Seasonal and Pandemic Influenza Vaccines : Vaccine Development and Production. Learning Objectives. Develop a basic understanding of how influenza vaccines are developed Be familiar with the major types of vaccines and methods of vaccine production
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Vaccine Development and Production
Antigens are replicated in host
Live attenuated vaccinesReplication restricted to the cooler upper airways
Microbial vector vaccines Bacterial vectors deliver DNA or RNA to host
Antigens are manufactured outside the host
Cannot use wild type highly pathogenic viruses
CDC/ Dr. Stan Foster
What type of manufacturing is most commonly used for influenza vaccines?
Answer: A. Currently available vaccines are manufactured using embryonated chicken eggs or egg-based manufacturing
Assuming 100 vaccinated and 100 unvaccinated in each set:
VE against influenza infection = 75% for both sets A and B,
VE against respiratory illness = 30% in set A and 15% in set B.
*Effectiveness lower when vaccine and circulating strains antigenically different. No vaccine effectiveness is sometimes observed when the prevalence of antigenically different strains in the community is high.
**Laboratory-confirmed influenza virus infection
Global Distribution of Influenza Vaccines, 1994-2003 and Risk Group, when Vaccine Strains Match Circulating Strains
WHO Global Influenza Vaccine Distribution
What are some of the individual or demographic attributes that affect vaccine effectiveness?
Treanor et al. N Eng J Med 2006;354:1343-51
Inactivated influenza A (H5N1) clade 1 antigen and proprietary adjuvant
Leroux-Roels et al. Lancet. 2007;370(9587):580-9.
Target paradigm of an ideal (GlaxoSmithKline)
H5N1 pandemic vaccine
From: S Sambhara, CB Bridges,
GA Poland. Lancet 2007.
Which technology that might be used to reduce the dose of antigen that is needed in a vaccine?
Antigen: Are proteins or polysaccharides that are parts of viral or bacterial structure and which prompt the immune system response
Adjuvant: A pharmacological or immunological agent added to a vaccine to modify (improve) the immune response to the vaccine, while having few if any direct affect when given by itself.
Biocontainment or Biosafety level (BSL): The isolation and containment of extremely infectious or hazardous materials in specialized and secure scientific facilities
Genetic engineering: the manipulation of genetic material, generally to produce a therapeutic or agricultural product either more quickly, or in greater quantities, than is seen in nature.
Embryonated: Egg containing an embryo, used to incubate viruses for vaccine study or production
Reassortant: Viruses that contain 2 or more pieces of genetic material from different viruses. Reassortant happens when two viruses mix within a cell (or lab environment).
Inactivated vaccine: a vaccine made from an infectious agent that has been inactivated or killed in some way.
Live, attenuated vaccine: Vaccine includes live pathogens that have lost their virulence but are still capable of inducing a protective immune response to the virulent forms of the pathogen.
Immunogenicity: Measure or ability of a substance (virus, drug, etc) to produce an immune system response
Clades: A biological group (for example, a viral species) that is classified according to genetic similarity
Subivirion: An incomplete virus or virus particle
Chemoprophylaxis: The use pharmaceutical or medical treatment to prevent disease or spread of infection
Virulence: The virulence of a microorganism (such as a bacterium or virus) is a measure of the severity of the disease it is capable of causing.
Pathogenicity: is the ability of an organism, a pathogen, to produce an infectious disease in another organism.
Trivalent influenza vaccine: synthetic vaccine consisting of three inactivated influenza viruses, two different influenza type A strains and one influenza type B strain. Trivalent influenza vaccine is formulated annually, based on influenza strains projected to be prevalent in the upcoming flu season. This agent may be formulated for injection or intranasal administration.
Candidate strains: strains of influenza that are used in vaccines that are still early in developmental stages
Antibody response: The immune system responds to antigens by producing antibodies. Antibodies are protein molecules that attach themselves to invading microorganisms and mark them for destruction or prevent them from infecting cells. Antibodies are antigen specific. That is antibodies produced in response to antigen exposure are specific to that antigen.
(S13) Egg-based (vaccine) manufacturing: Method of making influenza vaccines by inoculating live flu virus into fertilized chicken eggs, then purifying and inactivating the resulting egg-adapted virus. Vaccines created using this technique represent the majority of the currently licensed and marketed influenza vaccines worldwide
(S14) Cell-based (vaccine) manufacturing: Method of manufacturing influenza vaccine that is more rapid than egg-based manufacturing. The live flu virus is used to infect cells in culture. Once the viral infection has propagated through the cells, the live virus is harvested and inactivated for use in vaccines.
CDC/ Judy Schmidt
Will increase demand for seasonal influenza vaccines
1. Reduce disease burden from seasonal influenza infections
2. Increase manufacturing capacity for influenza vaccines
Strategy 1:WHO Regional Offices develop plans with input from member states for seasonal influenza vaccination programs. These plans should form the basis for the Global Pandemic Influenza vaccine action planStrategy 2:Mobilize resources to assist in the implementation of a global action plan to increase demand of seasonal influenza vaccine
Strategy 1: Increase production capacity for inactivated vaccines
Strategy 2: Explore development of other types of influenza vaccines
Strategy 3:Assess alternative ways to deliver vaccine
Strategy 1:Enhance protective efficacy and immunogenicity of
Strategy 2:Develop novel vaccines that induce broad
spectrum and long lasting immune responses
Strategy 3:Improve evaluation of vaccine performance
What are the three WHO strategies for increasing pandemic vaccine capacity?
Immunogenicity: Capability of inducing an immune response
Antigen: A substance that stimulates the production of an antibody when introduced into the body. Antigens include toxins, bacteria, viruses, and other foreign substances.
Antibody: A Y-shaped protein on the surface of B cells that is secreted into the blood or lymph in response to an antigenic stimulus, such as a bacterium, virus, parasite, or transplanted organ. Antibodies bind antigens and mark them for destruction or prevent cells from being infected. Antibodies are antigen specific.
Antibody Response: The immune system responds to antigens by producing antibodies. Antibodies produced in response to an antigen work best on that antigen, but might have some activity against similar antigens.
Clade: A group of organisms, such as influenza viruses, whose members share homologous features derived from a common ancestor.
Reactogenic: the capacity of a vaccine to produce adverse reactions
Subvirion: An incomplete viral particle (e.g. like the HA antigen).