Wichita, Kansas 2020-11-19 19:44:48 –
Wichita, Kansas (KSNW)-Getting FDA approval is easy. Fagron Sterile Services, a local company that manufactures generic drugs, said the products it sells are already FDA-approved and not an easy process.
The FSS said it could take years to get approval from the FDA, but the pandemic is putting more pressure on the process.
“They used the same fast track for the vaccine because it affects everyone,” said David Lawn, Fagron Product Development Leader.
Global Quality Director Jason McGuire said approval will be phased in.
Phase 1 and Phase 2 are small group clinical trials to confirm the efficacy of the vaccine.
If it proves to be effective, it goes to Phase 3 and the manufacturer conducts clinical trials on thousands of people.
McGuire said this would help find serious side effects and the right dose of the vaccine.
“In less than six months, we were able to complete and demonstrate Phase 3 testing, which is now on the market by the end of the year,” said McGuire.
Product development leader David Lawn said that fast turnarounds can reduce the time it takes to understand all side effects.
“This can be documented in the course of a longer clinical trial, but I think it can be used to do some of that learning while treating people,” he said. Mr. Lone said.
Distribution will take some time, but Mr. Lone said the development was impressive.
“Vaccination is very exciting. It’s the first way to get back to normal,” Lone said.
Sedgwick County plans to begin distributing the vaccine to front-line workers, first responders, and high-risk people after it has been distributed.
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Local experts explain the process for COVID-19 vaccine Source link Local experts explain the process for COVID-19 vaccine