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VACCINE APPROVAL
Safety Issues
The safety of vaccines is a controversial public health issue because vaccines are in
a unique niche in the marketplace. No vaccine is totally effectibe or 100% safe.
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In 1986, Congress enacted the National Childhood Vaccine Injury Act (NCVIA)
to establish a no fault compensation system for children who were harmed by
adverse events.
Vaccine Adverse Events Reporting System (VAERS) and the Clinical
Immunization Safety Assessment Network, are essential to ensure tracking of
actual but rare adverse events that may be related to vaccination.
In 2011, the U.S. Supreme Court ruled that vaccine makers are immune from
lawsuits alleging that the design of a vaccine is defective.
A U.S. Food and Drug Administration (FDA) approved vaccine must meet specific
requirements, as follows:
1. Produce protective immunity with only minimal side effects
2. Be immunogenic enough
3. Be stable during its shelf life
Vaccine development is an important focus of research related to acquired
immunodefieciency syndrome (AIDS) , malaria and other devastating diseases.
CONCERNS ABOUT VACCINES
In the past 20 years, the number of recommended pediatric vaccines has increased
dramatically, despite unproven theories alleging connections between vaccines and
illnesses, including autism, diabetes, and multiple sclerosis.
REPRESENTATIVE VACCINES
HIV-AIDS
The goal of an effective HIV vaccine is to induce a response in the recipient that is
unnatural immunity. The problem with HIV vaccine candidates is that although these
vaccines can be modestly protective, they generally do not induce neutralizing
antibodies nor reactive cytotoxic T cell responses against HIV.
The status of HIV vaccines to date is a follows:
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VACCINE DEVELOPMENT
The goal producing HIV vaccines is to destroy HIV or keep the virus in check so that
it causes no further damage. An ideal vaccine would stop progressibe
immunodeficiency and restore the immune system to a healthy state.
The requirement for a preventive HIV vaccine are to generate humoral and cellular
immunity against HIV in the host before exposure to the virus.
3 types of HIV vaccines:
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VACCINE PROBLEMS
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At the book
VACCINE EXPECTATIONS
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At the book
CYTOMEGALOVIRUS
No available vaccine
Only few CMV vaccines have been tested (live attenuated)
Do not spread easily
HAY FEVER
An experimental DNA based vaccine have been developed, to protect against
this disease after six injections
The vaccine lessens the immune system to turn off the Th2 helper cells
IgE activated by Th2 is a protein largely responsible for allergy symptoms
Dendritic cells, keeping inflammation in check over the long term and breaks
self-sustaining allergic cycle
HUMAN PAPILLOMAVIRUS
These vaccines work by exposing the bodys immune cells to weakened forms
of an antigen that form on the surface of an infectious agent.
These vaccines can prevent cervical cancer caused by HPV-16 and HPV18
INFLUENZA
FDA has approved FluLaval, an influenza vaccine, for immunizing people 18
years and older against flu.
Currently, there are 5 FDA licensed vaccines
LEUKEMIA
MALARIA
Bloodborne parasite
Transmitted throught the bite of Anopheles mosquitoes.
4 types of human malaria:
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Plasmodium falciparum
Vivax
Malariae
Ovale