Module 9 2024

03/09/2024

No Harm Principle

Vaccines target usually healthy population, often infants or children

⚫ Target population may have specific characteristics

▪ Vaccine effect can vary e.g. high malaria prevalence, nutrition, health status

▪ Vaccine effect can vary because of variation in prevailing disease – different vaccine may be needed (e.g. Malaria caused by Plasmodium falciparum - Plasmodium vivax )

▪ Vaccine schedule is adapted to population: concomitant medicines or vaccines, disease pressure

The Organisation for Professionals in Regulatory Affairs

23

Vaccines vs. Pharmaceutical Products - Study Populations

Vaccines

Pharmaceutical Products

Generally given prophylactically to people who are well

Generally given as treatments to people who are ill

Large study populations available – but recruitment for studies may be difficult as people may not realize an immediate ‘benefit’ from participation

Recruitment for studies easier as patients may find a ‘benefit’ in the experimental treatment vs. the current available options, but pool of patients to recruit from is small

The Organisation for Professionals in Regulatory Affairs

24

12

Made with FlippingBook Online newsletter creator