1976 Swine Flu Vaccine Debacle an

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					1976 Swine Flu Vaccine
Debacle and U.S.
Vaccine Strategy for
Avian Flu: History
Repeating Itself?
Jacqueline Doamekpor

Advisor: Jonathon Erlen, Ph.D.
Presentation Outline

I.     Research Objectives and Methodology
II.    General Information about Influenza
       Viruses, Vaccines, and Disease
III.   Profile of Swine Flu Vaccine Program of
IV.    Mistakes of Swine Flu Program/Lessons
V.     Profile of Avian Influenza Outbreak/U.S.
       Vaccine Strategy for Avian Influenza
VI.    Potential Obstacles in my Project
Research Project Objectives
1. Thoroughly research background information on
   President Ford’s swine flu vaccine program and current
   Avian flu outbreak/U.S. vaccine strategy for avian flu

2. Identify reasons why the swine flu vaccination program

3. Compare and contrast the vaccine strategies for 1976
   swine flu and avian flu to see whether the poor decision-
   making elements which led to the failure of 1976 vaccine
   program are also present in the U.S. government’s (CDC
   and HHS) mobilization of current vaccination strategies
   against avian flu
Research Methodology

 Objective 1 and 2: Obtain thorough
  background info by using journal articles
  (etc. JAMA, WHO, CDC), books,
  newspapers, videos, primary sources
 Objective 3: Research/Develop criteria
  for evaluating effectiveness of vaccine
     Evaluate swine flu vaccine program and
      US vaccine program
Why Should I Care?
1. Understanding the failure of the swine flu vaccine
   program and applying the lessons learned from the
   situation to management of the avian flu threat are critical
   if the U.S. wants to have an effective avian flu
   vaccination strategy

2. A form of the H5N1 virus which is transmissible from
   human to human could be devastating to the U.S. if there
   is no effective vaccine strategy in place (CDC)

3. If the U.S. government wants to protect its citizens
   against avian flu without wasting millions of dollars, it
   must avoid committing the errors associated with the
   swine flu vaccine strategy
General Info about Influenza
Viruses: Types
   There are three types of influenza viruses: A, B, and C:

   Type A = main focus of research
       Widely considered the most dangerous type because of its ability to infect a
        wide variety of mammals and birds
              Birds are only infected with type A
        Causes the most cases of the flu in humans and is the type most likely to
         become epidemic

   Type B
       Infects humans and birds
       Produces a milder disease than type A, but can also cause epidemics

   Type C
       Infects only humans
       Produces either a very mild illness indistinguishable from a common cold or
        no symptoms at all
       Does not cause epidemics
Influenza A Viruses:
                                                       Subtypes of influenza type A
                                                         viruses (e.g. swine flu and
                                                         avian flu) are named
                                                         according to two specific
                                                         surface proteins:
                                                         hemagglutinin (HA) and
                                                         neuraminidase (NA)
                                                             Hemagglutinin allows the
                                                              virus to “stick” to a cell
                                                              and initiate infection
                                                             Neuraminidase helps
                                                              newly constructed viruses
                                                              exit host cell
                                                       Subtypes could also named
                                                         by geographical region
                   Avian Flu Virus
( VIRUS-FLU-structure-L-500.jpg)
Influenza A Viruses:
Subtypes/Strains (cont.)
 Currently, 16 known variants of HA
  protein and 9 known variants of NA
 Swine flu virus = H1N1 New Jersey
     Variant 1 HA and variant 1 NA
 Avian flu virus = H5N1
     Variant 5 HA and variant 1 NA
Disease Terminology
 Endemic = “native to,” infection that can be
  maintained in a certain population without
  external input

 Epidemic = occurrence of disease within a
  specific geographical area or population that is
  in excess of what is normally expected
  (example with chicken pox)

 Pandemic = an epidemic which spreads
  worldwide, or over a large region (e.g. bubonic
  plague, Spanish flu)
How Vaccines Prevent
 Vaccines contain weakened or killed viruses or bacteria specific
   to the disease that is to be prevented
       Sometimes live pathogens for stronger immune response
 Vaccines help your body recognize and fight these germs and
  protect you each time you come in contact with someone who is
  sick with any of these diseases
 First: Vaccine usually given by a shot
 Next: Over the next few weeks, the body makes antibodies
  and memory cells against the weakened or dead pathogens in
  the vaccine
 Then: The antibodies can fight the real pathogens if the person
  is exposed to the germs and they invade the body
       The antibodies will help destroy the germs and the person will
        not become ill
 Finally: Antibodies and memory cells stay on guard in the body
   for years after vaccination
   Four antiviral medications have been approved by the U.S. Food and Drug Administration (FDA)
    for treatment of influenza:
         Amantadine
         Rimantadine
         Zanamavir
         Oseltamivir (commercially known as Tamiflu)
         All must be prescribed by doctor and taken for 3-5 consecutive days
         Four antiviral medications are effective only against influenza viruses
   Benefits of antivirals
         Antivirals can reduce influenza symptoms and may shorten duration of illness by 1 or 2 days
         Makes people less contagious
         Antivirals should be taken within 2 days after symptoms emerge to be effective
   Setbacks
         Influenza strains can become resistant to these drugs, and drugs may not always be effective
         They will not help symptoms associated with the common cold or many other influenza-like illnesses caused
          by viruses that circulate in the winter
   Antiviral use during flu epidemic
         Public health practice is to combine the use of influenza vaccine and antiviral medications
                E.g. If outbreak at nursing home, residents and staff are vaccinated and also given antiviral
                 medications to prevent influenza until the vaccine takes effect (about 2 weeks)
                This practice continues as long as influenza is occurring in that setting
Potential for an Influenza
   Flu viruses species-specific = each strain only infects a certain species
   All influenza viruses have the potential to change, or mutate
        Influenza virus strain which normally infects specific non-human species
         could mutate into form which spreads easily amongst humans
              Flu viruses lack a “proofreading” mechanism, so small errors that occur when
               the virus replicates are not corrected
              As a result, their genetic composition constantly changes in small ways.
              Updated influenza vaccine needed each year
        Little or no immune protection against them in the human population.
 If an avian virus were able to infect people and gain the ability to spread
  easily from person to person, an “influenza pandemic” could begin
 An influenza pandemic is a global outbreak of influenza and occurs
  when a new influenza virus emerges, spreads, and causes disease
 Past influenza pandemics have led to high levels of illness, death, social
  disruption and economic loss.
Past Influenza Pandemics
    There were three influenza pandemics in the 20th
     century, and all of them spread worldwide within 1 year
     of being detected:
    1.   Spanish flu (1918-19), most severe
            Killed 20-100 million worldwide
            ~675,000 died in US
            H1N1
    2.   Asian flu (1957-58)
            Killed 1-4 million people worldwide including 70,000 in
            H2N2
    3.   Hong Kong flu (1967-68)
           Killed 750,000 to 2 million people worldwide including
             34,000 in US
            H3N2
Spotlight on Spanish Flu
Pandemic (1918-19)
 So devastating that it is commonly used as a basis of
  comparison for all modern pandemics
 According to HHS, approximately 20-40% of the
  worldwide population became infected with the Spanish
  influenza virus
       20-100 million people died
       500,000-675,000 died in US
 Global mortality rate = 2.5-5% of human population
 25 million killed in its first 25 weeks, while AIDS killed 25
  million in its first 25 years
 Caused by an H1N1 influenza A RNA virus which was
  endemic to pigs
       Through mutation gained ability to infect people
Spanish flu Sanatorium in U.S.
during 1918 Pandemic
Spotlight on Spanish Flu
Pandemic (1918-19) cont.
 True origin unknown
       Did not originate in Spain/Name from less censored Spanish
        media during WWI
 Spanish flu strain was unusual because most victims were
   previously young and healthy victims
       Common influenzas kill mostly newborns and the old and infirm
 Upon infection, the Spanish flu virus killed victims within a short
   time period:
       victims who felt well in the morning would become sick by noon
        and dead by nightfall, pneumonia
 By April 1919, pandemic had mysteriously ceased
       No vaccine created
 Overarching fear of similar pandemic recurring during swine flu
   and avian flu outbreaks
How the Swine Influenza
Panic of 1976 Began
 Feb. 4, 1976, Army recruit died at Fort Dix, N.J.
  (recruit training camp) during an epidemic of
  respiratory infections following the holidays
 Throat washings were taken from 19 ill soldiers
      Majority tested positive for that winter's dominant
       strain of the influenza virus: A/Victoria
      But four samples had inconclusive test results, and
       New Jersey public health officials sent them to the
       CDC to be identified
CDC Report and Its
 On Feb. 12, 1976, the CDC delivered a chilling report:
       The four samples from Fort Dix (which included one from the
        dead soldier) contained influenza A H1N1 virus which was
        endemic to pigs a.k.a swine flu
 Further studies of Fort Dix's soldiers showed that about 500 had
  been infected with swine flu
 Officials also noted that the recruits were infected via human-to-
  human transmission
       Could easily lead to pandemic
 Spanish flu pandemic of 1918 was also caused by influenza A
   H1N1 virus endemic to pigs
       Spanish flu virus (H1N1) and swine flu (H1N1) in four samples
        are not identical but antigenically related to each other
 Fear of 1918 pandemic recurring
 Within days of identifying the swine flu strain, federal health
   officials met at the CDC to discuss what to do
Ford’s National Influenza
Immunization Program (NIIP)
   On March 24, 1976, the Ford
    Administration officially launched the
    National Influenza Immunization
    Program (NIIP), which was one of
    the most aggressive and universal
    vaccination programs in recent U.S.
        Objective: “to inoculate every
         man, woman and child in the
         United States against swine flu”
   $135 million appropriation from
   Early production of swine flu vaccine
    was possible because there was
    sufficient time between the period
    when the initial isolates were
    discovered and the beginning of the
    upcoming flu season
   On October 1, 1976, the first
    vaccines were given
Obstacles Facing NIIP

 Pharmaceutical companies undertook crash
  programs to make enough of the vaccine by the
  start of flu season in October
 But the Fort Dix bug grew poorly in chicken
  eggs (the growth medium for the influenza virus
  used in vaccine)
      This meant that yields ~50% of what was planned
      In addition, one company used the wrong virus and
       had to start over
Obstacles Facing NIIP (cont.)
 Within the first two weeks of the program’s initiation,
  three elderly people who had been vaccinated by the
  same clinic in Pittsburgh died
 On October 12, Pittsburgh health officials closed down
  the immunization program in Allegheny County pending
  an investigation of the recent deaths
 By the end of October, a total of 41 recently vaccinated
  people had died across US
 54 cases of Guillain-Barré syndrome (GBS) were
  reported in 10 states among people who had received the
  swine flu vaccine
       GBS is a serious neurological disease which is
        characterized by paralysis, loss of muscle control, and
        muscle weakness
Suspension of NIIP
 December 1976, the GBS cases led to a
  suspension of NIIP
      Never restarted
 In its entirety, Ford’s program only lasted for
  two and a half months
 After NIIP ended, the federal government was
  bombarded by lawsuits from people requesting
  compensation because they contracted
  Guillain-Barré syndrome (GBS) after being
 One final blow: a pandemic of swine flu never
Some Mistakes from NIIP
1.   Failure to deal with uncertainties in a tentative manner
         Idea that a swine flu epidemic was unlikely never received a full airing or a fair
          hearing, even though numerous experts held this view
         Notion that an epidemic was likely enough to warrant nation-wide vaccination
          grew from dominant opinion to unquestioned gospel
2.   Vaccine given too early
         A few experts suggested the vaccine be made and stockpiled but used only if
          there was more evidence of an epidemic
         Considered but rejected early on
         Argument against stockpiling was that the influenza vaccine had few, if any,
          serious side effects, and that it would be far easier (and more defensible) to get it
          into people's bodies before people started dying
3.   Effective communication from scientifically qualified persons lacking
         Prevailing perception that the program was motivated by politics rather than

    Contributing Factors
         Sensationalism in media (e.g. 1918 photographs during news broadcasts)
Mistakes of NIIP (cont.)

 Still researching!
What is Avian Influenza?

                       The H5N1 strain of the influenza virus, gold globules
                                    Courtesy of BBC News

   It is an infectious disease that is endemic in birds–rarely afflicts humans
    but this has occurred recently
        highly contagious among birds, and can be fatal to them
   Caused by an Influenza A H5N1 virus
   Prior H5N1 strains have existed, but they were significantly different
    from the current H5N1 strain on a genetic level
        Current H5N1 strain is a fast-mutating, highly pathogenic avian
         influenza virus (HPAI) found in multiple bird species
Avian Flu Timeline
   MAY 1997, HONG KONG: H5N1 Bird flu virus is isolated for first time
    from human patient
        Entire chicken population slaughtered in Hong Kong
   2003, ASIA: Bird flu virus continues to spread in humans and birds
   JAN 2004: WHO confirms H5N1 infection in 11 people
        The virus has wreaked havoc among poultry in Thailand, Vietnam,
         Japan and South Korea, and has also appeared in a duck farm in China
 NOV. 2004: WHO warns that H5N1 bird flu virus might spark a
  pandemic, and is concerned that "much of the world is unprepared for a
  pandemic" and needs to enhance preparedness to reduce its potential
 NOV 2005: The WHO's official count of human cases of H5N1 reaches
  122, with 62 deaths, in Vietnam, Thailand, Indonesia, and Cambodia
 PRESENT: WHO has confirmed a total of 229 human cases of H5N1
  flu; 131 have been fatal
Avian Influenza in Birds
                   Avian influenza viruses occur naturally
                    among birds
                   Wild birds worldwide carry the viruses in
                    their intestines, but usually do not get sick
                    from them
                   Avian influenza is very contagious among
                    birds and can make some domesticated
                    birds (chickens, ducks, and turkeys) very
                    sick and kill them
                   Infected birds shed influenza virus in their
                    saliva, nasal secretions, and feces
                   Susceptible birds become infected when
                    they have contact with contaminated
                    secretions, excretions or surfaces
                   Domesticated birds may become infected
                    with avian influenza virus through direct
                    contact with infected waterfowl or other
                    infected poultry, or through contact with
                    surfaces or materials that have been
                    contaminated with the virus
Avian Influenza in Birds (cont.)
 15 different subtypes of influenza virus
  circulating in bird populations
 Infection with avian influenza viruses in
  domestic poultry causes two main forms of
      Low pathogenic form = may go undetected and
       usually causes only mild symptoms (e.g. ruffled
       feathers and a drop in egg production)
      Highly pathogenic form = spreads more rapidly
       through flocks of poultry
          May cause disease that affects multiple internal
           organs and has a mortality rate that can reach 90-
           100% within 48 hours
Avian Influenza in Humans
 H5N1 virus does not usually infect people, but infections
    with these viruses have occurred in humans
   All of human cases during current outbreak have resulted
    from people having direct or contact with H5N1-infected
    poultry (slaughtering or de-feathering infected birds) or
    H5N1-contaminated surfaces
   In all human cases of current outbreak, avian influenza
    has been spread from birds to humans
   There have no incidences of human-to-human
   Experts say avian flu is not a food-borne virus, so eating
    poultry is safe
Global Impact of Avian Flu
   Countries affected by human cases: Azerbaijan,
    Cambodia, China, Djibouti, Egypt, Indonesia, Iraq,
    Thailand, Turkey, and Vietnam
   As of July 4, 2006: 229 cases total, 131 of these
   Tens of millions of birds have died of H5N1
   Collectively, hundreds of millions of birds have
    been slaughtered and disposed of to limit the
    spread of H5N1 in the following countries:
          Korea, Vietnam, Japan, Thailand, Cambodia,
           Laos, Indonesia, China, Malaysia, Russia,
           Kazakhstan, Mongolia, Turkey, Romania,
           Croatia, Ukraine, Cyprus, Iraq, Nigeria, Egypt,
           India, France, Niger, Bosnia, Azerbaijan, Albania,
           Cameroon, Myanmar, Afghanistan, Israel,
           Pakistan, Jordan, Burkina Faso, Germany,
           Sudan, Ivory Coast, Djibouti. Austria, Bulgaria,
           Czech Republic, Denmark, Greece, Hungary,
           Iran, Italy, Kuwait, Poland, Serbia and
           Montenegro, Slovakia, Slovenia, Spain, Sweden,
           Switzerland, United Kingdom
   Millions of birds have also been vaccinated
HHS map of Avian Flu Outbreaks
in Birds and Humans as of 6/6/06
WHO Pandemic Phase Chart
WHO Statistics on Avian Flu
 Age of victims
       Half of the cases occurred in people under the age of 20 years
       90% of cases occurred in people under the age of 40 years.
 Overall Mortality Rate = 56%
       Highest mortality rates in persons aged 10-39 years
       Case-fatality profile by age group differs from that seen in
        seasonal influenza, where mortality is highest in the elderly.
       The overall case-fatality rate was highest in 2004 (73%),
        followed by 63% to date in 2006, and 43% in 2005.
 Seasonal Effects
       Cases have occurred all year round
       Incidence of human cases peaked during the winter and spring
        in the northern hemisphere
Symptoms of Avian Flu (WHO)
 Incubation period = ~7 days
 Symptoms range from typical flu-like symptoms to life-
  threatening symptoms
 Minor Symptoms:
      Fever higher than 100.4°C
      Cough
      Lower respiratory tract infections
      Bleeding from nose and gums
      Diarrhea, vomiting
      Abdominal and chest pain
 Possibly Fatal Symptoms:
      Pneumonia (often fatal)
      Multi-organ failure
How would an Avian Flu
pandemic materialize?
 Current H5N1 strain is responsible for bird-to-bird and bird-to-
   human transmission of avian flu
       NO reported cases of human-to-human transmission
 In order for pandemic to occur, H5N1 strain must mutate into
   strain which is transmitted readily amongst humans
       Very good chance that this will happen, but not definite
 Every time bird or human is infected with avian flu, the virus
       Most mutations will not significantly affect virus’ capability to
       However, a small percentage of mutations could alter the avian
        flu virus enough so that it can be transmitted amongst humans

"Everything you say in advance of a pandemic is alarmist; anything
you do after it starts is inadequate."
    - US HHS Secretary Michael O. Leavitt
How would a pandemic of
avian flu be controlled?
 Same way flu epidemic would be controlled:
  combination of antivirals and vaccines
 Current avian flu virus that has caused human
  illness and death in Asia is resistant to
  amantadine and rimantadine
       Experts believe oseltamavir (Tamiflu) and
        zanamavir would probably work (additional studies
        still need to be done to demonstrate their
       The mass administration of antiviral drugs to the
        general population is not recommended by WHO,
        as this could accelerate the development of drug-
        resistant strains
Avian Flu Vaccine Production
 Scientists can only start producing a vaccine
  when an avian flu virus strain emerges, which
  causes human-to-human transmission of avian
      Such strain has not emerged yet
      Currently, there is only the H5N1 strain which
       causes bird-to-human transmission
      Once an avian flu strain emerges and causes
       human-to-human transmission vaccine can be
       made to directly combat this strain: at least 6 mts
 Scientists are testing a recently created vaccine
  from the circulating H5N1 strain
      Only partial protection during pandemic
U.S. Vaccine Strategy

 Need to research!
Obstacles in Research

 Hard time finding primary sources in
  researching swine flu
 Defining clear cut criteria to use as
  means of comparison between two
  vaccine programs
Luke, Catherine. and Subbarao, Kanta. Vaccines for Pandemic Influenza. Emerging
    Infectious Diseases ( Vol. 12, No. 1. January 2006
Neustadt, Richard and Fineberg, Harvey. The Swine Flu Affair: Decision-Making on a
    Slippery Disease. U.S. Dept. of Health, Education, and Welfare, 1978.
Osborn, June. History, Science, and Politics: Influenza in America: 1918-1976. Prodist:
    New York, 1977.
Pandemics and Pandemic Threats Since 1900.
Sencer, David. and Millar, J. Donald. Reflections on the 1976 Swine flu Vaccination
    Program. Emerging Infectious Diseases. Vol. 12. No. 1, January 2006.
Vaccine Distribution. U.S. Dept. of Health and Human Services.
World Health Organization, Division of Communicable Disease Control.
    Avian Influenza.
World Health Organization. Avian Influenza Fact Sheet.
World Health Organization. Cumulative Number of Confirmed Human Cases as of June
    6, 2006.
World Health Organization. Ten Things You Need to Know About Pandemic Influenza.

I would like to thank the Honors College for
    giving me this awesome opportunity.

Thanks to all of you for listening and being
              a great audience.

Good luck to all the Brackenridge Fellows
       with your research projects!

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