Morning Briefing
Summaries of health policy coverage from major news organizations
First Covid Pill That Prevents Infection After Exposure Awaits FDA Approval
Shionogi has submitted its new drug application (NDA) to the Food and Drug Administration (FDA) for the approval of its oral pill for COVID (ensitrelvir), the first antiviral drug for the prevention of COVID-19 following exposure to an infected person, according to a company news release today. Ensitrelvir, known as Xocova, is already approved for use in Japan. The drug is also available in Singapore and under review in Taiwan. (Soucheray, 9/2)
An over-the-counter nasal spray which has been used for years as a safe and effective treatment for seasonal allergies could potentially prevent Covid infections, according to clinical trial results released Tuesday. The antihistamine azelastine works as an antiviral against a range of respiratory infections, including influenza, RSV and the virus that causes Covid, a growing number of studies have shown. (Cox, 9/2)
A large UK target trial emulation analysis of data from the COVID-OUT trial suggests that early use of the type 2 diabetes drug metformin reduces the risk of long COVID by 36% at 1 year post-infection among overweight or obese adults. The study was conducted by University College London researchers based on data from a 2023 randomized phase 3 trial led by University of Minnesota investigators. That trial concluded that 14-day outpatient metformin treatment lowered the risk of persistent COVID-19 symptoms at 10 months by 63% in overweight or obese patients aged 30 to 85 years when given within 3 days of symptom onset. (Van Beusekom, 9/2)
If you asked most Americans, they'd probably tell you that one global pandemic in a lifetime is one more than they wanted. They'd rather not think about the next one. But for Center for Infectious Disease Research and Policy (CIDRAP) Director Michael Osterholm, PhD, MPH, the mistakes that were made during the emergency phase of the COVID-19 pandemic, and the lessons learned, provide an opportunity to explore how a future pandemic caused by an even deadlier virus than SARS-CoV-2 could play out. (Dall, 9/2)
On the flu shot —
The high-dose inactivated influenza vaccine may deliver better protection against myocarditis and pericarditis compared with the standard-dose shot in older adults, according to a secondary analysis of the randomized DANFLU-2 trial. (Rudd, 9/2)
Are there any changes in eligibility this year? No. The Food and Drug Administration determines who is officially eligible for vaccines, and while it has narrowed its approval of Covid shots, it has not done so for flu shots. Experts say the ideal window is from late September through October. “Try to get vaccinated before Halloween,” said Dr. William Schaffner, an infectious disease expert at Vanderbilt University Medical Center. That matches guidance from the C.D.C. (Astor, 9/2)
