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FDA Issues EUA to First COVID-19 Test Using Breath Samples

In other COVID news, Pfizer, BioNTech's COVID-19 vaccine is positive in a Phase 2/3 trial and Moderna announces positive data on its bivalent COVID-19 booster platform.

By
  • Samantha McGrail
Published: 25 Apr 2022

FDA recently issued an emergency use authorization (EUA) for the first COVID-19 test that detects chemical compounds in breath samples associated with SARS-CoV-2 infection.  

Qualified, trained providers can perform the test, InspectIR COVID-19 Breathalyzer, in environments where the patient specimen is collected and analyzed. These places include doctor's offices, hospitals, and mobile testing sites.  

"Today's authorization is yet another example of the rapid innovation occurring with diagnostic tests for COVID-19," Jeff Shuren, MD, JD, director of the FDA's Center for Devices and Radiological Health, said in the announcement.  

"The FDA continues to support the development of novel COVID-19 tests with the goal of advancing technologies that can help address the current pandemic and better position the U.S. for the next public health emergency," Shuren continued.  

The InspectIR COVID-19 Breathalyzer uses gas chromatography–gas mass spectrometry (GC–MS) to separate and identify chemical mixtures and rapidly detect five volatile organic compounds (VOCs) associated with COVID-19 in exhaled breath, an FDA spokesperson stated. 

The test detects the presence of VOC markers of SARS-CoV-2, and a presumptive positive test result is returned, although patients should confirm positive results with a molecular test. Negative results should be considered based on a patient's recent exposures, history, and the presence of symptoms consistent with the virus.   

In a recent study of 2,409 individuals with and without COVID-19 symptoms, the InspectIR COVID-19 Breathalyzer demonstrated a 91.2% sensitivity and 99.3% specificity. The test also had a negative predictive value of 99.6% in a population of only 4.2% of COVID-19-positive individuals. 

These results show that individuals who receive a negative test are likely truly negative in areas of low disease prevalence. The test performed with a similar sensitivity follow-up clinical study focused on the omicron variant.  

Pfizer, BioNTech's COVID-19 Vaccine Positive in Phase 2/3 Trial 

Pfizer and BioNTech recently announced positive results from a Phase 2/3 clinical trial evaluating the safety, tolerability, and immunogenicity of a 10 µg booster dose of their COVID-19 vaccine.  

The Phase 2/3 trial analyzed data from 140 healthy children aged 5–11 years of age who received a booster dose of the company's vaccine six months after the second dose. Trial data indicated that serum antibodies induced by a third dose neutralized the omicron variant in this age group. 

Additionally, researchers found an increase in SARS-CoV-2 omicron variant and wild-type strain neutralizing titers following a booster dose compared to two doses and a robust response regardless of prior SARS-CoV-2 infection. 

Pfizer and BioNTech plan to submit a request for emergency use authorization (EUA) for a booster dose for children in the United States. FDA previously authorized the primary series of two 10 µg doses of the company's vaccine for this age group.  

Moderna Announces New Clinical Data on Bivalent COVID-19 Booster Platform 

Moderna recently announced that a booster dose of its COVID-19 vaccine, mRNA-1273.211, demonstrated superiority against the beta, delta, and omicron variants one month after administration.  

In the study, a 50 µg booster dose was generally well-tolerated in 300 study participants and the 100 µg dosage level was well-tolerated in 595 participants. Superiority continued six months after administration for the beta and omicron variants. 

The reactogenicity profile was comparable to a booster dose of mRNA-1273 at the same dosage level. The results indicate that the bivalent booster vaccine candidate mRNA-1273.211 at the 50  µg dose level induced higher antibody responses than the 50  µg mRNA-1273 booster. 

"We are pleased with these data for our first bivalent booster candidate, mRNA-1273.211. We believe that these results validate our bivalent strategy, which we announced and began pursuing in February 2021," said Stéphane Bancel, CEO of Moderna, said in the announcement.  

"Our latest bivalent booster candidate, mRNA-1273.214, which combines the currently authorized Moderna COVID-19 booster with our Omicron-specific booster candidate, remains our lead candidate for the fall 2022 Northern Hemisphere booster​. We believe that a bivalent booster vaccine, if authorized, would create a new tool as we continue to respond to emerging variants," Bancel continued.  

Moderna is currently developing updated booster candidates to address the continued evolution of SARS-CoV-2, including monovalent and bivalent candidates targeting multiple variants of concern.  

Notably, the company's primary focus is on the bivalent booster approach to maintain high neutralizing antibody titers while improving the breadth of immunity to variants.​  

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