NAVIGATING THE WORLD OF VACCINES

1. NAVIGATING THE WORLD OF VACCINES Michael Martin, MD Inova Fairfax Hospital for Children

3. Objectives • Know the basic legislation related to vaccines and your legal obligations • Be familiar with the concerns parents have about vaccines and the evidence behind adverse events following immunization • Be familiar with the types of vaccines and ingredients • Know how to appropriately give vaccines

4. Why We Vaccinate - Morbidity Disease20th Century2001% Decrease Smallpox 481,642 0 100 Diphtheria 1,758,853 2 >99 Pertussis 1,472,714 7580 95 Tetanus 13,145 37 97 Polio 163,166 0 100 Measles 5,032,827 116 >99 Mumps 1,522,098 266 >99 Rubella 477,459 23 >99 HIB 2,000,011 18,112 >99

5. Legal Aspects of Vaccines

6. Legislation • The National Childhood Vaccine Injury Act (NCVIA) of 1986 includes requirements for notifying all patients and parents about vaccine benefits and risks. • Whether vaccines are purchased with private or public funds, this legislation mandates that a vaccine information statement (VIS) be provided each time a vaccine covered under the National Vaccine Injury Compensation Program (VICP) is administered

7. National Vaccine Injury Compensation Program • No-fault system in which people may seek compensation if they are thought to have suffered an injury, or a family member is thought to have died, as a result of administration of a covered vaccine • Trust Fund - 75 cents per dose imposed on each vaccine covered under the Program

8. Medical Documentation • Vaccine manufacturer, lot number, and date of administration • Site (eg, deltoid area) and route (eg, intramuscular) of administration and expiration date of the vaccine

9. Risk Communication • Do you have any cultural, religious, or personal beliefs regarding immunizations? • Has your child or any child you know had a serious adverse event after an immunization? • Do you have any vaccine safety concerns? • What vaccine safety information can I provide?

10. Dealing with the Fears • "Why should children be immunized when most vaccine-preventable diseases have been eliminated in the United States?" • many diseases prevalent in other areas of the world • could be reintroduced into the United States and, without immunization, could spread quickly • "Do immunizations work? Haven't most people who get a vaccine-preventable disease been immunized?" • childhood vaccines are 85% to 98% effective • "Aren't some vaccine lots more dangerous than others?" • No evidence indicates that individual lots of commonly used vaccines differ in safety. • The FDA and CDC conduct programs to continue surveillance after licensure for safety and efficacy of all recommended vaccines. • Active surveillance for vaccine-associated adverse events after licensure • "Isn't giving children more than one immunization at a time dangerous?" • Numerous studies have shown that multiple recommended childhood and adolescent immunizations can be given safely at the same time. Scientists estimate that the immune system can recognize and respond to hundreds of thousands, if not millions,

11. Adverse Events with No Supporting Evidence

12. Adverse Events Supported by Evidence

14. Mercury & Thimersol • Methyl Mercury vs. Ethyl Mercury • Bioaccumulation • Link to autism, ADHD, & speech or language delay? • Inadequate evidence to accept OR reject causal relationship (Institute of Medicine)

15. Terminology • Active Immunization • Body plays ACTIVE role in responding to an injectible antigen • Vaccines • Passive Immunization • No antigen injected, instead another animal or person’s antibodies injected into a host • IVIG, Rabies Immune Globulin, Antitoxin

16. Immunizing Antigens • Active immunizing antigen • Single antigen: diptheria toxoid or tetanus toxoid • Live attenuated = weakened virus • Killed virus or viral part • Recombinant • Conjugating Agents • Carrier proteins linked to less immunogenic polysaccharide antigens

17. Immunizing Antigens • Suspending Fluid • May be sterile water or saline • Proteins such as egg antigen, gelatin, or tissue culture derived antigens • Preservatives, stabilizers, and antimicrobial agents • Trace amounts of chemicals (eg, mercurials, such as thimerosal and certain antimicrobial agents (such as neomycin or streptomycin sulfate) prevent bacterial growth or stabilize an antigen

18. Immunizing Antigens • Adjuvants - An aluminum salt commonly is used in varying amounts to increase immunogenicity and to prolong the stimulatory effect, particularly for vaccines containing inactivated microorganisms or their products (eg, hepatitis B and diphtheria and tetanus toxoids)

19. Let’s Get to the Action Already! ADMINISTERING VACCINES

20. Site and Route of Immunization • Oral Vaccines - Vomiting within 10 minutes of receiving an oral dose is an indication for repeating the dose. If the second dose is not retained, neither dose should be counted, and the vaccine should be readministered

21. Which vaccines may be injected BOTH IM and SC?

22. IPV and Pneumococcal(polysaccharide)

23. Why IM injection? • Vaccines with adjuvants – DTaP, Hep B, Hep A • Can cause local irritation, inflammation, granuloma formation, and tissue necrosis • Immune responses after SC administration of hepatitis B or recombinant rabies vaccine are decreased compared with those after IM administration of either of these vaccines

24. Intramuscular (IM) Tissue 90°Angle Dermis Fatty Tissue (SubQ) Muscle Tissue

25. IM Site - Infant AnterolateralThigh (vastus lateralis muscle)

26. IM Sites Child/Adolescent/Adult Site of Injection Deltoid Muscle (preferred site) Site of Injection Vastus lateralis Muscle (alternative site)

27. Intramuscular Injection Technique

28. Subcutaneous • Subcutaneous (SC) injections can be administered at a 45º angle into the anterolateral aspect of the thigh or the upper outer triceps area by inserting the needle in a pinched-up fold of skin and SC tissue.

29. Subcutaneous (SubQ) Tissue 45° Angle Dermis Fatty Tissue (SubQ) Muscle Tissue

30. Subcutaneous Sites

31. Subcutaneous Injection Technique

32. 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 or • agency policy

33. Infection Control • Equipment disposal • never detach, recap or cut a used needle • place in puncture-proof container • dispose as infectious medical waste • use safety needles or needle-free devices whenever available to reduce risk of injury

34. Other Vaccine Administration Issues • Not necessary to change needles between drawing or reconstituting vaccine and administration unless needle is contaminated or bent • NEVER mix vaccines in the same syringe unless approved for mixing by the FDA

36. Other Vaccine Administration Issues • Injection sites in same limb should be separated by at least 1 inch if possible • Aspiration • not required • no reports of injury from failure to aspirate • can result in wastage of vaccine

37. Scheduling Vaccines • Live virus vaccines • Why not before 1 year of age? • Special circumstances: • Can they be given together? • How far apart? • Why so many doses of DTaP in infancy, but not in catch up schedules?

38. There remain some issues including short supply…

39. NOW GO OUT THERE AND VACCINATE!