FDA unveils emergency investigational COVID-19 convalescent plasma application program

To address the rapidly changing landscape of the COVID-19 outbreak in the U.S., on March 24, 2020, the FDA announced an emergency investigational new drug (IND) application program that allows healthcare providers to use plasma from convalescing COVID-19 patients to treat patients in the U.S. with serious or immediately life-threatening COVID-19 infections. Noting the possibility that SARS-CoV-2 antibodies found in plasma may be effective against the infection, the agency has committed to “timely response” to emergency IND requests. SARS-CoV-2 is the virus that causes COVID-19.

The FDA has identified two tiers of emergency response:

  • For time-sensitive emergencies (requiring less than four-hour response time), the provider may contact the FDA’s Office of Emergency Operations at 1-866-300-4374 to seek verbal authorization
  • Requests that are not highly time sensitive (allowing for response from the FDA within four to eight hours), the requesting physician may contact the agency by completing Form 3926 and submitting the form by email to CBER_eIND_Covid-19@FDA.HHS.gov

To be eligible for the COVID-19 plasma expanded access program, the FDA requires patients to meet several provisions:

  • The patient must have laboratory-confirmed COVID-19
  • The patient’s COVID-19 infection must be severe (e.g., labored or rapid breathing, low blood oxygen saturation, lung infiltrates) or immediately life-threatening (e.g., respiratory failure, septic shock, multiple organ dysfunction/failure)
  • The patient must provide informed consent

 

FDA guidance offers a potential lifeline to the sickest patients until other therapies are approved.

 

The legal basis for emergency INDs comes from expanded access provisions in 21 Code of Federal Regulations (CFR) Part 312, Subpart I. The FDA may permit expanded access to an IND for an individual patient when the applicable criteria in 21 CFR 312.305(a), which pertains to all types of expanded access, and the criteria in 21 CFR 312.310(a), which pertains to individual patient expanded access, including in an emergency, are met.

The FDA announcement states that the agency is continuing to work with its government partners including the National Institutes of Health (NIH) and the Centers for Disease Control and Prevention (CDC) to develop master protocols for use by multiple investigators in order to coordinate the collection and use of COVID-19 convalescent plasma.

To reduce potential risks associated with transfusion with convalescent plasma, the FDA has restricted plasma collection only from individuals who are eligible to donate blood and who have recovered from COVID-19. The agency published a Frequently Asked Questions document on March 26, 2020, with links and instructions for potential donors and physicians.

Although convalescent plasma is unlikely to be the most effective COVID-19 treatment in a physician’s toolkit, it might be a lifeline to the sickest patients in the meantime.

Continue checking our blog posts for additional updates and late-breaking news related to COVID-19. Cortellis Regulatory Intelligence users should set up alerts to receive updates on their desktop, or in the Cortellis Regulatory Intelligence mobile app.

 

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