FDA current COVID-19 updates, actions and advice As the vaccine goes into the arms of more people around the country, the US agency keeps on top of issues around the virus, offering resources and guidance.
The phenomenon of vaccine euphoria has taken hold in the US, with patients receiving their first or second shots gleefully sharing images on Facebook, Instagram and other social media platforms. Still, because the virus is not over, the US Food and Drug Administration (FDA) continues to act as a resource for medical professionals working on tests, treatments and vaccines.
COVID test program guidance
With schools, offices, communities and other entities interested in screening and testing for COVID-19, the FDA has provided a range of resources to help test developers streamline the emergency use authorization (EUA) process, and to help organizations set up effective, efficient testing programs.
Merck KGaA foresees post-pandemic localization of biologics supply chains Governments want to build up a vaccine and biologics infrastructure locally to insulate themselves from the sorts of supply disruptions seen in the COVID-19 pandemic, according to Merck KGaA CEO Stefan Oschmann.
Global competition for scarce, in-demand materials has exposed downsides of global supply chains throughout the pandemic, from early competition for personal protective equipment and diagnostic reagents through to the current rows over cross-border trade in COVID-19 vaccines. The experience could shape the attitudes of governments to trade and the need for local infrastructure.
“I have, almost on a daily basis, heads of government, people from the EU commission, from various countries on the phone who tell us that one of the lessons out of this pandemic is that our healthcare systems must become more resilient and that they.. want to build up a vaccine and biologics in
Biogen has estimated 10 million patients in the US are suitable for treatment with its Alzheimer’s disease candidate aducanumab, setting it up to generate blockbuster sales if it wins approval.
US biotech, Moderna, reports today that the first participants have been dosed in its Phase 2/3 clinical trial investigating the efficacy of its COVID-19 vaccine in children ages 6 months to less than 12 years.
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Monoclonal antibodies: GSK and Vir to seek US approval for their COVID-19 candidate, EMA starts rolling review of Lilly s medicines By Jane Byrne GSK and its partner, Vir Biotechnology, report that their jointly developed monoclonal antibody, VIR-7831, reduces hospitalization and risk of death in early treatment of adults with COVID-19.
A global phase 3 clinical trial, COMET-ICE, based its initial analysis on data from 583 patients at risk of hospital admission.
The partners said VIR-7831 is a new treatment for people with mild to moderate COVID-19 illness, and the efficacy seen in the trial was such that an independent data monitoring committee recommended stopping the study early; enrolment of patients has ended.