University:
The University Of Western Ontario
Course:
Biochemistry 3382A | Biochemical Regulation
Academic year:

2023
Views:

185

Pages:

3
Author:

Kyuwon J.

Mistreatment of Marginalized and impoverished people in medical testing ● Tuskegee syphilis study ○ Hundreds of black men untreated ○ Could be cured ○ 28 death ○ 100 more from related complication Vaccine Safety- The cutter Incident ● Cutter Laboratories Berkeley California 1955 ● Salk vaccine not properly inactivated ● 120,000 childrens given to ○ 40,000 symptomatic, 51 paralyzed 5 death ● Company liable without negligence ● Spurred changes in safety monitoring ● Vaccination resumed after short pause ● Salk vaccine highly effective ○ >97% reduction in US polio cases by 1961 Key points in safety and ethics ● Safety ○ Pre-clinical research and clinical trials ○ Regulatory reviews at multiple stages ○ Continued monitoring of safety after licensing ● Nuremberg Code ○ Followed WW2 ○ ethical research principles for human experimentation ○ Voluntary consent ● Declaration of Helsinki ○ Set obligation of physician investigator to research subj t ○ Research participants should receive the best known therapeutic treatments ○ Continues to amend by World Medical Association Moderna COVID-19 vaccine example ● Advert events ○ Injection site ■ Pain redness swelling ○ Systemic ■ Headache, fatigue, muscle pain ○ Vaccine efficacy ■ percent reduction in disease incidence in vaccinated group compared to unvaccinated groups The case of rotavirus vaccine and intussusception ● Rotavirus is important gastrointestinal infection of children globally ○ Aroung 5% of child deaths ● Rotavirus tetravalent vaccine (Rotashield) ○ 1 in 4670 to 1 in 9474 ○ License permanently withdrawn late 1999 ● Two current licensed vaccines ○ Highly effective ■ RotaTeq 2006, Rotarix 2008 ■ No increase in intussusception