Universal Immunization Programme Presentation outline Background and overview

Universal Immunization Programme

Presentation outline • • • Background and overview National Immunization Schedule (Jan. 2011) Vaccines and Cold Chain Safe injections, waste disposal AEFIs Desirable vaccines

Universal Immunization Programme • Largest UIP program in the world. • Targets include 27 million infants and 30. 2 million pregnant women every year • Protection against six Vaccine Preventable Diseases (VPDs) - Tuberculosis, Diphtheria, Tetanus, Pertussis, Polio and Measles • Two new vaccines (JE and Hepatitis B) introduced in select areas

Target infants : Fully immunized: Partial immunized: 26 million 14. 1 million 9. 0 million No immunized: 2. 9 million

National Immunization Schedule (Jan. , 2011) Age Vaccines Pregnant Women TT (2 doses/Booster) Birth BCG, OPV-O, Hep B 6 weeks DPT -1, OPV -1, Hep B 10 weeks DPT -2, OPV -2, Hep B 14 weeks DPT -3, OPV-3, Hep B 9 months Measles 16 -24 months DPT booster, OPV – Booster, MCV (Measles Containing Vaccine), JE* 5 years DPT Booster 2 10 years TT 16 years TT

If a dose is missed……. . • Give the dose at the next opportunity irrespective of the time gap • Do not start the schedule all over again

Tetanus toxoid • Intramuscular – upper arm – 0. 5 ml • Pregnancy – 2 doses - 1 st dose as early as possible and second dose after 4 weeks of first dose and before 36 weeks of pregnancy • Pregnancy – booster dose (before 36 weeks of pregnancy) – If received 2 TT doses in a pregnancy within last three years. Give TT to woman in labour, if she has not received TT previously • TT booster for both boys and girls at 10 years and 16 years • No TT required between two doses in case of injury

BCG • At birth or as early as possible till one year of age • 0. 1 ml (0. 05 ml until one month of age) • Intra-dermal • Left upper arm

Hepatitis B • • • Birth dose – within 24 hours of birth 0. 5 ml Intramuscular Antero-lateral side of mid-thigh Rest three doses at 6 weeks, 10 weeks and 14 weeks

OPV Zero dose – within first 15 days of birth 2 drops Oral First, second and third doses at 6, 10 and 14 weeks with DPT-1, 2 and 3 • OPV booster with DPT booster at 16 -24 months • •

DPT • Three primary doses at 6, 10 and 14 weeks with OPV-1, 2 and 3 • 0. 5 ml • Intra-muscular • Antero-lateral side of mid-thigh • One booster at 16 -24 m with OPV booster (antero-lateral side of mid-thigh) and second booster at 5 -6 years (upper arm)

Measles • At 9 completed months to 12 months • Give upto 5 years if not received at 9 -12 months age • Second dose at 16 -24 months (select states after catch-up campaign) – Measles Containing Vaccine • 0. 5 ml • Sub-cutaneous • Right upper arm • Along with Vitamin A (1 st dose) – 1 ml (1 lakh IU) - oral

Vitamin A • 1 st dose – 1 ml (1 IU) - along-with Measles first dose - Oral • Subsequent 8 doses (2 ml or 2 lakh IU) every six months till 5 years of age starting with DPT first booster at 16 -24 months • Use only plastic spoon provided with Vitamin A solution

Japanese Encephalitis • SA 14 -14 -2 vaccine in select endemic districts after campaign in UP, Bihar, Assam, Haryana, Andhra Pradesh, Goa, Karnataka, Manipur, West Bengal, Tamil Nadu • 16 -24 months with DPT and OPV booster • 0. 5 ml • Subcutaneous • Left upper arm

Vaccines and Cold Chain

Vaccines • Live attenuated – BCG, Measles and OPV • Inactivated killed – DPT, TT, whole–cell pertussis, hepatitis B • All vaccines should be stored at plus 2 to plus 8 degrees ideally in Ice Lined Refrigerators/ Domestic Refrigerators • All government supply vaccines come with Vaccine Vial Monitors (VVMs) • BCG and Measles vaccines are in powder form and come with diluents. Reconstitution is needed before use. • Use reconstituted BCG and Measles vaccines within 4 hours of reconstitution and JE within 2 hours of reconstitution if kept at +2 to +8 degrees • Use separate 5 ml syringes for each reconstitution

Why have the Cold Chain? If vaccines are exposed to excessive Heat Cold Light they may lose their potency or effectiveness.

HEAT DAMAGE • Heat damage is cumulative effect • Reconstituted vaccine is most sensitive to heat and light. • Measles and BCG vaccines should not be used 4 hrs after reconstitution and JE 2 hrs after reconstitution • Temperature of diluents & vaccine must be same during reconstitution

Heat sensitivity • BCG (after reconstitution) • OPV • Measles (before and after reconstitution) • DPT • BCG (before reconstitution) • DT • TT • Hep. B MOST SENSITIVE LEAST SENSITIVE

Sensitivity from Freezing MOST SENSITIVE • Hep. B • DPT • DT • TT LEAST SENSITIVE

Remember • All vaccines tend to lose potency on exposure to heat above +80 C • Some vaccines (Hep B, TT, DPT) lose potency when exposed to freezing temperatures • Some vaccines are sensitive to light (BCG, Measles). • The damage is irreversible • Physical appearance of the vaccine may remain unchanged but potency might be lost.

Vaccine carriers • Used for carrying vaccines (16 -20 vials) and diluents from PHC to the outreach session sites. • With 4 conditioned icepacks maintain inside temperature of 2 -80 C for 12 hours. • Close the lid of the carrier tightly. • Never use any day carriers with 2 icepacks or thermos flask for carrying vaccines.

Correct Packing of the Vaccine Carrier 1 Prepare Ice-Packs for Freezing 2 Condition Frozen Ice-Packs §Fill the Ice-Pack with water to mark. Check water level before every use. Do NOT add salt to this water. §Place frozen Ice-Packs in the open till they “sweat, ” (some condensation or droplets of water) §Fit the stopper and screw on the cap tightly §Check if an Ice-Pack has been conditioned by shaking it and listening for water §Make sure the Ice-Pack does not leak §Wipe the Ice-Pack dry and place in the Deep Freezer 3 Pack the Vaccine Carrier §Place four conditioned Ice-Packs against the sides of the carrier §Place the plastic bag containing all vaccines and diluents in the centre of the carrier. 4 Remember to. . § Collect vaccines in the carrier on the session day (Vaccine carriers may not store vaccines effectively beyond 12 hrs) § Do not drop or sit on the vaccine carrier. § Do not leave in sunlight. Keep in shade. § Do not leave the lid open once packed. Unconditioned Ice-Packs may damage freeze sensitive vaccines (DPT, DT, TT and Hepatitis B)

Storing vaccines in the Ice-Lined Refrigerator Keep thermometer hanging position in basket and maintain temperature between +2 O C to +8 O C (monitor morning and evening) Store all vaccines in baskets Diluent DPT DPTDPT DPT Diluent DPT DPT TT DT Measles Measles TT TT TT Diluent Measles Measles Diluent OPV OPV Store diluents in baskets, for 24 hours before next session Hep B DPT Hep B DTT DT TTBCG DT TT BCG OPV Hep B DPT DPT Hep B DT DT TT TT TT BCGBCG OPV Arrange vaccines in order (top to bottom) Hep B DPT, DT, TT BCG Measles OPV Follow Early Expiry First Out (EEFO) Keep space between boxes Discard any frozen Hep B, DPT, TT and DT

Freezing Ice-packs in the Deep Freezer Never store UIP vaccines in the DF. Use only for freezing icepacks Un-frozen icepacks for freezing Store frozen icepacks only up to half the height of the large compartment Large compartment Wipe dry and arrange 20 -25 unfrozen icepacks vertically (never flat) in a crisscross pattern with space for air circulation Small compartment Arrange and store frozen icepacks vertically, in layers. Also store in cold boxes

Domestic Refrigerators • Only in urban areas with assured electric supply • Hold over time (time taken in absence of power to raise temperature from minimum i. e. +2 degrees to maximum i. e. +8 degrees for an equipment) for a domestic refrigerator is only four hours • Specific order of storing ice packs and vaccines in domestic refrigerator

Storing vaccines in Domestic Refrigerator • Ice packs and OPV in freezer • Block door panels (where bottles are stored) and vegetable tray at the bottom with thermocol • Measles vaccine may be stored in the chiller tray below the freezer followed by T – series vaccines in the shelves below • Hepatitis B should be stored below all vaccines

Usable and Unusable stages of VVM

Safe vaccines and waste disposal

Safe Injections • Cover any small cuts on the service provider’s skin. • Wash or disinfect hands prior to preparing injection material. • Always use an Auto Disable Syringe (ADS) for each injection and a new disposable syringe to reconstitute each vial of BCG and measles • Avoid giving injections if the skin of the recipient is infected or compromised by local infection (such as a skin lesion, cut, or weeping dermatitis) • Check expiry date and VVM before use • If the injection site is dirty, wash with clean water • Use only diluent supplied with vaccine for reconstitution • Write time of reconstitution on label - Use reconstituted vaccines within 4 hours • Use hub cutters immediately after injection has been administered to separate needle from syringe • Disinfect sharps and non-sharps before disposal

Simple ways to improve injection safety • Follow product-specific recommendations for use, storage, and handling of a vaccine. • Discard any needle that has touched any non-sterile surface. • Discard a syringe that has been punctured, torn or damaged by exposure to moisture • Consider all used equipment as contaminated • Cut the used syringe at the hub immediately after use. Practice safe disposal of all sharps • Deposit used sharps (needles) in a hub cutter and disinfect before safe disposal. • Prevent needle-stick injuries. Do not recap or bend needles. • Anticipate sudden movement of child.

Adverse Events Following Immunization (AEFI)

AEFIs AEFI is any medical incident that takes place after an immunization, causes concern, and is believed to be caused by immunization AEFIs need to be detected, properly managed clinically, reported, investigated, monitored and promptly responded to for corrective interventions

AEFI…. . types • Vaccine reactions (high grade fever following DPT) – caused/precipitated by active component or one of the other components of vaccine such as adjuvant/ preservative/ stabilizer • Program error (bacterial abscess due to unsterile injections) – caused by vaccine preparation, handling or administration • Injection reaction (fainting spell in teenager after immunization) – caused by anxiety or pain from injection rather than due to vaccine • Coincidental (pneumonia after pulse polio NID during winters) - event occurs after immunization but is not caused by vaccine – chance temporal association • Unknown – cause of event cannot be determined

Common minor vaccine reactions • Local reaction (pain, swelling and/or redness), fever and systemic symptoms (e. g. vomiting, diarrhea, malaise) can result as a part of the immune response. • Local reactions and fever should be anticipated in only 10% of the vaccine recipients, except in the case of whole cell DPT which produces fever in nearly half of those vaccinated. • Fever and minor local and systemic reactions usually occur within a day or two of immunization (except for those produced by measles/MMR vaccine which occurs 6 to 12 days after immunization) and only last for few days. • Fever and minor local reactions can usually be treated symptomatically with paracetamol.

Rare Serious Adverse Events Vaccine BCG Hib Reaction Suppurative adenitis, BCG Osteitis, Disseminated BCG infection None known Hep B Anaphylaxis Measles/MMR Febrile Seizures, Thrombocytopaenia, anaphylaxis OPV Vaccine associated paralytic polio Tetanus Brachial Neuritis, anaphylaxis, sterile abscess DPT Persistent (>3 hrs) inconsolable crying, seizures, hypotonic hypo-responsive episode, anaphylaxis/shock Japanese Encephalitis Serious allergic reaction, neurological event

Reporting of AEFIs For Immediate Reporting and Investigation • Death, hospitalization, disability or other serious and unusual events that are thought by the public to be related to immunization • Anaphylaxis • Toxic shock syndrome (TSS) • Anaphylactoid (acute hypersensitivity) reaction • Acute Flaccid Paralysis (AFP) - Any case of AFP will be reported through the current system for AFP surveillance and reporting • • Encephalopathy Sepsis Any event where vaccine quality is suspected Events occurring in a cluster

Reporting of AEFIs • Report immediately by telephone/ fax/ messenger to PHC doctor/District Immunization Officer or Chief Medical Officer • First Information Report format for AEFI reporting to be used • Keep vaccines, diluents and syringes (including that used for reconstitution) for investigation • Be vigilant for other cases • Do not use multi dose vials further if AEFI occurs. If available use single dose vials.

Single dose vs multi dose vials • Single dose vaccines are more costly • Per dose cold chain space occupied is more • Less wastage of doses if number of beneficiaries are less • Lesser chance of AEFIs occurring due to incorrect handling • More immunization waste generation • Multi dose vaccines cheaper • Reduced per dose cold chain space required • Wastage is more if number of beneficiaries are less • More chances of AEFI (cluster) occurring due to incorrect handling • Less generation of immunization waste

Desirable vaccines • Pentavalent (DPT + Hep. B + Hib) • Hib • Typhoid • Chickenpox

Hib vaccine • Haemophilus influenzae b (pneumonia, meningitis) • 0. 5 ml • Intramuscular at Antero-lateral side of midthigh • At 6, 10 and 14 weeks and a subsequent booster after age of one year (currently not included officially in GOI’s Immunization Schedule) • Combination with DPT + Hep B also available

Pentavalent vaccine • • • DPT + Hep B + Haemophilus influenzae b Intramuscular Antero-lateral side of mid-thigh 0. 5 ml dose At 6, 10 and 14 weeks with booster at 16 -24 months • Proposed to be piloted in Kerala and Tamil Nadu – pending ICMR study completion

Typhoid vaccine • • • Salmonella typhi Vi polysaccharide vaccine 0. 5 ml dose Intramuscular or subcutaneous At two years of age (currently not included officially in GOI’s Immunization Schedule) • Revaccination every 3 -4 years

Chickenpox vaccine • Varicella vaccine • Any time after 15 months (currently not included officially in GOI’s Immunization Schedule) • One dose if less than 13 years of age • Two doses (gap of four to eight weeks) if more than 13 years of age • 0. 5 ml • Subcutaneous • Upper arm

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