WICHITA, Kan. (KSNW) – Getting FDA approval can be a challenge. Fagron Sterile Services is a local company that produces generic pharmaceutical products. It said the products it distributes adhere to rigorous current good manufacturing guidelines and strict DEA and FDA regulations and said receiving FDA approval is not an easy process.
FSS said getting approval from the FDA can take several years, but the pandemic has added more pressure to expedite the process.
“It’s affecting everyone, so they’ve sort of used the same fast track for the vaccine,” said Fagron Product Development Lead David Lawn.
Global Quality Director Jason McGuire said the approval goes in phases.
Phase one and two are clinical trials with smaller groups to find out the effectiveness of the vaccine.
If it is proven to be effective, it’s on to phase three, where manufacturers run clinical trials on thousands of people.
McGuire said this helps find serious side effects and the right dosage for the vaccine.
“In less than six months, they were able to get through the phase 3 trial completed, demonstrate, and now they are headed to market before the end of the year,” said McGuire.
Product Development lead David Lawn said that fast turnaround can mean less time to understand all side effects.
“That’s something you can document over the course of a longer clinical trial, but with this one, I think they will do some of that learning in process as they are treating people,” said Lawn.
While it takes time to distribute, Lawn said the development is impressive.
“Having a vaccine is very exciting, it’s the first path back to normalcy,” said Lawn.
Sedgwick County plans to start distributing the vaccine to frontline workers, first responders, and those who are at a higher risk, once distributed.