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Newer Vaccines

"With the exception of safe water, no other modality, not even antibiotics, has had such a major effect on mortality reduction…". Newer Vaccines. Presenter – Pramod Kumar Sah Moderator – Dr. Subodh S. Gupta. Framework. Introduction Vaccine Development of vaccines Need for new vaccines

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Newer Vaccines

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  1. "With the exception of safe water, no other modality, not even antibiotics, has had such a major effect on mortality reduction…" Newer Vaccines Presenter – Pramod Kumar Sah Moderator – Dr. SubodhS. Gupta

  2. Framework • Introduction • Vaccine • Development of vaccines • Need for new vaccines • Regulation & testing of vaccines • Newer / Improved vaccines • Vaccine on clinical trial

  3. Vaccine • It is a suspension of attenuated or killed microorganisms, or of antigenic proteins derived from them, administered for prevention or amelioration of infectious diseases. • Helps stimulate the body's own immune system to produce antibodies to fight particular disease. • Vaccine may contain • live but avirulent organism, or • killed microorganism , or • purified macromolecular component of a microorganism or • a plasmid that contains a complementary DNA encoding a microbial antigens. • Antibodies that are produced to protect against future infection.

  4. The Development Of Vaccines • First generation—whole - organism vaccines - Inactivated/Killed, -live attenuated • Second generation • subunit vaccine, • recombinant antigen Vaccine,, • synthetic peptide vaccines • Third generation----DNA vaccine

  5. Need For New Vaccines • Pathogens that have circulated for long but existence ignored : HepB, Pneumococcal diseases, Rota - virus  • Old pathogens change geographical habitat and are introduced into newer areas : Chikungunya, West Nile • New pathogens have emerged : SARS, Avian Flu • Pathogens thought to be controlled have re-emerged : M tuberculosis

  6. Framework For Decision Making On Introducing New Vaccines • Is the disease a public health problem? • Is immunization the best control strategy for this disease? • Is the immunization programme working well enough to add a vaccine? • What would be the net impact of the vaccine? • Is the vaccine a good investment? • How will be the vaccine funded? • How will the addition of the new vaccine be implemented?

  7. Regulation & testing of vaccines • Phase I: is a human trial & focuses on safety involving small groups. • Phase II: Involves moderate-sized "target" populations to determine both safety and the stimulation of immune response • Phase III: extensive testing performed on large target populations to establish whether a vaccine actually prevents a disease as intended (efficacy)

  8. General WHO position on new vaccines Vaccines for large-scale public health use should: • meet the quality requirements as defined in the Global Programme on Vaccines policy statement on vaccine quality • be safe and have a significant impact against the actual disease in all target populations • if intended for infants or young children, be easily adapted to schedules and timing of the national childhood immunization programmes • not interfere significantly with the immune response to other vaccines given simultaneously • be formulated to meet common technical limitations, e.g. in terms of refrigeration and storage capacity • be appropriately priced for different markets.

  9. Newer Vaccines

  10. Licensed Vaccines That Are Not Being Used Widely New/Improved: • Hib: PRP-conjugates • Pneumococcus: PS-conjugates • Cholera: inactivated • Rotavirus: live, attenuated • Typhoid: Vi, Ty2la • HAV: Inactivated • Group A Meningococcus: PS-conjugates • Varicella: Live-attenuated • Human papilioma virus • Japanese Encephalitis

  11. Vaccines on Clinical trials 1. Malaria 2.Dengue 4. HIV

  12. Haemophillus influenzae type b (Hib) Indications: • Pneumonia, respiratory infection common in children < 2 years Vaccine • Conjugate polysaccharide b vaccine Schedule: • 6,10,14 weeks booster at 12-15 months • Unvaccinated children ≥ 7 months of age- 2 doses • Unvaccinated children ≥ 15 months of age- 1 dose • Unvaccinated children ≥ 5 yrs- only if underlying immune disorder or asplenia

  13. Hib Vaccines cont… Dose: • 0.5 ml IM ant.lat.aspect of thigh Contra-indictaions: • Local pain, erythema, fever • Immunogenicity- • More than 95% of infants- protective antibody levels after a primary series of two or three doses. • Immunogenic in patients with increased risk for invasive disease, such as sickle-cell disease, leukemia, (HIV) infection, splenectomy. • Recently, quadruple vaccine (DPT+Hib) and pentavalent (DPT+Hib+HepB) available.

  14. WHO position •  Calls for the use of Hib vaccines in all infant immunization programs and • states that the vaccine is the only public health tool capable of preventing the majority of cases of serious Hib disease.

  15. Pneumococcal vaccine A. Pneumococcal polysaccharide vaccine (PV23):1977 - purified cap.polysaccharide Ag from 14 strains(14-valent) Indication:widely licensed for use in adults and children aged >2 years who have certain underlying medical conditions.(Sickle cell disease, damaged spleen / spleenectomised, AIDS, disease affecting immune system, diabetes, liver ds. chronic lung & heart disease, who is on immunosuppresive therapy). B .Pneumococcal conjugated vaccine (PCV7): 2000 Composition:Purified cap. Polysaccharide of 7 serotypes(PCV7) of pneumococci (4, 9V, 14, 19F, 23F, 18C, 6B) conjugated to a non toxic variant of diptheria toxin (CRM197) Indication: infants and toddlers (6 weeks to 9 years)

  16. Pneumococcal vaccine cont…. • Dose: 0.5 ml • Schedule – S/C or IM • <6 months 3 doses (6, 10, 14wks) • 7-11 months- 2 doses & booster after 1yr • 12-23 months-2 doses • >24mnths single dose • Not recommended for >59 months of age • No revaccination recommended • Side-effects: Redness, tenderness, swelling ,fever, loss of appetite, irritability, drowsiness • Contraindications: Allergic reaction to 1st dose, Severely ill • Efficacy of upto 57 % for cases of otitis media by serotypes represented in the vaccine is reported.

  17. Pneumococcal vaccine cont… • The Gambia Pneumococcal Vaccine Trial: • A Phase III trial of the vaccine involving 40 000 people was completed in South Africa in 2002, and • Phase III trial with 17 437 subjects was concluded in the Gambia in 2004 • 9-valent vaccine (PCV7+ 1 & 5) • 77% effective in preventing pneumococcal infections • 16% decrease in child mortality • New 10-valent pneumococcal vaccine: • “Synflorix” developed by GSK • Additional 3 serotypes to PCV7- 1, 5, 7F • Conjugated to protein D of Non TypableH.Influenza(NTHi) • GSK received European Commission authorisation on 31st March 2009

  18. Pneumococcal vaccine - India • Actual burden of pneumococcal disease in India- not known. • Currently available seven-valent conjugate vaccine (PCV-7) covers strains attributable to approximately 50% burden of S. pneumoniaein India. The steps needed for inclusion of these vaccines in UIP: • The burden of disease studies for S. pneumoniae • Evidence generation and cost effective analysis studies for vaccine • The support and advocacy for vaccine research to incorporate strains which are prevalent in India • The preparation of a decision making tool to introduce new vaccines in UIP.

  19. WHO position • WHO considers that pneumococcal conjugate vaccine should be a priority for inclusion in national childhood immunization programmes. • Countries with mortality among • children aged <5 years of >50 deaths/1000 births • or with more than 50 000 children’s deaths annually • should make the introduction of PCV-7 a high priority for their immunization programmes.

  20. Cholera vaccine:

  21. Cholera vaccine:

  22. WHO position • Cholera control should be a priority in areas where the disease is endemic. • Given the availability of 2 oral cholera vaccines and data on their efficacy, field effectiveness, feasibility and acceptance in cholera-affected populations, • immunization with these vaccines should be used in conjunction with other prevention and control strategies in areas where the disease is endemic and should be considered in areas at risk for outbreaks.

  23. Rotavirus vaccine:

  24. Rotavirus vaccines: India • A vaccine based on Indian neonatal strains: clinical trials. • RotarixTM (GSK) -now available in India • A monovalent attenuated human rotavirus vaccine • Human rotavirus strain 89-12 grown in vero cells and contains the G1P1 [8] strain Lyophilized vaccine • The vaccine and the diluents should be stored at 2 to 8° C and must not be frozen. • Administer promptly after reconstitution as 1 ml orally. • The first dose can be administered at the age of 6 weeks (no later than at the age of 12 weeks.) The interval between the 2 doses - at least 4 weeks. The 2-dose schedule should be completed by age 16 weeks, (no later than by 24 weeks of age.)

  25. WHO position • included in all national immunization programs, especially in countries with high death rates, such as those in South and South-eastern Asia and Sub- Saharan Africa. • the age restriction should be removed in countries where disease burden is high and delays in vaccinations and deaths from rotavirus are common. • low risk of intussusception from rotavirus vaccination (about 1 to 2 per 100,000 infants vaccinated),

  26. Typhoid vaccines Indications: • Travelers going to endemic areas who will be staying for a prolonged period of time, • Persons with intimate exposure to a documented S. typhi carrier • Microbiology laboratory technologists who work frequently with S. typhi • Immigrants • Military personnel

  27. Typhoid vaccines Two types: • Injectable Typhoid vaccine (TYPHIM –Vi,TYPHIVAX) 2. The live oral vaccine (TYPHORAL)

  28. Typhoid vaccine cont… • InjectableTyphim –Vi • This single-dose injectable typhoid vaccine, from the bacterial capsule of S. typhi strain of Ty21a. • This vaccine is recommended for use in children over 2 years of age. • Sub-cutaneous or intramuscular injection • Efficacy : 64% -72%

  29. Typhoid vaccine cont… Typhoral vaccine: • live-attenuated-bacteria vaccine manufactured from the Ty21a strain of S. typhi. • The efficacy rate of the oral typhoid vaccine ranges from 50-80% • Not recommended for use in children younger than 6 years of age. • The course consists of one capsule orally, taken an hour before food with a glass of water or milk (1stday,3rd day &5th day) • No antibiotic should be taken during this period • Immunity starts 2-3 weeks after administration and lasts for 3 years • A booster dose after 3 years

  30. WHO Position • Typhim –Vi and Typhoralvaccines provide appreciable levels of protection and have a good record of safety, improved vaccines against typhoid fever are desirable. • vaccines should confer higher levels and more durable protective immunity in all age groups, including those aged <2 years, preferably without the need for booster doses.

  31. Hepatitis A

  32. Hepatitis A Vaccines: India India: > one billion population over-crowded living conditions and lack of proper sanitation and education, Hepatitis A continues to be a very frequent infection. • HAV infection produces lifelong immunity to hepatitis A, • Based on recent studies (Pune, Mumbai, Delhi Chennai) children specially from low socio-economic category continue to be almost universally exposed to HAV. • Thus, at present, Indian population does not qualify for immunization with hepatitis A vaccine.

  33. WHO position • Highly endemic countries: HAV infects virtually all young children, without causing symptoms but effectively protecting the population against symptomatic hepatitis A disease in later life. In such countries, large-scale hepatitis A vaccination is not required. • Intermediate endemic countries where a relatively large proportion of the adult population is susceptible to HAV, and where hepatitis A represents a significant public health burden, large-scale childhood vaccination may be considered as a supplement to health education and improved sanitation. • Low endemic countries: indicated for individuals with increased risk of contracting the infection. • HAV be integrated into the national immunization schedule for children aged ≥1 year if indicated on the basis of incidence of acute hepatitis A, change in the endemicity from high to intermediate, and consideration of cost effectiveness.

  34. Combined Hepatitis A and Hepatitis B Vaccine • 2001- FDA • Twinrix (GlaxoSmithKline) • The vaccine is administered in a three-dose series at 0, 1, and 6 months • Twinrix is approved for persons aged ≥18 years with indications for both hepatitis A and hepatitis B vaccines.

  35. Meningococcal vaccine: Indications: • Travellers to industrialized countries are exposed to the possibility of sporadic cases. • Outbreaks of meningococcal C disease occur in schools, colleges, military barracks and other places where large numbers of adolescents and young adults congregate. • Long-term travellers living in close contact with the indigenous population may be at greater risk of infection. • Vaccines: - Polysaccharide vaccine - Conjugate vaccine

  36. Continuation…………… Polysaccharide vaccines: • bivalent (A and C) or tetravalent (A, C, Y and W-135) • One dose, provides protection for 3–5 years • Vaccine should be given 2 weeks before departure • Children under 2 years of age are not protected by the vaccine • Travellers should opt (A, C, Y, W-135) than the bivalent vaccine Conjugate vaccine: • Monovalent serogroup C conjugate vaccines • licensed for use since 1999 • incorporated in national vaccination programmes in an increasing number of countries. • prolonged duration of protection in infants who are vaccinated at 2, 3 and 4 months of age.

  37. WHO Position WHO recommends that countries with • high (>10 cases/100 000 population/year) or • intermediate endemic rates (2–10 cases/100 000 population/year) of invasive meningococcal disease and countries with frequent epidemics • In these countries, the vaccine may be administered through routine immunization programmes, supplementary immunization activities (SIAs), during outbreaks, or through private vaccination services.

  38. Varicella • In several industrialized countries, Varicella vaccines have been introduced into the childhood immunization programmes. • Most adult travellers from temperate climates are immune (as a result of either natural disease or immunization). • Adult travellers without a history of Varicella who travel from tropical countries to temperate climates may be at increased risk and should consider vaccination. • Use at 9 months of age and older. optimal age for Varicella vaccination is 12–24 months. • In Japan and several other countries 1 dose of the vaccine is considered sufficient regardless of age. • In the United States 2 doses 4–8 weeks apart, are recommended for adolescents and adults.

  39. Varicella vaccine cont… Side effects: • Mild Varicella-like disease with rash within 4 weeks. Contraindications • Pregnancy (pregnancy should be avoided for 4 weeks following vaccination), • Ongoing severe illness • Anaphylactic reactions • Immuno suppression.

  40. WHO Position • These position papers are concerned primarily with the use of vaccines in large-scale immunization programmes. • Limited vaccination for individual protection, as executed mostly in the private sector, may be a valuable supplement to the national programmes, but is not emphasized in this policy document.

  41. MMR Varicella Vaccine (MMRV) • Vaccination schedule and use- • 12 months- 12 yrs of age • 1st dose as early as possible after 12 months of age, 2nd after at least 3 months interval • Post-exposure prophylaxis within 3 days • Adverse reactions- • Fever, measles like rash 5-12 days after vaccination, febrile seizures ( risk higher than MMR and Varicella given separately) • Storage- • Very fragile, -15°C • Never at room temp.or refrigerator • Diluent (sterile water) - refrigerator or room temp.

  42. Human papilloma virus vaccine

  43. WHO position • HPV vaccination should be introduced into national immunization programmes where prevention of cervical cancer is a public health priority, • the introduction is programmatically feasible and economically sustainable, and • where cost-effectiveness aspects have been duly considered.

  44. Japanese Encephalitis Indications: • Vaccination is recommended for travellers with extensive outdoor exposure (camping, hiking, bicycle tours, outdoor occupational activities, in particular in areas where flooding irrigation is practiced) • In rural areas of an endemic region during the transmission season. • It is also recommended for expatriates living in endemic areas through a transmission season or longer.

  45. Japanese Encephalitis Vaccines • Currently, three types of JE vaccines in use: 1. Mouse brain-derived inactivated vaccine. 2. Cell culture-derived inactivated vaccine and 3. Cell culture-derived live attenuated vaccine. • No JE vaccine- WHO-prequalified • The Mouse Brain-derived Inactivated Vaccine: (MBD) • Produced in several Asian countries including India (Central Research Institute, Kasauli). • So far, the only type of JE vaccine that is commercially available in the international market. • Safe, efficacious

  46. Japanese Encephalitis Vaccines cont…. • Disdvantages of the MBD vaccine • Multiple doses ( 3 Primary + Booster) • Expensive vaccine, complicated schedule, side effects • Low availability - Production stopped by major manufacturers globally - CRI may also close down the production • Cell-culture-derived inactivated vaccine • Manufactured in China • Based upon the Beijing P-3 strain • High viral yields when propagated in primary hamster kidney cells. • Formalin-inactivated vaccine, inexpensive

  47. Japanese Encephalitis Vaccines cont… • Cell-culture-derived live attenuated vaccine • 1988 • Chinese vaccine based on a stable neuro-attenuated strain of the JE virus (SA-14-14-2). • Licensed for use in South Korea, Nepal and Sri Lanka. • Vaccination schedule- • 2 doses administered 12 months apart in children aged 1–2 years and a booster at 6 years of age • > 6 yrs- single dose • Immunogenicity- • Children 6-7 years- single dose & Older children- immunized twice at intervals of one to three months: Ab - 83%–100% • Modest reduction in both seroconversion and Abtitre when measles vaccine co-administered with JE vaccine

  48. Japanese Encephalitis Vaccines cont… • October 04, 2013, India’s first indigenously prodcued vaccine against Japanese Ence.phalitis (JE). • National Institute of Virology, Indian Council of Medical Research and Bharat Biotech Ltd. jointly developed the vaccine— JENVAC-- under the public-private-partnership.  • To begin with, the programme will focus on five worst affected states— Assam, Bihar, Tamil Nadu, Uttar Pradesh and West Bengal. • be administered free of cost under the National Immunization Programme. • The vaccine, developed by Bharat Biotech, will be more expensive than the Chinese option. • The imported vaccine costs around Rs.20 per dose while Jenvac is likely to be priced around Rs.70 per dose.

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