New Delhi: The US Food and Drug Administration (FDA) has approved emergency authorisation for the use of plasma to treat coronavirus patients.
The FDA has issued guidance to provide recommendations to health care providers and investigators on the administration and study of investigational convalescent plasma collected from individuals who have recovered from COVID-19 (COVID-19 convalescent plasma) during the public health emergency.
The FDA suggested the following pathways for administering or studying the use of COVID-19 convalescent plasma:
1. Clinical Trials: Investigators wishing to study the use of convalescent plasma in a clinical trial should submit requests to FDA for investigational use under the traditional IND regulatory pathway (21 CFR Part 312). CBER’s Office of Blood Research and Review is committed to engaging with sponsors and reviewing such requests expeditiously.
2. Expanded Access: An IND application for expanded access is an alternative for use of COVID-19 convalescent plasma for patients with serious or immediately life-threatening COVID-19 disease who are not eligible or who are unable to participate in randomized clinical trials (21 CFR 312.305). FDA has worked with multiple federal partners and academia to open an expanded access protocol to facilitate access to COVID-19 convalescent plasma across the nation. Access to this investigational product may be available through participation of acute care facilities in an investigational expanded access protocol under an IND that is already in place.
3. Single Patient Emergency IND: Although participation in clinical trials or an expanded access program are ways for patients to obtain access to convalescent plasma, for various reasons these may not be readily available to all patients in potential need.
Therefore, given the public health emergency that the COVID-19 pandemic presents, and while clinical trials are being conducted and a national expanded access protocol is available, FDA also is facilitating access to COVID-19 convalescent plasma for use in patients with serious or immediately life-threatening COVID-19 infections through the process of the patient’s physician requesting a single patient emergency IND (eIND) for the individual patient under 21 CFR 312.310. This process allows the use of an investigational drug for the treatment of an individual patient by a licensed physician upon FDA authorization, if the applicable regulatory criteria are met. Note, in such case, a licensed physician seeking to administer COVID-19 convalescent plasma to an individual patient must request the eIND.
Because COVID-19 convalescent plasma has not yet been approved for use by FDA, it is regulated as an investigational product. A health care provider must participate in one of the pathways, the FDA said.
Over 176,000 people have died from coronavirus in the United States, according Johns Hopkins University.
Around 5.7 million cases have also been reported nationwide.
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