I’ve been spending this week gathering information on some of the basics (or at least what I would consider basic) of Vaccine Development. Here are a few takeaways:
- The development of a vaccine can take several years to create and is broken down into phases. Initial research and testing is typically done using animals like mice, rabbits and monkeys. Phase 1 is a small group of volunteers, typically 20-100, and lasts a few months. Phase 2 consists of several hundred participants and lasts anywhere from a few months to two years. Phase 3 utilizes several hundred to several thousand volunteers for testing (“U.S. Vaccine Safety-Overview, History and How it Works” 2020).
- Vaccines should be safe across multiple population groups including pregnant women, children, older adults, and immunocompromised individuals (“U.S. Vaccine Safety-Overview, History and How it Works” 2020).
- Testing within vulnerable groups (children, pregnant women and elderly) presents ethical issues which can make it difficult to ensure a vaccine is safe and effective for those groups. Pregnant women are not currently included in SARS-CoV-2 testing.
- The vaccine goes through an approval process by the Federal Drug Administration. Next, the Advisory Committee on Immunization Practices works with medical and public heath experts to make recommendations on how the vaccine is to be used. Lastly, the Director of the Center for Disease Control and the U.S. Department of Health and Human Services reviews recommendations submitted by medical and health experts to make a determination on immunization.
The subject evolves as we learn more about how the virus operates. A vaccine is currently being tested in several countries all within different stages of development.
“U.S. Vaccine Safety - Overview, History, and How It Works.”
Centers for Disease Control and Prevention, Centers for Disease Control
and Prevention, 9 Sept. 2020,
www.cdc.gov/vaccinesafety/ensuringsafety/history/index.html.
