Renske de Veer (rdeveer)
Q7 Research - Vaccinations
HC 1. Concept of vaccination + national vaccine
policy
- Vaccines promote health, have an expansive
reach, have rapid impact upon introduction,
and save lives and costs.
➔ Vaccine is a biological preparation that
improves immunity to a particular disease.
o Typically contains an agent that
resembles a disease causing
microorganism, and is often made
from weakened or killed forms of
the microbe, its toxins or other
purified components.
o The agent stimulates the body’s immune system to recognize the agent as
foreign, destroy it, and “remember” it, so that the immune system can more
easily recognize and destroy any of these microorganisms that is later
encounters.
Natural infection vs. vaccination
- Vaccination: vaccine does not endure the illness, low risk of adverse reaction greatly
outweighs the risk of complications by natural infection.
- Natural infection: Immunization triggers an immune system response by which the vaccine
develops long-term protection (immunity) that would normal follow recovery from
(sometimes several) naturally occurring infections.
➔ Eradication: refers to complete and permanent worldwide reduction to zero new cases
of the disease through deliberate efforts.
➔ Elimination: refers to the reduction to zero (or a very low defined target rate) of new
cases in a defined geographical area.
Vaccine safety: vaccines are not risk-free and adverse events will occasionally occur following
vaccination:
- General public has low tolerance to adverse events as vaccines are usually given to healthy
persons (expectation to safety standard is higher with vaccines compared to medicines for
sick people ).
Adverse event following immunization (AEFI) can be due to:
- Vaccine-related event caused or precipitated by a vaccine when given correctly (adverse
vaccine reaction).
- Errors in administration of the vaccine
- Unrelated coincidence
,Renske de Veer (rdeveer)
Background rates
Continuous post-licensure monitoring: identify and evaluate rare adverse events with frequency
<1:10.000.
- Vaccines are used in general population and recipients are no longer monitored in clinical
trials with narrow in/exclusion criteria.
- Subpopulations frequently excluded from clinical trials.
- Large numbers of people are being vaccinated.
- Other factors leading to AEFI need to be monitored for safety.
- Uncommon and rare vaccine reaction and reactions with delayed onset may not be detected
pre-licensure.
- Benefit-risk ratio.
o Efficacy: ability of a vaccine to work as intended to protect from illness
o Risk: probability increased adverse event that harm the individuals or population.
Public acceptance essential to:
1. Monitor the incidence of AEFI’s.
2. Scientifically evaluate the likely associations.
3. Respond to newly identified risks from vaccines.
4. Communicate the benefits and risks to patients and parents through a trusted health care
source in advance of the vaccination visit.
Types of vaccines
- Monovalent vaccine: against a single
antigen/pathogen (measles).
- Polyvalent vaccine: against two or more
strains/serotypes of the same antigen (OPV).
- Combination vaccines: some antigens are
combined in a single injection that can
prevent different diseases or that protect
against multiple strains of infectious agents
causing the same disease (DPT).
o Logistic constraints of multiple
injections
o Children’s fear of needles and pain.
, Renske de Veer (rdeveer)
Routes of administration
- Administration done by consultation bureau (to the age of 4) and GGD.
National vaccine policy: RVP (rijksvaccinatieprogramma).
- RIVM coordinates RVP
o Vaccine purchase, monitoring (immunity, vaccination grade, illness, side effects,
pathogens), communication + information, outbreak management.
Herd immunity = resistance to the spread of contagious disease within a population that results if a
sufficiently high proportion of individuals are immune to the disease, especially through vaccination.
Admission of new vaccines in RVP
1. New vaccine developed, registered, and available on the marker.
2. Health Council advises minister of Health on admission in the RVP.
o Health Council: independent scientific advisory council for the government and
parliament.
o Assessment criteria: Disease burden, effectiveness, safety, acceptability of the
vaccination, acceptability of the vaccination program, efficiency, priority.
3. Minister of Health decides on admission in RVP.
Q7 Research - Vaccinations
HC 1. Concept of vaccination + national vaccine
policy
- Vaccines promote health, have an expansive
reach, have rapid impact upon introduction,
and save lives and costs.
➔ Vaccine is a biological preparation that
improves immunity to a particular disease.
o Typically contains an agent that
resembles a disease causing
microorganism, and is often made
from weakened or killed forms of
the microbe, its toxins or other
purified components.
o The agent stimulates the body’s immune system to recognize the agent as
foreign, destroy it, and “remember” it, so that the immune system can more
easily recognize and destroy any of these microorganisms that is later
encounters.
Natural infection vs. vaccination
- Vaccination: vaccine does not endure the illness, low risk of adverse reaction greatly
outweighs the risk of complications by natural infection.
- Natural infection: Immunization triggers an immune system response by which the vaccine
develops long-term protection (immunity) that would normal follow recovery from
(sometimes several) naturally occurring infections.
➔ Eradication: refers to complete and permanent worldwide reduction to zero new cases
of the disease through deliberate efforts.
➔ Elimination: refers to the reduction to zero (or a very low defined target rate) of new
cases in a defined geographical area.
Vaccine safety: vaccines are not risk-free and adverse events will occasionally occur following
vaccination:
- General public has low tolerance to adverse events as vaccines are usually given to healthy
persons (expectation to safety standard is higher with vaccines compared to medicines for
sick people ).
Adverse event following immunization (AEFI) can be due to:
- Vaccine-related event caused or precipitated by a vaccine when given correctly (adverse
vaccine reaction).
- Errors in administration of the vaccine
- Unrelated coincidence
,Renske de Veer (rdeveer)
Background rates
Continuous post-licensure monitoring: identify and evaluate rare adverse events with frequency
<1:10.000.
- Vaccines are used in general population and recipients are no longer monitored in clinical
trials with narrow in/exclusion criteria.
- Subpopulations frequently excluded from clinical trials.
- Large numbers of people are being vaccinated.
- Other factors leading to AEFI need to be monitored for safety.
- Uncommon and rare vaccine reaction and reactions with delayed onset may not be detected
pre-licensure.
- Benefit-risk ratio.
o Efficacy: ability of a vaccine to work as intended to protect from illness
o Risk: probability increased adverse event that harm the individuals or population.
Public acceptance essential to:
1. Monitor the incidence of AEFI’s.
2. Scientifically evaluate the likely associations.
3. Respond to newly identified risks from vaccines.
4. Communicate the benefits and risks to patients and parents through a trusted health care
source in advance of the vaccination visit.
Types of vaccines
- Monovalent vaccine: against a single
antigen/pathogen (measles).
- Polyvalent vaccine: against two or more
strains/serotypes of the same antigen (OPV).
- Combination vaccines: some antigens are
combined in a single injection that can
prevent different diseases or that protect
against multiple strains of infectious agents
causing the same disease (DPT).
o Logistic constraints of multiple
injections
o Children’s fear of needles and pain.
, Renske de Veer (rdeveer)
Routes of administration
- Administration done by consultation bureau (to the age of 4) and GGD.
National vaccine policy: RVP (rijksvaccinatieprogramma).
- RIVM coordinates RVP
o Vaccine purchase, monitoring (immunity, vaccination grade, illness, side effects,
pathogens), communication + information, outbreak management.
Herd immunity = resistance to the spread of contagious disease within a population that results if a
sufficiently high proportion of individuals are immune to the disease, especially through vaccination.
Admission of new vaccines in RVP
1. New vaccine developed, registered, and available on the marker.
2. Health Council advises minister of Health on admission in the RVP.
o Health Council: independent scientific advisory council for the government and
parliament.
o Assessment criteria: Disease burden, effectiveness, safety, acceptability of the
vaccination, acceptability of the vaccination program, efficiency, priority.
3. Minister of Health decides on admission in RVP.
