Introduction to Vaccines

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Introduction to Vaccines

• MedCh 401 Spring 2006
• Kirsten L. Vadheim, Ph.D.

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Why study vaccines?

• Patient education
• Pharmacists are often the most accessible medical
  professional
• too many choices!
• Flu yes or no?
• live or inactivated?
• Pneumococcal?
• Meningococcal?
• TD booster?

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Why study vaccines? II

• Misinformation
• Only children get pertussis - no
• MMR vaccination causes autism - no
• HepB vaccination is linked to development of
  autoimmune disorders - no
• Childhood vaccinations increase the risk of SIDS
  - no
• SV40-contaminated polio vaccine caused cancer -
  inadequate data

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More reasons to study vaccines

• Vaccine administration
• you may have to give them!
• New vaccines, changing recommendations
• Rotavirus
• Lyme disease
• OPV to IPV
• Pertussis
• Public health

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History

• Variolation
• c. 16th centure China
• 1721 - Lady Mary Montagu brought it to England
• 1774 - cattle breeder Benjamin Jesty inoculated
  his wife and children with cowpox to protect them
  from a smallpox epidemic

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History II

• Edward Jenner
• 1798 Variolae Vaccinae
• demonstrated that cowpox could be passed directly
  from one infected person to another, providing
  large-scale, effective inoculation against
  smallpox
• 1840 variolation made a felony in England

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History III

• Louis Pasteur
• 1880 attenuation of Pasteurella multocida to
  protect against chicken cholera
• 1881 developed animal vaccine for anthrax,
  demonstrating that one could create standardized,
  reproducible vaccines at will
• 1885 successful vaccination of first human
  (Joseph Meister, rabies)

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History III

• Killed vaccines
• Salmon and Smith, 1886 killed hog cholera virus
  vaccine (actually a bacterial vaccine against
  salmonellosis)
• 1896-7 Human typhoid, cholera, plague vaccines

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History IV

• Paul Ehrlich
• 1897 receptor theory of immunity explained
  toxin-antitoxin interactions
• active and passive immunity
• magic bullets
• Emil von Behring
• 1890 Development of diphtheria antitoxin as
  protection during diphtheria epidemics

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History V

• Early 1900s
• 23 U.S. children died from diphtheria antitoxin
  derived from horse infected with tetanus
• post-WWII progress on viral vaccines
• virus propagation in stationary cell culture
• CPE

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History VI

• Polio
• Salk et al. formalin-inactivated vaccine
• Sabin live attenuated vaccine
• Cutter incident
• inadequately inactivated vaccine
• 204 cases of type I polio

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Immune Globulins

• Immediate transfer of passive immunity
• Homologous pooled human antibody
• Homologous human hyperimmune globulines
• Heterologous hyperimmune serum (antitoxin)
• Tetanus, Rabies
• Polyclonal (RSV-IGIV)
• Monoclonal (Palivizumab)

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Comparison of Maximum and Current Morbidity
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Licensed Vaccines I

• FDA/CBER
• BLA
• IND
• Clinical trials
• Extensive agency review
• Inspection
• Approval

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Licensed Vaccines II

• Post-approval
• Lot release
• Biennial inspections
• Annual reports
• Pharmacovigilence
• 21CFR601.12

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Licensed Bacterial Vaccines

• Anthrax
• BCG
• DTaP
• Haemophilus influenzae b
• Meningococcal
• Plague
• Pneumococcal
• Typhoid - Ty21a and Vi

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Licensed Viral Vaccines

• Hep A
• Hep B
• Flu
• JEV
• Measles
• Mumps
• Polio

• Rabies
• Rotavirus
• Rubella
• Rotavirus
• Smallpox
• Varicella
• Yellow Fever

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Types of Vaccines I

• Prophylactic
• Therapeutic

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Types of Vaccines II
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Types of Vaccines III
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The Perfect Vaccine

• 100 effective
• Oral dosage form
• No adverse effects
• Highly immunogenic
• life-long immunity
• no boosters required
• Cheap
• Stable at room temperature
• no cold chain required

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Combination vaccines

• DT
• DTaP
• DTaP-HepB-IPV
• HepA-HepB
• MM
• MMR
• MMRV