Health Care — Feds OK breathing test for COVID-19

Apparently Dunkin’ makes iced coffee-flavored jelly beans. Who knew?

Today we’ll look at a new type of COVID-19 test that shows the technological progress on testing since the early days of the pandemic.

Welcome to Overnight Health Care, where we’re following the latest moves on policy and news affecting your health. For The Hill, we’re Peter Sullivan, Nathaniel Weixel and Joseph Choi. Someone forward you this newsletter? Subscribe here.

FDA authorizes first COVID-19 breath test

The Food and Drug Administration (FDA) authorized the first test to detect COVID-19 through breath for emergency use.

The InspectIR COVID-19 Breathalyzer—which is about the size of a carry-on piece of luggage — is able to identify five volatile organic compounds tied to the coronavirus in a person’s breath using a technique known as gas chromatography gas mass-spectrometry, delivering results within three minutes, according to the FDA.

The agency said that in a study of 2,409 people, which included both people with and without symptoms, the test had a 99.3 percent specificity rate, which measures the percent of correctly identified negative test samples.

The FDA also noted that the InspectIR COVID-19 Breathalyzer had a 91.2 percent sensitivity rate, which measures the percent of correctly identified positive test samples.

Still, the health agency said that a molecular test should be used to confirm positive test results returned by the COVID-19 breath test.

“Today’s authorization is yet another example of the rapid innovation occurring with diagnostic tests for COVID-19,” Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health, said in a statement.

About 100 of the InspectIR COVID-19 Breathalyzers, each of which the FDA said can be used to test roughly 160 samples per day, are anticipated to be made each week.

Read more here.

FDA to regulate e-cigarettes with synthetic nicotine

The Food and Drug Administration (FDA) now has oversight to regulate e-cigarette products from vaping companies operating under a loophole that was closed by a new law.

The law, which took effect Thursday, gives the FDA authority to regulate e-cigarettes and other products that use synthetic nicotine, a move that targets vaping companies that use manufactured nicotine to circumvent FDA regulation and sell the products to teenagers.

“As I’ve said before, this law closes the ‘loophole’ some tobacco product manufacturers have exploited to bypass FDA’s regulatory authority,” FDA Commissioner Robert Califf wrote in a tweet. “We’ll hold e-cigarette companies using synthetic nicotine to the same public health standards we’ve implemented for other tobacco products.”

The news comes after Congress passed a bipartisan provision last month that gave the FDA authority to regulate synthetic nicotine products.

The new law does not ban e-cigarettes and other similar products but brings them under the same level of oversight as e-cigarettes that contain nicotine from tobacco. The law prohibits selling the products to people under the age of 21 and prohibits marketing them as modified risk tobacco products without the FDA’s authorization.

Read more here.


People who are vaccinated against COVID-19 and have a history of certain mental illness may have an elevated risk of breakthrough infections, according to a new study.

Researchers at the University of California, San Francisco looked at data from 263,697 US Department of Veterans Affairs patients who had completed their vaccines and had at least one COVID-19 test. Slightly more than 51 percent received at least one psychiatric diagnosis within the last five years and 14.8 percent experienced a breakthrough COVID-19 infection.

Patients over 65 with substance abuse disorder, psychotic disorders, bipolar disorder, adjustment disorder and anxiety had increased risks of up to 24 percent for a breakthrough COVID-19 infection while patients younger than 65 faced 11 percent greater risk of a breakthrough case than those without a history of mental illness.

“Our research suggests that increased breakthrough infections in people with psychiatric disorders cannot be entirely explained by socio-demographic factors or pre-existing conditions,” said the study’s senior author Aoife O’Donovan. “It’s possible that immunity following vaccination wanes more quickly or more strongly for people with psychiatric disorders and/or they could have less protection to newer variants.”

“Mental health is important to consider in conjunction with other risk factors,” she continued, “and some patients should be prioritized for boosters and other critical preventive efforts.”

Read more here.


California is keeping its COVID-19 vaccine mandate for schoolchildren, Gov. Gavin Newsom’s (D) administration announced this week, though the state’s mandate won’t take effect until at least next summer.

Newsom has said he was waiting for federal health officials to approve giving the vaccine to younger children, and while those as young as 5 are currently able to get the shot under an emergency authorization, the Food and Drug Administration has not given final approval for giving the vaccine to young children.

California’s health secretary told The Associated Press that the state would not implement the mandate until at least July 2023.

Read more here.

Dems aim to expand maternal care, midwifery coverage

A group of House and Senate Democrats on Friday introduced legislation that would expand Medicaid to cover midwife care in an effort to improve the state of maternal health care.

Introduced during Black Maternal Health Week, the Mamas First Act would amend the Social Security Act to provide coverage under the Medicaid program for doulas and midwives. Medicaid currently covers 40 percent of all births, and 65 percent of Black mothers’ births, in the US each year.

“As Black mothers continue to bear the burden of our maternal health crisis, dying at three to five times the rate of white mothers, making these investments will have an immediate impact on the most vulnerable mothers,” Rep. Gwen Moore (D-Wis .), a sponsor of the bill, said in a statement.

Black women are more than three times as likely to die from a pregnancy-related causes than white women, according to data from the Centers for Disease Control and Prevention.

The US also has the highest maternal mortality rate compared to other high-income developed countries, a 2020 Commonwealth Study found. The study also found that demand for access to midwives grew during the coronavirus pandemic, with several states issuing emergency orders to expand midwifery services.

Read more here.

🎧 TUNE IN TO RISING, now available as a podcast. It’s politics — without the screaming.


  • Rare, severe liver damage reported in children in the US and Europe (NBCnews)
  • How the Test-to-Treat Pillar of the US Covid Strategy Is Failing Patients (Kaiser Health News)
  • South Korea to lift most COVID curbs next week as Omicron wanes (Reuters)


  • North Texas Experts Predict Small Uptick in COVID-19 Cases (NBC 5)
  • ‘A game changer’: University of Florida researchers help develop 30-second COVID test (Fox 13)
  • Boston COVID test positivity rate passes ‘threshold of concern’ (abcnews)

That’s it for today, thanks for reading. Check out The Hill’s Health Care page for the latest news and coverage. See you on Monday.


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