Public Health 6399: Vaccine Policy
What is the Vaccine Injury Compensation Trust Fund?
$0.75 Excise tax levied on each dose of vaccine for each disease prevented in the dose MMR Vaccine = 3 diseases at $0.75 each = $2.25 tax per dose Balance as of March 2013: $1.8 billion
Factors that encourage vaccine manufacturers...
1.) Development of financial incentives a.) Government support of R&D, constructing or upgrade of facilities 2.) Simplification of the regulatory process (FDA) a.) Harmonization of international requirements Increase payments for vaccines Development or enhancement of stockpiles Addressing liability issues a.) National Vaccine Injury Compensation Program Enhancing communication and collaboration among key stakeholders a.) Education
Factors that discourage vaccine manufacturers...
1.) Manufacturers unexpected departures from the market 2.) Decrease in private market 3.) Low insurance reimbursements 4.) Lack of infrastructure support 5.) Public attitudes towards vaccines 6.) Lack of immediate surge capacity 7.) Production problems 8.) Unable to satisfy current Good Manufacturing Practices 9.) Renovations causing halt in production 10.) Inadequate reserves to cover supply disruptions 11.) Smaller market generally when compared to drugs or influenza vaccine 12.) Product liability concerns
What was determined in Bruesewitz v. Wyeth?
10/12/2010 Supreme Court hears the case Involves an injury resulting from DPT vaccine Family petitioned Vaccine Court; rejected the award Petitioners filed a claim in state court and lost all appeals 2/22/2011 Supreme Court decision - VICP preempts all design defect claims against manufacturers
How have vaccine mandates grown?
1827 first mandate in Boston, targeted smallpox By 1963 a.) 20 states and DC had mandates targeting various vaccines Late 1960 - early 1970s a.) Measles outbreaks highlighted the value of enforcement By early 1990s, nearly half of states had mandates 2008 a.) All states have mandates for daycare through high school
What is the Vaccine Safety Datalink (VSD)?
1990: Collaborative Project a.) Immunization safety office, CDC b.) Nine large MCOs Objectives a.) Conduct population based research on immunization safety questions b.) Evaluate immunization safety hypotheses that arise from medical literature, passive surveillance systems, adjustments to immunization schedules, and introduction to new vaccines c.) Guide national immunization policy decisions d.) Partner with healthcare providers, public health officials, and others to ensure the public has the best available information regarding the risks and benefits of immunization Large Linked Database (LLDB) a.) Population based method to determine vaccine safety b.) Consists of defined populations: HMOs, Medicaid, single provider systems numbering from thousands to millions c.) Started with 500,000 individuals, birth through 6 years d.) Expanded to include adolescents and adults e.) Researchers are permitted to access data for study purposes
Vaccines prevent ___ million cases of vaccine preventable diseases, ___ premature deaths, and save $___ in direct costs and $___ in total societal costs.
20 million 42,000 $14 billion $69 billion
What is the Clinical Immunization Safety Assessment Network (CISA)?
2001, established as a collaborative project between the Immunization Safety Office a.) 6 medical research centers and America's Health Insurance Plans Goals a.) Study the basis of adverse events following immunization using hypothesis driven protocols b.) Study risk factors associated with developing an adverse event following immunization c.) Provide clinicians with evidence based guidelines when evaluating adverse events following immunization d.) Provide clinicians with evidence based vaccination or revaccination guidelines e.) Serve as a regional referral center to address complex vaccine safety inquires First coordinated facilities in US a.) Systematically collect and evaluate adverse events post-immunization on an individual patient level b.) CISA Network Sites i.) Boston University ii.) Columbia University iii.) Johns Hopkins iv.) Northern California Kaiser Permanente v.) Stanford University vi.) Vanderbilt University Peer Review a.) Several cross cutting challenges were identified Case Review and Working Group Environment a.) Consistent case review i.) On going analysis ii.) In depth review iii.) Consistent key issues iv.) Deep understanding at the provider level b.) Working group i.) Key methodological issues
What is the public's response to vaccine mandates?
95% of parents comply Government intrusion on personal medical decisions Vaccines are not safe, effective, necessary Public minimizes the seriousness of vaccine preventable diseases Costly and inconvenient
Proposed elements of a model mandatory vaccination law for health care workers...
Affected employees a.) Those who have direct or indirect contact with patients Affected employers a.) Health care facilities b.) Temporary agencies Employer Obligations a.) Choose appropriate timing for administration b.) Provision of vaccine c.) Pay for the vaccine d.) Develop and manage documentation requirements e.) Comply with reporting requirements f.) Develop and conduct education campaigns g.) Manage non-compliant employees (Different sanctions, up to and including termination) Employee Obligations a.) Receiving the vaccination according to law b.) Choosing site of administration c.) Providing employer with appropriate documentation Opt Outs a.) Medical contraindication b.) Personal belief c.) Religious d.) Declination Statement
Explain school immunization requirements...
All mandates permit at least one opt out possibility a.) Medical contraindication (all jurisdictions) b.) Religious (49 jurisdictions MS, WV) c.) Philosophical or Personal Belief (19 states) i.) Less than 1% use opt outs ii.) 95% of children receive all recommended vaccines d.) All vaccines must be individually considered for inclusion in the vaccine panel unless the state has adopted the ACIP standard Vaccine Mandates a.) Convert immunization recommendations into i.) Legally enforceable obligations ii.) That have been upheld by courts throughout the country Effectiveness of mandates a.) Have proven to be the most effective strategy to increase coverage levels for children
Vaccines have saved more lives than ___ or ___.
Any surgical technique or any medication, including antibiotics.
What are CBER's responsibilities in the vaccine approval process?
Approve a.) Investigational New Drug Application (IND) - 1) Describes the vaccine, 2) Method of manufacture, 3) Quality control tests for release; 4) Vaccine's safety & immunogenicity info from animal testing; 5) Proposed clinical protocol for studies in humans Supervise a.) Clinical Trials (Phase I - III) Review a.) Biologics License Application (BLA) - Describes efficacy & safety information necessary to make a risk/benefit assessment & to recommend the vaccine (or not) Voluntary Review a.) Collaborate with sponsor to present findings to FDA's Vaccines & Related Biological Products Advisory Committee (VRBPAC), a non FDA expert committee that advises on safety & efficacy Review a.) Product Labeling that is required to include: proper use, benefits, risks Monitoring a.) Requires manufacturers to test samples from each lot for safety, potency, purity b.) FDA performs facility inspections and spot sampling Clinical Trials a.) Phase IV may be required to identify all potential adverse events
How many reports does VAERS receive annually?
Approximately 30,000 annually Approximately 13% classified as serious
Vaccines and the violation of the free exercise clause - interference with religious beliefs...
Balanced an individual's right to religious expression against important societal interests Held that religious exemptions to immunization requirements are not constitutionally required
What is the National Vaccine Injury Compensation Program (NVICP)?
Before VICP ... 1970s to the mid 1980s a.) 1972: # of DTP vaccine manufacturers in the US = 5 b.) 1978: 1st lawsuit filed against a vaccine manufacturer in a state court i.) Asserted that the DTP vaccine caused serious injuries or death c.) 1980 to 1985: 219 claims filed requesting damages of over 3 billion dollars i.) Litigation and insurance costs = increase in vaccine prices ii.) 1984 cost per dose = $0.11 iii.) 1986 cost per dose = $11.40 ($8.00 = insurance) d.) 1984: # of DTP vaccine manufacturers in the US = 2 Vaccine shortages put millions of children at increased risk of disease a.) Congress understood b.) The critical need for vaccines to protect the public c.) The inevitable but rare adverse events d.) The inadequacy of the legal system to address compensation due to i.) Uncertain recovery ii.) High cost of litigation iii.) Delays in compensation The instability of the vaccine supply because a.) The cost of litigation b.) Occasional large recoveries c.) Higher insurance premiums d.) Rising cost of vaccines
What was decided in Jacobson v. Massachusetts?
Compulsory smallpox vaccination ordinance Henning Jacobson argued the ordinance infringed on his person liberty The liberty secured by the Constitution of the United States to every person does not import an absolute right in each person to be, at all times and in all circumstances, wholly freed from restraint. There are manifold restraints to which every person is necessarily subject for the common good
What does the National Vaccine Program Office (NVPO) do?
Coordinates & ensures collaboration among Federal agencies involved in vaccine & immunization activities Staffs the National Vaccine Advisory Committee (NVAC)
What is the role of the Advisory Committee on Immunization Practices (ACIP)?
Creates the national standard of care a.) Created by the Omnibus Budget Reconciliation Act of 1993 Goals a.) Provide advice to reduce disease b.) Increase safe use of vaccines Administered by the CDC 15 experts in immunization-related fields: chosen by HHS Sec'y Review new vaccines & provide continuing guidance to the Sec of HHS regarding the most appropriate application of licensed vaccines for the civilian population Defines appropriate populations for vaccines May alter or withdraw their recommendation as new information becomes available Draft the pediatric vaccine schedule The VFC-covered list of vaccines are updated to reflect recommendations
What kind of awards can you get from VICP?
Death award a.) Maximum $250,000 death benefit to the estate of the deceased (lump sum) b.) Attorneys' fees and reasonable litigation costs Injury Award a.) Unreimbursed past and future medical costs and related expenses (no limit but must be within reason) - e.g., durable medical equipment b.) Lost earnings c.) Pain and suffering (actual and projected) - up to $250,000 d.) Attorneys' fees and reasonable litigation costs Total Outlay a.) $2,669,557,246.13
The road to research and development is...
Difficult, complex, lengthy (8-18 yrs)* Costly (estimates $200 - $900 million)* Risky Rigidly controlled by the government must comply with cGMP More expensive than other pharmaceuticals: a.) Vaccines are given to healthy people b.) Often under compulsion, thus c.) Risk of adverse events must be low Primary goal = safety at all costs
What vaccines are part of the childhood immunization series?
Diphtheria, tetanus, pertussis, measles, mumps, rubella, polio, Influenzae B, Hepatitis B, Varicella, Pneumococal
FDA has adapted to demands for increased responsiveness by...
Early & intensive interaction with industry to encourage development of new products Collaborate in rapid turnaround in product review Inspect manufacturing facilities Increased communication with international regulatory counterparts Critical path research approach a.) Creates a bridge from discovery to licensure b.) Focuses on development in priority areas to promote increased efficiency, rapid product development and availability c.) Utilized during 2004 influenza vaccine shortage & pandemic preparedness
What is EPSDT?
Early, Periodic, Screening, Diagnosis and Treatment Medicaid is required to cover vaccines recommended by ACIP
What key aspects of vaccines does ACIP address?
Efficacy Dosage Contraindications & precautions Periodicity Storage & handling Administration techniques Recognized adverse events Cost & risk/benefit analyses
What is Section 317?
Enacted in 1963 under the public health services act 100% federally funded grants through discretionary annual appropriations process, administered by the CDC The CDC awards grants to 64 programs a.) 50 states b.) 6 large cities c.) 8 territories Funds support a.) Vaccine purchase b.) Infrastructure needs The majority of funds supports childhood programs for those ineligible for VFC a.) Due to funding decreases, Sec 317 vaccines can no longer be provider to privately insured children in County Health Departments and by some public providers AS of 1994, funds can be used to provide adults vaccines
What is CHIP?
Enacted in 1997 for children in families with incomes that are too high for Medicaid but have no insurance ACIP standard applies
Where are vaccine mandates developed?
Enactment of school attendance laws Development of schools where large numbers of children congregate Continuing outbreaks of infectious disease Availability of vaccine Enactment of school entry requirements Inclusion of new vaccines as they become available prevent the spread of disease in schools
When was the Vaccine Adverse Event Reporting System established? What were it's primary objectives?
Established in 1990: Implemented by CDC and FDA Covers the entire US population Primary objectives a.) Detect new, unusual, or rare vaccine adverse events b.) Monitor increases in known adverse events c.) Identify potential patient risk factors for particular types of adverse events d.) Identify vaccine lots with increased numbers of types of adverse events e.) Assess the safety of newly licensed vaccines
What is the Vaccines for Children program?
Established in 1994 100% federally funded Creates federal entitlement to immunizations for qualified children Provides free vaccines to children ages 0 to 19 who are a.) Uninsured b.) Underinsured c.) Only at FQHC or Rural Health) Medicaid Eligible, American Indian, Alaska Native Direct purchase and delivery system Negotiates vaccine price with manufacturers Vaccines are distributed to public health clinics that provide vaccine to enrolled private providers Participants a.) 61 state, local, territorial immunization programs Supports concept of medical home Increases access to new vaccines for low income families Very responsive to newly recommended vaccines Pediatric vaccine stockpile a.) Funds the stockpile, a 6 month supply of all vaccines b.) Alleviate impact of shortages 2010 statistics a.) $82 million doses b.) 44,000 participating providers c.) $3.6 billion d.) 40 million children vaccinated through VFC Sequester Effects on Vaccine Programs 1.) As a program VFC will not really be affected by sequester a.) But 317 will
What does the National Vaccine Advisory Committee (NVAC) do?
Established: 1987 Advises & makes recommendations to the Director of the Assistant Secretary for Health in his capacity as director of the National Vaccine Program Studies & recommends ways to encourage availability of an adequate vaccine supply Recommends research priorities & measures to enhance safety & efficacy of vaccines Advises the Program Director re: implementation of Sec, 2102 & 2103 of the Public Health Service Act Identifies most important areas of government & non-government cooperation
ACIP recommendations trigger 3 avenues to access...
Federal Funding a.) Ensured access to vaccines through VFC and 317 b.) Ensured access to vaccines through Medicaid, CHIP Private Market Funding a.) Increased access to vaccines through private health insurance coverage State statutes a.) Increased access to vaccines through school entry requirements
What are some common public attitudes that create barriers to immunization?
Government intrusion regarding personal medical decisions Vaccines are generally unsafe, ineffective, unnecessary Fail to appreciate the seriousness of vaccine preventable diseases Too expensive and inconvenient
By the team a female is 18, she should have routinely received vaccinations against 16 diseases. They are...
Hepatitis B Rotavirus Diphtheria Tetanus Pertussis Haemophilus influenzae type b Pneumococcal Inactivated Poliovirus Measles Mumps Varicella Rubella Hepatitis A Human Papillomavirus Meningococcal Influenza (Annually)
Final thoughts on vaccines and healthcare workers...
Impossible to predict with absolute certainty how a court will decide a care However, courts must rely on previous relevant decisions Health care workers have the same rights as other individuals In the final analysis, courts will prioritize the rights of the community as a whole when considering the case of mandatory health worker vaccination
What groups have an interest in the provision of population level vaccination?
Industry Governments Hospitals Healthcare Providers Workplace Vulnerable Populations
What is the disease burden of smallpox?
Mild Cases: Sunken scars in skin Severe Cases: Blood poisoning, secondary infection, No treatment Beauty decorations (veils, beauty marks) covered scars
What are some arguments in support of mandatory vaccination of healthcare professionals?
Moral imperative a.) Protect patients from harms b.) Act in best interest of patients Successful example = school entry requirements Failure to require vaccination may result in institutional liability for related harm to patients
What are some issues with universal purchase?
Newly Recommended Vaccines a.) High cost stresses states' ability to maintain programs b.) 2 tiered systems are developing c.) Maintenance of uniform coverage policy d.) UPS states Administration fees a.) Are determined by states and often do not cover providers' costs Vaccine manufacturer opposition a.) Single purchaser policy negatively impacts profit and suppresses incentives to conduct research and manufacture new vaccines Use of Public funds a.) Utilizes limited public funds for individuals who can purchase vaccines on the private market
Are pharmaceautical companies obligated to make vaccines?
No, they are not. They are businesses, not public health agencies.
Explain the global vaccine market...
Once considered a low-profit segment of pharmaceutical company's portfolios Premium priced vaccines (Prevnar, Gardasil & Cervarix): a.) Strengthened revenue streams b.) Prompted pharmaceutical companies to invest in the vaccine industry Investments in product extension strategies - common in pharmaceutical industry, now used in vaccine industry a.) Gardasil ? development to include 9 strains ? up from 4 Global vaccine industry valued at $24 billion in 2009 Expected to reach $52 billion in 2016
Does Medicaid cover vaccinations?
Optional adult vaccination coverage
Explain the history of variolation?
Originated in the southern province of Szechuan Prime Minister?s son dies of smallpox His father called upon all wise men, physicians and magicians from all over the Empire to try to identify a remedy A monk introduced variolation, precursor to vaccination
Vaccine coverage and Medicare Part B and Part D...
Part B a.) Individuals entitled to Part A and others 65 and older i.) Pneumococcal ii.) Hepatitis B iii.) Influenza iv.) Administration Fee Part D a.) Vary based on what plan you choose b.) All Part D plans must cover all vaccines that are not covered by B
How do you access VICP?
Persons eligible to file a claim a.) Those who received a vaccine while in US b.) If recipient was outside of the US i.) Must be US citizen employed by the US government or dependent of US citizen ii.) Must have received a vaccine manufactured in the US and the recipient returned to the US by 6 months post vaccination c.) Recipients of a covered vaccine d.) Recipient's parents or legal guardian e.) Decreased recipient's legal representative i.) If the death was believed to have been caused by a covered vaccine In order to file a claim the injury must a.) Last more than 6 months post vaccination, or b.) Require a hospital stay and surgery, or c.) Result in death Filing fee: $350 (must be waived by Special Master) Legal counsel not required Legal fees: routinely awarded, within reason, regardless of the outcome of the claim (for claims brought in "good faith") a.) Good faith: a state of mind representing i.) Honesty in belief or purpose ii.) Faithfulness to one's duty or obligation iii.) Observance of reasonable commercial standards of fair dealing in a given trade or business iv.) Absence of intent to defraud or to seek unconscionable advantage Filing deadlines a.) Injury: within three years after the first symptom i.) New injury ii.) Significant aggravation of existing condition b.) Death: within 2 years of the death i.) 4 years after the start of the first symptom of the vaccine related injury from which the death occurred
What are the four phases of vaccine trials?
Phase I a.) 20 - 80 participants, start with adults, then move to target population b.) Preliminary safety and immunogenicity must be demonstrated c.) If successful here, may move forward with development based on market size Phase IIA a.) Several hundred participants b.) Evaluate preliminary data on safety and immunogenicity c.) Determine the process for manufacture Phase IIB a.)Determine dose, dose interval, safety, immunogenicity among target subjects Phase III a.) Tens of thousands of participants b.) Move production from research lab to final plant for 10-20,000 doses according to cGMP c.) Manufacturing processes may NOT change once Phase III has begun d.) Randomized, double-blind, placebo-controlled tests e.) Measure reduction in incidence of disease compared to placebo recipients f.) Monitors for development of immune response that correlates with disease protection. g.)Evaluates vaccine safety for common events Phase IV a.) FDA may request post-marketing studies. Phase IV has become standard practice b.) Examines any concerns that may arise during population-wide use. c.) Reviews reaction to use with other medications
What are some voluntary efforts to increase the vaccination of healthcare professionals?
Popular strategies yield low uptake a.) Conducting annual education campaigns b.) Offering all eligible HCP free vaccine during all work shifts in convenient locations c.) Using organizational leaders to support vaccination d.) Permitting signed declination statements for nonmedical exemptions
What are the four goals of United States vaccine policy?
Prevent infectious disease Monitor, sustain and improve vaccine coverage rates for children and adults Provide immunizations in various settings Respond to vaccine safety concerns
What is priority review/accelerated approval?
Product is eligible if it: a.) Will provide meaningful therapeutic benefit over existing treatments for serious or life-threatening illness Must be predicted to produce clinical benefit Post-marketing studies are conducted to verify clinical benefit Withdrawal possible if benefits are not verified
What is the role of the Center for Biologics Evaluation and Research (CBER)? What products do they regulate?
Protect & improve public & individual health Facilitate the development, approval & access to safe and effective products Products Regulated a.) Vaccines b.) Blood products c.) Allergenics d.) Cell & Gene Therapies e.) Tissues f.) Xenotransplantation Products
ACIP recommendations trigger 3 avenues to access...
Public funding a.) Ensured access to vaccines through VFC & 317 b.) Ensured access to vaccines through Medicaid, CHIP c.) Ensured access to vaccines through State funds Private market funding a.) Increased access to vaccines through private health insurance coverage State statutes a.) Increased access to vaccines through school entry requirements
What is the Vaccine Safety Datalink (VSDs) Rapid Cycle Analysis?
Rapid Cycle Analysis (RCA) a.) Active surveillance system developed by VSD in 2005 b.) Monitors adverse events following vaccination in near real time c.) Monitors newly licensed vaccines and new vaccine recommendations d.) Uses data that is updated weekly e.) RCA projects based on i.) Early analyses from VAERS ii.) Concerns found in published scientific articles Focuses on both the clinical correlation of vaccines and adverse reaction and scientific methods of reporting, surveillance, and causation v. correlation
Prices should be based on a vaccine's value to society and strive to...
Reduction in healthcare costs Reduction in related costs Relief from pain and suffering Prevention of death These prices far exceed manufacturing costs, but are essential to: a.) Produce revenue stream that makes vaccines competitive with drugs for b.) R&D funds in large enterprises
How is VAERS administered?
Requires providers to report certain post-vaccination adverse events regardless of cause a.) 2001, parents were permitted to report b.) No restriction on the interval between vaccination and development of symptoms Administration a.) Collects all clinically significant adverse events by mail, fax, or online b.) Tracks follow up care in intervals of 60 says and 1 years post vaccination Reports are compiled in a database a.) Used by CDC, FDA, public
Vaccines and the Violation of Competent Adults' 14th Amendment Right to Bodily Autonomy
Right to bodily autonomy (Refuse Treatment) is not absolute Weigh extent of bodily invasion against the effectiveness of the intervention and the interests of the public
What are some mandatory efforts to increase the vaccination of healthcare professionals?
Safe and Effective a.) Virginia Mason, Seattle, Washington i.) 1st facility implement HCW influenza vaccination as a condition of employment b.) 300 facilities across the US have implemented similar policies c.) Have achieved unprecedented levels of HCW flu vaccination - up to 99.3% d.) Mandatory policies are more effective, and produce more reliable results than any voluntary measure
Who are the top 5 vaccine manufacturers in the US? (They held approximately 80% of the market in 2010)
Sanofi Pasteur GlaxoSmithKline Merck & Co. Pfizer Novartis
How is HPV mandated?
School Immunization Requirements a.) During the 2007 legislative sessions, ½ of states considered HPV vaccine mandates Virginia a.) Effective Date 10/01/08 b.) Standard opts out: medical and religious c.) Opt out for HPV vaccine: parental refusal for any reason and education DC a.) Effective date 01/01/09 b.) Educational campaign to commence 01/01/08 i.) Connection between HOV and cervical cancer ii.) Importance of protection against HPV infection
Is there state funding for vaccines at public health clinics?
Some states provide free or low cost vaccines to the uninsured or underinsured (children/adults) Programs attempt to satisfy gaps in coverage left by all other programs Programs are variable Universal purchase states a.) Some states purchase vaccines and make them available to all providers, in al settings b.) However, not all vaccines are included Enhanced VFC a.) Some states purchase vaccines and make them available to private providers for underinsured children
What is universal purchase?
Some states purchase recommended vaccines for all children through universal purchase programs Universal purchase predates VFC UP states commit to the highest level of state resources to vaccine purchase and to immunization programs overall
Who was Lady Mary Worthley Mantagu?
Spouse of British Ambassador to Turkey December 1715 a.) Contracted smallpox b.) Lost her eyelashes, c.) Left with deeply pitted skin 1717: Variolated her son 1721: Variolated her daughter 1772: Variolated the children of the Prince of Wales The preventive method became more accepted throughout Europe
Accessing vaccines through universal purchase...
State purchases pediatric vaccine at the federal negotiated rate All children in the state are eligible to receive vaccine regardless of insurance coverage State distributes vaccines to all participating providers at no cost Providers may not charge patients for vaccine Providers may charge a state determined administration fee
What are the strengths and limitations of the Vaccine Safety Datalink (VSD)?
Strengths a.) Examining relatively infrequent adverse events b.) Communication c.) Under-reporting and recall bias are reduced d.) Doses administered is available e.) Economical f.) Rapid Limitations a.) Enrollees do not represent the broader US population geographic, SES b.) Few non-vaccinated controls are available c.) Assessment of mild adverse events d.) Assessment of delayed adverse events
Vaccines and the deprivation of liberty without due process...
Supreme Court addressed a.) Smallpox vaccination requirement b.) School entry requirement Individuals do not have an absolute right to be, at all times and in all circumstances, wholly freed from restraint There are manifold restraints to which every person is necessarily subject for the common good
Vaccines and the Violation of Freedom of Contract Under 5th and 14th Amendments
The Contract Clause permits employees and employers to enter into contracts as they see fit, HOWEVER Public welfare trumps economic liberty States may limit and regulate contract rights to protect community health or vulnerable populations
Who ensures the safety and authorizes the licensure of vaccines?
The Food and Drug Administration (FDA)
What kind of research and funding changes were included in the ACA?
The Secretary of HHS, through the Director of CDC, shall provide funding for research in the area of public health service and systems that will Research supported under this section shall be coordinated with the Community Preventive Services Task Force and carried out with existing Federal, state, local and private partnerships and initiatives
Who is the largest purchaser of vaccines?
The government. Does not pay full price, pays 20% less than full market value.
Do we have enough vaccine manufacturers in the United States?
The number of vaccine manufacturers is inadequate to maintain an assured supply of vaccine to protect targeted populations As a result, there have been an unprecedented number of vaccine shortages since 2000
Who should get the flu vaccine? How often?
Those older than 6 months. Should get the vaccine annually.
Who should get the pneumonia vaccination? How often?
Those older than age 65. Should get the vaccine once per lifetime.
Where does the state derive it's power to mandate vaccinations?
US Constitution 10th Amendment Police Power a.) A state may issue regulations to protect the public health and public safety b.) Restraints may be placed upon individuals for the common good c.) A community has the right to protect itself against an epidemic of disease which threatens the safety of its members Limitations on Policy Power a.) Public health necessity b.) Reasonable means c.) Proportionality d.) Harm avoidance
Where does the state get it's power to mandate vaccinations?
US Constitution: 10th Amendment Police Power a.) A state may issue regulations to protect the public health and public safety b.) Restraints may be placed upon individuals for the common good c.) A community has the right to protect itself against an epidemic of disease which threatens the safety of its members Requirements a.) All mandates permit at least one opt out possibility i.) Medical Contraindications ii.) Religious iii.) Philosophical or Personal Belief
What vaccines are covered under universal purchase and universal purchase select? Who are eligible?
Universal Purchase a.) All ACIP recommended b.) All children in the state Universal Purchase Select a.) Some ACIP recommended b.) All children in state receive older vaccines c.) Only VFC eligible children receive new vaccines
What is the administrative fee policy for universal purchase and universal purchase select?
Universal Purchase a.) State may adopt VFC maximum b.) State may determine maximum fee based on reasonable methodology c.) State Medicaid may establish a lower rate than VFC Universal Purchase Select a.) State may adopt VFC maximum b.) State may determine maximum fee based on reasonable methodology c.) State Medicaid may establish a lower rate than VFC
What are the two types of universal purchase?
Universal Purchase a.) State purchases all recommended vaccines for ALL participating provides, who then provide vaccine to ALL children Universal Purchase Select a.) State purchases some recommended vaccines for ALL participating providers, who then provide vaccine to SOME children
What are the funding sources of vaccine purchase for universal purchase and universal select purchase?
Universal Purchase a.) VFC b.) 317 c.) State and local general revenue, using CDC negotiated pricing Universal Purchase Select a.) VFC b.) 317 c.) State and local general revenue i.) Covers non VFC children got new vaccines ii.) Funding shortfalls require providers to reject non-VFC patients or require their families to pay iii.) Utilizes CDC negotiated pricing
Which providers are eligible to participate in universal purchase and universal purchase select?
Universal purchase a.) All public and private Universal purchase select a.) ALL public and private
Who (i.e. insurance status) are covered under universal purchase and universal purchase select?
Universal purchase a.) Insurance status irrelevant Universal purchase select a.) Insurance status irrelevant
Who does the initial research around vaccines?
Universities NIH CDC
What are the limits of VAERS?
Unverified reports a.) Cannot establish a causal relationship between adverse event and vaccination without scientific study Under reporting Biased reporting Incomplete reporting Increases in vaccine coverage may lead to the appearance of increased incidents Coding Consistent utilization of reports
Increasing access to vaccines through universal purchase...
Up programs are considered an indication that universal vaccination is a positive intervention that helps society Removes vaccine cost as a barrier for consumers Maintains a child's medical home Has been effective in several states Administratively simple a.) Eliminates the need to screen for VFC eligibility, decreases provider workload b.) Streamlines paperwork: providers will complete on version of paperwork for all vaccines produced
What is the National Childhood Vaccine Injury Act of 1986?
VICP or Vaccine Court a.) Operational 10/01/88 Response to industry/provider liability concerns surrounding DTP vaccine b.) An optional, no fault, alternative to the tort system c.) The Court of First Resort - Lawsuits claiming a vaccine related injury ? $1000 must first be filed in Vaccine Court
What are some of the successes and challenges of VICP?
VICP: Successes a.) Fulfilling original program purposes i.) Ensures an adequate supply of vaccines ii.) Stabilizes vaccine costs iii.) Establishes and maintains an accessible, efficient forum for individuals found to be injured by certain vaccines iv.) Provides liability protection to industry and providers VICP: Challenges a.) Majority of claims assert an injury that is no listen on Injury Table making it more difficult for petitioners to prove causation b.) Claims process is difficult for stakeholders to understand c.) Many stakeholders are unaware of the Program
Are employers exposed to liability?
Vaccine Injury Compensation Program a.) Congress recognized the need for vaccines to protect the public b.) The reality of inevitable but adverse rare events c.) Established the Vaccine Court (1988) i.) Provide liability protection to industry and providers ii.) Permit those injured by vaccines to receive prompt and fair compensation
Two types of claims in VICP...
Vaccine Injury Table a.) Known adverse event + outlined Time Interval = presumed vaccine injury Non-table Injury or Death (over 93% of current claims) a.) Petitioner must prove it is more likely than not that the vaccine caused the injury (preponderance of the evidence standard) b.) Permissible proof i.) Expert medical opinion, or ii.) Medical records, or iii.) Circumstantial evidence, or iv.) Widely accepted, unproved scientific theories
Misperceptions regarding vaccine-related injuries...
Vaccine preventable diseases have decreases, so vaccination is not necessary Too many vaccinations = weakened immune system Mistrust of scientific community Reduced disease based on better hygiene and sanitation before vaccines were introduced Most people who develop disease have been vaccinated Existence of hot lots Vaccines cause undesirable side effects a.) MMR/Autism b.) SIDS c.) Thimerosal
How do we examine vaccine safety?
Vaccines highlight concerns regarding risk a.) Administered to healthy infants and children b.) Manufactured by humans rather than naturally occurring c.) Compulsory administration d.) Emergency situations Risk Benefit Analysis: Causation v. Correlation a.) Mistaken association or attributable risk can i.) Undermine confidence in system ii.) Negatively impact confidence, acceptance, and disease incidence Accuracy supports compensation program a.) Must not deny vaccine adverse events in the face of accumulation
What was decided in Zucht v. King (1992)?
Vaccines mandates in schools are constitutional and permissible City of San Antonia, Texas required children to show proof of vaccination to attend public and private schools Rosalyn claimed the requirement deprived her of liberty without due process of law Supreme Court relied on precedent set in Jacobson
What virus causes smallpox?
Variola virus Enters the lungs and is carried to internal organs and skin where it multiplies
Who was Edward Jenner?
While in medical school, he overheard a farm girl comment that she would not contract smallpox because she had once had cowpox (a very mild disease) 1796 a.) Transferred material from cowpox pustule to James Phipps. b.) 2 months later, exposed James to smallpox c.) James experienced only mild inflammation around the injection site 1798 a.) Jenner?s first case study rejected. He went to London to demonstrate his theory. b.) No one would submit to his vaccination. He went home. 1801 a.) Publication of The Origin of the Vaccine Inoculation. b.) Described how cowpox virus was prepared and used to vaccinate healthy persons against smallpox Vaccine Distribution a.) Material for the vaccine was taken from the arm of a vaccinated child, b.) Vaccinated children were carried all over Europe. c.) Orphans were often used for this purpose. d.) Eventually, material from infected cows was used directly as vaccine. e.) British Parliament granted Jenner the equivalent of >$1 million US Vaccination (Latin: vacca, cow) a.) Louis Pasteur adopted Jenner?s word for his method for immunization against any disease.
How do we monitor vaccine events? Why should we do so?
Why Monitor? a.) Prevent loss of public's confidence b.) Prevent decreased vaccine coverage c.) Prevent return of epidemic diseases Measuring Adverse Events a.) True adverse events v. coincidental or temporal associated events, identify risk factors to develop valid contraindications to develop safer vaccine
What kind of wellness and personalized prevention efforts are included in Medicare?
a.) Annual wellness visit b.) Comprehensive health risk assessment c.) Personalized prevention plan i.) A 5 to 10 year screening schedule ii.) A list of identified factors and conditions and a strategy to address them iii.) Health advice and referral to education and preventive counseling or community based interventions to address modifiable risk factors such as physical activity, smoking, nutrition iv.) Beneficiaries are eligible for the initial preventive physical exam in their first year of coverage and for personalized prevention services annually thereafter
Vaccine trials are larger than those for drugs because the public maintains:
a.) Risk-averse orientation b.) Need to test on representatives of larger population
How do we increase vaccine uptake by using school requirements?
a.) Students must demonstrate receipt of certain immunizations as a condition of attendance b.) Have proven to be the most effective tool ever devised to increase coverage rates among i.) The target population ii.) To reduce disease transmission
