Vaccine development is typically measured in years, not months. But as the COVID-19 pandemic rages on, scientists are racing the clock—and breaking records—to develop an immunization that provides protection against the virus.
The nation’s scientific community also faces another obstacle: convincing the public that the COVID-19 vaccine is safe, and how important it is to get a COVID-19 vaccination in the first place.
“Even the most effective vaccine can’t protect us or our loved ones if people are afraid to take it or will not take it,” said Kathleen Mullane, director of infectious disease clinical trials at University of Chicago Medicine. “We know things are moving faster than ever, but the nation’s scientific community has cooperated and collaborated in ways as never before and we are absolutely committed to making sure whatever is ultimately approved works and is safe. I am going to get vaccinated and am recommending vaccination for my family and friends because I believe in the safety and efficacy of these agents.”
The rapid progress on a COVID-19 vaccine means that data regarding the long-term safety and durability of these vaccines will still be flowing in long after a vaccine has been approved for emergency use. Nevertheless, those wondering about vaccine safety may be encouraged that despite the speed in which these vaccines have been developed, the important regulatory and evaluation checkpoints designed to protect patients were followed. These milestones help to determine how safe and effective a vaccine will be, and whether or not the benefits are worth any potential risks.
Operation Warp Speed
Before the COVID-19 pandemic, getting a new vaccine from concept to approval could take 10 years and billions of dollars. With only one in 10 vaccine candidates making it to market, vaccine development is a risky proposition for pharmaceutical manufacturers.
For those who are unfamiliar with the methodical process of clinical research, the process can feel torturously slow. First, researchers must study the structure and infectious behavior of a pathogen. Then they figure out how to get the human body to best produce an immune response to fight against it. Next, the vaccine is tested for safety and efficacy—first using cell, animal and mathematical models, and later in human clinical trials involving thousands of participants. Only then can the federal approval process begin.