FDA to Accelerate Development of Blood-Related Therapies for COVID-19

April 6, 2020

The FDA’s public- and private-sector partnership will expedite thousands of units of plasma to patients with severe COVID-19 symptoms, the news release said.

The FDA announced their commitment to expediting the development and accessibility of convalescent plasma and hyperimmune globulin as COVID-19 therapies, the agency said in a news release on Saturday.1

“This is an important area of research-the use of products made from a recovered patient’s blood to potentially treat COVID-19 in those affected by this illness,” said FDA commissioner Stephen M. Hahn, MD in a statement.1 The FDA remains actively engaged with partners across the US government, academia and industry to expedite the development and availability of critical medical products to prevent and treat this novel virus– both evaluating the safety and efficacy of potential therapies and facilitating emergency access for patients, as appropriate.”

“The FDA had played a key role in organizing a partnership between industry, academic institutions, and government agencies to facilitate expanded access to convalescent plasma. This is certainly a great example of how we can all come together to take swift action to help the American people during a crisis.”

Convalescent plasma and hyperimmune globulin are antibody-rich blood products made from blood donated by individuals who have recovered from SARS-CoV-2, the virus that causes COVID-19.1

The administration pointed to clinical trials done in China asserting the potential for convalescent plasma and hyperimmune globulin to alleviate the severity and duration of COVID-19 symptoms. The study’s primary endpoint was the safety of convalescent plasma transfusion, while among the secondary endpoints were the improvement of COVID-19 symptoms within 3 days of convalescent plasma transfusion. The trial discovered rapidly increasing antibody counts and significantly improved clinical symptoms.2

The study had also identified the need for “further investigation in larger well-controlled trials,” and the FDA affirmed that they are working on accomplishing just that. The agency has previously explained their commitment to providing access to convalescent plasma treatment through an emergency investigational new drug application process; now, the administration aims to expand access by way of facilitating clinical trials through coordinated effort among government organizations, private companies, and academic partners.

“Under President Trump’s leadership, the FDA is launching a new national effort to bring blood-related therapies for COVID-19 to market as fast as possible,” said Department of Health and Human Services Secretary Alex Azar, MD.1 “The President’s all-of-America approach has driven unprecedented cooperation between the public and private sector, with the FDA finding new ways for the private sector to bring their products to patients while gathering the data we need on efficacy. Thanks to the hard work of FDA staff, scientists and physicians elsewhere, and support from NIH and BARDA, patients will be able to benefit from these promising new options in the coming weeks.”

For patients who are unable to secure access to a clinical trial, the FDA has initiated a protocol for them, too. In cooperation with the Mayo Clinic and the American Red Cross, the FDA has announced their commitment to providing a simplified process to these patients in being treated with convalescent plasma.1

The FDA encouraged those who have recovered from the virus for at least 2 weeks to consider donating blood by visiting the American Red Cross website at www.redcrossblood.org/plasma4covid or contacting their local blood donor or plasma collection center.1

References:

1. Coronavirus (COVID-19) Update: FDA coordinates national effort to develop blood-related therapies for COVID-19 [news release]. FDA website. https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-coordinates-national-effort-develop-blood-related-therapies-covid-19. Accessed April 5, 2020.
2. Duan K, Liu B, Li C, et al. The feasibility of convalescent plasma therapy in severe COVID-19 patients: a pilot study. MedRxiv 2020;20036145 doi: https://doi.org/10.1101/2020.03.16.20036145