- s564 of the US Federal; Food, Drug, and Cosmetic Act permits the commissioner of the FDA to remove some regulatory hurdles for a drug on the grounds of a public health emergency.
- Side effects of a "successful vaccine" aren't known and cannot be studied without given time
- Each day the vaccine is delayed to the distribution billions of dollars of economic damage is caused 
- Use of patents and the delay it may cause on distribution

University of California, Santa Cruz

- Transitioning from animal testing to human clinical trials
- The resources needed to produce a vaccine
- The duration and magnitude of the immunity provided by a potential vaccine

Preclinical evaluation of vaccine efficacies and safety

Tham, B., & Findlay, M. J. (2020). COVID-19 Vaccine Research, Development, Regulation and Access. SSRN Electronic Journal. doi:10.2139/ssrn.3640153

COVID-19 Vaccine Research, Development,
Regulation and Access

- Phase 1 trials are based on dosage to test the strongest immune response without serious side effects (generally non-randomized)
- Phase 2 the evaluation is expanded and volunteers are separated by sex, age, health, and status
- Phase 3 thousands of candidates are given the vaccine, the results are then submitted to the WHO to be judged

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