The FDA has given the first emergency use permit for a breath test to detect COVID-19.
WASHINGTON – The Food and Drug Administration issued an emergency permit on Thursday, saying it was the first device it could detect. COVID-19 in breath tests.
The FDA said the InspectIR COVID-19 breathalyzer is about the size of a hand luggage unit and can be used in doctors’ offices, hospitals and mobile testing points. A test that can give results in less than three minutes should be performed 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 “another example of the rapid innovation that is happening with diagnostic tests for COVID-19”.
The FDA said the device was 91.2% accurate in identifying positive samples and 99.3% accurate in identifying negative samples.
“InspectIR expects to produce approximately 100 instruments per week, each of which can be used to evaluate approximately 160 samples per day,” the agency said. “At this level of production, testing power using the InspectIR COVID-19 breathalyzer is expected to increase by approximately 64,000 samples per month.”
While in the US the incidence of COVID-19 is now much lower, in recent weeks an even more contagious version of omicron, called BA.2, has become the dominant type locally and worldwide.
Pfizer is looking for a treatment for COVID-19 for healthy children aged 5 to 11 years
Pfizer said Thursday it wants to extend its additional injections of COVID-19 to healthy infants.
U.S. health authorities are already urging anyone 12 years of age and older to receive one booster dose for better protection against the latest options – and recently provided a second booster for those 50 and older.
Now Pfizer says new data suggests that healthy children between the ages of 5 and 11 could benefit from another vaccine the size of a child.
In a small study, 140 teens who had already received two vaccinations received a booster six months later, and the researchers found that the extra injection generally boosted their immune response. But a closer look at the 30 children revealed a 36-fold increase in the number of antibodies fighting the virus, high enough to fight the super-contagious version of omicron, Pfizer and its partner BioNTech said in a press release.
The data were not published or verified by independent experts.
In the coming days, companies plan to apply to the U.S. Food and Drug Administration for permission to booster for healthy children ages 5 to 11. They also plan to share data with European and other regulators.
