Fully liquid vaccines Innovation Dr Mohan Lumba Senior

Fully liquid vaccines - Innovation Dr Mohan Lumba Senior Consultant Pediatrician Chairman Kapricorn Trustee KPA

INTRODUCTION Since the advent of vaccines, the eradication of small pox… Can be considered as a Miracle

PIONEERING WHO • The greatest contribution to public health after safe water supply is vaccination History • Jenner – in 1896 observed that milk maids who got “cox pox” did not get chicken pox or only got a milder disease • • • He took fluid from the vesicles of cows who had cow pox & scratched the skin of young boys & applied the fluid. After 2 weeks he noticed that the boys developed cow pox and further on follow up documented that the boys did not get chicken pox or got only a milder variety. This experiment confirmed his suspicion that a milder variety of chicken pox rendered some immunity. 1 st Small Pox vaccine produced in 1898 • Louis Pasteur was the 1 st to mass produce vaccines | 3

EVOLUTION Whole Kill Cell Vaccines – TABC (Typhoid and paratyphoid A, B and Cholera) Serum Vaccines (from horse serum) – Rabies and snake bite – Anti-Diptheria Serum – Anti-Tetanos Serum Antigen and Toxoid – DPT (Diphtheria, Pertussis, Tetanos and Polio – OPV) Recombinant – RNA Vaccines – Hep B Vaccines (surface Antigen – grown in yest cells) Conjugate – Pneumo (PCV) and Meningo and Hib Conjugates Split Virion – Flu Fully liquid Vaccines | 4

ADJUVANTS ( Significance ) • In order to use lesser quantity of the Antigen but to achieve the Same or Better Response Adjuvants were Discovered and added to Vaccines – Common Adjuvants used : • • Aluminum Hydroxide Thermasol Gelatine Albumine By adding an “Adjuvant” it is possible to produce vast doses of vaccine | 5

RATIONALE FOR DEVELOPING COMBINED VACCINES Evolution of Immunisation policies from 2000: – Hib Vaccination included in wide majority of National Immunisation Programs (NIP) – Hepatitis B Vaccine in all NIP Calendars – Distinct move from OPV to IPV – Acellular Pertussis (a. P) Vaccines supplanting whole cell (w. P) Pertussis Vaccines – Pentavalent Vaccines – Hexavalent fully liquid Vaccines Combination vaccines……. fully liquid with all the benefits for Patients 6

ADVANTAGES OF COMBINED VACCINES • • Fewer Injections for the Child Less total Side Effects and Easier administration Less risk for mistakes No forgotten Vaccines Less use of Adjuvants Very good Immunogenic response Improved Vaccine uptake, timeliness and compliance 1 -4 1. Heininger U et al. Vaccine 2007; 25: 1055 -63; 2. Meyerhoff AS, Jacobs RJ. Prev Med 2005; 41: 540 -4; 3. Kailes H, et al. Pediatr Infect Dis J 2006; 25: 507 -12; 4. Marshall GS, et al. Pediatr Infect Dis J 2007; 26: 496 -500 7

HEXAVALENT FULLY LIQUID VACCINE DEFINIT BENEFIT | 8

HEXAVALENT FULLY LIQUID VACCINE KEY CONCEPTS THIS VACCINE HAS PROVEN TO BE SAFE AND IMMUNOGENIC IN A VARIETY OF CLINICAL STUDIES WORLDWIDE • High Immunogenicity of Each Antigen • Low Reactogenicity, similar to all other DTa. P-backboned Vaccines • Adapted to fit with Several Hepatitis B Vaccination Schedules • This Vaccine has Benefitted from Years of Experience accumulated from it’s Predecessors • Licensed to be Administered to Infant + Toddler Booster Schedule | 9

FULLY LIQUID HEXAVALENT VACCINE The Science behind it A) FULLY-LIQUID VACCINE DTa. P-IPV-Hep. B-Hib – Ready to use in “One Syringe” – No reconstitution B) DTa. P-Hep B-IPV / Hib – Not Fully liquid – Needs reconstitution or 2 products – Documented Evidence that the Reconstitution Vaccine does not provide optimum Antigenic response to Hep B | 10

ACELLULAR PERTUSSIS VACCINES ( a. PV ) • EFFECTIVENESS • Reasons for acellular vaccines (a. P) well known “Child Friendly Vaccine” • Studies in USA and Japan have Shown High and Long Term ( 5 to 7 years ) Effectiveness against Pertussis • The Pertussis Surveillance Data from Sweden and Austria, Finland France where the use have been widely Used for over 15 years Provided Sound Evidence that the a. P Valence in Hexavalent Vaccine is Effective in Protecting against Pertussis | 11

IMPORTANCE OF INACTIVATED POLIO VACCINE ( IPV ) • SAFETY AND SUITABILITY OF IPV In the pre-and post- Polio Eradication era • OPV synonymous with “Wild Polio Virus” eradication methods – In poor sanitary conditions – Didn’t require much expertise to give, but multiple doses needed – Mucosal Immunity – ‘Indirect Vaccination’ of the greater population – BUT, risks of VAP, VDPV • The Extensive Records of High Immunogenicity of IPV under Multiple Schedule and settings as well as Safety makes it the Vaccine of Choice in the Final Stages of Global Polio Eradication and the Only Option in the Post Polio Eradication Era. • Kenya has Introduced IPV in the National Immunization Program | 12

Pentavalent to Hexavalent • Pentavalent Vaccine – Dw. PT, Hep B, Hib (+OPV) – Da. PT, IPV / Hib ( Shan 5 – fully liquid ) ( Pentaxim – Non fully liquid ) • Hexavalent Vaccine – DTa. P, IPV, Hep. B, Hib – Da. PT, IPV, Hep B ( Hexaxim – fully liquid ) / Hib ( Non fully liquid ) • Quadrivalent Booster ( 5 years and Adults ) – da. PT, IPV ( Adacel Polio – fully liquid ) 13

Immunization success Success of Immunization Programs depends on : • The Quality as well AS PROPER ADMINISTRATION of Vaccines • PROPER HANDLING AND PREPARATION is CRITICAL in Maintaining the Integrity of the Vaccine • Right from Transfer of the Antigen from the Manufacturers Vial to the Syringe and Ultimately to the Patients 14

Immunization errors These can divided into two main categories A. ERRORS IN RELATION TO HEALTH COMPLICATIONS – Improper Manipulation Compromises Sterility Resulting in Contamination • • • Fingers Touching rubber Cap Fingers Touching Sterile part of Needle Syringe put down on Tray 15

Immunization errors B. ERRORS REDUCING IMMUNOGENICITY – Wrong Dosage • • • Contents of Vaccine NOT Mixed or Reconstituted Whole Content of Vial NOT Aspirated Needle Twisted when Inserted into the Vials Stopper No Purge at the end of Preparation Liquid “Leak” during Preparation or Administration Improper site adminstration 16

Benefits of combination vaccines • Delivering More Antigens in Fewer Injections • Synergism • Less Adjuvant • Better Coverage and Time Utilization • Improves Efficiency • Reduces Costs 17

Summary • Fully Liquid Vaccines takes HALF THE TIME TO ADMINISTER as Compared to Non Fully Liquid Vaccines • The Simplicity in Preparation of Fully Liquid Vaccines helps to Optimize REDUCTION OF IMMUNIZATION ERRORS. – 20% in Comparison to Non Fully Liquid Vaccines Vaccine Programs Seek High Immunization Coverage Across Populations with Minimal Adverse Events Following Immunization (AEFI) - WHO 18

Preparation time for fully liquid vaccines Fully liquid | 19

Fully liquid vaccines 5 times less risk of mishandling vaccine. Fully liquid | 20

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IN CONCLUSION • Vaccines Work – Eradication of Small pox, Eradication of Polio, Measles, Tetanus, Flu (Otitis Media)… • Immunization Provides : • Herd Immunity • Decreased Burden of Disease & Cost-effective • Evidence : Typhoid in Kenya (Bungoma and Naivasha) IDEALLY 1 VACCINE AGAINST ALL INFECTIOUS DISEASES GIVEN AT BIRTH SHOULD PROVIDE LIFE LONG PROTECTION TAKE HOME MESSAGE : A STITCH IN TIME SAVES 9 WHAT CAN BE PREVENTED MUST BE PREVENTED 22

• Thank You for Your Attention • I Hope your Knowledge has Increased Regarding Immunization and Vaccines especially the New Generation Vaccines • Feel Free to Ask any Question • God Bless Dr Mohan Lumba, E B S , O G W. 23