FDA: COVID Mutations Won't Require Long Vaccine Approval Processes
The US Food and Drug Administration said on Monday that vaccines against COVID-19 mutations won't take as long, according to CNBC.
This new guidance was released in a 24-page document on the FDA's website and would allow new vaccines to be used as an amendment to the originally approved emergency use application. The company would still need to show data depicting the effectiveness and process of the vaccine.
“Preliminary reports from clinical trials evaluating COVID-19 vaccine candidates in multiple countries including South Africa have added to concerns that vaccine efficacy against the B.1.351 variant may be lower than against the original virus,” the FDA said, referring to the South Africa strain. “Thus, there is an urgent need to initiate development and evaluation of vaccines against these SARSCoV-2 variants.”
As of Sunday, the CDC had recorded 1,661 cases of the COVID-19 mutation from South Africa.
There has been growing concern among health professionals that COVID-19 mutations could setback the ongoing vaccine campaign. Millions of Americans are being vaccinated daily in the hope that normalcy will be here sooner rather than later. Pfizer and Moderna, whose shots have been administered in the US, have plans to modify vaccines to target mutations of COVID-19.