Update on Vaccines

1
Update on Vaccines

• Kimberly A. Kendall, PharmD
• St. Elizabeth Regional Health
• June 2007

2
Objectives

• Discuss the history of vaccines.
• Discuss different types of vaccines.
• Identify different vaccines that are available on
  the market.
• Identify the various vaccines that we carry at
  our facilities.
• Identify appropriate vaccine doses for patients
  of different ages.

3
General

• The introduction of vaccines has led to a
  significant decline in worldwide morbidity and
  mortality due to various diseases.
• Vaccines have been shown to be generally safe
  and cost-effective.
• Vaccines trick the immune system into producing
  antibodies or immune cells that protect against
  disease-causing organisms.

4
General

• 1796- Edward Jenner, an English physician,
  observed that milkmaids stricken with cowpox
  rarely became infected with smallpox.
• This led to the development of first vaccine.
• He inoculated a young, healthy child with fluid
  from a cowpox pustule.
• He later inoculated the child with fluid from a
  smallpox pustule.
• The child remained disease free.

5
General

• By 1980, an updated version of Jenners vaccine
  led to the eradication of smallpox
• By the beginning of the 20th century, vaccines
  for rabies, diphtheria, typhoid fever and plague
  in addition to smallpox vaccine had been
  produced.
• We now have vaccines against more than 20
  infectious diseases.

6
Types of Vaccines

• Weakened microbes
• Killed microbes
• Inactivated toxins
• Subunit vaccines
• Conjugate vaccines
• Vaccines from biotechnology

7
Weakened Microbes

• Live microbes weakened by growing them for many
  generations in animals or tissue cultures
• Inoculated into humans to provide protection from
  disease causing microbes
• Ex Oral Polio Vaccine, Mumps, Measles, Rubella,
  Varicella

8
Killed Microbes

• Derived from whole organisms that have been
  killed
• Do not cause disease in people who receive them,
  but they can stimulate the immune system
• Ex Polio and Influenza

9
Inactivated Toxins

• Some bacteria cause disease by producing toxins
  that invade the bloodstream
• Inactivated toxins are used to prevent the same
  diseases
• Ex Tetanus and Diphtheria

10
Subunit Vaccines

• Use only part of a bacterium or virus
• Produce effective immune response without
  creating a separate and potentially harmful
  immune reaction to the other antigens on the
  microbe
• Ex Typhoid and Hepatitis B

11
Conjugate Vaccines

• Bacteria that cause certain diseases have an
  outer coat that cannot be recognized by the
  immature immune systems of infants
• These vaccines link together proteins or
  inactivated toxins from a second organism to the
  outer coat of the bacteria
• Allows the immune system to respond to the
  combined vaccine and produce antibodies
• Ex Haemophilus Influenza Type B

12
Vaccines from Biotechnology

• Made by altering an organisms genetic structure
  by cutting out a key gene
• Allows the organism to produce immunity but not
  disease
• Can also insert a gene into an organisms genetic
  material,causing it to mass produce foreign
  proteins or antigens which can induce an immune
  response
• DNA is removed from an organism and modified so
  that it contains only a fragment of the original
  genetic material
• When put into humans, the body generates antigens
  to protect against disease

13
Edible Vaccines

• Edible vaccines have been developed to produce an
  immune response to E. coli bacterium and Norwalk
  virus
• Potatoes, bananas, and tomatoes have been
  genetically engineered to initiate an immune
  response when eaten

14
Vaccine Administration

• SQ injections
• Thigh of infants
• Deltoid area of older children and adults
• IM injections
• Upper thigh of infants and toddlers
• Deltoid muscle of arm for children and adults
• The buttock should not be used
• Potential for inadequate response
• Potential risk of injury to sciatic nerve.
• Must be used for large doses of immunoglobulin.
  Use only the upper, outer quadrant.

15
Special Populations

• Age of the recipient is a determining factor in
  vaccine and toxoid response.
• In the first few months of life, passive immunity
  from the mother protects an infant and prevents
  adequate vaccine response to certain agents.
• Premature infants should be vaccinated at the
  same chronologic age using the same schedule and
  precautions as full-term infants.
• The full doses should be given regardless of age
  or birth weight. ( Hepatitis B vaccine should be
  given if the infant is 2,000 g or held until 2
  months old.)

16
Special Populations

• Administration of live, attenuated vaccines
  should be avoided during pregnancy.
• Inactivated vaccines should not be given until
  the 2nd trimester. (However, they have not been
  shown to be teratogenic during the first
  trimester.)
• Administration of rubella vaccine during
  pregnancy is not a reason to interrupt pregnancy.

17
Special Populations

• Diphtheria and tetanus vaccination should be
  carried out per usual schedule during pregnancy.
• Hepatitis B, inactivated polio and pneumococcal
  vaccines are all recommended during pregnancy, if
  indicated.
• Pregnant women in 2nd or 3rd trimester during flu
  season should get flu vaccine.

18
National Vaccine Injury Compensation Act (NVICA)

• Passed in 1986.
• Outlines compensation for vaccine-related
  injuries and limits size of awards to injured
  individuals.
• Frees manufacturers from liability if adequate
  warnings for vaccines are provided.
• Health care providers and manufacturers must
  report adverse reactions to vaccines to the FDA
  within 7 days of occurrence.

19
National Vaccine Injury Compensation Act (NVICA)

• Mandatory record keeping by health care providers
  in the permanent medical record (the manufacturer
  and lot number, date of administration, and name,
  address, and title of the person giving the
  vaccine must be recorded).
• Also mandates that healthcare providers report to
  their health department or the FDA any adverse
  reactions.
• Vaccine Adverse Event Reporting System (VAERS)
  1-800-822-7967.
• Policy at St Elizabeth Regional Health

20
Diphtheria Toxoid Adsorbed

• Suspension of modified toxins which produce
  immunity against exotoxin of organism
• Pediatric strength and adult strength (has less
  antigen than pediatric strength)
• Given to kids with tetanus toxoid and acellular
  pertussis vaccines (DTap)
• Dose- 0.5 ml IM given at 2,4,and 6 moa, then
  15-18moa, then 4-6 yoa
• Boosters every 10 years
• Component of ADACEL, BOOSTRIX, Pediarix,Tripedia,I
  nfanrix, and Daptacel

21
Diphtheria Antitoxin

• Antitoxin derived from hyperimmunized horses
• Used in patients with diphtheria
• Given IM or IV
• Dose is related to the severity and duration of
  illness

22
Tetanus Toxoid and Tetanus Toxoid Adsorbed

• Suspensions of toxoid from bacterium
• Tetanus Toxoid
• Not preferred product
• Tetanus Toxoid Adsorbed
• DECAVAC- single agent
• Adsorbed onto aluminum salts
• Preferred product because it elicits greater
  response with fewer adverse reactions

23
Tetanus Toxoid Adsorbed

• Children
• Use DTap 0.5ml IM at 2,4,6 moa,15-18moa
• gt 7yoa use Td (Tetanus Toxoid with Diphtheria
  Toxoid)- 0.5 ml IM
• Adults
• Same as for children gt7 yoa
• Boosters every 10 years with Td
• Also component of Pediarix, Tripedia, Infanrix,
  Daptacel, ActHib, ADACEL, and BOOSTRIX

24
Wound Management

• Traumatic wounds require booster with Td if
  patient has not gotten booster in past 5 years.
• Certain wounds also require administration of
  immunoglobulin.
• Clean wounds require no treatment.

25
Tetanus Immunoglobulin

• From hyperimmunized humans
• Provides passive immunity to tetanus following
  traumatic wounds in nonimmunized or sub optimally
  immunized persons
• Dose- prophylaxis 200-500 units IM
• Dose- treatment 3,000-6,000 units IM

26
Hepatitis A Vaccine

• Havrix and Vaqta
• Inactivated virus
• Havrix 2-18yo 0.5ml at 0 and 6-12 months
• gt18 yo- 1ml at 0 and 6-12 months
• Vaqta 2-17yo 0.5ml at 0 and 6-18 months
• gt17 yo 1 ml at 0 and 6 months
• Indicated for certain at risk populations and
  those who may expose large numbers of people if
  they became exposed.
• Plan is to eradicate Hepatitis A by vaccinating
  all children 2 yoa or younger
• TwinRx- combo product with Hepatitis B vaccine

27
Hepatitis B Vaccine

• Engerix-B and Recombivax-HB- both inactivated
• Vaccinate certain adult populations
• Vaccinate all newborns (thimerisol free products)
• Babies born to (-) moms
• 5 mcg Recombivax or 10 mcg Engerix-B
• 1st dose at 0-2 days old, 2nd dose at 1-2 moa,
  3rd dose at 6-18 moa or 2,4, and 6-18 moa
• Babies born to () moms
• 1st dose within 12 hours of birth, 1 moa and 6 moa

28
Hepatitis B Vaccine

• Adults/older children
• lt19yoa 5 mcg Recombivax or 10mcg Engerix at
  0,1,and 6 months
• 11-15 yoa 10mcg Recombivax (only) and 0 and 6
  months
• gt/ 19yoa 10mcg Recombivax or 20mcg Engerix at
  0,1,and 6 months

29
Hepatitis B Vaccine

• Combination products
• Twinrx - with Hep A
• Pediarix- with diphtheria,pertussis, tetanus and
  polio

30
Hepatitis B Immunoglobulin

• NABI-HB
• Post exposure
• From pooled plasma from human donors
• Passive immunity following exposure
• Infants born to Hep B carrier Moms
• Give within 24 hours of exposure
• Not recommended beyond 14 days of exposure

31
Haemophilus Influenza Type B Vaccines

• Conjugate products (linked to a protein carrier)
• Recommended for routine use only for patients up
  through 59 months of age
• ActHIB, HibTiter, PedvaxHib,OmniHIB,ProHIBiT,DTaP-
  Hib
• Peds- 2-6 months of age 0.5ml IM x 3 doses at 2
  month intervals. Booster at 15 months or older.
• 0.5ml IM at 2,4 and 6 moa. Booster at 12-15moa
• Not for kidslt6 weeks old
• Do not give shotslt 2 months after previous dose

32
Human Papillomavirus Vaccine Quadrivalent

• Gardasil
• Protects against certain cervical cancers and
  genital warts
• 0.5 ml IM at 0,2 and 6 months
• Not evaluated in patients gt26yoa or lt9 yoa
• Does not prevent all cervical cancers
• Not recommended for pregnant patients
• Cervarix- pending FDA licensure

33
Influenza Virus Vaccine

• Fluarix, FluLaval, Fluzone
• Antigenic composition of vaccine is determined
  year to year by the predominant circulating
  strains
• Inactivated virus
• Recommended for pts gt 6 moa with chronic medical
  conditions and all people over 50 yoa and other
  designated populations
• Adult dose 0.5ml IM
• October-November is the optimum time for
  immunization

34
Influenza Virus Vaccine

• Split-virus vaccine used for children
  6moa-12yoa-less reactogenic than whole virus
• Children 6-35moa receive 0.25ml
• All children lt9 yo need 2 doses at least 1 month
  apart if receiving vaccine for first time

35
Measles Vaccine

• MMR-II (measles, mumps and rubella)
• Live attenuated viral vaccine
• Peds 0.5 ml SQ at 12-15 months and 4-6 yoa
• Give 1 month before or after administration of
  other live viral vaccines
• Revaccination should be considered for students
  entering college

36
Meningococcal Vaccine

• Polysaccharide vaccine-Menomune
• Adult gt 55 yoa- 0.5ml sq as a single dose-
  primary or revaccination
• Pediatric
• 19 moa-10 yoa 0.5 ml SQ as single dose
• 3-18 moa 0.5 ml SQ for 2 doses

37
Meningococcal Vaccine

• Diphtheria conjugate- Menactra
• Adults up to 55 yoa- 0.5ml IM
• Pediatric 11yoa or older- 0.5 ml IM
• Provides longer lasting immunity
• Recent push to get adolescents and college
  freshmen vaccinated

38
Mumps Vaccine

• Live attenuated vaccine
• Usually given as MMR
• Dose 0.5ml SQ
• First dose at 12-15 moa with 2nd dose prior to
  entry into elementary school
• Vaccinate previously unvaccinated adults, those
  vaccinated with killed mumps vaccine or those
  with questionable hx of infections
• Should not be given to pregnant women
• Avoid conception for 3 months following
  vaccination

39
Pertussis Vaccine

• Acellular vaccines contain the toxin and some
  contain additional bacterial components
• Given at 2,4,6 and 15-18 moa
• Fifth dose at 4-6 yoa
• Administered in combination with Diphtheria and
  tetanus (DTaP)
• BOOSTRIX- 10-18 yoa- 0.5 ml IM
• ADACEL- 11-64 yoa- 0.5 ml IM
• Combo products Tripedia, Infanrix, Daptacel,
  Pediarix

40
Poliovirus Vaccines

• Inactivated vaccine recommended.
• Oral vaccine not routinely used in the US
• Ipol- poliovirus vaccine, inactivated
• Adults- 0.5ml IM/SQ x 3 doses at 0,1-2 months and
  6-12 months (not routinely recommended because of
  high level of immunity in ths age group)
• Pediatrics- not tested in childrenlt6 weeks
• 0.5ml IM/SQ x 4 doses at 2,4,6 moa with booster
  at 4-6 yoa
• Component of Pediarix

41
Pneumococcal Vaccine

• Recommended for personsgt/ 65yoa and certain
  other populations
• Polyvalent polysaccharide- Pneumovax23 and
  Pnu-Imune 23
• Adult- 0.5ml IM /SQ as single dose
• Pediatrics- not tested lt2 yoa- 0.5ml IM/SQ as
  single dose
• Pneumococcal vaccine, diphtheria conjugate-
  Prevnar
• Not for adults
• Pediatrics- 0.5ml IM x 4 doses- 2,4,6 mo and
  booster at 12-15 Mo
• not for childrenlt 6 weeks old

42
Rabies Vaccine

• Killed Vaccine
• Imovax Rabies and Rabavert
• Adult- post exposure prophylaxis- unvaccinated
• 1 ml IM x 5 doses, days 0,3,7,14 and 28
• Human Rabies Immune Globulin (HRIG, Imogam) on
  Day 0 20 international units/ kg IM
• Adult- post exposure prophylaxis-previously
  vaccinated
• 1 ml IM x 2 doses , Days 0 and 3

43
Rabies Vaccine

• Pre-exposure prophylaxis
• 1 ml IM x 3 doses, Days 0,7, and 21-28
• Booster- depends on titers
• Does not eliminate need for post exposure
  prophylaxis
• Peds dose same as adults.

44
Rubella Vaccine

• Contains attenuated virus- German Measles
• Available alone or in combo with measles and
  mumps vaccines
• Meruvax II- single agent
• MMR II- combination product
• Children 1 yoa or older 0.5 ml sq
• All women of childbearing potential should have
  documentation of receiving at least one dose or
  lab evidence of immunity

45
Varicella Vaccine

• Live, attenuated vaccine
• Varivax, Zostavax
• Varivax-
• gt/ 13 yoa- 0.5ml SQ x 2 doses at 0 and 4-8 weeks
• 12 moa-12 yoa-0.5ml SQ at 12-18moa and 4-6 yoa
• Not studied in children lt 12 moa
• Can be used for post-exposure prophylaxis w/in 3
  (possibly 5 days) of exposure
• Contraindicated in pregnancy

46
Varicella Vaccine

• Zostavax
• prophylaxis of herpes zoster and post herpetic
  neuralgia
• adults gt/ 60 yoa 0.65ml SQ x1
• Not approved in kids
• Targets herpes zoster manifestations of the
  varicella zoster virus (VZV)
• Same viral component as in Varivax, but at a 14-
  fold higher concentration

47
Varicella-Zoster Immunoglobulin

• Passive immunity to susceptible immunodeficient
  patients exposed to chickenpox
• Children with immunodeficiency, neoplastic dz, or
  who are on immunosuppressive therapy
• Neonates whose moms develop varicella within 5
  days before or 2 days after delivery
• Preterm infants who are exposed to chickenpox in
  hospital
• Susceptible pregnant women
• Immunosuppressed adults and adolescents

48
Varicella-Zoster Immunoglobulin

• Give within 48-96 hours post-exposure
• IM route 125units/10kg up to 625 units
• Newborns 125 units

49
Rotavirus Vaccine

• RotaTeq
• Viral gastroenteritis due to Rotavirus 2ml
  orally at 2 months, 4 months and 6 months of age
• First dose between 6 and 12 weeks of age, with
  all doses received by 32 weeks
• Should be separated by 4 to 10 week intervals
• Should not start series in children gt 12 weeks of
  age

50
Respiratory Syncytial Virus Vaccine

• Synagis
• Prophylaxis 15mg/kg IM monthly during RSV season
  (November-April) for up to 5 doses
• Who?-
• Certain preemies
• Certain infants and children with chronic lung
  disease
• Certain infants and children with congenital
  heart disease

51
Anthrax Vaccine

• Biothrax
• Post exposure 0.5 ml sq immediately with repeat
  doses at 2 and 4 weeks in conjunction with
  chemoprophylaxis (Cipro 500 or doxycycline 100mg
  po bid)
• Continue antibiotics until exposure is excluded
  or confirmed
• If confirmed, continue therapy at least 14 days
  after 3 rd vaccine dose

52
Anthrax Vaccine

• Chemoprophylaxis without vaccine is 60 days
• Pre-exposure 0.5 ml sq x 3 doses at 0,2,and 4
  weeks. Followed by 3 additional doses at 6,12
  and 18 months.
• Boosters every year
• Not FDA approved for kids
• Use different sq sites for sequential injections

53
Smallpox Vaccine

• Dryvax
• Intradermal administration only
• Children 12moa and older- not part of routine
  vaccinations
• Contraindicated in pregnancy

54
Combination Vaccines

• Boostrix and ADACEL
• Tetanus toxoid, reduced diphtheria toxoid and
  acellular pertussis
• Infanrix-diphtheria tetanus toxoids acellular
  pertussis vaccine, adsorbed
• Twinrix- Hep A and Hep B
• Pediarix- diphtheria, petussis, tetanus, polio
  Hep B
• ProQuad and MMRV- measles, mumps and rubella with
  varicella

55
Vaccines At St. Elizabeth Regional Health

• Prevnar
• Hibtiter, ActHib
• Hepatitis immune globulin- NabiHib
• Engerix B and Recombivax
• Flulaval
• MMR II
• Menomune
• Infanrix
• ADACEL

• Pneumovax 23
• IPOL
• Imogam Rabies HT
• Rabavert
• Meruvax II
• DECAVAC
• Tetanus toxoid/diphtheria adsorbed
• Synagis

56
Link to Autism

• No proof of a link
• Suspect thimerosal/mercury used as a preservative
  in vaccines (especially the MMR Vaccine)
• Why? Similarity between autism and symptoms of
  mercury poisoning

57
Specific Recommendations

• Splenectomy patients
• Pneumococcal, H flu, Meningococcal vaccines plus
  annual flu vaccine
• HIV patients
• Pneumococcal and annual flu vaccines
• Community acquired pneumonia-prevention
• Pneumococcal and annual flu vaccines

58
Under Investigation

• Cancer vaccines- potential advantage of
  controlling systemic disease using the bodys own
  innate ability to destroy unwanted cells with
  minimal toxicity
• Colorectal cancer - Breast cancer
• Melanoma
• Others
• HIV/AIDS - TB
• Plague - Alzheimer's
• Lyme Disease - Bird Flu

59
References

• Aberg JA, Gallant JE, Anderson J. et al. Primary
  Care Guidelines for HIV. CID 200439 (1
  September).
• Bertino JS and MS Hayney. Vaccines, Toxoids, and
  Other Immunobiologics. Pharmacotherapy A
  Pathiophysiologic Approach. 5th ed. Dipiro, JT,
  Talbert, RL, and GC YEE, eds. New York Appleton
  and Lange 2002 2123-2142.

60
References

• CDC Homepage. Resource on World Wide Web. URL
  www.cdc.gov. Available from Internet. Accessed
  2007 Jan 21.
• Gardasil Home Page. Resource on the World Wide
  Web. URL www. Gardasil.com. Available from
  Internet. Accessed 2007 Jan 28.
• Gardner P, Pickering LK, Orenstein WA. Quality
  Standards of Immunization. CID 200235 (1
  September).

61
References

• Mandell LA, Wunderink RG, Anzueto, Antonio et al.
  IDSA/ATS Guidelines for CAP in Adults. CID
  200744 (Suppl 2).
• Micromedex Healthcare Series. Resource on World
  Wide Web. URL www.thomsonhc.com Available from
  Internet. Accessed 2007 Jan 28.
• Pharmacists Letter Home Page. Resource on World
  Wide Web. URL www.pharmacistsletter.com.
  Available from Internet. Accessed 2007 April 18.

62
References

• Reisinger KS, Block SL, Laycano-Ponce E et al.
  Safety and Persistent Immunogenicity of a
  Quadrivalent Human Papillomavirus Types
  6,11,16,18 Virus. Journal of Pediatric Infectious
  Disease. 2007 26(3) 201-209.
• TACA Home Page. Resource on World Wide Web.
  URL www.tacanow.com. Available from Internet.
  Accessed 2007 Jan 2007.