Monitoring side effects
12 important questions on Monitoring side effects
What are the main differences between a drug and a vaccine?
- Given to general patients
- Effect for a short period of time
- Compound and amount fixed
- Chemically synthesized
- Not always produced in batches
Vaccine:
- Given to healthy people
- Effect lasts for a long time
- Amount of active substance may vary
- Biological product
- Production in batches
What are the two different types of vaccines?
- Live attenuated (weakened) vaccines
- Inactivated (dead) vaccines
What is the time of onset for live attenuated vaccines?
Generalized (systemic) reactions depend on the type of vaccine, for MMR it is 5-12 days. It has to do with the incubation period of the microorganism.
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How has the WHO classified AEFI?
- Vaccine product-related reaction
- Vaccine quality defect-related reaction
- Immunization error-related reaction
- Immunization anxiety-related reaction
- Coincidental event
What can be the causes of vaccine product-related reactions?
- Active ingredients (antigens) (non-replicating/live attenuated)
- Additives: adjuvants, preservatives, stabilizers
- Residuals (antibiotics)
- Medium, diluent
What are the mechanisms of vaccine product-related reactions?
- Inflammation
- Microbiological, vaccinitis
- Following immunological reaction
- Allergy (direct; delayed)
- Thermic, chemical, toxic, mechanic
What is meant with WHO 2 - vaccine quality defect reactions? Can you give an example?
Examples:
- 1929/1930: BCG Lübeck incident
- 1955: IPV Cutter incident
- 1992 UK discontinuation of MMR Urabe AM9 strain
What is meant with WHO 3 - reactions from programmatic errors?
- Vaccine failure due to problems in the cold chain
- Unsterile practices
- Injection technique or material
- Errors in preparation or administration
- Unsafe waste removal
What are examples of WHO 5 - coincidental events?
- Background risks of diseases
- Coincidental infections
- Not yet manifested or identified underlying developmental disabilities (e.g. Autism)
- Not yet manifested or identified underlying diseases (epilepsy; cancer)
What are common reasons for vaccination hesitancy?
- Religious reasons
- Personal beliefs or philosophical reasons
- Concerns about the safety of vaccines
- Need for more information regarding vaccinations
What are the assessment challenges in finding causality with an adverse event and a vaccine?
- Often multiple vaccines are administered simultaneously
- Background risk and coincidence
- AEFIs with a long time of onset
- Reports with a reporting delay
- Effect/bias due to media attention; social media
What are the challenges of pandemic vaccine safety surveillance?
- Relatively new vaccines
- Potential long term effects not yet known
- Rare (short term) serious events may still occur
- Risk groups for developing certain AEFI are not well established yet
- A large population is vaccinated in a short amount of time
- Differentiating between events (coincidental) and reactions may be difficult
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