Assessment 4

Question 1

Vaccines are considered drugs but require different surveillance systems to monitor adverse events. Below is a list of differences between vaccines and drugs, which lead to the need for specific ‘immunization safety’, or AEFI surveillance.

Vaccines usually differ from drugs in in terms of:

Select one or more:

	A. Recipient’s age.
	B. Recipient’s health-status.
	C. Registration processes in National Regulatory Authorities.
	D. Staff administrating the vaccine/drug.
	E. Expectations towards substance’s safety.

Answer

Answers A, B, D and E are correct.

Key differences between vaccines and drugs:

Vaccines	Other drugs
Who gets them?
Usually, healthy people including infants. Often most of the population, birth cohort, or group at high risk for disease or complications.	Usually, sick people.
Why?
To prevent disease.	Usually to treat disease.
How do they get them?
Vaccines are often administered through public health programmes. In some countries, vaccination may be a prerequisite for enrolment in school.	Often administered by a medical doctor or pharmacist.
When do they get them?
Most childhood vaccines are administered at specific ages, or in relation to special circumstances such as outbreaks or travel. The age at the time of vaccination may coincide with the emergence of certain age-related diseases (e.g. neurodevelopmental disorders).	Normally at time of illness.
What about adverse events?
Low acceptance of risk. Intensive investigation of severe AEFIs, even if rare, is necessary. Minor AEFIs also should be carefully monitored because they may suggest a potentially larger problem with the vaccine or immunization, or have an impact on the acceptability of immunization in general.	Acceptance of adverse events often depends on the severity of illness being treated and the availability of alternative treatment options.
How many?
8–15 Childhood vaccines globally recommended.	Thousands of drugs are available.

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