Pfizer will begin phase 2 and 3 trials of its COVID-19 antiviral pill in children 6 years and older; lawmakers respond after e-cigarette companies began using unregulated synthetic nicotine to get around FDA regulation; the American College of Rheumatology released a new guideline on the management of Kawasaki disease.
Pfizer announced it will begin phase 2 and 3 testing of its COVID-19 antiviral pill, Paxlovid, in children 6 years and older, Politico reported. The FDA approved Paxlovid for children 12 years and older at high risk for COVID-19 in December 2021. These trials will focus on a younger age group who have tested positive for COVID-19, are not hospitalized, and are at risk of developing severe COVID-19. Based on the findings in these trials, Pfizer plans to develop a Paxlovid dose for children younger than 6 years and enroll children in this age group in the ongoing trial.
Despite an FDA crackdown on flavored e-cigarettes back in 2020, sales have “soared” in 2022 due to a loophole. The FDA had regulated e-cigarettes containing tobacco plant-derived nicotine. To get around this, some companies such as Puff Bar have switched to using an unregulated synthetic nicotine. On Tuesday, US lawmakers proposed to adjust the language in the Congressional omnibus budget bill to give the FDA authority to regulate synthetic nicotine as well, although it is unclear if this issue will be included in the final bill, The New York Times reported.
The American College of Rheumatology (ACR) released a new guideline regarding the management of Kawasaki disease. This guideline, released in partnership with the Vasculitis Foundation, focuses on Kawasaki disease diagnosis issues, treatment in high-risk patients, and disease management in convalescent or recovering patients. Eleven treatment recommendations are included in the new ACR guideline, including 2 that differ from the current standards: higher-risk patients should receive short courses of corticosteroids at time of first diagnosis, and physicians can decide whether to use high- or low-dose aspirin for therapy.