CLAYTON – President Donald Trump announced emergency authorization to treat COVID-19 patients with convalescent plasma — a move he called “a breakthrough,” one of his top health officials called “promising” and other health experts said needs more study before it’s celebrated. And that news could be good for Grifols, which operates a huge plasma production plant in Clayton.
The announcement Sunday came after White House officials complained there were politically motivated delays by the Food and Drug Administration in approving a vaccine and therapeutics for the disease.
On the eve of the Republican National Convention starting in Charlotte, Trump put himself at the center of the FDA’s announcement of the authorization at a news conference Sunday evening. The authorization makes it easier for some patients to obtain the treatment but is not the same as full FDA approval.
But what might be the impact in Clayton?
“No statement, other than the news that we’ve been working on an anti-SARS-CoV-2 hyperimmune globulin at our Clayton plant for clinical trials,” a Grifols spokesperson told WRAL-TechWire.
“The anti-SARS-CoV-2 hyperimmune globulin, which is derived from the blood plasma of healthy donors recovered from COVID-19, has the potential to be a highly specific, pure and safe medicine that delivers a high and consistent concentration of protective antibodies against the novel coronavirus.”
Production was announced earlier this month, and Grifols has delivered the first batches of a therapeutic product manufactured in Clayton.
Since April, Grifols has been collecting blood plasma donated by healthy people who have recovered from COVID-19. The plasma, collected at the company’s more than 245 U.S. donation centers, is processed to yield hyperimmune globulin, a solution containing protective antibodies against the novel coronavirus.
“Grifols is grateful to all the plasma donors who through their generosity are now helping to develop a medicine, a hyperimmune globulin, whose concentrated antibodies will potentially provide others with passive immunity to overcome the disease,” said Victor Grifols Deu, co-chief executive officer of Grifols.
The efforts are part of a collaboration agreement with U.S. government entities, including the Food and Drug Administration, the National Institutes of Health and the Biomedical Advanced Research Development Authority.
(NCBiotech writer Barry Teater contributed to this story.)
Original Article Source: WRAL TechWire