PORT ANGELES — The lack of full approval by the Food and Drug Administration of vaccines available against COVID-19 not a reason to avoid getting vaccinated, health officers in Clallam and Jefferson counties said last week.
The issue of FDA’s go-ahead was cited last week at a primary election candidate forum for the Port Angeles School Board. The federal agency has approved the Pfizer vaccine for emergency use authorization for children 12-15 years old.
“Today’s action allows for a younger population to be protected from COVID-19, bringing us closer to returning to a sense of normalcy and to ending the pandemic,” Acting FDA Commissioner Dr. Janet Woodcock said in a statement.
Moderna and Johnson & Johnson are approved for those 18 and older.
The emergency use authorization “is a common source of confusion,” Clallam County Health Officer Dr. Allison Berry said Friday.
“It’s not like the FDA thinks it’s bad to get vaccinated,” she said.
“To get emergency use authorization is a very intensive process,” she said, adding it is “very similar” to full FDA approval.
“The only difference is the company has to request moving from the EUA (emergency use authorization) to full approval, then they look at the data again,” she said.
“It does not require any more testing.”
The FDA reviewed thousands of points of data in issuing the EUA for the vaccines, including clinical trials she said.
“It’s a very intensive, safety-oriented process to get the EUA. It’s far from experimental,” Berry said.
“We know that the vaccine is now documented to be safe, and we really know that COVID-19 is not safe.”
Jefferson County Health Officer Dr. Tom Locke said full FDA approval allows drug companies to directly market the vaccine to the general public.
“Typically, full approval is a very slow process,” he said Saturday, predicting full approval later this year and possibly by the beginning of the new school year.
“We’ve given this vaccine to over 150 million people and administered over twice that many doses, and it’s just got an excellent safety record,” Locke said.
He said that the lack of full FDA approval is used as a rationalization by some to justify not getting vaccinated.
“In reality, full approval is a technical thing,” he said.
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Senior Staff Writer Paul Gottlieb can be reached at 360-452-2345, ext. 55650, or at pgottlieb@peninsuladailynews.com.
