Moderna first to start drug trial against COVID-19
Moderna (Cambridge, MA), a biotechnology company focused on discovery and developed based on messenger RNA, is the first biopharma to launch a drug trial on humans for an investigational drug against COVID-19. Moderna’s messenger RNA (mRNA) vaccine, mRNA-1273, has been shipped to the National Institute of Allergy and Infectious Diseases (NIAID) for a Phase 1 test to start in early April. It will be tested on dozens of healthy patients to asses safety and immune response. Moderna saw its shares jump more than 18% after hours on the news. Juan Andres, chief technical operations and quality officer at Moderna, said, “I want to thank the entire Moderna team for their extraordinary effort in responding to this global health emergency with record speed.” Read more here.
FDA taking steps to ensure quality of foreign products in coronavirus outbreak
The FDA today provided updated and more detailed information about the status of FDA inspections in China and the agency’s oversight of imported products from China that have been impacted by the outbreak. At this time, over 60% of FDA-regulated products imported from China are medical devices and 20% are housewares (like food packaging). The FDA is not currently conducting inspections in China in response to the U.S. Department of State’s Travel Advisory to not travel to China due to the novel coronavirus outbreak. Although the FDA is not able to conduct inspections in China right now, the agency says that is not hindering its efforts to monitor medical products and food safety. The FDA said it is using additional tools to monitor the safety of products from China, and that it continues to monitor the global drug supply chain by prioritizing risk-based inspections in other parts of the worldTHe agency said that, when the travel advisory is changed, it will resume routine inspections as soon as feasible.
“Fortunately, currently, we are not seeing the impacts of this outbreak resulting in an increased public health risk for American consumers from imported products,” the FDA said in a statement on its website. “There is no evidence to support transmission of COVID-19 associated with imported goods and there have not been any cases of COVID-19 in the United States associated with imported goods. As noted, this remains a dynamic situation and we will continue to assess, and update guidance as needed.” Read more here.
U.S. now confirms 53 coronavirus cases
The U.S. now has 53 confirmed cases of the coronavirus, including 19 new patients diagnosed over the weekend. The cases include 39 evacuees from the Diamond Princess cruise ship and Wuhan. “We are keeping track of cases resulting from repatriation efforts separately because we don’t believe those numbers accurately represent the picture of what is happening in the community in the United States at this time,” said Dr. Nancy Messonnier, director of the CDC’s National Center for Immunization and Respiratory Diseases. Fourteen other cases were patients in California, Illinois, Massachusetts, Washington, Arizona and Wisconsin. More here.
Iran’s deputy health minister tests positive for coronavirus
Iran’s news agency ILNA has reported that Iran’s deputy health minister has tested positive for the coronavirus. Iran has recorded the highest number of deaths from the coronavirus outside of China. A spokesperson for the Islamic Republic’s health ministry said that 95 people had been infected with 16 deaths nationwide. Read more worldwide updates here.
More coronavirus resources from The Journal of Healthcare Contracting:
- Day-by-day Timeline of major events
- FAQ/Insights – Helpful and relevant links to help you keep track of the ongoing epidemic