The extraordinary speed with which mRNA technology has delivered what appear to be safe and highly efficacious vaccines for preventing COVID-19 herald the start of a “golden age of vaccinology,” according to C. Buddy Creech, director of the vaccine research program at Vanderbilt University in Nashville and principal investigator on the phase III trial of Moderna Inc.’s mRNA-1273 COVID-19 vaccine.
The extraordinary speed with which mRNA technology has delivered what appear to be safe and highly efficacious vaccines for preventing COVID-19 herald the start of a “golden age of vaccinology,” according to C. Buddy Creech, director of the vaccine research program at Vanderbilt University in Nashville and principal investigator on the phase III trial of Moderna Inc.’s mRNA-1273 COVID-19 vaccine.
PERTH, Australia – The COVID-19 pandemic has highlighted the importance of digital health technology, and the Australian government quickly enabled programs in telehealth and e-prescriptions. It now is embracing opportunities to build on this momentum to accelerate the country’s economic digital transformation. Not only will this transformation contribute to Australia’s recovery, but also to its long-term prosperity, said Sue MacLeman, chair of Australia’s Medical Technologies and Pharmaceuticals Industry Growth Centre (MTPConnect), during a recent ANDHealth teleconference.
Developers of tests for the COVID-19 pandemic are deploying an increasingly wider range of test systems for molecular testing, but the FDA’s Toby Lowe said that despite the seeming interchangeability of real-time PCR (rt-PCR) systems, performance of a reference panel for a tweaked test must reflect the use of the rt-PCR system that is listed in the existing emergency use authorization (EUA).
TORONTO – What’s the difference between an organ transplant container tucked under a paramedic’s arm and an ordinary beer cooler packed with ice? Surprisingly, not much, according to researchers at London, Ontario’s Western University. They’ve come up with a portable, temperature-controlled container that prevents spoilage of donor organs during transport to the operating room – and of potential vaccines.
As hospitals faced a deluge of patients early in the COVID-19 pandemic, many implemented remote solutions to manage individuals at home to keep from being overwhelmed – all at a speed unthinkable in more normal times. That experience promises to accelerate and transform telemedicine long after the threat of COVID-19 recedes, according to a report by Vizient Inc.
COVID-19 stalled clinical trials, halted elective surgeries, and body slammed many med-tech companies’ revenues. Despite that, an industry report released by Ernst & Young (EY) finds that the pandemic also drove some positive changes in the med-tech industry including long-neglected attention to enterprise-wide business continuity.
COVID-19 has prompted dramatic rethinking of supply chains, health care delivery, regulations, and collaboration that are likely to permanently restructure the med-tech industry, according to industry leaders speaking at a panel during the Advanced Medical Technology Association’s (Advamed) Virtual Medtech Conference on Oct. 6. In addition, the significant increase in debt and strong fundamentals position the industry for a burst of M&A activity.
Device makers have wondered in the past whether they like the idea of the Centers for Medicare & Medicaid Services (CMS) peering over the U.S. FDA’s shoulders in premarket applications, which might be a concern as well for the Medicare program for coverage of breakthrough devices. Tamara Syrek Jensen, director of the Coverage and Analysis Group at CMS, declined to say whether her office has any influence over what would be designated as a breakthrough device by FDA, stating little more than that “we will constantly be talking with the FDA” about breakthrough devices.
The COVID-19 pandemic has done little to encourage bipartisan comity in Washington, and the Oct. 2 hearing of the House Select Subcommittee on the Coronavirus Crisis reflected that partisan tension. Secretary of Health and Human Services Alex Azar noted, however, that the department is doing its best to cooperate with oversight of the vaccine program by the Government Accountability Office (GAO), but that the nearly three dozen GAO requests for oversight have come at a difficult time.