Tips and Techniques in Immunization

1. Tips and Techniques in Immunization Ma. Liza M. Gonzales, MD, MSc Infectious and Tropical Disease Section, Department of Pediatrics, PGH-CM University of the Philippines

2. Objectives • To present practical TIPS on • Vaccine timing and interval • Vaccine storage and handling • Vaccine safety • To review proper TECHNIQUES on vaccine administration

3. Vaccines Plotkin S, Orenstein W, Offit P. Vaccines, 5th ed. Saunders, 2008. “With the exception of safe water, no other modality, not even antibiotics, has had such a major effect on mortality reduction…”

5. Classification of Vaccines • Live attenuated vaccines • Viral • Bacterial • Inactivated • Whole • Fractional • Protein-based • Polysaccharide-based

6. Live attenuated Vaccines • Attenuated (weakened)form of the “wild”virus or acterium • Must replicate to be effective • Immune response similar to natural infection • Usually produce immunity with one dose (except vaccines given orally) Live Attenuated Vaccines • Viral : measles, mumps, rubella, varicella zoster, yellow fever, rotavirus, oral polio, intranasal influenza • Bacterial: BCG, oral typhoid

7. Inactivated Vaccines • Cannot replicate • Less interference from circulating antibody than live vaccines • Generally require 3-5 doses • Immune response mostly humoral • Antibody titer diminishes with time Inactivated Whole Cell Vaccines • Viral : polio, hep A, rabies, influenza • Bacterial: pertussis, typhoid, cholera Inactivated Whole Cell Vaccines • Subunit: hep B, influenza, acellularpertussis, HPV • Toxoid: diphtheria, tetanus

8. Inactivated Vaccines • Polysaccharide Vaccines - unique type of inactivated subunit vaccine composed of long chains of sugar molecules that make up the surface capsule of certain bacteria Pure Polysaccharide Vaccines • Pneumococcal, meningococcal, Salmonella typhi(Vi) Conjugate Polysaccharide Vaccines • Hib, pneumococcal, meningococcal

9. Timing and Spacing of Vaccines: Simultaneous and Nonsimultaneous Administration • All vaccines can be administered at the same visit following the minimum age for each vaccine. • Vaccines not given simultaneously should follow appropriate intervals

10. Spacing and Administration of Live and Inactivated Antigen • Exception is diphtheria-reduced tetanus toxoid-acellularpertussis vaccine (Tdap) and meningococcal polysaccharide-protein conjugate vaccine (MCV4) vaccines which should be separated by at least 4 weeks if simultaneous administration is not feasible • Live oral vaccines, e.g., oral poliovirus vaccine, rotavirus vaccine, Ty21a typhoid vaccine, can be administered simultaneously or at any interval before or after inactivated or live parenteral vaccines Dennehy PH et al. In Feigin and Cherry”s Textbook of Pediatric Infectious Diseases.6th ed. 2009

11. Interval Between Doses of the Same Vaccine • Increasing the interval between doses of a multidose vaccine does not diminish the effectiveness of the vaccine. • Decreasing the interval between doses of a multidose vaccine may interfere with antibody response and protection.

12. Intervals between Ab-containing products and Measles or Varicella Containing Vaccines

13. Intervals between Ab-containing products and Measles or Varicella Containing Vaccines *Recommended interval before administration of measles- or varicella-containing vaccine (months) **Rates of antibody clearance after receipt of an immune globulin preparation might vary CDC. Epidemiology and Prevention of Vaccine-Preventable Diseases. Atkinson W et al, eds. 11th ed. Washington DC: Public Health Foundation, 2009

14. Tips on Timing and Interval of Vaccines • For > 2 live parenteral vaccines (measles, MMR, MMRV, varicella) not given at the same visit, minimum interval between vaccines is at least 4 weeks • Follow the recommended minimum AGE and INTERVAL for each vaccine. • Other combination of vaccines (live and inactivated, > 2 inactivated, live oral and live parenteral), can be given simultaneously or at any interval between vaccines

15. WHO recommended vaccine storage conditions Sensitive to Heat Sensitive to Cold Hep B Hib (liquid) DTP DT DT Td TT • OPV • Measles • DTP, yellow fever • BCG • Hib,DT • Td,TT, Hep B Most sensitive Most sensitive Least sensitive Least sensitive WHO IVB. Temperature sensitivity of vaccines 2006. WHO/IVB/06.10

16. WHO recommended vaccine storage conditions • ALL vaccines are recommended to be transported and stored at +2°C to +8°C • Exception: OPV which alternatively may be stored at -15°C to -25°C • It is unnecessary to store freeze-dried vaccines at -20°C • Vaccines sensitive to cold and diluents must NEVER be frozen • ALWAYS store the vaccine with their diluent between +2°C and +8°C WHO IVB. Temperature sensitivity of vaccines 2006. WHO/IVB/06.10

17. Vaccine Storage and Handling • Follow recommendations found in each vaccine’s package insert for storage, handling, and administration • Inspect vaccines upon delivery and monitor refrigerator and freezer temperatures to ensure maintenance of cold chain • Rotate vaccine stock so the oldest vaccines are used first • Never administer a vaccine later than the expiration date CDC. Epidemiology and Prevention of Vaccine-Preventable Diseases. Atkinson W et al, eds. 11th ed. Washington DC: Public Health Foundation, 2009

18. Tips on Vaccine Storage and Handling • Always maintain proper cold chain during transport and storage. Rotate vaccine stock, use the oldest vaccines first. Never administer a vaccine later than the expiration date • Store all vaccines in a separate refrigerator in good working condition with uninterrupted power supply.

19. Vaccine Administration Errors • Wrong diluent • Administration of the wrong formulation • Incorrect route or site of administration www.who.int/injection_safety/en/index.htm

20. Importance of Proper Vaccine Administration Technique • Promote optimal antibody response • Reduce risk of local adverse reactions • Deep IM preferable for vaccines with adjuvants • depot effect and less granuloma formation • SC/Intradermal- better for live vaccines • lessen risk of neurovascular injury but still immunogenic (e.g. BCG)

21. Vaccine Injection Techniques Subcutaneous Intramuscular Intradermal

22. Preferred Sites of Vaccine Administration Anterolateral Thigh (vastuslateralis muscle) Deltoid muscle Infants and children with inadequate muscle mass Older children and adolescents http://www.cdc.gov/vaccines

23. Best Infection Control Practices for ID, IM and SQ Injections • Use sterile injection equipment • Prevent needle-sticks • Prevent access to used needles • Place in puncture-proof containers • Prevent contamination of equipment and medication Unsafe practices with multidose vaccine vials www.who.int/injection_safety/en/index.htm

24. Infection Control • Hand hygiene • recommended between patients • alcohol-based waterless antiseptic can be used • Gloves • not required by OSHA unless • potential for exposure to blood or body fluids • open lesions on the hands • agency policy Staphylococcal contamination of a multidose vial led to the septic deaths www.who.int/injection_safety/en/index.htm

25. Follow Open Vial Policy www.who.int/injection_safety/en/index.htm

26. Vaccine Administration • Administer vaccines within the prescribed time periods following reconstitution • Draw vaccines into syringes immediately prior to administration • NEVER mix vaccines in the same syringe unless they are specifically approved for mixing • Record vaccine and administration information, including lot numbers and injection sites, in the patient’s record (may use pre-printed vaccine labels) CDC. Epidemiology and Prevention of Vaccine-Preventable Diseases. Atkinson W et al, eds. 11th ed. Washington DC: Public Health Foundation, 2009

27. Other Vaccine Administration Issues • Not necessary to change needles between drawing or reconstituting vaccine and administration unless needle is bent or contaminated • Injection sites in same limb should be separated by at least 1 inch • Aspiration is not required • no reports of injury from failure to aspirate CDC/ACIP MMWR 2006; www.who.int/injection_safety/en/index.htm

28. Tips on Vaccine Administration • Always read the package labels to avoid vaccine administration errors (wrong diluent, wrong formulation). • Comply with infection control practices during and after vaccination. • Do NOT deviate from recommended route of administration.

29. Importance of Vaccine Safety • Decreases in disease risk and increased attention on vaccine risks • Public confidence in vaccine safety is critical • Higher standard of safety expected of vaccines • Vaccinees generally healthy • Lower risk tolerance  need to search for rare reactions • Vaccination universally recommended and mandated CDC. Epidemiology and Prevention of Vaccine-Preventable Diseases. Atkinson W et al, eds. 11th ed. Washington DC: Public Health Foundation, 2009

30. What Is an Adverse Event Following Immunisation (AEFI)? A medical incident that takes place after an immunization, causes concern, and is believed to be caused by immunization • Vaccine reactioncaused by vaccine’s inherent properties and individual response of vaccinee • Programmeerror caused by error in vaccine preparation, handling, or administration • Coincidentalhappens after immunization but not caused by it - chance occurrence or due to underlying illness • Injection reaction anxiety or pain of injection not vaccine, e.g. syncope (vasovagal reaction) or fainting, hyperventilation • Unknown cause cannot be determined WHO Immunization safety surveillance. 1999 WPRO/EPI/99.01

31. Vaccine reactions • Common, minor reactions • Vaccines stimulate immune system • Usually self-limiting • Warn parents and advise how to manage (e.g. paracetamol, cool cloths, sponging, give extra fluids) • Rare, more serious reactions • anaphylaxis • vaccine specific reactions WHO Immunization safety surveillance. 1999 WPRO/EPI/99.01

32. Vaccine Adverse Event • Plausible time period following vaccination • Previously associated with a particular vaccine • Event conforms to a specific clinical syndrome (strong biologic plausibility ) • Laboratory confirmation (e.g., isolation of vaccine strain) • Recurrence on re-administration of the vaccine (“positive rechallenge”) • Controlled clinical trial or epidemiologic study shows greater risk in vaccine recipients vs controls CDC. Epidemiology and Prevention of Vaccine-Preventable Diseases. Atkinson W et al, eds. 11th ed. Washington DC: Public Health Foundation, 2009

33. Precautions during and following Vaccine Administration • Have patients sit or lie down during injection • Observe patients for 15 -20 minutes after vaccination • Be prepared for emergency care of a person who experiences an anaphylactic reaction • If syncope develops, observe patients until symptoms resolve; never leave patient alone • Epinephrine and equipment for maintaining an airway should be available for immediate use CDC. MMWR 2006;55(No. RR-15):1–48; AAP. Pickering LK et al, eds., Red Book: 2009

34. Time Scale of Anaphylaxis WHO Immunization safety surveillance. 1999 WPRO/EPI/99.01

35. Management of Anaphylaxis *Epinephrine (1:1000) 0.01ml/kg up to max 0.5ml deep IM. May repeat tevery 10–20 minutes up to 3 doses CDC. MMWR 2006;55(No. RR-15):1–48; WHO Immunization safety surveillance. 1999 WPRO/EPI/99.01

36. Common, minor vaccine reactions *Rate of local reactions likely to increase with booster doses, up to 50-85% WHO Immunization safety surveillance. 1999 WPRO/EPI/99.01

37. Rare, more serious reactions WHO Immunization safety surveillance. 1999 WPRO/EPI/99.01

38. Rare, more serious reactions * Hypotonic hyporesponsive episode WHO Immunization safety surveillance. 1999 WPRO/EPI/99.01

39. Weighing the Risks and Benefits of Vaccination DISEASE RISK VACCINE REACTION

40. No evidence that vaccines increase the risk for... • Diabetes 1, 2 • Multiple sclerosis 3 • GuillainBarre Syndrome 4 • Inflammatory bowel disease 5 • Autism Spectrum Disorder 6,7 • Neurodevelopmental disorders 8 • Sudden Infant death syndrome 9 • Infantile spasm 9 1. Canadian Study Group Diabetes Care 1997; 2. DeStefano F et al. Pediatrics 2001; 3. Ruthschmann OT et al Neurology 2002;4. Stowe J et al. Am J Epidemiol 2009; 5. IOM. National Academy Press, 2002; 6. Halsey N. Pediatrics 2001; 107(5);e84; 7. Wilson K et al. Archives of Pediatric and Adolescent Medicine 2003; 157:628-634; 8. Thompson W et al. N Engl J Med 2007;357:1281-92; 9. Howson CP et al. Pediatrics 1992;89(2): 1448-1453

41. Rising incidence or increasing recognition of: Vaccination and Autoimmune Disease, Inflammatory Disease, or Autism Increasingly crowded vaccination calendar • Vaccination in age groups with high incidence of specific disease conditions or autoimmune disorders • Autoimune disease • Autism Spectrum Disorder • Atopy or Allergy • Diabetes

42. Vaccine Safety: Benefit Risk Communication TRUST = Competency + Caring Paling J. BMJ 2003;327:745-74; Alaszewski A, Horlick-Jones T. BMJ 2003;327:728-731

43. Tips on Vaccine Safety Prior to Vaccination: Screen patients for contraindications and precautions prior to each vaccine dose; provide information on vaccine to be administered After Vaccination: Observe necessary precautions, be prepared for emergency care of anaphylactic reaction;provide information and advice on vaccine side effects • During Vaccination: Do NOT deviate from recommended route, site and dosage of vaccine

44. Conclusion: Role of Immunization Provider • Timing and spacing of vaccine doses • Proper vaccine storage and administration • Observe vaccine precautions and contraindications • Educate patients and parents about vaccine benefits and risks • Manage vaccine side effects • Report suspected side effects CDC. Epidemiology and Prevention of Vaccine-Preventable Diseases. Atkinson W et al, eds. 11th ed. Washington DC: Public Health Foundation, 2009

45. Thank you and have a good day!

46. Selected References • CDC. General recommendations on immunization: recommendations of the Advisory Committee on Immunization Practices. MMWR 2006;55(No. RR-15):1–48. • AAP. Pickering LK, Baker CJ, Long SS, McMillan J. eds., Red Book: 2009 Report of the Committee on Infectious Diseases. 28th ed. Elk Grove Village, IL: American Academy of Pediatrics; 2009. • CDC. Surveillance for safety after immunization. MMWR 2003;52(No.SS-1):1–24. • CDC. Update: Vaccine side effects, adverse reactions, contraindications and precautions: recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR 1996;45(No. RR-12):1–35. 57