1. Breaking the barriers to introduce Intra-dermal ARV
Low cost Anti-rabies vaccination in India
Omesh Kumar Bharti

2. Himachal Pradesh

3. Shimla- A beautiful Himalayan town of India

4. Global Epidemiology- 1.74 million DALYs lost each year

5. Rabies a dreaded disease
55,000 deaths in the world each year, mostly in Asia and Africa
31,000 deaths in Asia
20000 deaths in India*- one every half an hr.17.4 Million bites every year
In India, annual Medical cost* for animal bite treatment is approx.
$ 4,444,445
Patients take loans to vaccinate entire family in case of death in the household.
* WHO-APCRI Study 2004

6. WHO Recommended low cost ID Anti Rabies Vaccination since 1992

7. High cost of IM route a barrier for poor patients around the world to seek post exposure prophylaxis Annual cost- $ Million

8. Barriers for low cost ARV introduction
“Game-play” by drug regulatory authorities
Hierarchy among Medical Doctors and medical institutions
Unaware/Unconvinced doctors
Ignorant decision makers at lower level
Reluctance of Pharmaceutical companies
Lack of advocacy efforts to convince decision makers, especially at lower levels
Lack of skill to organize low cost clinics through pooling strategy
Lack of community awareness

9. “Game-play” by drug regulatory authorities
Drug regulatory authorities willing to give only conditional approvals without logic.
Insistence on trials before intra-dermal (id) use despite the fact that WHO in 2002* clearly stated that “Any country willing to adopt an id regimen of proven efficacy with the recommended vaccines need not repeat immunogenicity studies in their own population”.
Many countries still doing trials and wasting time depriving poor from benefit.
Though many other vaccines are being used without trials in their own countries**.
*Current WHO GUIDE for Rabies Pre and Post Exposure Treatment in Humans (2002), 18.
**Jacob Puliyel, C Sathyamala,D Banerji, (2007) Protective efficacy of a monovalent oral type 1 poliovirus vaccine, : 129

10. Hierarchy among Medical Doctors and medical institutions Conflict at Implementation levels
Principal of hierarchy in medical circles proved to be a big barrier as the lower health institution not ready to do something a referral institution or medical college is not doing. That is why despite instructions no body wanted to start this technique and put his/her job at risk.
Doctors simply not ready to follow WHO guidelines as they are not convinced with it.

11. Doctors not aware of efficacy studies of intra-dermal ARV

12. Ignorant authorities as letter of Drug regulatory authorities (DCGI) not available at lower levels

13. Many Companies reluctant to write on the vaccine vial “For IM/ID use”, though some has started writing as demand for id use shoots up in India
OMESH BHARTI

14. How did we overcome the Barriers
We took
the
initiative and
responsibility
Sensitized
the Media, politicians,
administration,
NGOs & bureaucrats
We went to the media during vaccine shortages to high light the new technique which was vaccine sparing and one vial of vaccine can be used for five patients, we filed a write in the Himachal High Court to get direction for ID use, engaged the medical associations, vaccine companies and authorities to convince them of the usefulness of the intra-dermal technique.
Letter of DCGI was traced and given to authorities for further directions.
We on August 2, 2008 started first ID clinic of North India at our own so called “Risk”.
Continued
Advocacy with
Stakeholders
Writ Petition
in High Court

15. Pooling technique of Himachal
the patients
The Vaccine
We pooled the patients and the vaccine vials to make this method cost effective. We have defined a geographical area (Say 25 KM) within which the patients are given first aid by the health worker/ Doctor and then the patients is referred to our clinic for vaccination that we do with pooling technique. For the first time a patients is asked to purchase a vials and then told that now onwards we would give all shots to him free. We share the vials between four patients and keep other three vials for use next time among those four patients. We call it as pooling technique of Himachal.

16. Pooling technique of Himachal
Pool the patients
Money thus saved utilized to purchase other essential drugs for the poor.
Pool the vaccine vials
Distribute the left over accumulated vaccine over the time (0.2ml/vial) amongst poorest of the poor
Mechanism: Every patient is asked to bring one vial on first visit, rest we say, would be given free by pooling strategy!
One vial is shared with four patients and rest three vials are stored in fridge to be used on next due dates one by one.

17. Increased compliance with low cost intervention of ID ARV

18. More acceptability of poor patients because of low spending

19. Lives and money saved in less than two years in Himachal
In less than two years time, we have vaccinated 5,769 animal bite victims in Himachal using insulin syringes and needles without any failure, even in cases of proven rabid dog victims.
Around 12,000 vials of ARV vaccine were given, saving more than $ 200,000
$ 60,000 saved by CMO utilized for purchase of medicines for the poor in a year.
Averted approximately 15 deaths*(5769/460)
*WHO (2010), Rabies Vaccines, WHO position paper, Weekly Epidemiological Record, 2010; 85, ; Link;

20. 255 Rag pickers/ Local Municipal corporation workers, waiting for preventive rabies vaccination with the vaccine saved due to pooling technique

21. Mass vaccination camp in a school for poor children of remote area

22. Further scaling up
After starting clinics in all the districts of Himachal Pradesh, we started training neighboring states like Uttrakhand and Madhya Pradesh etc.
We hope to introduce this technique in entire country by next year.
Even neighboring countries like Bangladesh and Pakistan can be trained in this technique as they are still using Nervous Tissue Vaccine.
A smooth shift over from NTV to CCV can be achieved with similar costs.
OMESH BHARTI

23. Way Forward is financial support for trainings on Intra-dermal vaccination to different countries by experts in hospital settings- Supported by WHO
Asia…
Africa..
Many Asian and African countries can be trained in this technique in an actual hospital setting, as they are still using banned Nervous tissue vaccine (NTV) or are short of cell culture vaccines (Indonesia). If India and Africa jump onto this ID technique, we can save million of rupees and more than 55, 000 deaths can be averted.. For this we need to keep track of the forces that are bent upon to showcase this effective technique as inferior cousin of Intramuscular vaccination, for this, advocacy with doctors associations, vaccine companies and government officials is required. Just decision to allow intra-dermal ARV is not enough, we need to put in place the mechanisms for its implementation at different levels.

24. Approx. Cost savings if we shift from IM to ID Globally
With introduction of ID method, the cost can come down to one fifth from approx 292 Million $ to 58.5 Million $, with a saving of Million $ or say 200 Million $ if we exclude the cost of immunoglobulins. This can be used for other health interventions. Bur here lies the real power struggle as the gain of the patients is perceived a direct loss to the companies.

25. Intradermal route an effective way to spare the costs and the vaccines
There is a possibility of 10* other vaccines being given intra-dermal like Polio, hepatitis-B, yellow fever vaccines, influenza vaccines including H1N1 etc., to cut costs and make them affordable and easily available. WHO urgently need to expedite such cost saving and vaccine saving studies.
* PATH (2009) Intradermal delivery of vaccines: a review of the literature and potential for development for use in low- and middle-income countries. Seattle: Program for Appropriate Technology in Health (PATH); 2009, vi

26. Can a strategic plan be made to control Rabies world over?
Massive IEC campaign to educate masses about importance of “ Wound Wash and antiseptics” especially in Asia and Africa.
Pre-exposure prophylaxis
to school children
With intra-dermal
ARV in endemic areas.
Pet birth control
Pet vaccination
Stray animal control

27. Universal Access to Affordable Treatment”
“Our Vision”
Universal Access to Affordable Treatment”
“Sometimes Less can be More - Intra-dermal route”
OMESH BHARTI

28. Let’s work together towards a rabies free world by 2020
Thank you
Let’s work together towards a rabies free world by 2020