Immunizations Flashcards
Immunization definition
The process by which a person becomes protected against a disease
Process confers protection then that protection is called immunity
Vax approval process: Phase 1
Initial human studies for safety and immunogenicity
Performed on a small number of people who are very closely monitored
All volunteers
Vax approval process: Phase 2
Dose ranging studies
Continue to monitor the safety and immunogenicity of vaccines
Studying on a larger number of people (several hundred)
Vax approval process: Phase 3
Provides documentation of effectiveness and additional safety data that required for licensing (thousands of people)
Vax approval process: Phase 4
Formal studies on a vaccine onceit is out on the market
Can be administered to anyone
FDA will continue to monitor everyone who receives vaccine for A/E
VICP (Vaccine injury compensation program)
People used to think that their children were getting harmed by vax and would sue pharmaceutical companies
These companies stopped making the Vax
We were at risk for vax shortage
This program says that the government compensates the people who have been found (through a court system) to really have been harmed.
(All vax on the childhood schedule are covered)
VAERS (Vaccine adverse event reporting system
Government relies on this system through which they identify problems after the marketing process begins
A way to report reactions and or adverse effects (anything!!!)
This is a public nationwide database to find trends
Vaccine Information System (VIS)
Required to be given prior to receiving each dose of vaccine, allowing the parent to ask questions regarding vaccine before administration
Informed consent
Documentation with Vax administration
Lot number on the bottle
Where you administered it, which side
That you gave parent vaccine information statement
Date of VIS
ACIP (Advisory Committee in Immunization Practices)
A group of individuals that look at all possible evidence available on this particular vaccine to determine whether it should be recommended as a routine vaccination
ACIP Members
Medical and public health experts
15 voting members
14/15 are Vaccinology, immunology, pediatrics, internal medicine, nursing, family med, virology, public health, and preventative medicine
1/15 is the consumer (regular person)
8 more: ex-officio: represent federal government
30 more non-voting members: liaison organization that help bring immunization expertise
ACIP Meetings
3 meetings each year
Broadcasted on the web
You can attend in person but must go through clearance
Participate in work groups broken up by specific preventable disease (work all year round)
Immunity
to tolerate self and eliminate anything it considers foreign or “non-self”
Give protection from infectious disease, since microbe identified as foreign by the immune system
Precautions with: IPV
Pregnancy
Active immunity
Protection from our own immune system
Produces humoral immunity (antibody) and cellular immunity
Permanent: Memory B cells will quickly activate antibodies when reinfected
Active immunity: Received:
Surviving infection by disease causing organism
Vaccination that produce an immune response and confer immunological memory
Passive immunity
Protection from another
Mom to baby (we don’t give MMR to babies <1yr) - during the last 1-2 mo of pregnancy
Breastfeeding
Temporary (Synagis must be given every 30 days)
Live attenuated Vaccine
Produced by modifying a disease producing virus or bacteria
Organism retain the ability to replicate and produce immunity but does not cause illness
Inactive Vaccine
Produced from whole or fractions of viruses or bacteria
Inactive Vaccine: Whole
Made from entire organisms but inactivated
Inactive Vaccine: Fractional
Either protein or polysaccharide based
Diphtheria: Transmission
Respiratory droplet
Skin to skin
Diphtheria: Clinical features
Involve any mucus membrane, typically classified based on the site of infection
Interior nasal, pharyngeal, tonsillar
Diphtheria: Complications
Attributed to the toxin the bacteria produces causing neuritis and myocarditis
Death: 5-10%