VACCINATION : PROGRAMMES & IMPLEMENTATION

Dr jj

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Introduction

Immunisation

Vaccine preventable diseases

Vaccination

Types of vaccination

Routes of administration

Levels of vaccines

History

CONTENTS

Vaccination history in India

Pulse polio vaccination

The cold chain

Hazards of Immunisation

Precaution

Vaccination coverge

Conclusion

References

VACCINATION PROGRAM

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AIM

To prevent or protect against serious disease.

To eliminate a particular disease from a defined population.

To eradicate a disease entirely e.g. smallpox

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However it is not possible to eradicate all vaccine-

preventable diseases:

Asymptomatic carriage

Mutating organisms e.g. influenza

Animal reservoirs e.g. SARS, avian influenza

Environmental reservoirs e.g. tetanus

Global travel/mass immigration

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VACCINE PREVENTABLE DISEASES(BACTERIAL)

Diptheria

Haemophilus influenzae B (Hib)

Meningococcal (meningitis)

Pneumococcal disease

Tetanus

Tuberculosis

Whooping cough (pertussis)

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VACCINE PREVENTABLE DISEASES (VIRAL)

Chickenpox

Flu

Measles

Mumps

Polio

Rubella

HPV

Immunity

Passive immunityActive immunity

Following clinical infection

Following subclinical infection

Following vaccination Following administration ofImmunoglobulin or antiserum

Transfer of maternal Antibodies Through milk

Transfer of maternal Antibodies Through placentanatural

acquired

Vaccination

Vaccination is a method of giving antigen to stimulate the

immune response through active immunization.

A vaccine is an immuno-biological substance designed to produce

specific protection against a given disease.

Types of vaccines

Live vaccines

Attenuated live vaccines

Inactivated (killed vaccines)

Toxoids

Polysaccharide and polypeptide (cellular fraction) vaccines

Surface antigen (recombinant) vaccines.

Live vaccines

Live vaccines are made from live infectious agents without

any amendment.

The only live vaccine is “Variola” small pox vaccine, made of

live vaccine cow-pox virus which is not pathogenic, giving

cross immunity for variola.

Live attenuated (avirulent) vaccines

Virulent pathogenic organisms are treated to become attenuated

and avirulent. They have lost their capacity to induce full-blown

disease but retain their immunogenicity.

Live attenuated vaccines should not be administered to persons with suppressed immune response due to:

Leukemia and lymphoma Other malignancies Receiving corticosteroids and anti-metabolic agents Radiation pregnancy

Inactivated (killed) vaccines

Organisms are killed or inactivated by heat or chemicals but

remain antigenic.

They are usually safe but less effective than live attenuated

vaccines.

The only absolute contraindication to their administration is a

severe local or general reaction to a previous dose.

ToxoidsThey are prepared by detoxifying the exotoxins of some

bacteria rendering them antigenic but not pathogenic.

Adjuvant (e.g. alum precipitation) is used to increase the

potency of vaccine.

The antibodies produces in the body as a consequence of

toxoid administration neutralize the toxic moiety produced

during infection rather than act upon the organism itself.

In general, toxoids are highly efficacious and safe

immunizing agents.

Polysaccharide and polypeptide (cellular fraction) vaccines

They are prepared from extracted cellular fractions e.g.

meningococcal vaccine from the polysaccharide antigen of

the cell wall, the pneumococcal vaccine from the

polysaccharide contained in the capsule of the organism, and

hepatitis B polypeptide vaccine.

Their efficacy and safety appear to be high.

Surface antigen (recombinant protien) vaccines

It is prepared by cloning HBsAg gene in yeast cells where it

is expressed. HBsAg produced is then used for vaccine

preparations.

Their efficacy and safety also appear to be high.

Types of vaccinesLivevaccines

LiveAttenuated vaccines

KilledInactivated vaccines

Toxoids Cellular fraction vaccines

Recombinant vaccines

•Small pox variola vaccine

• BCG• Typhoid

oral• Plague• Oral

polio• Yellow

fever• Measles• Mumps• Rubella• Intranasal• Influenza• Typhus

•Typhoid•Cholera•Pertussis•Plague•Rabies•Salk polio•Intra-muscular influenza•Japanise encephalitis

•Diphtheria•Tetanus

•Meningococcal polysaccharide vaccine

•Pneumococcal polysaccharide vaccine

•Hepatitis B polypeptide vaccine

•Hepatitis B vaccine

Routes of administration

Deep subcutaneous or intramuscular route (most vaccines)

Oral route (sabin vaccine, oral BCG vaccine)

Intradermal route (BCG vaccine)

Scarification (small pox vaccine)

Intranasal route (live attenuated influenza vaccine)

Levels of effectiveness

Absolutely protective(100%): yellow fever vaccine.

Almost absolutely protective (99%): Variola, measles,

mumps, rubella vaccines, and diphtheria and tetanus toxoids.

Highly protective (80-95%): polio, BCG, Hepatitis B, and

pertussis vaccines.

Moderately protective (40-60%) TAB, cholera vaccine, and

influenza killed vaccine.

HISTORY

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HISTORY OF VACCINATION

1796 -Jenner – cowpox1885 - Pasteur – cholera, diphtheria, chickenpox, rabies1911 - first typhoid vaccine1927 - first tetanus vaccine1931 - Calmette & Guerin – first crude BCG1936 - influenza Modern era of vaccination1940 - diphtheria national programme in UK1950’s - polio, pertussis, modern BCG1960’s - measles, mumps & rubella, modern tetanus1980’s - H. Influenzae B (Hib)2000’s - Meningitis C, Human papilloma virus (HPV)

The world's first immunization campaign: the Spanish Smallpox

Vaccine Expedition, 1803-1813.

The first vaccine-preventable disease targeted for eradication

was smallpox

The last naturally occurring case of smallpox occurred in

Somalia in 1977.

According to United Nations Children’s Fund12 (UNICEF)

vaccine preventable diseases (VPDs) cause an estimated 2 million

deaths or more every year, of which approximately 1.5 million

deaths occur amongchildren below five year age.

VACCINATION HISTORY IN INDIA

Ancient times till first documented smallpox vaccination in India in 1802

• The history of vaccines and vaccination starts with the first effort to prevent

disease in the society.

• Smallpox was well known since ancient times and believed to have originated in

India or Egypt, over 3,000 years ago.

• From India, there are a few descriptions of occurrence of disease; however, one

of the best recorded smallpox epidemics was reported from Goa in 1545 AD,

when an estimated 8,000 children died. Historians and physicians have

sometimes referred smallpox as ‘Indian Plague’, which suggests that the disease

might be widely prevalent in India in the earlier times.

VACCINATION IN INDIA (1802-1899)

• The first doses of smallpox vaccine lymph in India arrived in May

1802.

• Anna Dusthall, a three year old child from Mumbai became the

first person in India to receive smallpox vaccine on June 14, 1802.

• From Bombay, through human chain of vaccinees, the smallpox

vaccine as lymph was sent to Madras, Pune, Hyderabad and Surat.

• The Compulsory Vaccination Act was passed in India in 1892 to

ensure higher coverage with smallpox and reduce the epidemic.

VACCINE AVAILABILITY AND MANUFACTURING IN INDIA (1802-1899)

.

• In India, till 1850, the vaccine was imported from Great Britain.

• Another important event of this period was a cholera epidemic in

Bengal and other parts of India.

• Dr Haffkine developed plague vaccine in 1897 and it is arguably,

the first vaccine developed in India.

• This laboratory was called Plague Laboratory since 1899, renamed

as Bombay Bacteriological Lab in 1905 and then finally named as

Haffkine Institute in 1925.

VACCINATION IN INDIA (1900-1947)

The beginning of twentieth century witnessed a few socio-scientific-

geopolitical events, which had lasting effect on vaccination efforts in

the country. These changes were:

(i) Outbreak of cholera and plague in India (1896-1907) and the

services of already limited number of vaccinators were diverted to

epidemic control efforts,

(ii) The First World War (1914-1918) started and with coinciding

Influenza Pandemic (which reportedly killed around 17 million

Indians) became a priority for the Government.

(iii) New scientific understanding that two doses of smallpox

vaccine would be needed for long lasting protection. It was a

challenge considering that it meant convincing people to get

vaccinated twice with perceived inconvenient and painful

procedure.

Evaluated full immunization coverage by district in India.

.New Delhi: Government of India and UNICEF; 2010. United Nations International Children's Fund. Coverage evaluation survey: all India report 2011.

VACCINATION PROGRAMME AND VACCINES IN INDIA: YEARS AHEAD

• The science of vaccine evolved across the globe in late 19th

century and India was amongst a few countries to have been

involved in these efforts.

• The cholera and typhoid vaccine trials and research and discovery

of plague vaccine took place in the country. Vaccine institutes

were set up in early and whole of twentieth century.

The national vaccine policy of India has suggested that ‘a number

of linkages need to be explored between academia, industry and

international institutions such as National Institute of Health

(NIH), Gates Foundation, the GAVI Alliance, World Health

Organization and the International Centre for Genetic Engineering

and Biotechnology (ICGEB), etc.

• The immunisation programme in India was flagged off in 1978

as Expanded Programme on Immunisation (EPI).

• It gained impetus in 1985 as the Universal Immunisation

Programme (UIP) and was carried out in phased manner to

cover all districts in the country by 1989-90.

• Centrally sponsored programme.

• UIP became a part of the Child Survival and State Motherhood

(CSSM) Programme in 1992 and Reproductive and Child

Health (RCH) Programmein 1997.

• It is currently under National Rural health Mission - NRHM All

the vaccines are procured by central government with 100%

domestic funding.

Universal Immunisation program (UIP)

• The objective of UIP was to cover at least 85% of all infants

against the six vaccine-preventable diseases by 1990 and to

achieve self-sufficiency in vaccine production and the

manufacture of cold-chain equipment.

• The target now is to achieve 100% immunization coverage

although technically 85% coverage levels would ensure herd

immunity.

• Programme targeted ~ 26 million infants and 30 million

pregnant women in 2009-10.

Coverage States/UT

Low(<50%)

Uttar Pradesh, Meghalaya, Madhya Pradesh, Tripura, Arunachal Pradesh, Bihar, Manipur and Rajasthan

Medium(50-70%)

Mizoram, Assam, Jharkhand, Gujarat, Chhattisgarh, Haryana, Orissa, Jammu & Kashmir, Uttarakhand, Andhra Pradesh, Delhi and Maharashtra

High(>70%)

Tamil Nadu, Kerala, Karnataka, West Bengal, Sikkim, Punjab, Pondicherry, Himachal Pradesh, Lakshadweep, A & N Islands and Goa

Coverage state wise

Tamilnadu -91% (2014)

Universal Immunisation Program

• A second dose of DT vaccine should be given at an interval of

one month if there is no clear history or documented evidence

of previous immunization with DTPw.

** A second does of TT vaccine should be given at an interval of

one month if there is no clear history or documented evidence of

previous immunization with DTPw, DT or TT vaccines.

IAP Schedule

• If the mother is known to be HBsAg negative, HB vaccine can

be given along with DPT at 6, 10, 14 weeks/ 6 months. If the

mother's HBsAg status is not known, it is advisable to start

vaccination soon after birth to prevent perinatal transmission of

the disease.

• If the mother is HBsAg positive, the baby should be given

Hepatitis B Immune Globulin (HBIG) within 24 hours of birth,

along with HB vaccine.

• Combination vaccines can be used to decrease the number of

pricks being given to the baby and to decrease the number of

clinic visits.

• Under special circumstances (e.g. epidemics), measles vaccine

may be given earlier than 9 months followed by MMR at 12-15

months.

• We should continue to use OPV till we achieve polio

eradication in India. IPV can be used additionally for individual

protection.

Pulse Polio Immunization (PPI)

• India launched the Pulse Polio Immunization (PPI) program in

1995 as a result of World Health Organization's (WHO) Global

Polio Eradication Initiative.

• Under this programme, all children under 5 years are given 2

doses of Oral Polio Vaccine (OPV) in December and January

every year until polio is eradicated.

• It aims to reach the unreached children through improved social

mobilization and plan mop-up operations in areas where

poliovirus has almost disappeared.

The last reported cases of wild polio in India were in

West Bengal and Gujarat on 13 January 2011.

The Cold Chain

The "cold chain" is a system of storage and transport of

vaccines at low temperature from the manufacturer to the

actual vaccination site.

The cold chain system is necessary because vaccine failure

may occur due to failure to store and transport under strict

temperature controls.

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COLD CHAIN

System of transporting and

storing vaccines within the

recommended temperature

range of 2 – 80C

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WHY IS THE COLD CHAIN IMPORTANT?

Effectiveness of vaccines cannot be guaranteed if

exposed to temperature extremes.

Provides assurance/ confidence in potency of the

product.

Ensures patient obtains maximum benefit from

immunisation.

The Cold Chain Equipment Cold chain equipment consists of the following:

(a) Walk in cold rooms: They are located at regional level,

meant to store vaccines up to 3 months and serve districts.

(b) Deep freezers (300 ltr) and Ice lined Refrigerators: supplied

to all districts to store vaccines. Deep freezers are used for

making ice packs and to store OPV and measles vaccines.

(c) Small deep freezers (140 ltr) : One set is provided to PHCs,

and Family Planning Centers.

(d) Cold boxes: Cold boxes are supplied to all peripheral

centers. These are used mainly for transportation of the

vaccines.

(e) Vaccine carriers: Vaccine carriers are used to carry small

quantities of vaccines (16-20 vials) for the out of reach sessions.

4 fully frozen ice packs are used for lining the sides, and vials of

DPT, DT, TT and diluents should not be placed in direct contact

with frozen ice packs. The carriers should be closed tightly.

(f) Ice packs: The ice packs contain water and no salt should be

added to it.

Among the vaccines, polio is the most sensitive to heat,

requiring storage at minus 20 degree C.

Vaccines which must be stored in the freezer compartment are

: polio and measles.

Vaccines which must be stored in the COLD PART but never

allowed to freeze are : typhoid, DPT, tetanus toxoid, DT, BCG

and diluents.

HAZARDS OF IMMUNIZATION• No immune response is entirely free from the risk of adverse

reactions or remote squeal. The adverse reactions that may

occur may be grouped under the following heads:

1. Reactions inherent to inoculation

2. Reactions due to faulty techniques

3. Reactions due to hypersensitivity

4. Neurological involvement

5. Provocative reactions

6. Others

1. Reactions inherent to inoculation:

These may be local general reactions. The local reactions may

be pain, swelling, redness, tenderness and development of a

small nodule or sterile abscess at the site of injection.

The general reactions may be fever, malaise, headache and

other constitutional symptoms. Most killed bacterial vaccines

(e.g., typhoid) cause some local and general reactions.

Diphtheria and tetanus toxoids and live polio vaccine cause

little reaction.

2. Reactions due to faulty techniques:

Faulty techniques may relate to

faulty production of vaccine (e.g. inadequate inactivation of the microbe,

inadequate detoxication),

too much vaccine given in one dose,

improper immunization site or route,

contraindications ignored (e.g. a child who experienced a severe reaction

after a previous dose of DPT vaccine is immunized with he same

vaccine),

reconstituted vaccine of one session of immunization used again at the

subsequent session.

3. Reactions due to hypersensitivity:

Administration of antiserum (e.g., ATS) may occasionally

give rise to anaphylactic shock and serum sickness. Many

viral vaccines contain traces of various antibiotics used in

their preparation and some individuals may be sensitive to the

antibiotic which it contains.

Anaphylactic shock is a rare but dangerous complication of

injection of antiserum. There is bronchospasm, dyspnoea,

pallor, hypotension and collapse.

4. Neurological involvement:

Neuritic manifestations may be seen after the administration

of serum or vaccine. The well-known examples are the post

vaccinial encephalitis and encephalopathy following

administration of anti -rabies and smallpox vaccines.

Guillain Barre syndrome in association with the swine

influenza vaccine is another example.

5. Provocative reactions:

Occasionally following immunization there may occur a

disease totally unconnected with the immunizing agent (e.g.,

provocative polio after DPT or DT administration against

diphtheria).

The mechanism seems to be that the individual is harboring

the infectious agent and the administration of the vaccine

shortens the incubation period and produces the disease or

what may have been otherwise only a latent infection is

converted into a clinical attack.

6. Others:

These may comprise damage to the fetus (e.g., with rubella

vaccination); displacement in the age-distribution of a disease

(e.g., a potential problem in mass vaccination against measles,

rubella and mumps).

Precautions

The risk of adverse reactions can be reduced by proper

sterilization of syringes and needles, by proper selection of the

subject and the product, and if due care is exercised in carrying out

the procedure.

Measles and BCG vaccines should be reconstituted only with the

diluent supplied by the manufacturer.

Reconstituted vaccine should be discarded at the end of each

immunization session and NEVER retained for use in

subsequent sessions. In the refrigerator of the immunization

centre, no other drug and substances should be stored beside

vaccines.

Training of immunization worker and their close supervision

to ensure that proper procedures are being followed are

essential to prevent complications and deaths following

immunization.

Vaccination Coverage

Vaccination coverage is the percent of at risk or susceptible

individuals, or population who have been fully immunized

against particular diseases by vaccines or toxoids.

To be significantly effective in prevention of disease on mass

or community level at least a satisfactory proportion (75% or

more) of the at risk population must be immunized.

A caries vaccine  is a vaccine to prevent and protect

against tooth decay.

Development of a vaccine for tooth decay has been under

investigation for more than 50 years. In 1972, a caries

vaccine was said to be in animal testing in England, and

that it would have begun human testing soon.

Intrinsic difficulties in developing it, coupled with lack of

strong economic interests are the reasons why no such

vaccine is commercially available as of now.

DENTAL CARIES VACCINE

The International Association for Dental Research and

American Association for Dental Research announced a study

performed by the Chinese Academy of Sciences which looked

at using an inhaled vaccine that uses a protein filament as a

delivery vehicle.

Trials performed in rats showed an increase in antibody

response along with a decrease in the amount of Streptococcus

mutans adhering to teeth, leading to significantly fewer

cavities observed among the test population.

Ways of achieving satisfactory immunization coverageEfficient immunization service; urban and rural.

Health awareness and cooperation of the public.

Periodic mass immunization campaigns, to cover those who missed regular immunizations.

Outreach programs in rural and nomad areas, and home visits.

Vaccination for special occupationsHealth care workers: hepatitis B, influenza, MMR, polio

Public safety personnel (police, fire fighters) and staff of

institutions for the developmentally disabled: hepatitis B,

influenza

Vets and animal handlers: rabies, plague and anthrax

Sewage workers: DT, hepatitis A, polio, TAB

Food handlers: TAB

Military troops and camp dwellers: pneumococcal,

meningococcal, influenza, BCG (for non reactors), tetanus.

Vaccination for Preterm babies

No withholding of vaccines.

All vaccine to be given as per Chronological age unless birth

weight is less than 2 kgs.

Vaccination in specific infectionsHIV

live vaccines to be avoided and killed vaccines in double strength

doses

Diseases with no or poor spleen

Pnemococcal, Meningiococcal & Influenza vaccines (capslated

organisms)

Progressive Neurological disorder

DPT should not be given

Vaccination for special life styles and special environmental situations

Homosexually active males, Heterosexual with promiscus

sexual partner specially who has STDs, and Injecting drug

users.

Inmates of long term correctional institutes, residents of

institutions for the developmentally disabled, and household

contacts of HBV carriers or patients.

All should receive hepatitis B vaccine

Vaccinations for special health status personsImmuno-compromised persons ( Leukemia, lymphoma, HIV,

malignancy)

Hemodialysis and transplantation

Should receive the following vaccines according to their situation:

HBV, Influenza, Pneuomococcal vaccines

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TRAVEL VACCINES

Vaccinations in travelVaries according to the country of arrival and departure.

Specific vaccine according to the country traveled to:

Haj for instance necessates meningococcal vaccination

from all over,

cholera from places like India.

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TRAVEL VACCINATION

Increased risk of transmission of infectious disease due

to dramatic in global travel.

Study revealed 67% of travellers to high/medium risk

areas had not taken medical advice.

Need consultation at least 1 month before travel.

Are two compulsory vaccinations – yellow fever/

meningitis.

Vaccines against bioterrorism

Anthrax

Small pox

Plague

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BARRIERS TO IMMUNISATION UPTAKE

Poor information/ misconceptions/ myths

Conflicting advice: family, media etc

Inconvenience: time, transport, lack of flexibility in

system

Vaccine supply issues

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POOR INFORMATION/ MISCONCEPTIONS/ MYTHS

Misconceptions have always been around e.g

Vaccines can give you the infection e.g flu

Multicomponent vaccines overload the immune system

Giving vaccines singly is safer

Risk from vaccine is worse than the infection – no-one

dies these days from measles!

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VACCINE SUPPLY ISSUES

Can affect uptake of immunisation

Clinics cancelled – patients forget to return for next dose

Increased number of injections having to be given puts

people off!

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VACCINE PRODUCTION

Two main stages

Biological - antigen preparation

Pharmaceutical - ready to use product

Production cycles are long

Tetanus vaccine - 9-10 months

Diphtheria vaccine - 11 months

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RISKS ASSOCIATED WITH INCORRECT VACCINE STORAGE

Risk to patient

Risk of acquiring infection due to ineffective

vaccination

Risks associated with possible re-vaccination

Risk to Healthcare professionals

Loss of confidence in service

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IMMUNISATION ADMINISTRATION ERRORS

e.g. Administration of the wrong vaccine

Administration of extra/ unnecessary

vaccines.

Administration of out of date vaccines

All should be reported using medication incident

reporting systems

Reports should be reviewed and analysed

The evolution of vaccination efforts in India is far more complex

than presented here and every single event merits a detailed

analysis.

Though preventive efforts from diseases were practiced in India,

the reluctance, opposition and slow acceptance of vaccination

have been the characteristic of vaccination history. The

operational challenges keep the coverage inequitable in the

country. The lessons from the past events have been analysed

and interpreted to guide immunization efforts.

CONCLUSION

• REFERENCES

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Unicef, World Bank. State of the world's vaccines and immunization.

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Organization. Global immunization data 2011. Available from:

www.who.int/hpvcentre/Global_Immunization_Data.pdf .

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Organization; 1988. Smallpox and its eradication; pp. 369–71.

• 4. New Delhi: Government of India and UNICEF; 2010. United Nations

International Children's Fund. Coverage evaluation survey: all India report 2009.

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Organization, South-East Asia Regional Office; 1979. The

eradication of smallpox from India.

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Longman; 2006. Fractured states: Smallpox, public health and

vaccination policy in British India, 1800-1947.

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smallpox: Edward Jenner and the first and only eradication of a

human infectious disease.

•Janes Kuby, 2007, Vaccines, Immunology, W.H. Freeman and Company, Newyork, sixth Edition, Pg. 413- 428.

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THANK YOU