Ethical Issues with Vaccines & Monoclonal Antibodies (AQA AS Biology): Revision Note
Exam code: 7401
Ethical issues with vaccines & monoclonal antibodies
Ethical issues associated with the use of vaccines
- Use of animals - Vaccines are first tested on animals, which some view as unethical 
- Animal-derived substances may also be used in vaccine production 
 
- Human testing - Trial vaccines carry risks (e.g. side effects or a false sense of protection) 
- Volunteers may be vulnerable if motivated by payment, raising concerns over exploitation 
 
- Side effects - Some avoid vaccines due to the small risk of side effects 
- Herd immunity protects them, which some argue is unfair 
- Ethical concern over parents refusing vaccines for children, potentially putting them at risk 
 
- Epidemics and access - Questions over priority groups during epidemics (e.g. priority vaccines for the elderly or healthcare workers during the COVID-19 pandemic) 
- Global inequality, where wealthier countries may access vaccines before poorer nations, raises concerns over fair distribution 
 
Ethical issues associated with the use of monoclonal antibodies
- Use of animals - Mice are used to produce mAbs: mice are injected with with an antigen before activated B cells are extracted from the spleen 
- This may cause suffering or harm to the mice and raises concerns for those who oppose animal testing or genetic modification 
 
- Human use in treatment and trials - mAbs are used in cancer and disease treatment, but may have serious side effects 
- Informed consent is essential to ensure that patients fully understand the risks 
- Trials may involve vulnerable participants (e.g. financially motivated or severely ill) 
 
- Accessibility and cost - Monoclonal antibody treatments are often expensive 
- Raises concerns about fair access, especially in lower-income countries or healthcare systems 
 
Examiner Tips and Tricks
Be ready to outline ethical issues, particularly those involving animal welfare, consent, and access to treatment.
Evaluating the ethical issues & studies of vaccines & monoclonal antibodies
- Claims about vaccine or mAb safety and effectiveness must be backed by scientific evidence - This requires repeatable studies and reproducible results 
 
- Scientists must also critically evaluate the data and methods used to support any claim - This ensures findings are - reliable 
- valid 
- not misleading 
 
 
Example: The MMR Vaccine
- The MMR vaccine protects against measles, mumps, and rubella 
Study 1:
- A 1998 study based on just 12 children suggested a link between the vaccine and autism 
- It was later revealed that a conflict of interest existed — one author was consulting for parents suing vaccine manufacturers 
- The study was discredited and retracted, but caused a drop in vaccination rates 
- This example highlights the importance of: - large, unbiased sample sizes 
- peer review and replication 
- transparency in funding and conflicts of interest 
 
Study 2:
- In 2005, a study was published on the incidence of autism in 30,000 children in an area of Japan between 1988 and 1996 - The MMR vaccine was first introduced in this area in 1989 but stopped being administered in 1993 
- The results of the study are shown below: 
 

- Describing the data: - The number of children with autism continued to increase even after the MMR vaccine stopped being administered 
- For example, in 1992 (when children were given the vaccine), approximately only 75 per 10,000 children were diagnosed with autism by age 7, but in 1994 (when children were no longer given the vaccine), approximately 200 per 10,000 children were diagnosed with autism by age 7 
 
- Drawing conclusions: - This study suggests there is no link between the MMR vaccine and autism 
 
- Evaluating the study: - We can have greater confidence in the results of this study (compared to the one in 1998) as the sample size was very large (30,000 children) 
- This improved methodology means that the results are less likely to be due to chance 
 
Examiner Tips and Tricks
If you are asked to evaluate the methods or results of an experiment or study in an exam, remember to consider the following:
- Repeatability – Were enough repeats taken? Would the same person get similar results again? 
- Reproducibility – Would other scientists get similar results using the same method? 
- Validity – Does the data answer the question, and were variables well controlled? 
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