Information immunizes against disinformation: what you need to know about vaccine development

Sars-CoV-2, colloquially and unlovingly known as “COVID-19,” has been devastating the lives of Americans this past year. Masks, social distancing and the advent of rapid and accurate testing are decent stopgap measures for now. However, the only real way out of our current circumstance will come from seasonal inoculation against the virus. With our safety, collective sanity and potential livelihoods on the line, the biomedical community and its efforts to produce a vaccine are increasingly being placed under the microscope.

The conversation around a potential COVID-19 vaccine has also stoked the already problematic skepticism around vaccine safety, and so I wanted to address vaccines and their development, both normally and for COVID-19, in a Beat here on the CGS Speaks blog. Today, I want to talk briefly about the basics of vaccine development.

“The conversation around a potential COVID-19 vaccine has also stoked the already problematic skepticism around vaccine safety, and so I wanted to address vaccines and their development, both normally and for COVID-19, in a Beat here on the CGS Speaks blog.”

-- Luke Watson
Fourth-year CGS student

Vaccine discovery is a herculean task even in the best of times, such as when there is not a pandemic scourging our communities. According to the website run by the Food and Drug Administration (FDA), the government regulatory body overseeing drugs and vaccines, there are typically four rigorous processes that must be completed before vaccines become available for use: discovery and development, preclinical research, clinical research and FDA Review. Any biomedical sciences graduate student who stayed awake for first-year coursework should be familiar with the two earliest processes, if not in name then at least in their concepts.

Prior to clinical testing, research focuses on probing the biology underlying diseases and assessing whether a vaccine candidate works in cell culture and animal models (sound familiar?). Researchers at this stage are asking whether the vaccine is safe and effectively provides immunity in cell culture and animal models. All told, it can take years, even decades, to discover a promising vaccine and perform these experiments. To put this into perspective, think about how far your laboratory has progressed on a single issue over the past year – is anything you are working on ready to be put into humans? Now look back further to five years, ten years. How about now? Even the titans of big pharma struggle to move their basic science from the bench into clinical studies because the standards are set so high even before testing in humans can become an option. Everything needs to be rigorously tested, and pulling that off can cost billions (with a capital B) of U.S. dollars.

Following the successful completion of this work, an Investigational New Drug application (IND) is submitted to the FDA. This document details data collected from the preclinical work and discusses how these findings may indicate efficacy in humans. Subsequent IND approval allows the company to enter into clinical studies, broken down into four phases. The first, aptly named phase one, screens the use of the vaccine in tens of otherwise healthy individuals. Barring unforeseen medical complications or abnormal findings, the company can then progress their vaccine into phase two and phase three studies, which screen hundreds and thousands of people, respectively, for vaccine safety and effectiveness. After successful completion of phase three, the company submits a Biological License Application for review first by an FDA panel and then by a non-FDA panel, the Vaccines and Related Biological Products Advisory Committee. These groups are invaluable to the development process, as they are charged with critically evaluating the data for safety and efficacy.

When the vaccine meets all FDA requirements and all of the related medical information is up to snuff for distribution to medical providers, it is given the green light for distribution. Even after the drug is on the market, the company will undertake phase four studies to observe longer-term outcomes of the vaccine, which is ultimately followed up on by the FDA.

I hope I have laid a sufficient foundation for further commentary on the impending COVID-19 vaccine. All told, given the significant time and resource (and financial!) investment into vaccine research, coupled with the oversight provided by the regulatory body during and after clinical studies, I firmly align myself in the “safe to use” camp. Keep an eye out for future posts that will tackle how the timeline for COVID-19 vaccine development compares to the norm, and why mercury in vaccine formulations does not, by any stretch of the imagination, relate to autism development. Until next time!