Right now, there is no FDA-approved vaccine for COVID-19, but researchers are racing to create one. The process of creating a vaccine is complicated. Each step involves a lot of small details, each of which takes time.
"At the end of the day, that's really what you want is a vaccine that not only is efficacious but also is safe," said Dr. Jennifer Pancorbo of NC State's Bio-manufacturing Training and Education Center.
Dr. Pancorbo knows all about vaccines and she says the first step is design. Researchers learn about the virus, how it spreads and takes over the body. Once that is understood, scientists can find ap lace to stop the virus along its pathway.
"So that's what companies are trying to do, trying to use genetic materials to help the body find the path to the pathogen," said Dr. Pancorbo.
Next comes manufacturing. First, what is called the upstream process, where Dr. Pancorbo says researchers grow cells and produce the "vaccine component" or "active ingredient" that will be put into the vaccine.
It then goes to the downstream process, where the vaccine component is purified, separated and put in the final formulation, one that is stable, ready to use and easy to transport.
"And that's how you end up with a vaccine in a vial or syringe that travels around the world in a fairly stable manner," said Dr. Pancorbo.
The FDA says safety and effectiveness are the top priorities for a COVID-19 vaccine. The agency's commissioner said this week that the process takes time because at each step, the FDA wants to analyze the data.