Newer vaccine new ppt

yes its updated one with Rota and PCV and Measles Rubella vaccination compaign, excluded IPV . comments and suggestion are welcome.

1. Newer vaccines/ MR Compaign Presenter: Dr. Walied K Balwan Moderator : Dr Rohul Jabeen Shah

2. 1 . INTRODUCTION i . HISTORY. ii. CONCEPT OF VACCINE . 2. NEED AND NECCESITY OF VACCINE. 3. NEWER VACCINE. i . RECENTALY DEVELOPED VACCINE ii. DEVELOPING VACCINE iii. FUTURE VACCINE 4. MR vaccination compaign 2017 5. New techniques for delivering vaccine

3. “A vaccine is a biological preparation that improves immunity to a particular disease.” • A vaccine typically contains an agent that resembles a disease-causing microorganism, and is often made from weakened or killed forms of the microbe. • The agent stimulates the body's immune system to recognize the agent as foreign, destroy it, and "remember " it, so that the immune system can more easily recognize and destroy any of these microorganisms if later encounters.

4. History 18th century 1796 First Vaccine for Smallpox ( the first vaccine ever developed ) 19th century • 1879 First vaccine for cholera • 1885 First vaccine for rabies by Louis Pasteur • 1890 First vaccine for tetanus • 1896 First vaccine for typhoid fever • 1897 First vaccine for bubonic plague 1796 First Vaccine for Smallpox ( the first vaccine ever developed )

5. 20th century • 1921 First vaccine for diphtheria • 1921 First vaccine for Tuberclousis • 1926 First vaccine for pertussis (whooping cough) • 1932 First vaccine for yellow fever • 1937 First vaccine for typhus • 1945 First vaccine for influenza • 1952 First vaccine for polio by Jonas Salk • 1954 First vaccine for Japanese encephalitis • 1954 First vaccine for anthrax • 1957 First vaccine for adenovirus-4 and 7 • 1962 First oral polio vaccine • 1963 First vaccine for measles

6. • 1967 First vaccine for mumps • 1970 First vaccine for rubella • 1974 First vaccine for chicken pox • 1977 First vaccine for pneumonia ( Streptococcus pneumoniae ) • 1978 First vaccine for meningitis ( Neisseria meningitides ) • 1981 First vaccine for hepatitis B (first vaccine to target a cause of cancer.) • 1985 First vaccine for Haemophilus influenzae type b ( HiB ) • 1992 First vaccine for hepatitis A • 1998 First vaccine for Lyme disease • 1998 First vaccine for rotavirus

7. 21st century • 2003 First nasal vaccine for influenza approved in US • 2006 1ST vaccine for Human Papillomavirus .

8. Term VACCINE AND TYPE The term vaccine derives from Edward Jenner's 1796 use of cow pox (Latin variola vaccinia , adapted from the Latin vaccīn , from vacca , cow), to inoculate humans, providing them protection against smallpox. Types Vaccines are dead or inactivated organisms or purified products derived from them. There are several types of vaccines in use. These represent different strategies used to try to reduce risk of illness, while retaining the ability to induce a beneficial immune response. So different type of vaccines are:

9. Killed – Some vaccines contain killed, but previously virulent, microorganisms that have been destroyed with chemicals, heat, radioactivity or antibiotics. Attenuated— Some vaccines contain live attenuated microorganism. Many of these are live viruses that have been cultivated under conditions that disable their virulent properties, or which use closely related but less dangerous organisms to produce a broad immune response. They typically provoke more durable immunological responses and are the preferred type for healthy adults. But they may get reverted to the virulent form and cause the disease.

10. Subunit :- Rather than introducing an inactivated or attenuated microorganism to an immune system (which would constitute a "whole-agent" vaccine), a fragment of it can create an immune response. Examples include the subunit vaccine against Hepatitis B Virus that is composed of only the surface proteins of the virus. Previously it extracted from the blood serum of chronically infected patients, but now produced by recombination of the viral genes into Yeast, Other examples are Human Papillomavirus (HPV) that is composed of the viral major Capsid protein,

11. Toxoid- Toxoid vaccines are made from inactivated toxic compounds that cause illness rather than the microorganism. Examples of toxoid -based vaccines include tetanus and diphtheria. Toxoid vaccines are known for their efficacy. Conjugate – Certain bacteria have polysaccharide outer coats that are poorly immunogenic. By linking these outer coats to proteins (e.g. toxins), the immune system can be led to recognize the polysaccharide as if it were a protein antigen. This approach is used in the Haemophilus influenzae type B vaccine

12. Recombinant DNA Vaccine • In recombinant DNA Vaccine, immunogenic part of antigen produced by recombinant DNA and that immunogenic part injected in body. • Like in Hep -B vaccine , H.P.V. vaccine 1. Gene taken for Surface protein, of hep -b + yeast cell genome. 2. kept in culture media (work as a production unit) 3.Produce surface protein 4. purified surface protein use as vaccine

13. Valence :- Vaccines may be monovalent (also called univalent) or multivalent (also called polyvalent). A monovalent vaccine is designed to immunize against a single antigen or single microorganism. A multivalent or polyvalent vaccine is designed to immunize against two or more strains of the same microorganism, or against two or more microorganisms. In certain cases a monovalent vaccine may be preferable for rapidly developing a strong immune response.

14. Examples of Vaccines Live attenuated – measles, mumps, rubella, oral polio, BCG, yellow fever, varicella Inactivated – influenza, rabies, anthrax, IPV, pertussis Inactivated toxins – tetanus, diphtheria Subcellular fraction – pneumococcal, Hib Genetically engineered – Hepatitis B

15. The efficacy of these vaccine. • the disease itself (for some diseases vaccination performs better than for other diseases) • the strain of vaccine (some vaccinations are for different strains of the disease) • whether one kept to the timetable for the vaccinations • some individuals are "non-responders" to certain vaccines, meaning that they do not generate antibodies even after being vaccinated correctly • other factors such as ethnicity, age, or genetic predisposition.

16. NEED AND NECCESITY OF VACCINE Always said “prevention is better then cure”  Vaccines are the important tool in preventive medicine as well as in public health.  vaccines are the one of the important tool to control the emergence of disease ,stop that to make public health problem.e.g . swine flu pandemic  Vaccines is work at very grass root level and compare to treatment it become cost effective then other measures e.g. Small Pox , Polio , Measles are good examples

17. NEWER VACCINE 1. RECENTALY DEVELOPED VACCINE 2. DEVELOPING VACCINE 3. FUTURE OF VACCINES

18. Some Recently Developed Vaccine SINGLE ANTIGEN VACCINE 1. pneumococcal conjugate vaccine 2002 2. 1st live attenueted influenza vaccine 2003 3. 1st killed Influenza vaccine 2004 4. new meningococcal vaccine 2005 5. Rotateq (Rota vaccine) 2006 6. HPV vaccine ( Gardasil )2006 7. Varivax (for chicken pox)2007 8. Flumist nasal vaccine of 1st live attenueted influenza vaccine 9. Rotarix ( rota virus vaccine) 2008 10. Influenza-A (H1N1) 2009

19. Panenza / Humenza (H1N1) Both vaccines are for influenza A H1N1 virus but basic difference is panenza is non-adjuvant and humenza is adjuvant vaccine, so humenza need less strenght of vaccine. • STORAGE:- Store in a refrigerator between +2°C and +8°C. • DISCARD opened vials within 7 days (opened vials can be used for a maximum of 7 days) if kept between +2°C and +8°C

20. Schedule and Dose

21. SWINE FLU VACCINE Recommended influenza vaccine formulation for 2017 the trivalent IIV 2017 A/Michigan/45/2015 (H1N1)pdm09-like virus A/Hong Kong/4801/2014 (H3N2)-like virus and B/Brisbane/60/2008-like virus. The IIV is available in both the public sector (at designated clinics and hospitals) and the private sector (at pharmacies, certain healthcare facilities, etc.)

22. Dosage of influenza vaccine – Adults 0.5ml IMI single dose 3 years - 8 years – 0.5ml IMI 1 or 2 doses 6 months-2 years-0.25ml IMI 1 or 2 doses 2 doses should be administered ≥ 1 month apart during 1st year of vaccination, thereafter one dose

23. Groups that are prioritized for the targeted public funded influenza vaccination campaign in 2017: Pregnant women at all stages of pregnancy, including the postpartum period HIV-infected individuals Individuals (adults or children ≥ 6 months) who are at high risk for influenza and its complications because of underlying medical conditions who are receiving regular medical care for conditions such as chronic pulmonary (including tuberculosis) and cardiac diseases, chronic renal diseases, diabetes mellitus and similar metabolic disorders, individuals who are immunosuppressed . Persons aged >65 years

24. Recently added in NIS Presently ROTAVIRUS vaccine its intriduced in four states Andhra Pradesh, Haryana, Himachal Pradesh and Odisha PCV has recently been added in UIP in Five states Himachal pradesh,Bihar , Uttar pradesh , Rajasthan and madhya pradesh

25. Pneumococcal Vaccine

26. 2. In adults 50 years of age and Older Active immunization for invasive disease caused By streptococcus pneumoniae serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F. Adults 50 years and older: a single dose.

27. Rota virus Rota shield :- in 1998, a rotavirus vaccine (rot shield, by Wyeth) was licensed for use in the united states, but withdrawal from market due toincreased incidence of intussusception,in 1999-2000.

28. Currently Licensed Rotavirus Vaccines There are three Rotavirus Vaccines available in market; Rotavac ® (ORV116E), a monovalent vaccine containing suspension of live rotavirus 116E (G9P[11])prepared in Vero cells manufactured by Bharat Biotech. It is derived from a neonatal strain isolated in India and given in 3 doses at ages 6 weeks, 10 weeks and 14 weeks. Rotarix ® (RV1), a monovalent Rotavirus Vaccine (contains the RIX4414 rotavirus strain; G1P[8]) manufactured by GlaxoSmithKline Biologicals . It is given in 2 doses at ages 2 months and 4 months. RotaTeq ® (RV5), a live Attenuated Pentavalent human bovine reassortant Rotavirus Vaccine (containing G1, G2, G3, G4, or P1A[8]) manufactured by Merck and Co. It is given in 3 doses at 2, 4 and 6 months of age.

29. The US Federal Drug Administration licensed Merck’s RotaTeq ® in February of 2006 and GSK’s Rotarix ® in April of 2008. The European Commission and the European Medicines Agency (EMA) licensed GSK’s Rotarix ® in February 2006 and Merck’s RotaTeq ® in June 2006. The WHO prequalified Rotarix ® in January 2007 and RotaTeq ® in October 2008. Following a multisite clinical trial, Rotavac ® was licensed in India by Drug Controller General (India) in 2013 and 2015.

30. Menactra (N. Meningitidis ) INDICATIONS AND USAGE :- Menactra vaccine is indicated for active immunization to prevent invasive meningococcal disease caused by N meningitidis serogroups A, C, Y and W-135. Menactra is approved for use in individuals 9 months through 55 years of age. Menactra vaccine does not prevent N meningitidis serogroup B disease. DOSAGE AND ADMINISTRATION A 0.5 mL dose for intramuscular injection• Children 9 through 23 months of age: Two doses, three months apart. Individuals 2 through 55 years of age: A single dose. CONTRAINDICATIONS Severe allergic reaction ( eg , anaphylaxis) after a previous dose of a meningococcal capsular polysaccharide-, diphtheria toxoid - or CRM197-containing vaccine, or to any component of Menactra vaccine.

31. 34 Vaccine GARDASIL ® HPV Quadrivalent vaccine (2006) Types 6,11,16,18 CERVARIX,Bivalent vaccine (2009) Types 16,18 Indications Girls & women 9-26 years boys & men 9-26 years Females 9 – 25 years of age Dose &route 0.5ml IM. 0.5ml IM. Schedule 0, 2 & 6 months 0, 1 & 6 months Side effects Syncope, Headache, Fever, Nausea, dizziness, Injection site pain, erythema, pain, pruritus, swelling ≥20% of patients – pain, redness & swelling at injection site, fatigue, headache, GI symptoms, arthralgia, myalgia Contra-indications Severe allergic reactions to previous dose, severe acute illness, pregnant females Same Protection 70% against cervical cancers 70% against cervical cancers

32. Varivax ( against Varicella ) INDICATIONS AND USAGE :- VARIVAX is indicated for vaccination against Varicella in individuals 12 months of age and older. The duration of protection of VARIVAX is unknown; however, long-term efficacy studies have demonstrated continued protection up to 10 years after vaccination. DOSAGE AND ADMINISTRATION: (FOR SUBCUTANEOUS ADMINISTRATION ) • Children :- 12 months to 12 years of age should receive a 0.5-mL dose administered subcutaneously. If a second 0.5-mL dose is administered, it should be given a minimum of 3 months later. Adolescents and Adults :-Adolescents and adults 13 years of age and older should receive a 0.5-mL dose administered S.C. at elected date and a second 0.5-mL dose 4 to 8 weeks later. CONTRAINDICATION :- Individuals with leukemia, lymphomas of any type, or other malignant neoplasm affecting the bone marrow or lymphatic systems.

33. Developing Vaccine 1. HIV Vaccine : In 1984, after the confirmation of the etiological agent of AIDS by scientists at the U.S. National Institutes of Health and the Pasteur Institute, the United States Health and Human Services Secretary Margaret Heckler declared that a vaccine would be available within two years. But still it is a dream.

34. The ineffectiveness of previously developed vaccines primarily stems from two related factors. • First, HIV is highly mutable. Because of the virus' ability to rapidly respond to selective pressures imposed by the immune system, • Second, HIV isolates are themselves highly variable. HIV can be categorized into multiple clades and subtypes with a high degree of genetic divergence. Therefore, the immune responses raised by any vaccine need to be broad enough to account for this variability. Any vaccine that lacks this breadth is unlikely to be effective

35. AIDSVAX experimental HIV vaccine( San Francisco) synthetic version of a protein gp120. stimulates the production of neutralizing antibodies, proteins that block HIV from infecting cells. The ALVAC-HIV vaccine - an attenuated (weakened) canarypox virus that has been genetically altered and when injected it stimulates the body’s production of CTLs against HIV

36. Classification of all theoretically possibleHIV vaccines • Any theoretically possible HIV vaccines must inhibit or stop the HIV virion replication cycle. So, the targets of the vaccine are the following phases of the HIV virion cycle: • Phase I. Free state • Phase II. Attachment • Phase III. Penetration • Phase IV. Uncoating • Phase V. Replication • Phase VI. Assembling • Phase VII. Releasing

37. Future work • First, greater translation between animal models and human trials must be established. • Second, new, more effective, and more easily produced vectors must be identified. • Finally, and most importantly, there must arise a robust understanding of the immune response to potential vaccine candidates. • A vaccine, SAV001, that has had success in animal subjects began Phase 1 human trials in London, Ontario in 2011.

38. 43 IF THE VACCINE TARGETS.. ITS GOAL IS TO.. Pre- erythrocytic stage Prevent infection Blood stage Reduce clinical disease Sexual stage or transmission blocking (altruistic) Prevent the spread of parasites by mosquitoes MALARIA VACCINE – C oncept of stage targeting

39. Malaria vaccine community goal • Strategic Goal : To develop an 80% efficacious malaria vaccine by 2025 that would provide protection for at least four years • Landmark goal: To develop and license a first-generation malaria vaccine that has protective efficacy of more than 50% against severe disease and death and lasts longer than one year Malaria Vaccine Technology Roadmap P. vivax and Pf / Pv transmission-blocking vaccines

40. RTS,S/AS01 (commercial name: Mosquirix ) • which started Pivotal Phase III evaluation in May 2009. • It is designed not for travellers but for children resident in malaria-endemic areas who suffer the burden of disease and death related to malaria. • The RTS,S vaccine was engineered using genes from the outer protein of Plasmodium falciparum malaria parasite and a portion of a hepatitis B virus plus a chemical adjuvant to boost the immune system response.

41. Reconstituted 0.5mL vaccine Administered by intramuscular injection into, Antero-lateral thigh in 6-12 weeks age group, and Left deltoid in 5-17 months age group

42. RTS,S/AS01 – VACCINE EFFICACY 5-17 month old children – 4 doses (0,1,2,20m) 39% against clinical malaria 31.5% against severe malaria 6-14 weeks infants – 4 doses (6,10,14w & 18m) 27% against clinical malaria with 4 th dose 18% against clinical malaria WITHOUT 4 th dose Efficacy difference in 6-14 weeks infants, Lower immune responses Co-administration with DTP-containing vaccines Maternal acquired antibodies Immunological immaturity

43. Vaccine for DENGUE

44. DENGVAXIA (CYD-TDV) 49 By Sanofi Pasteur – first licensed in December, 2015, in Mexico Registered for use in individuals 9-45 years of age living in endemic areas CYD-TDV – live recombinant tetravalent vaccine 3-dose vaccine given on a 0/6/12 month schedule

45. Leprosy vaccine A vaccine containing ICRC bacilli (which are cultivable leprosy derived mycobacteria probably belonging to M. Avium intracellulare complex) was prepared in 1979 at the Cancer Research Institute, Mumbai. Studies, both on humans and animals, show that the ICRC bacilli exhibit antigenic cross-reactivity with M. leprae with reference to both B and T cell antigens

46. Future Vaccine Cancer Vaccines Nicotine Vaccine Diabetes Vaccine

47. Cancer Vaccine Biological response modifiers. Two types – Preventive (or prophylactic) Treatment (therapeutic vaccines) preventive cancer vaccines are Gardasil and Cervarix , HPV - types 16 and 18 Treatment vaccines by strengthening the body’s natural defenses against the cancer. This vaccine, sipuleucel -T (men with metastatic prostate cancer)

48. LIFESTYLE VACCINES NicVAX (Nicotine Conjugate Vaccine) NicVAX -nicotine molecules with protein (induce an immune response ) Diamyd , a vaccine to prevent diabetes, It is intended for the treatment of children and adolescents with recent-onset type 1 diabetes. undergoing Phase III clinical trials in Europe

49. Vaccine for Infectious diseases T-cell receptor peptide vaccines are under development for several diseases using models of Valley Fever , stomatitis , and atopic dermatitis . These peptides have been shown to modulate cytokine production and improve cell mediated immunity.

50. Newer Technologies Of Vaccine Delivery Mono dose Prefilled Syringes Jet Injectors Micro needles Intra dermal Needles Intranasal Delivery Trans cutaneous Immunization Edible vaccines

51. INTRANASAL DELIVARY

52. TRANSCUTANEOUS IMMUNISATION

53. MICRONEEDLE TECHNIQUE

54. INTRADERMAL ROUTE OF VACCINE DELIVARY

55. JET INJECTION DEVICE

56. EDIBLE VACCINES BANANA , POTATO, TOMATO Used in tropical countries as weaning foods

57. Cold chain

58. Measles Rubella Vaccination Campaign-2017

59. Why MR compaign

60. Measles mortality: complications Corneal scarring causing blindness Vitamin A deficiency Encephalitis Older children, adults ≈ 0.1% of cases Chronic disability Pneumonia & diarrhea Diarrhea common in developing countries Pneumonia ~ 5-10% of cases, usually bacterial

61. Complications Rubella lymphadenopathy Arthritis Children: rare Adult female up to 70% Thrombocytopenic purpura 1/3000 cases Encephalitis 1/6,000 cases CRS is the most potential complication 90% chance if infected during 1st trimester of pregnancy) Congenital Rubella Syndrome (CRS) Hearing Impairment Cataracts / Glaucoma Heart defects ( PDA ) Microcephaly Developmental Delay Mental retardation Hematological disorder Liver and spleen damage

62. Congenital Rubella Syndrome Infection early in pregnancy most dangerous (<12 weeks gestation) Weeks 1- 10 – 90% CRS* Weeks 11-12– 33% Weeks 13-14– 11% Weeks 15-16– 24% Weeks > 17– 0% May lead to fetal death or premature delivery Organ specificity generally related to stage of gestational infection *Miller E. Lancet 1982;2:781-4.

63. Measles and Rubella Targets Global targets by 2015: Measles vaccination coverage ≥ 90% national and ≥ 80% district Measles reported incidence <5 cases per million Measles mortality reduction of 95% vs. 2000 Regional targets: Measles Elimination goals: 2000 AMRO 2012 WPRO 2015 EURO, EMRO 2020 AFRO, SEARO Rubella Elimination goals: 2010 – AMRO, 2015 – EURO

64. Measles and Rubella Elimination Goals by WHO Region, 2015 2015 2015 2012 Americas, Europe, E. Mediterranean, W. Pacific, Africa, South East Asia have measles elimination goals Americas and Europe have rubella elimination goals as well 2020 2000 2010 2020 India had set a goal to Eliminate Measles and control Rubella & Congenital Rubella Syndrome by the year 2020 .

65. Measles Elimination Status

66. Rubella Elimination Status

67. The major stake holders for planning & implementation of MR Campaign at the District level District Health & Family Welfare Education Department ( Govt , Aided, Private, Montessori, Madrasa etc) Department of Women and Child Development PRI Corporations Railways & Defence Medical & Nursing Colleges Professional organizations- IAP, IMA, Fogsi , Private hospitals association Social Welfare Department WHO, Unicef Loins, Rotary & other NGO’s Parents / Community

68. Achieving the Goal, (key strategic objectives) At least 95% population immunity with 2 doses against measles and rubella through routine and/or supplementary immunization. Develop case-based measles and rubella and CRS surveillance system that fulfils recommended surveillance performance indicators. Develop accredited measles and rubella laboratory network Strengthen support and linkages to achieve the above three strategic objective

69. Rationale for MR compaign Country Population Immunity is insufficient to stop ongoing MR transmission as evident form MR surveillance data MR outbreaks wide spread across the entire country Population immunity is waning. Five state/UT are providing RCV in the form of MR vaccine including some urban municipalities, including Indian Army Rubella vaccine introduction requires high level of population immunity to prevent the paradoxical effect as a risk mitigation strategy NTAGI has recommended wide age range MR vaccination campaign targeting 9 months-<15 years before introducing RCV in routine immunization in all the states of India

70. Phase MR campaign Year No. of States No. of Districts Estimated Target Population (9 m - < 15 years) Phase 1-A 2017 5 69 35,783,000 Phase 1-B 2017 7 95 30,632,000 Phase 2 2017 16 209 110,702,000 Phase 3 2018 6 202 123,101,000 Phase 4 2018 2 108 108,582,000 Total 2017 – 2018 36 683 408,800,000 Source: Projected Target population (9 months to 15 years) based of 2011 census data, GoI Statistical Division Proposed Measles-Rubella Vaccine Introduction Plan, (2017-2018) Karnataka, Tamil Nadu, Puducherry , Goa and Lakshadweep

71. MR vaccination campaign scheduled from 7th to 28th February 2017 All children between 9 months to <15 years age should receive one dose of MR vaccine during campaign (irrespective of previous vaccination dose with Measles or Rubella) After the campaign 2 doses of MR vaccine will be introduced into Routine Immunization schedule (UIP) replacing 2 doses of Measles vaccine Measles Rubella Vaccination Campaign Measles-Rubella Vaccination Campaign February 2017 onwards

72. MR campaign: Vaccination strategy Target age group: 9 months to <15 years ( regardless of their prior M/R immunization status or any past history of Measles/Rubella disease) Target 100% : Evaluated More than 95 % Types of MR vaccination Booths: 1. School Vaccination Booth 2. Outreach Vaccination Booth ( Anganwadi , community hall) 3. Health Facility booth 4. Special teams to cover migratory populations Average Campaign duration: ~ 3+ 1 weeks = ~16-20 working days 1 st week: School based campaign (for 5-15 year children) 2 nd and 3 rd weeks: Community based campaign for non-school going children 4 th week will be for sweeping/ repeat activity based on supervision-monitoring To cover one school in one day; one village in one day

73. Summary • MR Campaign started from 7th February to 28th February 2017 • Make sure to Vaccinate all Children between 5 years to 15 years at schools • Vaccinate all children between 9 months to 5 years at Play homes / Anganwadi centre • MR Vaccine also available at all PHCs / UHCs/ Major Hospitals and Medical colleges

74. Polio is gone! Measles-Rubella is next!

75. Future

76. THANK YOU