WASHINGTON — The Food and Drug Administration on Thursday issued an emergency use authorization for what it said is the first device that can detect COVID-19 in breath samples.
The InspectIR COVID-19 Breathalyzer is about the size of a piece of carry-on luggage, the FDA said, and can be used in doctor’s offices, hospitals and mobile testing sites. The test, which can provide results in less than three minutes, must be carried out under the supervision of a licensed health care provider.
Dr. Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health, called the device “yet another example of the rapid innovation occurring with diagnostic tests for COVID-19.”
The FDA said the device was 91.2% accurate at identifying positive test samples and 99.3% accurate at identifying negative test samples.
“InspectIR expects to be able to produce approximately 100 instruments per week, which can each be used to evaluate approximately 160 samples per day,” the agency said. “At this level of production, testing capacity using the InspectIR COVID-19 Breathalyzer is expected to increase by approximately 64,000 samples per month.”
While COVID-19 cases now are at much lower levels in the U.S., in recent weeks an even more contagious version of omicron, called BA.2, has become the dominant type locally and around the world.
Pfizer to seek COVID booster for healthy 5- to 11-year-olds
Pfizer said Thursday it wants to expand its COVID-19 booster shots to healthy elementary-age kids.
U.S. health authorities already urge everyone 12 and older to get one booster dose for the best protection against the newest variants -- and recently gave the option of a second booster to those 50 and older.
Now Pfizer says new data shows healthy 5- to 11-year-olds could benefit from another kid-sized shot.
In a small study, 140 youngsters who’d already gotten two shots were given a booster six months later, and researchers found the extra shot generally revved up their immune response. But a closer look at 30 of the children found a 36-fold increase in virus-fighting antibodies, levels high enough to fight the super-contagious omicron variant, Pfizer and its partner BioNTech said in a press release.
The data has not been published or vetted by independent experts.
In the coming days, the companies plan to ask the U.S. Food and Drug Administration to authorize a booster for healthy 5- to 11-year-olds. They also plan to share the data with European and other regulators.