (>3.92 EU/ml) - AF Antifimbrial Pertussis (>2.24 EU/ml) - AP Antipertactin 81% Hib (>0.15 g/ml) 100% Hib (> 1.00 g/ml) 90% 100% Hepatitis B (>10 IU/ml) 0 20 40 60 80 100 % children with protective titres 24 May 2014 8 FP-F-22, 12th Asian Pediatric Conf 2004

9. COMBINATION VACCINES - VCurrent state of development VaccineDevelopedUnderdevelopment DTaP - IPV + - DTaP - Hib + - DTwP - HB + - DTwP - Hib + - DTaP - IPV - Hib + - Hep A - Hep B + - DTaP - Hib - IPV - HB + - MMR - V + - DTaP - Hib - IPV - HB - HA - + Measles - BCG recombinant - +

10. TRIPLE “I” STRATEGY Integrated Infant Immunization Strategy 7 – 4 – 9concept 7Vaccine formulations Before the Infant attains4months of age To prevent9Vaccine Preventable Diseases ? ? ? 24 May 2014 10

11. GoI’s Pentavalent Introduction Plan States where pentavalent vaccine with Hib will be introduced • Pentavalent vaccine (DTP-HepB-Hib) will be introduced initially in 10 states in India • National roll out to follow 24 May 2014 11

12. 5-in-one Vaccine to be rolled out in Tamilnadu and Kerala >The original decision to introduce Pentavac in 10 Pilot states of India was reversed following a PIL filed in the High Court of Delhi by two Pediatricians. >Mr Bill Gates, Chairman,Gates & Mellinda Foundation, partner in GAVI,offered to bear total cost of the vaccine requirements in two states TN & Kerala for 3 years to start with before the National Roll out when he visited India on 17Oct’11. Source ToI,Chennaiedn. 18 Oct’11

13. TN, Kerala to introduce controversial Vaccine • Dr.Jacob Puliyal, NTAGI Member New Delhi gave a press release in TOI on 19.10.2011 that the 5 in one vaccine is being considered for introduction for NIP with out sufficient clinical trials. • Kerala based RTI Activist and physician Dr.K.V.Babu in another press release in TOI and Mathru Bhoomi on 19.10.2011 claimed that the Penta vac could have caused deaths in Sri Lanka and Bhutan where it was introduced in the NIP. • Hon.Shri Ghulam Nabi Azad denied this allegation in the parliament

14. 5-in- one vaccine to be launchedin TN & Kerala in December 2011 - 1 • New Delhi: The much awaited five-in-one vaccine will be rolled out from December. To begin with, Tamil Nadu and Kerala, which have high routine immunization coverage rate, will use the penta valent vaccine in their universal immunization drive. • Six other states - Gujarat, Karnataka, Haryana, Goa, Jammu and Kashmir and Himachal Pradesh - have expressed their interest to use the five-in-one vaccine. The ministry will take a final call on allowing these states to roll out penta valent vaccine over the next few months. • Source;ToI,Chennai Edn,18 Nov,‘11

15. 5-in- one vaccine to be launchedin TN & Kerala in December 2011 - 2 • Union health secretary P.K.Pradhan said the GAVI Alliance, (a Geneva based public-private partnership aimed at improving health in the world's poorest countries), is supplying the penta valent vaccine to lndia for free. "GAVI” is giving us vaccines worth > Rs. One crore for three years for 10 states. The consignment will arrive by the end of next month. • However we are first rolling it out in two states. We will decide on the request of the other six states by analyzing their capability to handle adverse effects of vaccination. Most of these states have high routine immunization rates. • India will bear the expense for procuring the penta valent vaccine after three years," Pradhan said. The introduction of a pentavalent vaccine was recommended by the National Technical Advisory Group on Immunization (NTAGI on June 16, 2008.)

16. 5-in- one vaccine to be launchedin TN & Kerala in December 2011 - 3 • The pentavalent vaccine will reduce chances of dropout, will need no additional cold chain space and the number of syringes used will dip as well. lndia plans to vaccinate 16 lakh children in these two states in the first year. • The five-in-one vaccine will have diphtheria, pertussis, tetanus (DPwT), Hepatitis B and HIb (Haemophilus influenzae type b – (the bacterial micro organism that causes several serious childhood illnesses like meningitis and pnetrmonia). Children will also get their oral polio doses as part of the routine immunization program. • Source;The T0I,Chennai edn.,18 Nov’11

17. Pentavalent vaccine to be introduced today (17.12.2011) - 1 • NEW DELHI: Dismissing reports of the deaths of children after administration of pentavalent vaccine in Sri Lanka, Bhutan and Pakistan as unrelated, the Centre has decided to introduce this vaccine as part of the routine immunization program in Kerala on 14 Dec’11. • The vaccine, that will prevent children from five life-threatening diseases, will be introduced in Tamil Nadu on December 17. • 12 lacs doses of the pentavalent vaccine has been supplied to both the States and all preparatory activities including training and logistics are completed, a statement issued by the Ministry of Health and Family Welfare said. • Source;The Hindu,Chennai edn.,14 Dec’11

18. Pentavalent vaccine to be introduced today (17.12.2011) - 2 • The vaccine will protect children from Diphtheria, Pertussis, Hepatitis B and Haemophilus influenzae Hib disease which is in addition to the routine immunization program in the country. • It is administered to children at 6, 10 and 14 weeks of age and will replace the existing DPwT and Hepatitis B vaccines, the primary dose of which is given at the same age. • At present, there are I70 countries using the penta valent vaccine of the 193 World Health Organization member states.

19. Pentavalent vaccine to be introduced today (17.12.2011) - 3 • Goa has been administering the vaccine from the State budget since 2008, initially introduced in selected blocks covered the entire State in 2011. As on November 2011, more than 28,000 doses of the penta valent vaccine have been administered in Goa with no adverse events following immunization (AEFI) reported. • Introduction of Hib vaccination as a combination vaccine carries the added advantage of reducing the number of injections given to a child from nine (three each for DPwT, Hepatitis B and Hib) to only three shots.

20. Pentavalent vaccine to be introduced today (17.12.2011) - 4 • It is estimated that 40 per cent of all under-five mortality in India is attributed to pneumonia, meningitis and diarrhoeas. Hib disease is estimated to cause 2.6 lakh cases of pneumonia and 52,000 cases of meningitis every year. • Haemophilus influenza B is difficult to culture from pneumonia and meningitis cases due to prior use of antibiotics and stringent culture conditions. The facility for collecting the sample for culture is available only in tertiary care hospitals.

21. Pentavalent vaccine to be introduced today (17.12.2011) - 5 • Based on the recommendations of WHO and the National Technical Advisory Group onImmunization (NTAGI), the penta valent vaccine will be introduced in these two States with the Global Alliance for Vaccines and Immunization (GAVI) assistance and will provide 'free vaccine for three years following which the Centre will take over the program. • Pointing out that there had been reports of AEFI in three countries, the statement said that Sri Lanka and Bhutan had resumed vaccination after investigation of these cases while Pakistan continued with the vaccination. • "The reports on the said deaths following penta valent vaccine were assessed for casualty by respective countries and WHO and concluded that there is no real evidence of a link between the use of the vaccine and deaths," it read.

22. SUMMARY & RECOMMENDATIONS • >The safety of Hib Component in Pentavac formulation has been well established without any significant AEFI in various clinical trials and by introduction in their NIP by 170 member countries of the WHO. • >Members of IAP are using Pentavac formulation in their day to day Immunization Practice with utmost safety profile since 2001. • >Mis-Information Campaigns have been countered by IAP,GoI,UNICEF and WHO sources. • > A Media Subcommittee of IAPCoI should be formed to counter such mis-information in future.