April 13, 2020

In the race to identify and provide safe, effective treatments for hospitalized patients with COVID-19 , the U.S. Department of Health and Human Services (HHS) will 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 and are intended 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 (BARDA), 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, Inc. of Sioux Falls, South Dakota.

“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 Rick Bright, Ph.D. “Together, we are hyper focused on a single goal, to save lives.”

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.

Currently, there are no COVID-19 treatments approved by the U.S. Food and Drug Administration (FDA). However, 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 COVID-19.

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 (NIAID), part of the National Institutes of Health, to include the 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 (JPEO-CBRND), 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 United States 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 for COVID-19.

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.

About HHS, ASPR, and BARDA

HHS works to enhance and protect the health and well-being of all Americans, providing for effective health and human services and fostering advances in medicine, public health, and social services. The mission of ASPR is to save lives and protect Americans from 21st century health security threats. Within ASPR, BARDA invests in the innovation, advanced research and development, acquisition, and manufacturing of medical countermeasures – vaccines, drugs, therapeutics, diagnostic tools, and non-pharmaceutical products needed to combat health security threats. To date, 54 BARDA-supported products have achieved regulatory approval, licensure or clearance. To learn more about federal support for the nationwide COVID-19 response, visit coronavirus.gov.

https://www.phe.gov/Preparedness/news/Pages/immunotherapies-COVID-13April20.aspx