Vaccination strategies

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Medicinal Chemistry 401 Immunizing Agents 2007
Instructor Valerie Daggett, daggett_at_u.washington
.edu
Date Time Lecturer Topic Readings Slides
5/4 830 am Daggett Vaccine Basics Chapters 1, 2, 3, 4 Chapters 1, 2, 3, 4
5/4 1030 am Daggett Vaccine Basics Chapters 1, 2, 3, 4 Chapters 1, 2, 3, 4
5/9 1030 am Daggett D, T, P Chapters 5, 6, 7 Chapters 5, 6, 7
5/11 830 am Daggett Hib, pneumo Chapters 9, 17 Chapters 9, 17
5/11 1030 am Daggett Polio Chapter 8 Chapter 8
5/23 1030 am Tasha Downing MMR Chapters 10, 11, 12 Chapters 10, 11, 12
5/25 1030 am Tasha Downing Varicella Chapter 13 Chapter 13
5/30 1030 am Daggett Influenza Chapter 16 Chapter 16
6/1 1030 am Daggett Hep. B Chapter 15 Chapter 15
Download and learn Childhood immunization schedule
The slide sets associated with the topics will be
the basis for the lectures. Extra slides may be
added and presented in lecture. You should print
the slides before class and bring them to
lecture. RESOURCES Childhood Immunization
Schedule CDC Pink Book
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Why Teach about immunizing agents in Pharmacy?

• Important health care issue
• Pharmacists can play a role with education
• Efficacy
• Vaccine controversies
• Changing recommendations
• Misinformation
• Patient compliance
• New vaccines

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Why immunize?

• It is effective
• The widespread use of vaccines has reduced the
  peak-level of incidence in the US by 95
• Immunizing also indirectly protects other people
  such as infants or those with contraindications
• It saves lives
• Ex. Measles
• Before 1963 there were gt500,000 cases/yr and
• 400-500 deaths/yr
• Now, 85 cases/yr

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Comparison of Maximum and Current Reported
Morbidity, Vaccine-Preventable Diseases
andVaccine Adverse Events, United States
Maximum cases reported in pre-vaccine era
Invasive type b and unknown serotype
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Why immunize?

• Diseases still with us
• Measles outbreak in 1989-1991
• there were gt55,000 cases and 132 deaths
• It saves money
• Measles outbreak -gt 44,000 days of
  hospitalization
• 3-4 million in direct medical treatment costs
  per 1000 cases
• 3000-4000/person
• You may be administering vaccines

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Vaccines are different

• Compounds are not drugs until they are approved
  by a regulatory agency
• Vaccines have a low rate of market entrance
• It is expensive and difficult to get them to
  market

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Vaccines are different

• Why?
• Drugs go to a small number of sick people
• Vaccines are administered to millions of healthy
  people
• Higher safety expectations
• Fear of lawsuits

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National Childhood Vaccine Injury Act

• Passed in 1986
• Goal Protect manufacturers of vaccines
• No-fault alternative to the tort system for
  resolving claims resulting from adverse reactions
  to particular vaccines
• Assumed that vaccine is responsible, which is
  very hard to prove in court

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• This act requires 2 things of those who
  administer vaccines
• Maintain permanent vaccination records
• Vaccination histroy, date, vaccine manufacturer,
  lot number, name, adverse reactions
• Report certain adverse effects to the Vaccine
  Adverse Events Reporting System (VAERS)

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• Frist Bill
• Reform to vaccine injury compensation program
• Law to apply to individual componentsmercury
• Later, new provisions to protect health care
  workers with respect to smallpox vaccine
  administration

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for act

• Excise tax
• 0.75 - 3.00 per vaccine
• All childhood vaccines carry this tax
• Fund paid out 50,000,000 in 1998
• 116,000,000 was taken in that year

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Other legal issues

• There have been many lawsuits filed against
  physicians and hospitals for failure to immunize
• All were due to ignorance usually involving
  either new vaccines or new guidelines

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Examples

• Hepatitis B carrier gives birth
• after delivery baby did not get HBIG nor HepB
  vaccine. Infant became a chronic carrier
• Hib. Child developed Hib disease which led to
  brain damage. Parents had tried to get the
  vaccine but told no because the doctor didnt
  know about it.

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Missed Opportunity
A healthcare encounter in which a person is
eligible to receive vaccination but is not
vaccinated completely
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Reasons for Missed Opportunities

• Lack of simultaneous administration
• Unaware child needs additional vaccines
• Invalid contraindications
• Inappropriate clinic policies
• Reimbursement deficiencies

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Reduction to Barriers to Immunization

• Physical barriers
• waiting time
• distance
• Psychological barriers
• unpleasant experience
• safety concerns
• misinformation

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Importance of Vaccine Safety

• Decreases in disease risks and increased
  attention on vaccine risks
• Public confidence in vaccine safety is critical
• higher standard of safety is expected of vaccines
• vaccinees generally healthy (vs. ill for drugs)
• lower risk tolerance need to search for rare
  reactions
• vaccination universally recommended and mandated

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Importance of Vaccine Safety

• Ongoing safety monitoring needed for the
  development of sound policies and recommendations

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Prelicensure Vaccine Safety Studies

• Laboratory
• Animals
• Humans

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Prelicensure Human Studies

• Phases I, II, III trials
• Common reactions are identified
• Vaccines are tested in thousands of persons
  before being licensed and allowed on the market

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Postlicensure Surveillance

• Identify rare reactions
• Monitor increases in known reactions
• Identify risk factors for reactions
• Identify vaccine lots with unusual rates or
  types of events
• Identify signals

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Postlicensure Vaccine Safety Activities

• Phase IV Trials
• 10,000 participants
• better but still limited
• Large-Linked Databases
• Clinical Immunization Safety Assessment Network

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Vaccine Adverse Event Reporting System (VAERS)

• National reporting system
• Jointly administered by CDC and FDA
• Passive (depends on healthcare providers and
  others to report)
• Receives 15,000 reports per year

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Vaccine Safety Datalink (VSD)

• Large-linked database
• Links vaccination and health records
• Active surveillance
• 8 HMOs
• 2 of the U.S. population
• Powerful tool for monitoring vaccine safety

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The Providers Role

• Immunization providers can help to ensure the
  safety and efficacy of vaccines through proper
• vaccine storage and administration
• timing and spacing of vaccine doses
• observation of contraindications and precautions

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The Providers Role

• Immunization providers can help to ensure the
  safety and efficacy of vaccines through proper
• management of vaccine side effects
• reporting of suspected side effects to VAERS
• vaccine benefit and risk communication

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Benefit and Risk Communication

• Opportunities for questions should be provided
  before each vaccination
• Vaccine Information Statements (VISs)
• must be provided before each dose of vaccine
• public and private providers
• available in multiple languages