FDA Issues Emergency Use Authorization for Convalescent Plasma as Potential Promising COVID–19 Treatment, Another Achievement in Administration’s Fight Against Pandemic

For Immediate Release: August 23, 2020

Today, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for investigational convalescent plasma for the treatment of COVID-19 in hospitalized patients as part of the agency’s ongoing efforts to fight COVID-19. Based on scientific evidence available, the FDA concluded, as outlined in its decision memorandum, this product may be effective in treating COVID-19 and that the known and potential benefits of the product outweigh the known and potential risks of the product.

Today’s action follows the FDA’s extensive review of the science and data generated over the past several months stemming from efforts to facilitate emergency access to convalescent plasma for patients as clinical trials to definitively demonstrate safety and efficacy remain ongoing.

The EUA authorizes the distribution of COVID-19 convalescent plasma in the U.S. and its administration by health care providers, as appropriate, to treat suspected or laboratory-confirmed COVID-19 in hospitalized patients with COVID-19.

Alex Azar, Health and Human Services Secretary:
“The FDA’s emergency authorization for convalescent plasma is a milestone achievement in President Trump’s efforts to save lives from COVID-19,” said Secretary Azar. “The Trump Administration recognized the potential of convalescent plasma early on. Months ago, the FDA, BARDA, and private partners began work on making this product available across the country while continuing to evaluate data through clinical trials. Our work on convalescent plasma has delivered broader access to the product than is available in any other country and reached more than 70,000 American patients so far. We are deeply grateful to Americans who have already donated and encourage individuals who have recovered from COVID-19 to consider donating convalescent plasma.”

Stephen M. Hahn, M.D., FDA Commissioner:
“I am committed to releasing safe and potentially helpful treatments for COVID-19 as quickly as possible in order to save lives. We’re encouraged by the early promising data that we’ve seen about convalescent plasma. The data from studies conducted this year shows that plasma from patients who’ve recovered from COVID-19 has the potential to help treat those who are suffering from the effects of getting this terrible virus,” said Dr. Hahn. “At the same time, we will continue to work with researchers to continue randomized clinical trials to study the safety and effectiveness of convalescent plasma in treating patients infected with the novel coronavirus.”

Scientific Evidence on Convalescent Plasma

Based on an evaluation of the EUA criteria and the totality of the available scientific evidence, the FDA’s Center for Biologics Evaluation and Research determined that the statutory criteria for issuing an EUA criteria were met.

The FDA determined that it is reasonable to believe that COVID-19 convalescent plasma may be effective in lessening the severity or shortening the length of COVID-19 illness in some hospitalized patients. The agency also determined that the known and potential benefits of the product, when used to treat COVID-19, outweigh the known and potential risks of the product and that that there are no adequate, approved, and available alternative treatments.

The EUA is not intended to replace randomized clinical trials and facilitating the enrollment of patients into any of the ongoing randomized clinical trials is critically important for the definitive demonstration of safety and efficacy of COVID-19 convalescent plasma. The FDA continues to recommend that the designs of ongoing randomized clinical trials of COVID-19 convalescent plasma and other therapeutic agents remain unaltered, as COVID-19 convalescent plasma does not yet represent a new standard of care based on the current available evidence.

Terms of EUA

The EUA requires that fact sheets providing important information about using COVID-19 convalescent plasma in treating COVID-19 be made available to health care providers and patients, including dosing instructions and potential side effects. Possible side effects of COVID-19 convalescent plasma include allergic reactions, transfusion-associated circulatory overload, and transfusion associated lung injury, as well as the potential for transfusion-transmitted infections.

Mayo Clinic Expanded Access Program

The FDA initially facilitated access to convalescent plasma for treating COVID-19 by using pathways that included traditional clinical trials and emergency single-patient investigational new drug (IND) applications. 

An Expanded Access ProgramExternal Link Disclaimer for convalescent plasma was initiated in early April to fill an urgent need to provide patient access to a medical product of possible benefit during a time that the FDA was working with researchers to facilitate the initiation of randomized clinical trials to study convalescent plasma. As the number of single patient IND requests started to number in the hundreds on a daily basis, the FDA worked collaboratively with industry, academic, and government partners to implement an expanded access protocol to provide convalescent plasma to patients in need across the country via the national expanded access treatment protocol. The program was developed with funding from the HHS’ Biomedical Advanced Research and Development Authority (BARDA), with the Mayo Clinic serving as the lead institution. To date, the program has facilitated the infusion of over 70,000 patients with convalescent plasma.

The EUA was issued to the HHS Office of the Assistant Secretary for Preparedness and Response.

The EUA remains in effect until the termination of the declaration that circumstances exist justifying the authorization of the emergency use of drugs and biologics for prevention and treatment of COVID-19. The EUA may be revised or revoked if it is determined the EUA no longer meets the statutory criteria for issuance.

Image: COVID-19 Convalescent Plasma Reduction in Death at 7 Days

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

Anne Keating

Senior Advisor

Anne Keating, former Senior Vice President of Public Relations for Bloomingdale’s, was responsible for the initiation, creation and direction of Bloomingdale’s press efforts, special events and philanthropic endeavors for all stores nationwide up until August 2017. She was also the company’s official spokesperson.  In October 2017, Anne transitioned into a consultant to Bloomingdale’s CEO for philanthropy and other projects, in addition to establishing her own private consultancy.

 

Keating is a member of the Board of Trustees for the American Associates of the Old Vic and HELP USA/Mentoring USA. She previously served on the board of NYC & Company and continues on the Director’s Council of the Children’s Museum of the Arts. She also serves as an advisor to the Child Mind Institute and is a member of the Dream Team for Memorial Sloan-Kettering Cancer Centers.

 

Due to her leadership in steering the public relations and philanthropic efforts for Bloomingdale’s and her personal mission to give back to her community, New York Women in Communications, Inc. (NYWICI) proudly named Keating as a recipient of the 2010 Matrix Award.  She has also been recognized for her guidance, commitment and philanthropic work by Upward Inc., the New York Center for Children, the Elizabeth Glaser Pediatric AIDS Foundation, the Children’s Museum of the Arts, as well as the Girls Scouts of Greater New York.

 

In addition, Help USA awarded Keating the HELP HERO award for her years of leadership in the effort to combat domestic violence and homelessness. The Anne Keating Scholarship Fund was established in her honor in 2008 to grant young mothers the funds to pursue educational opportunities.

 

Prior to joining Bloomingdale’s in 1995 as Vice President of Public Relations, Keating was the Vice President of Public Relations, Special Events, and Corporate Services at FAO Schwarz. She also served as the Director of Bridal and Gift Services at Bloomingdale’s earlier in her career. She began her retail career at Tiffany & Co.  Keating holds a Bachelor of Arts degree in Art and Education from the College of Saint Elizabeth in New Jersey.

Michael Brekka

Web and Graphic Designer

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Emma Stern

Operations Manager

Emma is currently an Assistant at Second Alpha Partners and manages the implementation of executive administration, business, and personal support to the CEOs and CFO. She has previously held internships in the wealth management, accounting, and event planning industries. She has also volunteered in the special needs and health education spaces. She holds a bachelor’s degree in Business Economics from UCLA. 

James Sanger

Senior Advisor

James Sanger is a Managing Partner and Co-Founder of Second Alpha Partners, a value-oriented private equity firm focused on secondary and secondary-linked direct investments in mature venture-stage, growth-equity and middle-market companies showing prospects for superior future growth.  He is an author and frequent speaker on topics related to advanced technologies, business innovation and the evolution of venture capital investing. Jim has spent more than twenty years as a venture capitalist, secondary investor, corporate advisor and technology executive. He currently serves as a board member of HealthCare.com and TeraGo Networks (TSX:TGO). Previously, Jim served as a board observer of EverQuote (NASDAQ: EVER), as a board member and Chairman of Sixth Sense Media (acquired by Evolving Systems) and as a board member of AVST (acquired by StoneCalibre).

Prior to Second Alpha, Jim was a General Partner at ABS Ventures, where he focused on investments that combined elements of traditional venture investing with secondary share purchases in growth companies. At ABS, Jim’s investments included Everbridge (NASDAQ: EVBG), Qualys (NASDAQ: QLYS), Gomez (acquired by Compuware), Inxight Software (acquired by Business Objects/SAP), AlphaBlox (acquired by IBM (NYSE: IBM)), Overtone (acquired by KANA) and Intralinks (acquired in a syndicated buyout led by Rho Partners). Jim was also a senior member of the ABS team that structured the secondary purchases of several portfolios of venture assets from Deutsche Bank.

Sara Roberts

Senior Advisor

Sara Roberts McCarley is a non-profit professional with experience in global, national and local organizations.  With over 25 years of experience in this sector, she has worked in healthcare philanthropy, international program development and a myriad of state/local organizations with a variety of missions and focus areas. 
 
Currently, Sara serves as the founder and chairman of the Randy Roberts Foundation that works to cultivate Florida’s future leaders through civic engagement and public service. Since 2009, the Randy Roberts Foundation has pledged $331,000 in undergraduate scholarships and impacted more than 200 high school students through leadership programming. Alumni of the organization are now doctors, lawyers, teachers, national security staff, military leaders, all making a difference in their respective communities. The Randy Roberts Foundation is currently in partnership with and housed at Florida Southern College where Sara graduated with a Bachelor of Arts in Mass Communication. 

Sara was elected as a Lakeland City Commissioner in Lakeland, Florida, in January 2019.  She continues to support many organizations as an active board member including, Lakeland Vision Education Chair, Lakeland Area Mass Transit and Citrus Connection Vice Chair, Harrison School for the Performing Arts Parent Association President, Polk County Transportation Planning Organization member, and Bonnet Springs Park Arts and Culture Co-Chair.

Richard Brekka

Co-Founder

Richard Brekka is a Managing Partner and Co-Founder of Second Alpha Partners, a value-oriented private equity firm focused on secondary and secondary-linked direct investments in mature venture-stage, growth-equity and middle-market companies showing prospects for superior future growth. He is a passionate spokesman for the importance of secondary investing to the overall health of the innovation economy. For more than twenty years, Richard has invested in growth-oriented tech companies – particularly software-as-a-service, mobile content, communication services and Internet opportunities.

He currently serves as a board member of TeraGo Networks (TSX: TGO) and as a board observer of Payfone. Previously, Richard served on the boards of Appia Communications (acquired by CallTower), AVST (acquired by StoneCalibre), TouchCommerce (acquired by Nuance Communications (NASDAQ:NUAN)), Sixth Sense Media (acquired by Evolving Systems), the Guild (acquired by Digital Fuel Capital) and SeaPass (acquired by Internet Capital Group).

Prior to founding Second Alpha, Richard was President, Managing Partner and founder of Dolphin Equity Partners, a New York-based venture firm. Between 1998 and 2010, Dolphin raised two funds and invested in nearly three dozen portfolio companies. At Dolphin, Richard was Chairman of the Board of Gomez (acquired by Compuware – the acquisition represented one of the top ten largest exits in the venture industry during 2009), and was a board member of Mobile Armor (acquired by Trend Micro), Enpocket (acquired by Nokia), Seapass (acquired by Internet Capital Group), AVST (acquired by StoneCalibre), SixthSense Media (acquired by Evolving Systems) and Overtone (acquired by KANA).

Before Dolphin, Richard was a Managing Director in the private equity investment group at CIBC and President of CIBC’s U.S. private equity subsidiaries. While at CIBC, he was on the board of ten communications companies, including Telesystems International Wireless (acquired by Vodaphone), Orion Network Systems (acquired by Loral), and Transit Communications (acquired by DialPage). Prior to CIBC, he was with Chase Capital and led the Firm’s investments in Nextel (NASD: NXTL) and DisCom Communications (acquired by Nextel).

Richard holds a bachelor’s degree from the University of Southern California and an MBA from the University of Chicago.

Marisol Lugo Brekka

Co-Founder

Marisol Lugo Brekka is a Cuban American and the co-founder of the Brekka Group, LLC. The Brekka Group is a boutique investment firm that makes long term investments in growing companies in diverse sectors and markets. Its portfolio consists of companies in the financial services, technology, e-commerce, real estate, and consumer product sectors.

Marisol began her career in 1994 with Bank of America’s management training program.  Marisol specialized in mergers and acquisitions within the manufacturing and distribution industries. Her portfolio consisted of several Fortune 500 companies mostly in the Mid-Atlantic and Mid- West regions. She has been in the financial services industry for 28 years. Her passion is working with entrepreneurs helping to create financial and strategic solutions to growing companies.

Marisol has always been a strong advocate for non-profits dedicated to making a difference in the lives of the underprivileged and Latino communities. She is co-founder of PlasmaSaves.org which is a not-for-profit she help start as a direct response to the COVID-19 pandemic that facilitated the donation of COVID-19 convalescent plasma to save lives.  PlasmaSaves.org assisted in the collection of over 600,000 units of convalescent plasma during the pandemic. It has been nationally recognized by the Fight Is In Us Coalition and the Bill and Melinda Gates Foundation as one of the US leading organizations that helped create a national awareness campaign for plasma collection.  Marisol has previously also served on the board for the Tampa Bay YMCA and Columbus Children’s Hospital Development Board. 

Marisol was raised in Perth Amboy, New Jersey and learned to speak English at the age of five. She received a degree in Finance from Florida Southern College and MBA from the University of Tampa. She is member of the Harvard Business School 2021 Women on Boards Program.   Marisol resides in New York City with her husband and two children.