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

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

3. PIONEERING WHO History
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
Louis Pasteur was the 1st to mass produce vaccines
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.
1st Small Pox vaccine produced in 1898

4. 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

5. 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

6. 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 (aP) Vaccines supplanting whole cell (wP) Pertussis Vaccines
Pentavalent Vaccines
Hexavalent fully liquid Vaccines
Combination vaccines…….fully liquid with all the benefits for Patients

7. 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 compliance1-4
1. Heininger U et al. Vaccine 2007;25: ; 2. Meyerhoff AS, Jacobs RJ. Prev Med 2005;41:540-4; 3.Kailes H, et al. Pediatr Infect Dis J 2006;25:507-12; Marshall GS,et al. Pediatr Infect Dis J 2007;26:

8. HEXAVALENT FULLY LIQUID VACCINE DEFINIT BENEFIT

9. 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 DTaP-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

10. FULLY LIQUID HEXAVALENT VACCINE The Science behind it
FULLY-LIQUID VACCINE
DTaP-IPV-HepB-Hib
Ready to use in “One Syringe”
No reconstitution
B) DTaP-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

11. ACELLULAR PERTUSSIS VACCINES ( aPV )
EFFECTIVENESS
Reasons for acellular vaccines (aP) 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 and France where the use have been widely Used for over 15 years Provided Sound Evidence that the aP Valence in Hexavalent Vaccine is Effective in Protecting against Pertussis

12. 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

13. Pentavalent to Hexavalent
Pentavalent Vaccine
DwPT, Hep B, Hib (+OPV) ( Shan 5 – fully liquid )
DaPT, IPV / Hib ( Pentaxim – Non fully liquid )
Hexavalent Vaccine
DTaP, IPV, HepB, Hib ( Hexaxim – fully liquid )
DaPT, IPV, Hep B / Hib ( Non fully liquid )
Quadrivalent Booster ( 5 years and Adults )
daPT, IPV ( Adacel Polio – fully liquid )

14. 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

15. Immunization errors These can divided into two main categories
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

16. Immunization errors 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

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

18. Summary 20% in Comparison to Non Fully Liquid Vaccines
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

19. Preparation time for fully liquid vaccines

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

22. WHAT CAN BE PREVENTED MUST BE PREVENTED
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

23. Dr Mohan Lumba, E B S , O G W. 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.
Q&A
Availability
Cost – effective – Subsidized as compared to developed countries