Biden administration to speed up at-home COVID-19 test authorization

White House COVID-19 response team discusses plan for kids 5-11

The White House COVID-19 Response Team held a briefing on Oct. 20, 2021, to discuss the government's preparation for COVID-19 vaccines to eventually be approved for kids ages 5 to 11.

WASHINGTON - The Biden administration announced Monday it was taking steps to increase the availability of at-home COVID-19 tests.

The goal is to increase the overall supply and options for consumers, hoping it would lead to lower costs.

According to the U.S. Department of Health and Human Services, the National Institutes of Health will invest $70 million from President Joe Biden’s American Rescue Plan to establish its own "Independent Test Assessment Program." The program aims to accelerate the process of tests getting authorization from the U.S. Food and Drug Administration.

Under the program, NIH officials will identify manufacturers of high-quality tests and encourage them to bring the tests to the U.S. More health agencies, including the U.S. Centers for Disease Control and Prevention, will conduct studies on the over-the-counter COVID-19 tests and work with manufacturers to compile the proper data and other information needed to get FDA emergency use authorization.

Companies that are able to manufacture the tests at a large scale will be given priority, according to HHS officials.

"Access to easy-to-use, affordable and reliable COVID tests is key to bringing peace of mind to our families, especially as we approach winter," HHS Secretary Xavier Becerra said in a news release.

"As we pursue our path out of this pandemic under President Biden, we will continue doing everything we can to keep people safe and healthy," he added.

Pfizer COVID-19 vaccine highly effective in kids 5-11, company says

Pfizer says its COVID-19 vaccine is safe and nearly 91% effective at preventing symptomatic infections in kids 5-11, based on clinical trial data released Oct. 22, 2021.

The FDA also announced it will streamline its authorization process to get more COVID-19 tests on the market.

Meanwhile, the agency also authorized another rapid test, the Celltrion Diatrust COVID-19 Home Ag Test, for emergency use.

"These actions demonstrate our continued commitment and flexibility to providing a streamlined approach to developers to increase the availability of rapid at-home tests," Dr. Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health said.

Biden recently announced he wants to quadruple the supply of at-home tests by the end of the year with a $3 billion investment. It will make up to 200 million at-home tests per month available by the end of the year.

His moves come after experts say encouraging signs last spring led to false confidence about the shrinking role for tests: falling case numbers, rising vaccination rates and guidance from health officials that vaccinated people could largely skip testing. Officials recently reversed that advice as cases and deaths driven by the delta variant surged anew.

Indeed, parts of the U.S. testing system are faring better than during prior surges. The large commercial labs that process the majority of tests performed at hospitals and testing sites still report plenty of capacity. Labcorp, one of the biggest laboratory chains, said it was delivering results for 150,000 tests daily, with the ability to double that number.

Still, rapid tests have a clear advantage in that they can be done anywhere and have a 20-minute turnaround time, but most school testing programs still rely on tests processed in labs, which return results in a day or two.

The Associated Press contributed to this report. This story was reported from Los Angeles.

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