FDA plans for new variants, monitors safety of vaccines

CLEVELAND, Ohio (WOIO) - The FDA now wants to make it faster for vaccine companies to upgrade their shots as we continue to learn more about new coronavirus variants.

The agency said it will continue to ensure updated vaccines are safe and effective.

The FDA said allowing drug companies to make changes without massive clinical trials again could help fight the new variants faster.

But top agency officials pointed out they do believe the vaccines available will work against these variants.

The Pfizer and Moderna vaccines have been deemed safe and effective in the fight against COVID-19 and it’s the FDA’s job to make sure they stay that way, even after the vaccine trials are over.

“Whenever FDA approves or authorizes a vaccine our work doesn’t stop there. We’re on the job constantly, and we’ll be helping to set up programs and surveillance to actually detect ongoing safety events,” said Dr. Stephen Hahn, former commissioner of the U.S. Food and Drug Administration and member of the White House Coronavirus Task Force.

He said the agency has an active role throughout the process of the development of a vaccine from the pre-clinical animal trials all the way through human clinical studies.

Then they continue to monitor the safety of the vaccines after clinical trials.

Through a special surveillance program, Hahn said the FDA will watch the safety of a vaccine for up to two years or longer after authorization or approval.

“FDA has incredible scientific expertise, we have openness and transparency on our process, and there will be an outside review committee. We believe that the American public should have great confidence in FDA’s approval or authorization process,” Hahn said.

You can read more about the FDA’s regulatory process for Covid-19 vaccines here.

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