How and why to control FMD? Why are we failing?

Abstract

Foot and Mouth Disease (FMD) is a devastating disease in many of the developing countries including India despite control programs. The FMD in India is associated with loss of about Rs. 20000 crores per annually. Government of India and different provincial governments are spending hundreds of crore rupees per year to control the disease. The FMD control programme (FMD-CP) is running in India since more than 13 years but control of the FMD is still far away dream and the Disease is regularly visiting even the government farms managed by the India’s leading Veterinary and Dairy Institutes. The pros and cons of FMD-CP has been discussed in the presentation.

Full text

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 Control
Strength and Weaknesses of FMD Control
Programe Going on in India: Means and Ways
Programe Going on in India: Means and Ways
for Success
for Success

Notifiable disease-World Organization for Animal Health (OIE)
(Kumar et al.,2011)
 First animal virus by Friedrich Loeffler and Frosch in 1897-1898
Foot and Mouth Disease (FMD)

Family: Picornaviridae
Genus: Apthovirus
(Verma et al.,2012)
 Endemic in India.
(OIE,2009)
Infects cloven footed animals.
(Order: Artiodactyla)

Serological Types of FMD Virus
Based on Capsid Coating Proteins
(Pereira,1977)
Serotype C is uncommon
and has not been reported
since 1995. (Singh et
al., 2007; Verma, 2008)

Sign and Symptoms of FMD
 Erosion of tongue epithelium.
Swollen tongue similar to the
allergic diseases.
(Deb et al., 2012).
Lesions in inter-digital space.
Anorexia and fever (up to 41°C)
 Mayocarditis in young one (tiger heart).
Mastitis, panters, abortion.
(Sobrino and Dormingo,2001;Deb et al.,2012)

Diagnosis
Clinical signs of FMD: Excessive salivation (except in pigs and sheep)
Before 1997, FMDV was identified by complement fixation test
(CFT)
(Ferris et al., 1984).
ELISA, AGID and VNT.
RT-PCR
For isolation BHK-21
(Whiteside et al., 1983)

Treatment
Symptomatic treatment.
Potassium permanganate mixed antiseptic mouth wash.
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 India
Manufacturer 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®
Clovax
Intervet 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 10
th
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
covered
80-85 M animal
covered

FMD-CP
Rs. 400 crores of fund up till now.
640 districts expansion in 12
th
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-CP
Andhra 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 system
FMDV : Antigenic variability and genetic
diversity
Variable 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 information
The vaccine of Foot & Mouth Disease (FMD) found substandard at
CCSNIAH Baghpat, India, in November 2014
(https://www.researchgate.net/publication/267705649_Testing_of_FMD_Vac
cine_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 Vaccine
Foot 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,201
1;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)
WEAKNESSE
S OF FMD
CONTOL
PROGRAMME
DISEASE
REPORTIN
G SYSTEM
EXTENSION
ACTIVITY
VACCINE
AVAILABILI
TY
VACCINATI
ON
COVERAGE
ANIMAL
MOVEMENT
COLD CHAIN
MAINTAINANCE
(R.Venkataramanan,201
4)

Means and Ways for Success of FMD Control
Programme
Good infrastructure
Trained Manpower

Well equipped laboratories
Testing of vaccine for quality at multiple places
(monopoly must be removed)
 Good governance
Rapid and accurate diagnosis
Continuous 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
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/
burial
Rodent 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.

Save
cows
from
Foot
and
Mouth
Disease
Save
cows
from
Foot
and
Mouth
Disease