The cost of providing COVID-19 vaccines and therapies for a possible fall surge in the U.S. is coming at the expense of testing and personal protection equipment. While other countries are planning for the expected surge by placing their orders for vaccines and therapies, “we are starting to lose our place in line,” White House Coronavirus Response Coordinator Ashish Jha said during a June 9 media briefing.
Even as new waves of COVID-19 cause less direct disruption in the delivery of health care, the ongoing pandemic leaves a dramatically altered landscape for medical devices in its wake. The RBC Global Healthcare Conference revealed trends that will continue to reshape the utilization of medical technology and delivery of health care, while industry leaders drilled down into the details in a focused panel discussion. All agreed: the pandemic catapulted telemedicine and remote monitoring ahead five or more years, a hybrid delivery system with greater fluctuations in volume will emerge, devices that facilitate the movement of care out of the hospital to home or outpatient settings will remain in high demand and patient-centered control of health care will continue to attract additional industries into health care markets.
The Biden administration recently reported that a new round of free rapid tests for the SARS-CoV-2 virus is available to the public, a development that coincides with a new surge of the latest sub-variant of the omicron variant. However, the administration is also expected to renew the public health emergency (PHE) for the pandemic, even as the White House continues to press Congress for another $22 billion in pandemic-related funding.
Among the policies the U.S. FDA’s device center leveraged for testing during the COVID-19 pandemic was the long-standing enforcement discretion lever, which drew less attention than the agency’s use of emergency use authorizations (EUAs). Nonetheless, the Government Accountability Office (GAO) urged the FDA to develop a formal policy for the use of enforcement discretion for pandemic-related tests, including some metrics for when that discretion would come to an end.
With one-quarter of China’s population affected by rolling shutdowns, manufacturers worldwide are preparing for a summer of supply chain nightmares. Shanghai and its normally bustling port have been closed now for a month and the nation’s COVID-Zero policy is now threatening Beijing. So far, though, the med-tech industry remains minimally affected, but the coming months may tell a different story.
The FDA continues to issue new and revised emergency use authorizations for testing for the COVID-19 pandemic in recent days, including three reissued and four revised EUAs dated March 24.
LONDON – T cells generated as a result of infection with common cold coronaviruses provide cross-protection against being infected with SARS-CoV-2, according to a new study.
A new engineered glycated vaccine induced production of neutralizing antibodies against severe acute respiratory coronavirus 2 (SARS-CoV-2) and other coronaviruses in mice, scientists at The University of Osaka and the RIKEN Center for Integrative Medical Science in Yokohama have reported.
More than 21 months since the SARS-CoV-2 virus was first identified in Wuhan, China, the questions just keep coming, and the longer they go unanswered, the more divisive the opinions become. Controversies over the efficacy of current vaccines, over whether boosters are necessary for the general population, over the safety of COVID-19 vaccines for young children, over how to distribute the shrinking supply of highly effective monoclonal antibodies, and over how the virus originated in the first place – all of these looming questions have created a firestorm of uncertainty that will not stop burning.
When the SARS-CoV-2 virus first emerged in the U.S., the knee-jerk reaction by biopharma researchers was to make the best vaccines and therapeutics possible and to do so quickly. Since then, the number of those that have entered development has reached 1,001, more than for any other viral infection aside from HIV.
