Formal Collaboration with US Government to Produce the First Vaccine Specifically Targeting COVID-19
Grifols announced Wednesday they have entered into a formal collaboration with the United States Biomedical Advanced Research Development Authority (BARDA), the Food and Drug Administration (FDA) and other Federal public health agencies to collect plasma from convalescent COVID-19 patients to attempt to find a vaccine for the coronavirus.
In a news release, Grifols said it will volunteer its expertise and resources in the areas of plasma collection using its network of FDA-approved plasma donor centers; test and qualify donors in conjunction with other health agencies; process plasma into hyperimmune globulin in its purpose-built facility in Clayton, NC, for the isolated processing of immune globulins to treat emerging infectious diseases; and support preclinical and clinical studies to determine whether they can find a vaccine for COVID-19 disease.
Grifols said this innovative public-private partnership presents opportunities to expedite development and, if successful, availability of a front-line therapeutic in the face of the spreading COVID-19 pandemic. The FDA is specifically working to reduce unnecessary regulatory hurdles and ensure a rapid turnaround without compromise to product safety or integrity,
At the same time, in Spain Grifols is working on a clinical trial with inactivated plasma from recovered patients. In addition, the company is collaborating with certain hospitals in the design of diverse clinical studies on the use of certain plasma-derived products, with the goal of proving their efficiency in the treatment of COVID-19.
Grifols has also accelerated the development of a diagnostic procedure, able to detect the virus. The test can be performed on automatic instruments, with each unit able to run more than 1,000 samples per day. The new test should be ready in a few weeks.