What goes into making a vaccine?
(CNN) – There’s no FDA-approved vaccine for COVID-19 yet, but researchers are racing to create one.
So, what goes into making a vaccine?
It’s a complicated process. Each step involves many small details, each of which takes time.
“At the end of the day, that’s really what you want: a vaccine that not only is efficacious, but also is safe,” Dr. Jennifer Pancorbo said.
Pancorbo knows all about vaccines from her role at North Carolina State University’s Biomanufacturing Training and Education Center.
She said the first step is design, in which researchers learn about the virus: how it spreads, attacks and takes over the body.
Once that’s understood, scientists can find a place 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,” Pancorbo said.
Next comes manufacturing. The first step in that stage is what’s called upstream process, in which 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, in which 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 in a syringe that travels around the world in a fairly stable manner,” Pancorbo said.
The Food and Drug Administration said 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.
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