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May 30, 2023
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Top in ID: Paxlovid approval; drug-resistant bacteria treatment

The FDA has fully approved Paxlovid to treat COVID-19 in adults after the antiviral pill was first granted emergency use authorization in December 2021.

The approval follows the FDA Antimicrobial Drugs Advisory Committee’s 16-1 vote supporting Paxlovid in adults, as well as favorable results from the randomized, double-blind, placebo-controlled EPIC-HR clinical trial. Patrizia Cavazzoni, MD, director for the FDA’s Center for Drug Evaluation and Research, said in a press release that Paxlovid remains “an important treatment option for people at high risk for progression to severe COVID-19, including those with prior immunity.” It was the top story in infectious disease last week.

 The main entrance of FDA Building 1.
The FDA has fully approved Paxlovid to treat COVID-19 in adults. Image: Adobe Stock

Another top story covered the FDA’s approval of IV sulbactam-durlobactam, marketed by Innoviva as Xacduro, to treat health care-associated pneumonia caused by strains of Acinetobacter baumannii-calcoacetius complex, a drug-resistant bacteria the CDC and WHO have designated as an urgent public health threat.

Read these and more top stories in infectious disease below:

FDA approves Paxlovid as treatment for adults at high risk for severe COVID-19

The FDA granted full approval for Paxlovid, making it the first oral antiviral pill approved by the FDA to treat COVID-19 in adults. Read more.

FDA approves new treatment for nosocomial pneumonia

The FDA has approved IV sulbactam-durlobactam to treat hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia caused by susceptible strains of Acinetobacter baumannii-calcoaceticus complex. Read more.

Myocarditis, pericarditis incidence low across 10 million doses of mRNA COVID-19 vaccines

The incidence of myocarditis/pericarditis among veterans was low across more than 10 million doses of messenger RNA COVID-19 vaccines, given as a primary or booster dose, administered at the Veterans Health Administration, researchers found. Read more.

Symptom-based scoring system may help diagnose long COVID

Researchers created a symptom-based scoring system that may help diagnose long COVID more easily. Read more.

Mandatory ID approval associated with improved C. difficile testing

An intervention requiring that infectious diseases approve testing for Clostridioides difficile infection increased the appropriateness of testing for hospital-onset C. difficile and lowered the positive testing rate by more than 50%. Read more.