On Sept. 15, President Donald Trump stated that a vaccine for COVID-19 could be ready within four weeks — a claim that was quickly denounced by drug industry executives and other government officials. Well, it’s been four weeks, and he was completely wrong. But his statements have raised questions regarding the availability of such a vaccine, and whether or not it can be trusted.
Like most other medical products, vaccines are tested in three phases. The first phase is an assessment of how the body metabolizes the drug, to ensure that it is not toxic. This phase usually involves only 20 to 80 healthy subjects. From there, the drug moves into Phase 2, which tests a range of doses of the vaccine and looks closer at the short-term side effects. Finally, Phase 3 is a randomized, controlled trial to test whether the vaccine is safe and effective enough for widespread use, which involves testing tens of thousands of patients.
Although it may seem like this research is only being performed by large pharmaceutical companies, this research is happening right at our doorstep. UNC is working on vaccine trials of its own, as well as implementing treatment trials — which involve investigational medication, observational studies and studying the impact of COVID-19 on health care workers. Researchers have been collaborating for several months to share research and knowledge in order to develop the most effective vaccine possible.
At the moment, 45 vaccines are in human clinical trials and 91 are in animal investigation in order to create a vaccine by early next year. Ten of these vaccines are in Phase 3, awaiting success and the approval to move into limited use. Additionally, six vaccines — none of which are being developed in the United States — have been approved and are being implemented with limited use in countries such as China, the United Arab Emirates and Argentina.
Eli Lilly and Company, a well-known pharmaceutical firm, halted its Phase 3 trial this week, releasing a statement that it had been paused “out of an abundance of caution” over a potential safety concern. Similarly, Johnson & Johnson put its 60,000-person Phase 3 vaccine trial on a “study pause” due to an “unexplained illness” in a study participant. The illness is being reviewed and evaluated by an independent data and safety monitoring board, as well as the company’s clinical and safety physicians.