When it comes to the coronavirus, good news is scant, but the U.S Department of Health and Human Services has made a pair of announcements that may provide some encouragement.
The federal agency has announced five new contracts for ventilator production, as well as a collaboration on development of immunotherapy treatments for COVID-19 patients.
The five new ventilator production contracts, rated under the Defense Production Act, include contracts with General Electric, Hill-Rom, Medtronic, ResMed, and Vyaire, as well as two other contracts for ventilator production to Hamilton and Zoll.
In total, combined with contracts with General Motors and Philips rated under the DPA earlier this week, HHS has finalized contracts to supply 6,190 ventilators for the Strategic National Stockpile by May 8 and 29,510 by June 1. The seven new ventilator contracts announced by HHS this month should provide a total of 137,431 ventilators by the end of 2020.
The rating of the five contracts under the DPA follows President Trump’s direction to HHS Secretary Alex Azar on April 2 to invoke the Act with regard to General Electric, Hill-Rom, ResMed, Medtronic, and Vyaire.
WHAT’S THE IMPACT: CONTRACT DETAILS
General Electric’s contract, at a price of $64.1 million, is for 2,410 ventilators produced by June 29, with 112 by May 4 and 736 by June 1.
Hamilton’s contract, at a price of $552 million, is for 14,115 ventilators produced by July 3, with 850 by May 8 and 4,404 by May 22.
Hill-Rom’s contract, at a price of $20.1 million, is for 3,400 ventilators produced by July 13, with 400 by June 1.
Medtronic’s contract, at a price of $9.1 million, is for 1,056 ventilators to be produced by June 22, with 200 by May 4 and 678 by June 1.
ResMed’s contract, at a price of $31.98 million, is for 2,550 ventilators produced by July 13, with 400 by May 4 and 1,150 by June 1.
Vyaire’s contract, at a price of $407.9 million, is for 22,000 ventilators produced by June 29, with 1,200 ventilators by May 4 and 9,100 by June 1.
Zoll’s contract, at a price of $350.1 million, is for 18,900 ventilators produced by July 3, with 1,010 by May 4 and 4,410 by June 1.
In the race to identify and provide safe, effective treatments for hospitalized patients with COVID-19 , HHS will also collaborate with multiple non-government organizations on the development of convalescent plasma and hyperimmune globulin immunotherapies. These treatments would use antibodies against SARS-CoV-2 from COVID-19 survivors to stimulate the immune systems of people currently ill from the virus.
To facilitate the development of these investigational treatments, the Biomedical Advanced Research and Development Authority, part of the HHS office of the Assistant Secretary for Preparedness and Response, is providing support to the American Red Cross; Emergent BioSolutions of Gaithersburg, Maryland; Grifols USA of Los Angeles, California; and SAb Biotherapeutics of Sioux Falls, South Dakota.
The products in development include convalescent plasma and hyperimmune globulin. Both are based on the blood plasma of people who have recovered from a disease. Convalescent plasma contains antibodies produced by the immune system to fight bacteria or viruses.
Investigational convalescent plasma that is collected from blood donated by people who have recovered from COVID-19 may contain antibodies to SARS-CoV-2, the virus that causes COVID-19. Using convalescent plasma may help other COVID-19 patients recover from the disease more quickly, while giving them more time to develop their own antibodies to fight the infection. Hyperimmune globulin is a product developed by concentrating antibodies found in convalescent plasma.
THE LARGER TREND
Currently, there are no COVID-19 treatments approved by the U.S. Food and Drug Administration. But the FDA is playing a role in a national effort to facilitate the development of, and access to, convalescent plasma and hyperimmune globulin as investigational treatments for COVID-19.
As part of the national effort, BARDA is collaborating with the American Red Cross to set up the systems and procedures needed to recruit donors and collect, store, and distribute convalescent plasma donated by patients who have recovered from the coronavirus.
BARDA also expanded a long-standing public-private partnership with Emergent BioSolutions. Emergent will collect donated plasma and use the company’s hyperimmune platform to develop and manufacture COVID-19 hyperimmune globulin (COVID-HIG). The platform was established in partnership with BARDA to produce hyperimmune globulin to treat anthrax.
Emergent also will work with the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health, to include COVID-HIG in future clinical trials to evaluate the product’s use in treating patients with COVID-19.
Through a partnership with BARDA and the Department of Defense’s Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense, Grifols will produce convalescent plasma and hyperimmune globulin.
With the support of BARDA, Grifols will collect plasma through a network of more than 250 plasma donor centers in the U.S. to manufacture COVID-19 convalescent plasma and hyperimmune globulin. These products can be used in controlled clinical trials to evaluate their safety and efficacy as treatments.
Through a partnership with BARDA and JPEO-CBRND’s Medical CBRN Defense Consortium, SAb Biotherapeutics will develop a unique immunotherapy called SAB-185. The product, part of a new class of immunotherapies, relies on SAb’s platform technology to produce human antibodies without donated human blood from patients who have recovered from the virus. This approach produces greater quantities of the product than the traditional methods that rely on donated blood.
SAb will complete manufacturing of the immunotherapy product and conduct preclinical studies. BARDA could support a Phase 1 clinical trial for initial testing in humans.
ON THE RECORD
“President Trump and HHS’s use of the DPA is getting private manufacturers what they need to ramp up ventilator production rapidly,” said HHS Secretary Alex Azar. “We are grateful to the patriotic Americans at companies working around the clock and retooling factories to increase ventilator production. The thousands of ventilators delivered to the Strategic National Stockpile starting this month, continuing through the spring and summer, will mean we have more capacity to respond to the pandemic as it evolves. HHS and FEMA deployment of ventilators from the stockpile have helped ensure that hospitals in states such as New York have not run out of ventilator capacity while working to save lives.”
“We are working with partners across the federal government and private industry to make safe and effective treatments available as soon as possible in this pandemic,” said BARDA Director Dr. Rick Bright. “Together, we are hyper focused on a single goal, to save lives.”
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