Vaccines Learning Objectives Seasonal Flu Vaccine flu strain

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					Slide 1                                                                     Hello, my name is Lisa Johns,
            Pandemic Influenza Preparedness for Local Health Departments:   and I am a registered nurse and
                                                                            clinical consultant with the North
                                 Vaccines                                   Carolina Immunization Branch. I
                                                                            will be your host today for the
                                                                            vaccine module of the Pandemic
                                                                            Influenza Preparedness Training
                                                                            for Local Health Departments. I
                        Lisa Johns, RN, BSN                                 hope the information provided
                       NC Immunization Branch                               today will be helpful to you in
                                                                            your work.

Slide 2                                                                     After completing this training,
                     Learning Objectives                                    you should be able to meet the
                                                                            following objectives: No script,
          Upon completion of this module, the learner will be               read text from slide
           able to:
          Understand the key differences between seasonal
           influenza vaccine and pandemic influenza
          Recognize the key challenges that arise when
           planning for the use of pandemic influenza
          Describe newer technology being developed to
           address some of these challenges

Slide 3                                                                     To start this session, lets talk
                   Seasonal Flu Vaccine                                     about seasonal flu vaccine. No
                                                                            script, read text from slide
          Two types of flu vaccine:
           ♦ Trivalent influenza vaccine (TIV)
               Intramuscular injection
           ♦ Live Attenuated Influenza Vaccine
              Administered intranasally
Slide 4                                                     Each year the World Health
            Deciding on the Antigen Content                 Organization makes
                                                            recommendations for the flu
          • World Health Organization (WHO) makes           vaccine content for the following
            recommendations yearly for the upcoming         flu season, based on the
            flu season vaccine based on the                 circulating strains of flu vaccine
            circulating flu strains throughout the world.
                                                            in the world. These
          • FDA reviews these recommendations
                                                            recommendations are then
            along with surveillance information from
            U.S. for previous year. May adopt WHO
                                                            reviewed by the FDA along with
            recommendations or change them                  surveillance information from the
                                                            previous flu season. Then the
                                                            FDA decides if they will adopt
                                                            the WHO recommendations or
                                                            make their own.

Slide 5                                                     Currently, the manufacturing
               Manufacturing Seasonal Flu                   process for seasonal flu vaccine
                        Vaccine                             is quite lengthy about nine
          Nine month production cycle                       months to complete the entire
          Requires large quantities of eggs                 production cycle. Viruses are
          Often, yield of virus grown in eggs is            grown in fertilized eggs requiring
            unpredictable                                   large quantities of eggs to be
          Must go through purification process              available. The virus strains must
          Cannot be administered to anyone with an          be purified after growing in the
            allergy to eggs                                 egg. Small amounts of egg
          Does produce an effective vaccine                 protein usually still remain, which
                                                            makes the vaccine
                                                            contraindicated for persons with
                                                            an allergy to eggs. Though the
                                                            production method is lengthy
                                                            and does have drawbacks, the
                                                            vaccine produced is very
                                                            effective against the flu.
Slide 6                                                                Because of staggered delivery
           Recommended Priority Groups for                             schedules, and sporadic
               Seasonal Flu Vaccine                                    shortages of vaccine, for the
          • Infants 6 months – 36 months of age                        past several flu seasons the
          • Children and adults with chronic illnesses                 CDC has recommended that the
          • Caregivers of infants less than 6 months of                following groups be given priority
            age                                                        for receiving seasonal flu
          • Household contacts of the above groups                     vaccination. No script, read text
          • Healthcare workers providing direct patient                from slide

Slide 7                                                                There are several differences
          Differences Between Seasonal and                             between seasonal flu vaccine,
                  Pandemic Vaccines                                    and vaccine that would be
          Seasonal                        Pandemic                     produced and used during a
          Contains three strains of flu   Contains one strain of
            virus                           influenza virus            pandemic. No script, read text
          Can be prepared in advance      Cannot be prepared until     from slide
            of the flu season               the pandemic occurs
          Antigens in vaccine may not     Will match the circulating
            match what is circulating       strain unless the strain
            during flu season               mutates again
          Production plants are           Will require building new
            currently set up for this       production plants
            type of manufacturing

Slide 8                                                                The most likely influenza strain
                      The Top Candidate                                to cause a pandemic at this time
                                                                       is the H3N1 avian strain.
          H3N1 strain of avian influenza is considered                 However the virus would have to
            the most likely candidate to cause a                       mutate in order for it to be
            pandemic at this time                                      passed from human to human.
          Would have to mutate to be transmitted from                  Cases of bird to human
            human to human
                                                                       transmission of this virus have a
          High mortality rate in bird to human cases                   high mortality rate. It is possible
          Commonly referred to as the “bird flu”                       however that a pandemic could
                                                                       be caused by another flu virus.
Slide 9                                                     The World Health Organization
               Strains of H5N1 Used for                     (WHO) identified 3 strains of
                Vaccine Development                         H5N1 virus to be used for
                                                            development of an egg-based
          • A/Vietnam/1203/2004                             pandemic flu vaccine. These
          • A/Vietnam/1194/2004                             three strains are : No script, read
          • A/Hong Kong/213/03                              text from slide. These strains
                                                            were isolated from humans with
          • Identified by the World Health                  actual cases of avian influenza.
            Organization (WHO)

Slide                                                       The National Institute for
10               Vaccine Development                        Allergies and Infectious
                                                            Diseases at the National
          • NIAID/NIH awarded contracts to sanofi-          Institutes of Health awarded
            pasteur and Chiron to use reference virus       contracts to several
            to produce vaccine for clinical trials.         pharmaceutical manufacturers to
          • First clinical trials for safety and efficacy   take these reference viruses and
            started April, 2005, on healthy subjects
                                                            produce vaccines (using current
            18-64 years old,64 years and older and 2-
            9 years old.
                                                            egg-based technology) for
                                                            clinical trials. The first clinical
                                                            trials for safety and efficacy of
                                                            these vaccines started in April
                                                            2005, on three groups of healthy
                                                            subjects – those 18-64 years old,
                                                            64 years old and over, and
                                                            children 2-9 years of age.

Slide                                                       No script, read text from slide
11                Variations in Testing
          Vaccine formulations tested:

          Varying amounts of antigen
          Giving one dose or two of vaccine
          Given intradermally instead of
          With and without adjuvants
Slide                                                 For those of you not familiar with
               What is an adjuvant?                   the term, and adjuvant is a
                                                      substance that helps the body to
        • An adjuvant is a substance added to a       produce a more vigorous
          vaccine that causes the body to respond     immune response to the vaccine,
          more vigorously to the vaccine, but the     but does not have any effect of
          substance does not have any effect of its
                                                      its own. The most commonly
                                                      used adjuvants in vaccines are
        • Most commonly used vaccine adjuvants
          are aluminum salts
                                                      the aluminum salts – aluminum
                                                      hydroxide, aluminum phosphate
                                                      and aluminum potassium sulfate.

Slide                                                 No script, read text from slide
13       Results of Initial Clinical Trials
        • Vaccine elicited immune response but
          required large amount of antigen
        • Works best with two doses given 3-4
          weeks apart
        • Vaccines containing adjuvants work better
        • Adjuvants that work best are aluminum
          salts and Chiron’s MF59

Slide                                                 Recognizing the need to develop
         What’s Next for H5N1 Vaccine                 a more efficacious pandemic flu
                                                      vaccine and one that can be
        • In May 2006, federal government awarded     produced more quickly the
          one billion dollars in contracts to         federal government awarded one
          companies to develop H5N1 vaccines that     billion dollars in contracts to
          do not require eggs or adjuvants            several pharmaceutical
        • Cell based technology used would be         manufacturers to develop H5N1
          similar to current method used to produce   vaccines that do not require
          inactivated polio vaccine (IPOL)            eggs for production or adjuvants.
                                                      This is of particular importance if
                                                      a pandemic were caused by the
                                                      avian flu strain as this might
                                                      make it difficult to get adequate
                                                      numbers of fertilized chicken
                                                      eggs to use in vaccine
                                                      production. It would also make
                                                           the pandemic flu vaccine
                                                           contraindicated for anyone who
                                                           is allergic to eggs. Cell based
                                                           technology, similar to what is
                                                           currently used to manufacture
                                                           inactived polio vaccine will be
                                                           used to produce this new
                                                           generation of vaccines.

Slide                                                      No script, read text from slide
15        What is Cell-based Technology?
        Flu viruses are grown in mammal cells instead of
        Cells can be made in advance of an epidemic and
          frozen, or developed very rapidly
        Reduces the risk of contamination of vaccine
        More reliable, flexible and expandable than egg-
          based technology
        Vaccine can be produced in a matter of weeks!

Slide                                                      No script, read text from slide
          How Will Vaccine Be Distributed
              During a Pandemic?
        • Assumptions:
            No vaccine available for several
            When available, supplies very limited
            Prioritization of administration will be
            Could possibly come through SNS or a
              private distributor
Slide                                                                     The federal government has
           Priority Groups for Pandemic
17                                                                        established priority groupings
        Critical assumptions:
        The greatest risk of death from pan flu will be in infants, the   should a pandemic event occur.
          elderly and those with underlying health conditions.
        Healthcare system will be severely taxed if not
                                                                          These groupings were based on
        Critical infrastructure of communities will be severely taxed
        Vaccine and antiviral production must be maintained at
                                                                          the critical assumptions that: No
                                                                          script, read text from slide
        For a complete list of the pandemic priority groups go

Slide                                                                     No script, read text from slide
18                         Security of Vaccine
        • Significant issue during a pandemic
        • Vaccine must be kept in a secure, locked
          area with limited access.
        • May need to store vaccine at an alternate,
          more secure site such as a hospital.

Slide                                                                     No script, read text from slide
19                           Learning Activities
         1. Assess storage capacity at your agency
            for pandemic flu vaccine. Keep in mind
            the following:
            Location must be secure
            Reliable refrigeration
            Functional disaster back-up plan
            Unlikely you will need large amount of
Slide                                                    No script, read text from slide
20            More Learning Activities
        2. Locate a copy of the state and federal
           prioritization plans for a pandemic
        3. Determine how these priority groups
           would need to be adjusted to meet the
           needs of your county.

Slide                                                    A question for you to think about
21               Think About This…                       – No script, read text from slide
        During a pandemic influenza outbreak, you
         are told that 100 doses of vaccine is
         coming to your county. You are
         responsible for distribution of this vaccine.
         How would you handle this challenge?

Slide                                                    To see an extensive array of
22                 Need More Info?                       information on pandemic flu
                                                         planning visit these websites
        The CDC and HHS are the primary sources          regularly. The information is
         of information on pandemic flu planning.        updated on a regular basis.
        Their websites are:
Slide                            This concludes our module for
23      Thanks for all you do!   today. Thank you for listening,
                                 and thank you for all you do
                                 everyday to protect the health of
                                 the citizens of North Carolina.

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Description: Vaccines Learning Objectives Seasonal Flu Vaccine flu strain