Countering what it called a “troubling drop in routine childhood immunizations” due to COVID-19 shutdowns, the U.S. Department of Health and Human Services (HHS) amended its public health emergency declaration to increase access to those vaccines and decrease the risk of preventable disease outbreaks as children return to daycare and school. The amendment authorizes state-licensed pharmacists, and supervised, licensed pharmacy interns, to order and administer FDA-licensed vaccines to individuals ages 3 through 18. In issuing the amendment, HHS noted that “an unfortunate result” of families following lockdown orders was that many children missed routine vaccinations. “This decrease in childhood-vaccination rates is a public health threat and a collateral harm caused by the COVID-19 pandemic,” HHS said, as it can place additional strains on the health care system, especially if avoidable outbreaks coincide with a resurgence of COVID-19.
The U.S. Drug Enforcement Administration is finalizing its March 10, 2020, interim rule making cenobamate, including its salts, a schedule V controlled substance, according to a notice to be published in the Aug. 20 Federal Register. The FDA approved the SK Biopharmaceuticals Co. Ltd. drug, marketed as Xcopri, last November to treat partial-onset epileptic seizures in adults.
The FDA and the NIH’s National Center for Advancing Translational Sciences updated CURE ID to make it a more effective tool during the COVID-19 pandemic. The updates allow doctors to more easily report real-world experiences in treating COVID-19 patients who are unable to be enrolled in a clinical trial. An internet-based repository that lets clinicians report novel uses of existing drugs for difficult-to-treat infectious diseases through a website or mobile device, CURE ID enables the crowdsourcing of medical information to facilitate the development of new treatments for neglected diseases. The updates include a case report form tailored to COVID-19 with data fields harmonized with other real-world data and clinical trial platforms.
Citing the influx of COVID-19-related clinical trials, Health Canada is temporarily extending its default period for reviewing clinical trial applications and amendments from 30 days to 45 days. However, it will continue to expedite clinical trial applications for therapies to prevent, mitigate or treat COVID-19, according to an order issued last week from the Minister of Health. Under normal operating procedures, if Health Canada doesn’t object within 30 days of receiving a clinical trial application or amendments, authorization is presumed and the trial may go ahead. But the increase in trial applications due to the pandemic “is making it difficult for Health Canada to review all applications and amendments in the 30-day period,” the agency said. The order will expire Nov. 16.