Dr. KALE BALASAHEB M. Division of Veterinary Public Health, IVRI Under supervision of Dr. Bhoj R Singh, HD. Epidemiology, ICAR-IVRI, Izatnagar Strength and Weaknesses of FMD Strength and Weaknesses of FMD Control Programe Going on in India: Control Programe Going on in India: Means and Ways for Success Means and Ways for Success
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Dr. KALE BALASAHEB M. Division of Veterinary Public Health, IVRIUnder supervision of
Dr. Bhoj R Singh, HD. Epidemiology, ICAR-IVRI, Izatnagar
Strength and Weaknesses of FMD Control Strength and Weaknesses of FMD Control Programe Going on in India: Means and Ways Programe Going on in India: Means and Ways
for Successfor Success
Notifiable disease-World Organization for Animal Health (OIE) (Kumar et al.,2011)
First animal virus by Friedrich Loeffler and Frosch in 1897-1898
Sodium carbonate, boric acid and glycerin may be applied over the lesion.
Feet of the affected animals may be washed with 2% copper sulphate solution.
Broad spectrum antibiotics.
Fluid therapy.
Antiviral approaches including 2'-C-Methylcytidine (Meyer et al., 1997)
Ribavirin (Kim et al., 2012)
Types Of Vaccine Available in IndiaManufacturer Product Name Type Strain/
Subtype Adjuvant Licensed Countries
Biovet Private Limited
BioFMD-Oil™ Killed O, A, Asia-1 Oil India
Brilliant Bio Pharma Ltd
FUTVAC™ Killed O, A, Asia-1 Oil India
Indian Immunolicals
Limited
Raksha Triovac (FMD, HS, BQ)
Killed O, A, Asia-1 (FMD)
Oil India
Raksha Biovac (FMD, HS)
Killed O, A, Asia-1 (FMD)
Oil India
Raksha Ovac Killed O, A, Asia-1 Oil India
Raksha Killed O, A, Asia-1 Aluminum hydroxide,
saponin
India
Vaccine Production Technology
All manufacturers use BHK suspension culture technique for manufacture of vaccine.
Bioreactors/fermentors ranging from 50 L to 10000 L are being used for production of vaccine.
Binaryethyleneimine (BEI) is used as an inactivant.
Aluminium hydroxide and oil adjuvant vaccines are manufactured.
(Research and Development Centre Indian Immunologicals Limited, Hyderabad,2012 )
Product Name Manufacturer Ingredients/adjuvant Dose Primary Booster Revaccination
Bovilis®
ClovaxIntervet India Binary ethyleneimine (BEI)
inactivated FMD mineral oil emulsion vaccine containing a mixture of virus
serotypes O, A and Asia-1
2ml, i/m(Vial: 100
ml)
3 months onwards
I)After 4-6 weeks of primary vaccination
II) After 24 weeks of first
booster
Every 44-48 weeks after 2nd booster vaccination
Raksha Indian Immunologicals
Inactivated tissue culture FMD virus strains O, A and Asia-1 adsorbed on
Al (OH)3gel and saponin as an adjuvant
3 ml in the mid-neck region, s/c
(Vial: 30 ml)
4 months 2-4 weeks after primary
vaccination
Every 6 months after booster and every 4 months
in endemic areas
Raksha Ovac
-do- Inactivated tissue culture FMD virus strains O, A, and Asia-1 adjuvanted
with mineral oil
2 ml in the mid-
neck region, deep i/m
4 months 9 months after primary
vaccination
Annually
FMD Vaccination Schedule as per Type of Vaccine
Need of FMD Control India: Worlds largest susceptible population
5000 Million population
(DAHD, 2007)
(DAHD,2007)
199 M cattle
105 M buffalo
140 M goat
71 M sheep
11 M PIG
Need of FMD Control
Rs. 15,000-20,000 crores direct losses / Annum. (Venkataramanan et al.,2006)
India losing Rs 18,000 cr. annually due to FMD in cattle.
(Times of India,Aug 2011)
FMD-CP Foot and Mouth Disease Control Programme (FMD CP) -2004 by DAHD&F
in 54 districts of the country governing 9 states and 1 union territory (A&N islands).
Vaccination was 100% and done twice a year with trivalent (O, A and Asia1) vaccine. Serum samples of 10 cattle and 10 buffalo before vaccination and 21 to 30 days post vaccination were collected and screened for level of type specific neutralizing antibodies by Liquid Phase Blocking ELISA(LPB ELISA) developed by the central FMD laboratory before launch of the FMD CP in the country.
The reagents and training to conduct post vaccination monitoring is provided by the Central FMD Laboratory, Mukteswar.
One sixty seven districts in which the control programme started in 2010-11.
Strength of FMD Control Programme (FMD-CP) in India
“National FMD control Programme” Vaccination with trivalent (O, A, ASIA-1)*
vaccine . Twice a year (Pattnaik et al.,2012)
* From 2004-05
FMD Control Programs in India In 10th plan 2 programs started :-
RKVY funds also used
.
FMD-CP 100% GOI
funded
ASCAD program of
GOI and state govt.
38.36% C/B/P
covered80-85 M animal
covered
FMD-CP Rs. 400 crores of fund up till now.
640 districts expansion in 12th plan covering 316 M animals. (As per FAO-PCP)
4 large vaccine manufacturer.
Now 356 Million trivalent doses/year.
Demand expected to go up to about 625 millions/yr from 2015.
(R.Venkataramanan,2014)
FMD-CPAndhra Pradesh has been declared free of FMD in
2016.H.P., Haryana, Punjab, Delhi: Hold promise to
become “disease free zone” in coming years due to intensive vaccination and monitoring.
(Pattnaik et al.,2012)
Central authority: Purchase of vaccine, maintain cold chain and other logistic support.
FMD-CP
State Authority: Supplies the manpower.
As a result FMD-CP prevented SIGNIFICANT economic losses and facilitated the development of herd immunity in cloven footed animals.
(DAHD,2011)
FMD Vaccine Quality Control
300 M doses/year.By manufacturers: As per DCGI regulations.CCS National Institute of Animal Health, DADF : GOI
central agency in govt. sector – mandatory to undertake testing. (R.Venkataramanan,2014)
• However, hardly 1% batches are tested every year for quality.
Why Control is Difficult?Fastest multiplying virus
Pig amplifier host
FMD Control- Tedious Task
Larger host range
Fast spread
More antigenic diversity
Why Control is Difficult ?
Corruption in the systemFMDV : Antigenic variability and genetic diversityVariable antigenic type in different geographical
areas or same areas (Rudreshappa et al.,2012)
FMD- Difficult to Eradicate
FMD-Difficult to control &
eradicate
Vaccine from one strain no immunity to
other(kitching,1998)
High mutation
Complexity in viral population
during transmission & multiplication
(Morelli et al.,2013)
No cross protection between serotypes
Weaknesses of FMD control Program in India
QUALITY OF VACCINE? Corruption in testing? COLD CHAIN MAINTAINANCE? IMPROPER VACCINATION?
Vaccination failure
Corruption in the system?Only one example is sufficient to understand the corruption in the system:
As per RTI informationThe vaccine of Foot & Mouth Disease (FMD) found substandard at CCSNIAH
Baghpat, India, in November 2014 (https://www.researchgate.net/publication/267705649_Testing_of_FMD_Vaccine_intended_to_be_used_under_FMD-CP_of_Govt_of_India_at_CCS_NIAH_Baghpat_UP_India) was retested at IVRI Izatnagar, Bareilly under directions of chairman of the Re-testing committee Dr. Gaya Prasad (ADG, AH, ICAR, New Delhi), presently VC at SVBP Agric. & Technology University, Modipurum, Meerut.
Retesting of FMD vaccine completed on 6th February 2015 at ICAR-IVRI, Izatnagar (a non recognized place for FMD vaccine testing) and report was submitted to Dr. Gaya Prasad by email on 7th February 2015. However, the final report in favour of producers of sub-standard FMD vaccine was submitted by Dr. Gaya Prasad on 12 January 2015, almost 25 days before the completion of testing and submission of testing report.How? Why? What for?
Failure of FMD VaccineFoot and Mouth Disease (FMD) outbreak were there in 2016 at ICAR-Indian Veterinary Research Institute’s Dairy Farm, Izatnagar, Bareilly, UP; CMVL Meerut Dairy Farm, GADVASU,
Ludhiana, Punjab, Dairy farm. All the three Farms were routinely vaccinated with IIL, Hyderabad FMD Oil adjuvant Vaccine. No antigenic
variation has been reported in the virus causing outbreaks.
(Singh B.R., et al. 2016)
Weaknesses Of FMD Control Programs
No strict quality monitoring of the vaccine.No cold chain facilities are available, how it can be
hundreds of hospitals are devoid of refrigerators and even electricity.
No required coverage is provided due to multiple passage steps for vaccine production.
(FAO,2013)
Year wise break-up of outbreaks and FMDV serotypes involved during last 3 years
• Year Total O A Asia1• 2013-14 472 454 08 10• 2014-15 76 75 - 01• 2015-16 252 244 06 02
(PD-FMD ,annual report,2015-16)
Weaknesses of FMD Control Programme in India
Unrestricted movement of animals in India
(Biswal,2012)
Spread of FMD
Wild animals also affected and act as source of infection
Vaccine Problem
(Rodriguez&gay,2011;parida,2009)
Weaknesses of FMD Control Programme in India
In India FMD policies targeted only towards cattle and buffaloes.
But sheep and goat also play important in epidemiology and transmission of FMDV.
Hence FMDV vaccination is important in sheep and goat.
(Singh et al.,1994; Shankar et al.,1908)
Weaknesses of FMD Control Programme in India
In India decision to vaccinate is complex
Weaknesses of FMD Control Programme in India (SWOT ANALYSIS)
WEAKNESSES OF FMD CONTOL PROGRAMME
DISEASE REPORTING
SYSTEM
EXTENSION ACTIVITY
VACCINE AVAILABILIT
Y
VACCINATION COVERAGE
ANIMAL MOVEMENT
COLD CHAIN MAINTAINANCE
(R.Venkataramanan,2014)
Means and Ways for Success of FMD Control Programme
Good infrastructure
Trained Manpower
Well equipped laboratoriesTesting of vaccine for quality at multiple places
(monopoly must be removed) Good governanceRapid and accurate diagnosisContinuous monitoring and surveillance.Veterinarians reporting the FMD cases in their practice
area should be rewarded instead of punishment (the current policy)
Means and Ways for Success of FMD Control Programme
Compulsory vaccination (Corrales irrazabal,2001)
Most effective strategy for prevention of viral diseases is vaccination including FMD.
(Pastoral,2012)
Means and Ways for Success of FMD Control Programme
Ways for FMD Control Programme Success
Determination of exact status of disease (Rashtibaf et al.,2011)
No import of unvaccinated animals.No cross border animal movement.Restriction of movement of animals during outbreak
time.More powers to veterinarians to implement the
policies.
Rapid Response
FMD outbreak
Immediate information to regulatory authority for rapid diagnosis
Any vesicular disease immediately inform state and central vet authorities
As FMD Virus is resistant to chloroform & ether – Use sodium hydroxide(2%) & sodium carbonate(4%) for inactivation of virus
(Krug et al.,2011)
More focus on ‘O’ strain ( 80% cases)
Means and Ways for Success of FMD Control Programme
Means And Ways for Success of FMD Control Programme
Vaccination after sero-monitoring
Quarantine
Biosecurity measures
Boil milk for more than 100ºC and slurry 67ºC for 3 min.
Means and Ways for success of FMD control programme
Disposal : animal products, manure
carcasses of infected animals:
Incineration/rendring/
burialRodent killing:
mechanical transmitters
Means and Ways for Success of FMD Control Programme
Endemic areas : Vaccination of all susceptible and eligible livestock . (EUFMD, The European commission for the control of FMD,2007)
Key of success against FMD: -Continuous sero-monitoring -Biannual vaccination all susceptible and eligible
population -Culling of positive animals.
Current Vaccine
Need of new vaccine (Rodriguez and Gay,2001;Bhattacharya et al.,2005)
Conclusion Foot and Mouth Disease is an acute highly contagious vesicular disease that has significant economic impact on the INDIAN livestock industry. Efforts should be made to control the disease by means of effective and systematic vaccination programs, sero-surveillance and vigorous stamping out policy wherever possible. Vaccination against FMD should be strengthened in all susceptible population for generating “herd immunity”.Continuous sero-monitoring, biannual vaccination with existing serotype and culling of positive animals is the key to success against FMD. Third party monitoring of vaccine quality.Punishment to the agencies and persons involved in fraudulent/ substandard vaccine production, clearance, quality monitoring.Generation of facilities for maintenance of vaccine under cold chain.Rewards to veterinarians reporting FMD cases.